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1. Morris M, Platell C, Iacopetta B: Tumor-infiltrating lymphocytes and perforation in colon cancer predict positive response to 5-fluorouracil chemotherapy. Clin Cancer Res; 2008 Mar 1;14(5):1413-7
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  • [Title] Tumor-infiltrating lymphocytes and perforation in colon cancer predict positive response to 5-fluorouracil chemotherapy.
  • The aim of the present study was to investigate the prognostic significance of TILs and other routinely reported pathologic features in colon cancer, particularly in relation to the use of adjuvant chemotherapy.
  • EXPERIMENTAL DESIGN: Pathologic markers, disease-specific survival, and the use of adjuvant chemotherapy were recorded in a retrospective, population-based series of 1,156 stage III colon cancer patients with a median follow-up time of 52 months.
  • RESULTS: In patients treated by surgery alone (n = 851), markers with significant prognostic value included poor histologic grade, T4 stage, N2 nodal status, vascular invasion, and perforation, but not the presence of TILs.
  • In patients treated with 5-fluorouracil-based chemotherapy (n = 305), TILs were associated with significantly improved survival [hazard ratio (HR), 0.52; 95% confidence interval, 0.30-0.91; P = 0.02] and perforation with a trend for improved survival (HR, 0.67; 95% confidence interval, 0.27-1.05; P = 0.16).
  • Patients with TILs or perforation seemed to gain more survival benefit from chemotherapy (HR, 0.22 and 0.21, respectively) than patients without these features (HR, 0.84 and 0.82, respectively).
  • Because the presence of TILs reflects an adaptive immune response and perforation is associated with inflammatory response, these results suggest that there may be interactions between the immune system and chemotherapy leading to improved survival of colon cancer patients.
  • [MeSH-major] Adenocarcinoma, Mucinous / drug therapy. Antimetabolites, Antineoplastic / therapeutic use. Colonic Neoplasms / drug therapy. Fluorouracil / therapeutic use. Intestinal Perforation / diagnosis. Lymphocytes, Tumor-Infiltrating / pathology
  • [MeSH-minor] Aged. Chemotherapy, Adjuvant. Cohort Studies. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Invasiveness / pathology. Prognosis. Retrospective Studies. Survival Rate. Treatment Outcome

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  • (PMID = 18316563.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; U3P01618RT / Fluorouracil
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2. Fata F, Mirza A, Craig G, Nair S, Law A, Gallagher J, Ellison N, Bernath A: Efficacy and toxicity of adjuvant chemotherapy in elderly patients with colon carcinoma: a 10-year experience of the Geisinger Medical Center. Cancer; 2002 Apr 1;94(7):1931-8
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  • [Title] Efficacy and toxicity of adjuvant chemotherapy in elderly patients with colon carcinoma: a 10-year experience of the Geisinger Medical Center.
  • BACKGROUND: Although the benefit from adjuvant chemotherapy has been established clearly in patients with Stage III colon carcinoma, the degree to which elderly patients with colon carcinoma can tolerate such therapy generally has remained unknown.
  • METHODS: The authors reviewed all patients in their Tumor Registry with Stage II and Stage III adenocarcinoma of the colon who underwent potentially curative resection for their disease at the Geisinger Medical Center between January 1990 and September 2000.
  • One hundred twenty patients underwent complete resection of their colon carcinoma and received 5-fluorouracil-based (5-FU) adjuvant chemotherapy.
  • Nine of 56 patients in Group A (16%) experienced Grade 3-4 toxicity compared with 14 of 64 patients in Group B (22%) (P = 0.420).
  • There were no correlations between preoperative carcinoembryonic antigen level, tumor grade, or lymph node involvement and patient age (P = 0.258, P = 0.256, and P = 0.519, respectively).
  • CONCLUSIONS: Elderly patients with Stage II and Stage III colon carcinoma benefit from 5-FU-based adjuvant therapy without a significant increase in toxicity compared with their younger counterparts.
  • Adjuvant chemotherapy should be presented to elderly patients with high-risk, resected colon carcinoma.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colonic Neoplasms / drug therapy
  • [MeSH-minor] Age Factors. Aged. Carcinoembryonic Antigen / metabolism. Chemotherapy, Adjuvant. Disease-Free Survival. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Follow-Up Studies. Humans. Leucovorin / administration & dosage. Leucovorin / adverse effects. Levamisole / administration & dosage. Levamisole / adverse effects. Lymph Nodes / pathology. Male. Middle Aged. Neoplasm Staging. Registries. Survival Rate

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  • [Copyright] Copyright 2002 American Cancer Society.
  • (PMID = 11932894.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Carcinoembryonic Antigen; 2880D3468G / Levamisole; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
  • [Number-of-references] 28
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3. Kuebler JP, Colangelo L, O'Connell MJ, Smith RE, Yothers G, Begovic M, Robinson B, Seay TE, Wolmark N: Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin: a prospective analysis. Cancer; 2007 Nov 1;110(9):1945-50
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  • [Title] Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin: a prospective analysis.
  • BACKGROUND: Cases of severe gastrointestinal toxicity were monitored prospectively during NSABP C-07, a randomized clinical trial of adjuvant therapy for patients with stage II/III colon cancer.
  • RESULTS: Of 1857 patients, 79 (4.3%) developed a syndrome of bowel wall injury (BWI, small or large) characterized by hospitalization for the management of severe diarrhea or dehydration and radiographic or endoscopic evidence of bowel wall thickening or ulceration.
  • Enteric sepsis (ES), characterized by grade 3 or greater diarrhea and grade 4 neutropenia with or without proven bacteremia occurred in 22 patients treated with FLOX, versus 8 in those treated with FL (P = .01).
  • Patients >60 years were at higher risk for BWI after treatment with FLOX (6.7%) versus treatment with FL (2.9%, P < .01).
  • Severe gastrointestinal toxicity usually occurred during the third or fourth week on the first cycle of therapy, required hospitalization, and was managed with fluids, antidiarrheals, and antibiotics.
  • Seventy-one percent of patients resumed treatment with FL after recovery.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Colonic Diseases / chemically induced. Colonic Neoplasms / drug therapy

