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1. Gridelli C, Frontini L, Perrone F, Gallo C, Gulisano M, Cigolari S, Castiglione F, Robbiati SF, Gasparini G, Ianniello GP, Farris A, Locatelli MC, Felletti R, Piazza E: Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses. Gem Vin Investigators. Br J Cancer; 2000 Sep;83(6):707-14
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  • [Title] Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses. Gem Vin Investigators.
  • Our aim was to study the activity and toxicity of the gemcitabine plus vinorelbine (Gem Vin) combination and to identify the optimal dose.
  • Previously untreated patients aged < 70 years, with stage IV or IIIb (not candidates for radiotherapy) non-small cell lung cancer were eligible.
  • Studied dose-levels of Gem Vin, administered on days 1 and 8 every 3 weeks, were (mg m(-2)): level I = 1000/25; level II = 1200/25; level III = 1000/30; level IV = 1200/30.
  • Dose-level IV was unfeasible because of grade 4 neutropenia.
  • The treatment was well tolerated.
  • Gem Vin is feasible at different doses.
  • A phase III study to compare the effect on quality of life of Gem Vin (level I) vs cisplatin-based chemotherapy is ongoing.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Carcinoma, Non-Small-Cell Lung / drug therapy. Lung Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Neutropenia / chemically induced. Quality of Life. Survival Analysis. Treatment Outcome. Vinblastine / administration & dosage. Vinblastine / analogs & derivatives

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  • [Copyright] Copyright 2000 Cancer Research Campaign.
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  • (PMID = 10952772.001).
  • [ISSN] 0007-0920
  • [Journal-full-title] British journal of cancer
  • [ISO-abbreviation] Br. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] SCOTLAND
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; 5V9KLZ54CY / Vinblastine; B76N6SBZ8R / gemcitabine; Q6C979R91Y / vinorelbine
  • [Other-IDs] NLM/ PMC2363528
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2. van Poelgeest MI, van Seters M, van Beurden M, Kwappenberg KM, Heijmans-Antonissen C, Drijfhout JW, Melief CJ, Kenter GG, Helmerhorst TJ, Offringa R, van der Burg SH: Detection of human papillomavirus (HPV) 16-specific CD4+ T-cell immunity in patients with persistent HPV16-induced vulvar intraepithelial neoplasia in relation to clinical impact of imiquimod treatment. Clin Cancer Res; 2005 Jul 15;11(14):5273-80
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  • [Title] Detection of human papillomavirus (HPV) 16-specific CD4+ T-cell immunity in patients with persistent HPV16-induced vulvar intraepithelial neoplasia in relation to clinical impact of imiquimod treatment.
  • PURPOSE: Topical application of the immune response modifier imiquimod is an alternative approach for the treatment of human papillomavirus (HPV)-positive vulvar intraepithelial neoplasia (VIN) and aims at the immunologic eradication of HPV-infected cells.
  • We have charted HPV16-specific immunity in 29 patients with high-grade VIN and examined its role in the clinical effect of imiquimod treatment.
  • EXPERIMENTAL DESIGN: The magnitude and cytokine polarization of the HPV16 E2-, E6-, and E7-specific CD4+ T-cell response was charted in 20 of 29 patients by proliferation and cytokine bead array.
  • The relation between HPV16