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  • (PMID = 17853393.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00004931
  • [Grant] United States / NCI NIH HHS / CA / U10-CA-12027; United States / NCI NIH HHS / CA / U10-CA-37377; United States / NCI NIH HHS / CA / U10-CA-69651; United States / NCI NIH HHS / CA / U10-CA-69974
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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4. Law CC, Fu YT, Chau KK, Choy TS, So PF, Wong KH: Toxicity profile and efficacy of oral capecitabine as adjuvant chemotherapy for Chinese patients with Stage III colon cancer. Dis Colon Rectum; 2007 Dec;50(12):2180-7
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  • [Title] Toxicity profile and efficacy of oral capecitabine as adjuvant chemotherapy for Chinese patients with Stage III colon cancer.
  • PURPOSE: The Xeloda in Adjuvant Cancer Therapy trial, conducted in a white population of patients, established capecitabine (Xeloda) as adjuvant chemotherapy for Stage III colon cancer.
  • Given the ethnical difference in toxicity of adjuvant chemotherapy in colon cancer, this study was designed to evaluate the safety and efficacy of adjuvant capecitabine in Chinese patients with colon cancer.
  • METHODS: Chinese patients with curatively resected Stage III colon adenocarcinoma, who received adjuvant capecitabine, were entered into a prospective database.
  • Grade 3 toxicities occurred as follows: stomatitis (1.7 percent), diarrhea (0 percent), hand-foot syndrome (41.4 percent), leucopenia (1.7 percent), neutropenia (3.4 percent), and hyperbilirubinemia (1.7 percent).
  • No Grade 4 or 5 toxicity was noted.
  • Compared with the Xeloda in the Adjuvant Cancer Therapy trial, a much higher incidence of serious hand-foot syndrome and a lower rate of severe diarrhea were found in this study.
  • CONCLUSIONS: A different toxicity profile of adjuvant capecitabine was noted in this study on Chinese patients with colon cancer compared with that reported in the Xeloda in Adjuvant Cancer Therapy trial, whereas the efficacy outcomes were comparable.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antimetabolites, Antineoplastic / administration & dosage. Antimetabolites, Antineoplastic / adverse effects. Colonic Neoplasms / drug therapy. Deoxycytidine / analogs & derivatives. Fluorouracil / analogs & derivatives
  • [MeSH-minor] Administration, Oral. Adult. Aged. Capecitabine. China / epidemiology. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Staging. Prodrugs. Prospective Studies. Survival Rate. Treatment Outcome

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  • (PMID = 17963003.001).
  • [ISSN] 0012-3706
  • [Journal-full-title] Diseases of the colon and rectum
  • [ISO-abbreviation] Dis. Colon Rectum
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0 / Prodrugs; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; U3P01618RT / Fluorouracil
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5. Sinicrope F, Foster NR, Sargent DJ, Thibodeau SN, Smyrk TC, O'Connell MJ, North Central Cancer Treatment Group: Model-based prediction of defective DNA mismatch repair using clinicopathological variables in sporadic colon cancer patients. Cancer; 2010 Apr 1;116(7):1691-8
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  • [Title] Model-based prediction of defective DNA mismatch repair using clinicopathological variables in sporadic colon cancer patients.
  • BACKGROUND: : Colon cancers with defective DNA mismatch repair (MMR) have a favorable prognosis and may lack benefit from 5-fluorouracil-based adjuvant chemotherapy.
  • The authors developed models to predict MMR deficiency in sporadic colon cancer patients using routine clinical and pathological data.
  • METHODS: : TNM stage II and III colon carcinomas (n = 982) from 6 5-fluorouracil-based adjuvant therapy trials were analyzed for microsatellite instability and/or MMR protein expression.
  • Tumor site and histologic grade were the most important predictors of MMR status.
  • Distal tumors had a low likelihood of defective MMR (3%; 13 of 468); proximal tumors had a greater likelihood (26%; 130 of 506).
  • By using tumor site, grade, and sex, the logistic regression model showed excellent discrimination (c statistic = 0.81).
  • CONCLUSIONS: : Defective MMR is rare in distal, sporadic colon cancers, which should generally not undergo MMR testing.
  • Proximal site, poor differentiation, and female sex detect 51% of tumors with defective MMR; substituting TILs for grade increases the PPV to 81%.

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  • (PMID = 20186699.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / CA15083; United States / NCI NIH HHS / CA / CA104683-02; United States / NCI NIH HHS / CA / P30 CA015083; United States / NCI NIH HHS / CA / R01 CA104683; United States / NCI NIH HHS / CA / K05 CA142885; United States / NCI NIH HHS / CA / R01 CA104683-02; United States / NCI NIH HHS / CA / N01 CA015083
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Other-IDs] NLM/ NIHMS163421; NLM/ PMC2855300
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6. Velenik V, Anderluh F, Oblak I, Strojan P, Zakotnik B: Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial. Croat Med J; 2006 Oct;47(5):693-700
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Capecitabine as a radiosensitizing agent in neoadjuvant treatment of locally advanced resectable rectal cancer: prospective phase II trial.
  • METHODS: Between June 2004 and January 2005, 57 patients with operable, clinical stage II-III adenocarcinoma of the rectum entered the prospective phase II study.
  • Radiation dose was 45 Gy (25x1.8 Gy).
  • Concurrent chemotherapy with a daily dose of 1650 mg/m2 capecitabine was administered orally, divided into two equal doses per day, including weekends.
  • RESULTS: A single female patient died after receiving 27 Gy, because of pulmonary embolism.
  • All other patients completed the preoperative chemoradiotherapy according to the protocol and a definitive operation was performed in all but one of these patients.
  • The most frequent side-effect of the combined therapy was dermatitis (grade 3 in 19 patients).
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Antimetabolites, Antineoplastic / therapeutic use. Deoxycytidine / analogs & derivatives. Fluorouracil / analogs & derivatives. Radiation-Sensitizing Agents / therapeutic use. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Capecitabine. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Neoadjuvant Therapy. Radiotherapy Dosage

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  • (PMID = 17042060.001).
  • [ISSN] 1332-8166
  • [Journal-full-title] Croatian medical journal
  • [ISO-abbreviation] Croat. Med. J.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] Croatia
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0 / Radiation-Sensitizing Agents; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; U3P01618RT / Fluorouracil
  • [Other-IDs] NLM/ PMC2080466
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7. Pasetto LM, Falci C, Basso U, Gasparini G, D'Andrea M, Bonginelli P, Bajetta E, Platania M, Alabiso O, Miraglia S, Bertona E, Oniga F, Biason R, Chetrì MC, Fedele P, Massara G, Romaniello I, Negru ME, Luchena G, Giordano M, Buzzi F, Ricottao R, Sienao S, Monfardini S: Adjuvant treatment for elderly patients with colon cancer. An observational study. Anticancer Res; 2008 Jul-Aug;28(4C):2513-8

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant treatment for elderly patients with colon cancer. An observational study.
  • BACKGROUND: Adjuvant 5-fluoruracil-based chemotherapy significantly reduces mortality in patients with stage II-III colon cancer, but is less prescribed with rising age.
  • In this study we were interested in the pattern of adjuvant treatment and possible effects on survival among elderly patients.
  • PATIENTS AND METHODS: From January to December 2004, 63 questionnaires on the management of stage II-III resected colon cancer patients aged over 70 years, collected from 10 Italian Centres, were retrospectively examined.
  • Determinants of receipt of adjuvant chemotherapy and their relation to survival were considered.
  • RESULTS: The proportion of elderly patients receiving adjuvant chemotherapy was 79.4%, distinct of age, gender, educational level and comorbidities.
  • Grade 3-4 toxicities were the following: haematological in 4 (8.5.
  • Due to the paucity of events, the impact of prognostic factors (patient's age and comorbidity, tumour stage and grade) on DFS and OS could not be assessed.
  • CONCLUSION: An increasing proportion of elderly patients with colon cancer may be treated with a tolerability and OS similar to those observed in the younger population.
  • Development of age-based guidelines and increased awareness of both physicians and patients through education is important to prevent undertreatment of those elderly patients who are eligible for chemotherapy.
  • [MeSH-major] Adenocarcinoma / drug therapy. Colonic Neoplasms / drug therapy
  • [MeSH-minor] Age Factors. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Disease-Free Survival. Female. Humans. Male. Neoplasm Staging. Retrospective Studies

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  • (PMID = 18751443.001).
  • [ISSN] 0250-7005
  • [Journal-full-title] Anticancer research
  • [ISO-abbreviation] Anticancer Res.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study
  • [Publication-country] Greece
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8. Jensen SA, Vilmar A, Sørensen JB: Adjuvant chemotherapy in elderly patients (&gt;or=75 yr) completely resected for colon cancer stage III compared to younger patients: toxicity and prognosis. Med Oncol; 2006;23(4):521-31
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  • [Title] Adjuvant chemotherapy in elderly patients (>or=75 yr) completely resected for colon cancer stage III compared to younger patients: toxicity and prognosis.
  • PURPOSE: To compare benefits and risks to adjuvant chemotherapy following complete resection of node-positive colon cancer stage III for patients aged >or=75 yr and younger.
  • METHOD: A retrospective study compared recurrence-free and overall survival, toxicity, and dose intensity of adjuvant bolus 5-FU according to the Mayo regimen chemotherapy in consecutive patients aged 19-74 (n=203) and >or=75 yr (n=24).
  • The frequencies of anemia (0%), thrombocytopenia (0%), leukopenia (4%), infection (8%), vomiting (0%), mucositis (17%), diarrhea (13%) CTC grade 3 or 4 toxicity in elderly patients were not significantly different from that in younger patients (p > 0.05).
  • Significantly more elderly (8%) had a decline in performance status to grade 3 or 4, as compared to younger patients (4%) (p=0.002).
  • 5-FU dose reduction was necessary for significantly more elderly (51%) as compared to younger patients (28%) (p=0.02), and fewer elderly (54%) completed the scheduled six treatment courses as compared to younger patients (82%) (p=0.05).
  • CONCLUSIONS: Adjuvant 5-FU chemotherapy should be considered for elderly patients aged >or=75 yr in good performance at high risk of recurrence of colon carcinoma after resection.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Colonic Neoplasms / drug therapy
  • [MeSH-minor] Adult. Age Factors. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Female. Fluorouracil / adverse effects. Humans. Leucovorin / adverse effects. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Staging. Prognosis. Survival Analysis. Survival Rate

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  • (PMID = 17303911.001).
  • [ISSN] 1357-0560
  • [Journal-full-title] Medical oncology (Northwood, London, England)
  • [ISO-abbreviation] Med. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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9. Arkenau HT, Bermann A, Rettig K, Strohmeyer G, Porschen R, Arbeitsgemeinschaft Gastrointestinale Onkologie: 5-Fluorouracil plus leucovorin is an effective adjuvant chemotherapy in curatively resected stage III colon cancer: long-term follow-up results of the adjCCA-01 trial. Ann Oncol; 2003 Mar;14(3):395-9
Hazardous Substances Data Bank. LEUCOVORIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] 5-Fluorouracil plus leucovorin is an effective adjuvant chemotherapy in curatively resected stage III colon cancer: long-term follow-up results of the adjCCA-01 trial.
  • BACKGROUND: Adjuvant postoperative treatment with 5-fluorouracil (5-FU) and leucovorin in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrences and improves survival.
  • PATIENTS AND METHODS: Patients with a curatively resected stage III (International Union Against Cancer) colon cancer were stratified according to tumor, node and grading category and randomly assigned to receive one of the two adjuvant treatment schemes: 5-FU 400 mg/m2 body surface area intravenously in the first chemotherapy course, then 450 mg/m2 x 5 days, plus leucovorin 100 mg/m2, 12 cycles (arm A), or 5-FU plus levamisole (Moertel scheme; arm B).
  • After a median follow-up time of 82 months, the 5-FU plus leucovorin combination significantly improved disease-free survival [79.8 months in arm A versus 69.3 months in arm B (P = 0.012)] and significantly increased median overall survival (88.9 months in arm A versus 78.6 months in arm B; P = 0.003).
  • Adjuvant treatment with 5-FU plus levamisole as well as 5-FU plus leucovorin was generally well tolerated; only a minority of patients experienced grade 3 and 4 toxicities.
  • CONCLUSIONS: After curative resection of a stage III colon cancer, adjuvant treatment with 5-FU plus leucovorin is generally well tolerated.
  • This long-term follow-up study demonstrates that adjuvant treatment with 5-FU plus leucovorin given for 12 cycles is significantly more effective than 5-FU plus levamisole (Moertel scheme) in reducing tumor relapse and improving survival.

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  • (PMID = 12598344.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial
  • [Publication-country] England
  • [Chemical-registry-number] 2880D3468G / Levamisole; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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10. André T, Colin P, Louvet C, Gamelin E, Bouche O, Achille E, Colbert N, Boaziz C, Piedbois P, Tubiana-Mathieu N, Boutan-Laroze A, Flesch M, Billiau V, Buyse M, Gramont A, Groupe d'Etude et de Recherche Clinique en Oncologie Radiotherapies: Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: study design and preliminary safety results. Groupe d'Etude et de Recherche Clinique en Oncologie Radiotherapies. Semin Oncol; 2001 Feb;28(1 Suppl 1):35-40
Hazardous Substances Data Bank. LEUCOVORIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: study design and preliminary safety results. Groupe d'Etude et de Recherche Clinique en Oncologie Radiotherapies.
  • The aim of this randomized open-label study was to compare a bimonthly with a monthly regimen of 5-fluorouracil (5-FU) and leucovorin for the adjuvant treatment of colon and high-rectum adenocarcinoma.
  • Nine hundred five patients with recently resected stage B2 or C colon or high-rectum adenocarcinoma (inferior pole of the tumor subperitoneal) were recruited into the study.
  • Characteristics of the patients in the two different treatment groups were similar at baseline.
  • The incidence of maximal grade III-IV toxicities for LVSFU2 and FUFOL was neutropenia 6% and 16% (P < .001), diarrhea 4% and 10% (P < .001), and mucositis 2% and 7% (P < .001), respectively.
  • Maximum grade III-IV toxicities in the LV5FU2 treatment group were significantly lower than in the FUFOL group (10% v 26%; P < .001).
  • [MeSH-major] Antimetabolites, Antineoplastic / therapeutic use. Colonic Neoplasms / drug therapy. Fluorouracil / therapeutic use. Leucovorin / therapeutic use. Rectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Chemotherapy, Adjuvant. Drug Administration Schedule. Female. Humans. Male. Middle Aged

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  • (PMID = 11273588.001).
  • [ISSN] 0093-7754
  • [Journal-full-title] Seminars in oncology
  • [ISO-abbreviation] Semin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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11. Arkenau HT, Rettig K, Porschen R: Adjuvant chemotherapy in curative resected colon carcinoma: 5-fluorouracil/leucovorin versus high-dose 5-fluorouracil 24-h infusion/leucovorin versus high-dose 5-fluorouracil 24-h infusion. Int J Colorectal Dis; 2005 May;20(3):258-61
Hazardous Substances Data Bank. LEUCOVORIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant chemotherapy in curative resected colon carcinoma: 5-fluorouracil/leucovorin versus high-dose 5-fluorouracil 24-h infusion/leucovorin versus high-dose 5-fluorouracil 24-h infusion.
  • BACKGROUND: Adjuvant postoperative treatment with 5-fluorouracil (5-FU) and leucovorin in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrence and improves survival.
  • PATIENTS AND METHODS: Patients with a curatively resected UICC stage III colon cancer were stratified according to T, N and G category and randomly assigned to receive one of the three adjuvant treatment schemes: 5-FU 450 mg/m2 and leucovorin 100 mg/m2 x 5 days every 4 weeks; six cycles, arm A; 24-h infusion of high-dose 5-FU/leucovorin 2,600 mg/m2 and 500 mg/m2, two cycles of six applications, arm B; 24-h infusion of high-dose 5-FU 2,600 mg/m2, two cycles of six applications, arm C.
  • After a median follow-up time of 45 months, there was no statistical difference in survival and tumor recurrence between the three treatment arms.
  • Adjuvant treatment in all arms was generally well tolerated; only a minority of patients experienced grade 3 and 4 toxicities.
  • CONCLUSION: There is no statistical difference in efficacy and toxicity in patients receiving either high-dose 5-FU with or without leucovorin or the standard 5-FU bolus regime after a curative resection of a stage III colon cancer.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antimetabolites, Antineoplastic / administration & dosage. Colectomy / methods. Colonic Neoplasms / drug therapy. Fluorouracil / administration & dosage. Leucovorin / administration & dosage
  • [MeSH-minor] Chemotherapy, Adjuvant. Disease-Free Survival. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Follow-Up Studies. Humans. Infusions, Intravenous. Male. Middle Aged. Neoplasm Staging. Postoperative Period. Retrospective Studies. Treatment Outcome

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  • (PMID = 15549327.001).
  • [ISSN] 0179-1958
  • [Journal-full-title] International journal of colorectal disease
  • [ISO-abbreviation] Int J Colorectal Dis
  • [Language] eng
  • [Publication-type] Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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12. Andre T, Colin P, Louvet C, Gamelin E, Bouche O, Achille E, Colbert N, Boaziz C, Piedbois P, Tubiana-Mathieu N, Boutan-Laroze A, Flesch M, Buyse M, de Gramont A: Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial. J Clin Oncol; 2003 Aug 1;21(15):2896-903
Hazardous Substances Data Bank. LEUCOVORIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial.
  • PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly (LVFU2) with a monthly (FULV) regimen of fluorouracil and leucovorin and 24 versus 36 weeks of each regimen as adjuvant treatment of patients with stage II (Dukes' B2) and III (Dukes' C) colon cancer.
  • Disease-free survival was similar between the LVFU2 and FULV groups (127 v 124 events; hazard ratio [HR] = 1.04; P =.74) and between 24 and 36 weeks of therapy (128 v 123 events; HR = 0.94; P =.63).
  • The most commonly observed grade 3 to 4 toxicities were neutropenia, diarrhea, and mucositis.
  • At a median follow-up of 41 months, no statistically significant difference could be detected in disease-free or overall survival between the treatment groups or treatment durations.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colonic Neoplasms / drug therapy
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant. Chi-Square Distribution. Disease-Free Survival. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Humans. Infusions, Intravenous. Leucovorin / administration & dosage. Leucovorin / adverse effects. Male. Middle Aged. Prognosis. Proportional Hazards Models. Survival Analysis. Treatment Outcome

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  • (PMID = 12885807.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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13. López-Cano M, Mañas MJ, Hermosilla E, Espín E: Multivisceral resection for colon cancer: analysis of prognostic factors. Dig Surg; 2010 Aug;27(3):238-45

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Multivisceral resection for colon cancer: analysis of prognostic factors.
  • BACKGROUND/AIMS: To assess outcome of multivisceral resection in colon cancer patients and to identify predictors of survival.
  • METHODS: One hundred and thirteen consecutive patients with primary locally advanced colon cancer infiltrating adjacent organs undergoing multivisceral resection between 1998 and 2007 were reviewed.
  • The diagnosis was conventional adenocarcinoma in 94 patients.
  • Eighty-three patients received postoperative adjuvant therapy.
  • Hematochezia and adjuvant chemotherapy were independent factors of favorable outcome and grade G3 and tumor stage III-IV of poor survival.
  • CONCLUSION: Hematochezia and adjuvant chemotherapy were associated with a better survival, and poorly differentiated tumors and stage IV disease with a poor survival.
  • [MeSH-minor] Abdomen, Acute. Adenocarcinoma / mortality. Adenocarcinoma / pathology. Adenocarcinoma / surgery. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Disease-Free Survival. Female. Follow-Up Studies. Gastrointestinal Hemorrhage / complications. Humans. Male. Middle Aged. Neoplasm Staging. Prognosis. Recurrence

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  • (PMID = 20571272.001).
  • [ISSN] 1421-9883
  • [Journal-full-title] Digestive surgery
  • [ISO-abbreviation] Dig Surg
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Switzerland
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14. Colacchio TA, Niedzwiecki D, Compton C, Warren R, Benson AI, Goldberg R, Kerr D, Fields A, Hollis D, Mayer R: Phase III trial of adjuvant immunotherapy with MOAb 17-1A following resection for stage II adenocarcinoma of the colon (CALGB 9581). J Clin Oncol; 2004 Jul 15;22(14_suppl):3522

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase III trial of adjuvant immunotherapy with MOAb 17-1A following resection for stage II adenocarcinoma of the colon (CALGB 9581).
  • : 3522 Background: MoAb 17-1A targets a cell surface antigen expressed on many adenocarcinomas and improved survival in early trials of adjuvant therapy in Stage III colon cancer.
  • The primary clinical objective of this study was to determine whether adjuvant treatment with MoAb 17-1A improved overall (OS) and failure-free survival (FFS) in patients who have had resection of a stage II (pT3NO or pT4bNO) colon cancer.
  • The secondary objective was to investigate a panel of prognostic biological markers for potential association with OS and FFS after adjuvant therapy in these patients.
  • METHODS: Patients were randomized to either treatment with MoAb 17-1A or observation only with stratification according to degree of differentiation, vascular or lymphatic invasion, and preoperative serum CEA.
  • Therapy consisted of an initial 2-hour infusion of 500 mg of MoAb 17-1A (cycle 1) followed by a lower dose (100 mg) every 28 days for four doses.
  • The study was activated 5/31/97 and closed to accrual on 5/31/02 because of the discontinuation of the drug supply.
  • RESULTS: The final patient accrual was 1738 of 2100 targeted, with 865 on the treatment arm and 873 on the observation arm.
  • As of December 2003 there were 93 (11%) Grade 3 toxicities, 18 (2%) Grade 4 toxicities, and no deaths due to treatment.
  • There were no significant differences between treatment arms (OS p=0.36; FFS p=0.49).
  • CONCLUSION: MoAb 17-1A does not appear to prolong OS or FFS in patients with Stage II colon cancer following resection.

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  • (PMID = 28016523.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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15. Woell E, Greil R, Eisterer W, Fridrik M, Grünberger B, Zabernigg A, Mayrbäurl B, Russ G, Thaler J: Oxaliplatin, irinotecan, and cetuximab in advanced gastric cancer. First efficacy results of a multicenter phase II trial (AGMT Gastric-2) of the Arbeitsgemeinschaft Medikamentoese Tumortherapie (AGMT). J Clin Oncol; 2009 May 20;27(15_suppl):4538

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 4538 Background: Patients (pts.) suffering from advanced gastric cancer have still a poor prognosis and treatment options are limited.
  • This chemotherapy regimen was tested in combination with cetuximab in a multicenter phase II trial.
  • 51 patients with histological proven unresectable and/or metastatic gastric adenocarcinoma were treated in a first line setting.
  • RESULTS: Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included neutropenia (35% of pts.
  • Grade 3 and 4 toxicities included neutropenia in 9/1 pts., thrombocytopenia in 1/0 pts., anemia in 3/1 pts., nausea in 2/0 pts., and diarrhea in 7/2 pts.
  • Sensory neuropathy occurred mostly as grade 1 and 2 in 37% of pts., in 7 pts. grade 3 neurotoxicity was observed.
  • Acneiform skin rash grade 1 / 2 / 3 / 4 was reported in 31% / 20% / 6% / 2% of pts. respectively.
  • 16 pts. went off-study due to neutropenia (n=5), nausea/vomiting (n=1), diarrhea (n=1), progressive disease (n=3), toxic colon (n=2), and allergic reaction to cetuximab at first (n=2), second (n=1) or third infusion (n=1).
  • Median time to progression was 24.8 weeks (n=29), median overall survival 38.1 weeks (n=32).

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  • (PMID = 27962987.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Berger AC, Sigurdson ER, LeVoyer T, Hanlon A, Mayer RJ, Macdonald JS, Catalano PJ, Haller DG: Colon cancer survival is associated with decreasing ratio of metastatic to examined lymph nodes. J Clin Oncol; 2005 Dec 1;23(34):8706-12
COS Scholar Universe. author profiles.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Colon cancer survival is associated with decreasing ratio of metastatic to examined lymph nodes.
  • PATIENTS AND METHODS: We analyzed data from Intergroup trial 0089 of adjuvant chemotherapy for stage II and III patients with colon cancer, in which all patients received fluorouracil-based therapy.
  • Covariates included in the models were age, sex, tumor stage, grade, histology, number of positive LNs, number of LNs removed, and LNR.
  • CONCLUSION: After curative resection for colorectal cancer, the LNR is an important prognostic factor and should be used in stratification schemes for future clinical trials investigating adjuvant treatments.
  • [MeSH-major] Adenocarcinoma / therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colonic Neoplasms / therapy. Lymphatic Metastasis / pathology
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Chemotherapy, Adjuvant. Combined Modality Therapy. Digestive System Surgical Procedures. Female. Follow-Up Studies. Humans. Male. Middle Aged. Multivariate Analysis. Neoplasm Staging. Randomized Controlled Trials as Topic. Survival Analysis. Time Factors. Treatment Outcome

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  • (PMID = 16314630.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
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17. Nozoe Y, Ogata Y, Miyagi Y, Nakagawa M, Matono K, Sasatomi T, Araki Y, Shirouzu K: [Efficacy of postoperative adjuvant chemotherapy for colorectal cancer]. Gan To Kagaku Ryoho; 2002 Jan;29(1):67-72
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Efficacy of postoperative adjuvant chemotherapy for colorectal cancer].
  • We attempted postoperative adjuvant chemotherapy for stage II or III colorectal cancer.
  • To investigate the efficacy of the adjuvant chemotherapy, we retrospectively reviewed all 293 colorectal cancer patients who underwent curative resection between 1990 and 1996 in Kurume University Hospital.
  • The patients were divided into two groups according to whether or not they received postoperative adjuvant chemotherapy.
  • The disease-free survival rate in Group 1 was significantly higher than that in Group 2, but only for those with rectal cancer, with no significant difference for those with colon cancer.
  • Findings were similar between the two groups for those with stage II, stage IIIa, a low grade of lymphatic and venous invasion, and well-differentiated adenocarcinoma.
  • Postoperative adjuvant chemotherapy in colorectal cancer might reduce the risk of recurrence, particularly in cases of rectal cancer.
  • However, postoperative adjuvant chemotherapy was insufficient for those with highly advanced cancer or a biologically aggressive tumor.
  • [MeSH-major] Colonic Neoplasms / drug therapy. Rectal Neoplasms / drug therapy
  • [MeSH-minor] Aged. Antibiotics, Antineoplastic / administration & dosage. Antimetabolites, Antineoplastic / administration & dosage. Chemotherapy, Adjuvant. Female. Fluorouracil / administration & dosage. Humans. Male. Middle Aged. Mitomycin / administration & dosage. Postoperative Care. Retrospective Studies. Survival Rate

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  • (PMID = 11816480.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Antimetabolites, Antineoplastic; 50SG953SK6 / Mitomycin; U3P01618RT / Fluorouracil
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18. Habr-Gama A, Perez RO, Sabbaga J, Nadalin W, São Julião GP, Gama-Rodrigues J: Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period. Dis Colon Rectum; 2009 Dec;52(12):1927-34
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Increasing the rates of complete response to neoadjuvant chemoradiotherapy for distal rectal cancer: results of a prospective study using additional chemotherapy during the resting period.
  • OBJECTIVES: Addition of chemotherapy in the resting period between radiotherapy completion and response assessment during neoadjuvant treatment for distal rectal cancer could potentially increase rates of complete tumor regression.
  • METHODS: Thirty-four consecutive patients with nonmetastatic distal rectal cancer were prospectively included.
  • Patients were managed by 5,400 Gy of radiation and 5-fluorouracil/leucovorin-based chemotherapy given for three consecutive days every 21 days for six cycles (three cycles concomitant with radiotherapy).
  • Twenty-eight (97%) successfully completed treatment.
  • Fifteen of 16 patients had Grade III toxicities that were skin-related (93%).
  • CONCLUSIONS: The addition of chemotherapy during the resting period after neoadjuvant chemoradiation is associated with acceptable toxicity and high tolerability rates.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Neoadjuvant Therapy. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Female. Fluorouracil / administration & dosage. Humans. Leucovorin / administration & dosage. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Recurrence, Local. Radiotherapy Dosage

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  • (PMID = 19934911.001).
  • [ISSN] 1530-0358
  • [Journal-full-title] Diseases of the colon and rectum
  • [ISO-abbreviation] Dis. Colon Rectum
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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19. Templ E, Mostbeck G, Wagner L, Weissel M: [Spontaneous healing of retroperitonea fibroasis after successful therapy of sigmoid carcinoma]. Acta Med Austriaca; 2000;27(5):168-70

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Spontaneous healing of retroperitonea fibroasis after successful therapy of sigmoid carcinoma].
  • [Transliterated title] Spontanheilung einer Retroperitonealfibrose nach erfolgreicher Therapie eines Sigmakarzinoms.
  • In the following hemicolectomy this tumor of the colon turned out to be a medium high grade adenocarcinoma (tumor staging pT2, pN1, DUKES C).
  • Chemotherapy with 450 mg/m2 5-FU once a week and a concomitant therapy with laevamisol was added for 6 months.
  • Computer-tomography revealed a significant reduction of the retroperitoneal masses already before induction of chemotherapy.
  • One year after termination of chemotherapy retroperitoneal fibrosis was no longer detectable.
  • [MeSH-major] Adenocarcinoma / diagnosis. Paraneoplastic Syndromes / diagnosis. Retroperitoneal Fibrosis / diagnosis. Sigmoid Neoplasms / diagnosis
  • [MeSH-minor] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Chemotherapy, Adjuvant. Colectomy. Combined Modality Therapy. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Staging. Remission, Spontaneous

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  • (PMID = 11261269.001).
  • [ISSN] 0303-8173
  • [Journal-full-title] Acta medica Austriaca
  • [ISO-abbreviation] Acta Med. Austriaca
  • [Language] ger
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Austria
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20. Abe T, Hachiro Y, Kunimoto M: [Clinical usefulness of oral aprepitant for alleviation of delayed nausea and vomiting induced by mFOLFOX6--report of a case]. Gan To Kagaku Ryoho; 2010 Dec;37(13):2933-5
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  • A 50-year-old-woman underwent high anterior resection for sigmoid colon adenocarcinoma.
  • Modified oxaliplatin/l / -LV/ 5-FU(mFOLFOX6)was started as adjuvant treatment due to final-stage III b.
  • Granisetron 3 mg and dexamethasone 8 mg for prophylaxis chemotherapy-induced nausea and vomiting (CINV) were administered intravenously 30 min before oxaliplatin administration.
  • Grade 3 delayed CINV was observed at course 4.
  • CINV could not be controlled by any rescue medications.
  • Afterward, delayed vomiting was completely controlled and chemotherapy could be continued to course 12.
  • Aprepitant is a very active antiemetic drug for the prevention of delayed nausea and vomiting induced by mFOLFOX6 regimen.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antiemetics / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Morpholines / therapeutic use. Nausea / chemically induced. Nausea / drug therapy. Sigmoid Neoplasms / drug therapy. Vomiting / chemically induced. Vomiting / drug therapy

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  • (PMID = 21160274.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antiemetics; 0 / Morpholines; 0 / Organoplatinum Compounds; 1NF15YR6UY / aprepitant; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; Folfox protocol
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21. Nikolic-Tomasevic Z, Jelic S, Cassidy J, Filipovic-Ljeskovic I, Tomasevic Z: Fluoropyrimidine therapy: hyperbilirubinemia as a consequence of hemolysis. Cancer Chemother Pharmacol; 2005 Dec;56(6):594-602
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fluoropyrimidine therapy: hyperbilirubinemia as a consequence of hemolysis.
  • BACKGROUND: Hemolytic anemia has been noted during treatment with a variety of chemotherapeutic agents.
  • We observed mild compensated hemolytic anemia in a patient receiving capecitabine during a randomized, controlled trial of adjuvant therapy.
  • In order to investigate the hypothesis that hemolysis is the underlying cause of the hyperbilirubinemia sometimes observed during capecitabine treatment, we evaluated factors associated with hemolysis in ten patients.
  • METHODS: Twenty chemotherapy-naïve patients undergoing surgery for Dukes' C colon cancer were included in the phase III, 'X-ACT' trial, and randomized to receive 24-week adjuvant treatment with either oral capecitabine (eight cycles of 1,250 mg/m2 twice daily for 14 days, followed by a 7-day rest period) (n=10) or 5-FU/LV administered according to the Mayo Clinic regimen (six cycles of LV 20 mg/m2 followed by 5-FU 425 mg/m2, administered as an i.v. bolus on days 1-5 every 28 days) (n=10).
  • Ten patients randomized in each treatment arm were evaluated.
  • RESULTS: Seven patients receiving capecitabine and three patients receiving 5-FU/LV experienced grade 1/2 elevations of bilirubin during the 24-week treatment period.
  • Five episodes of grade 1 compensated hemolytic anemia were reported in four capecitabine-treated patients, all of which were associated with hyperbilirubinemia.
  • CONCLUSION: Adjuvant treatment with capecitabine or 5-FU/LV in a small sample of patients with Dukes' C colon cancer was associated with alterations in hemolytic parameters.
  • These alterations, in particular hyperbilirubinemia, were associated in some patients with low-grade compensated hemolytic anemia.
  • [MeSH-major] Antimetabolites, Antineoplastic / adverse effects. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Deoxycytidine / analogs & derivatives. Hemolysis / drug effects. Hyperbilirubinemia / chemically induced
  • [MeSH-minor] Adenocarcinoma / blood. Adenocarcinoma / drug therapy. Adenocarcinoma / pathology. Adult. Aged. Capecitabine. Colonic Neoplasms / blood. Colonic Neoplasms / drug therapy. Colonic Neoplasms / pathology. Fluorouracil / administration & dosage. Humans. Injections, Intravenous. Leucovorin / administration & dosage. Middle Aged

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  • (PMID = 16044340.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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22. Ohnishi T, Kanoh T, Danno K, Miyazaki S, Kimura Y, Iwazawa T, Tono T, Nakano Y, Yano H, Monden T, Imaoka S: [A complete response of locally-advanced poorly differentiated adenocarcinoma of the rectum to pre-operative chemo-radiation therapy]. Gan To Kagaku Ryoho; 2008 Nov;35(12):2159-61

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [A complete response of locally-advanced poorly differentiated adenocarcinoma of the rectum to pre-operative chemo-radiation therapy].
  • A 71-year-old woman with peri-anal pain and anal bleeding was found to have a tumor in lower rectum in colonoscopic examination, which was histologically diagnosed as poorly differentiated adenocarcinoma.
  • Computed tomography and magnetic resonance imaging showed a tumor 5 cm in diameter deeply infiltrating mesorectum, and swelling of intra-pelvic lymph nodes.
  • After chemo-radiation therapy of 50.4 Gy and 5-FU plus levofolinate calcium (Isovorin) infusion, the tumor was reduced in size and lymph nodes were extremely decreased.
  • The patient underwent an abdominoperinial resection 6 weeks after the end of chemo-radiation, and pathological examination revealed a complete replacement of tumor with necrosed tissue, and no viable tumor cell was found.
  • Poorly differentiated adenocarcinoma of the colon is reported to be highly malignant and associated with poor prognosis.
  • Preoperative chemo-radiation therapy can be a promising candidate for adjuvant treatment of locally-advanced poorly differentiated adenocarcinoma of the rectum.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Cell Differentiation. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Aged. Colonoscopy. Female. Humans. Neoadjuvant Therapy. Neoplasm Staging. Remission Induction. Tomography, X-Ray Computed

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  • (PMID = 19106556.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
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23. Tsunoda A, Nakao K, Tsunoda Y, Watanabe M, Matsui N: Health-related quality of life of colorectal cancer patients receiving oral UFT plus leucovorin compared with those with surgery alone. Int J Clin Oncol; 2010 Apr;15(2):153-60
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: Adjuvant chemotherapy of oral uracil/ftorafur (UFT) plus leucovorin (LV) has been accepted as the standard of care in the treatment of patients with stage II and III carcinoma of the colon.
  • The objective of the study was to compare HRQOL reported by patients receiving oral UFT plus LV (UFT/LV group) versus no adjuvant treatment (control group) following surgery for colorectal cancer.
  • HRQOL was assessed with the European Organization for Research and Treatment of Cancer QLQ-C30 and HRQOL data measured longitudinally following surgery were compared between the groups.
  • The most common type of toxicity in the UFT/LV group was fatigue, which was generally mild.
  • Six patients each had grade 3 diarrhea or anorexia.
  • CONCLUSIONS: HRQOL in colorectal cancer patients with adjuvant chemotherapy with oral UFT plus LV deteriorated during this phase of treatment compared with those with surgery alone, despite the biased stage of tumor between the groups.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / surgery. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colectomy. Colorectal Neoplasms / drug therapy. Colorectal Neoplasms / surgery. Quality of Life
  • [MeSH-minor] Administration, Oral. Adult. Aged. Aged, 80 and over. Case-Control Studies. Chemotherapy, Adjuvant. Chi-Square Distribution. Colostomy / adverse effects. Colostomy / psychology. Drug Combinations. Female. Humans. Leucovorin / administration & dosage. Longitudinal Studies. Male. Middle Aged. Surveys and Questionnaires. Tegafur / administration & dosage. Time Factors. Treatment Outcome. Uracil / administration & dosage

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  • (PMID = 20191299.001).
  • [ISSN] 1437-7772
  • [Journal-full-title] International journal of clinical oncology
  • [ISO-abbreviation] Int. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Drug Combinations; 0 / UFT(R) drug; 1548R74NSZ / Tegafur; 56HH86ZVCT / Uracil; Q573I9DVLP / Leucovorin
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24. Chung KY, Kelsen D: Adjuvant Therapy for Stage II Colorectal Cancer: Who and with What? Curr Treat Options Gastroenterol; 2006 Jun;9(3):272-80

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant Therapy for Stage II Colorectal Cancer: Who and with What?
  • The role of adjuvant chemotherapy for patients with stage II colon adenocarcinoma remains controversial.
  • The high surgical cure rate for patients with "low-risk" stage II colon cancer, ranging from 75% to 80%, and the available clinical trials and meta-analyses provide conflicting recommendations for or against adjuvant chemotherapy for this group of patients.
  • For fit "high-risk" stage II patients with clinical obstruction or perforation at presentation, in which the 5-year survival rate is 60% to 70%, there is little controversy, as these patients are routinely treated with adjuvant chemotherapy.
  • Other potential high-risk factors, including high histologic grade, microsatellite instability, and loss of 18q, have yet to be validated in prospective trials.
  • These patients may have stage III disease and should receive adjuvant therapy.
  • The decision to use adjuvant chemotherapy to treat low-risk stage II colon cancer patients (no obstruction or perforation) should be an informed decision weighing the magnitude of a net 2% to 5% survival benefit, a 0.5% to 1.0% risk of mortality with chemotherapy in addition to 6 months of chemotherapy-related toxicities, other coexisting patient morbidities, and the anticipated life expectancy of each patient.
  • As adjuvant chemotherapy is therapy addressing local or metastatic microscopic disease, and the effectiveness of systemic and biologically targeted therapy for advanced macroscopic colon cancer continues to improve rapidly, it remains to be determined by clinical trials whether therapies including newer agents such as cetuximab and bevacizumab administered in the adjuvant setting may affect survival for stage II cancer patients.

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  • (PMID = 16901391.001).
  • [ISSN] 1092-8472
  • [Journal-full-title] Current treatment options in gastroenterology
  • [ISO-abbreviation] Curr Treat Options Gastroenterol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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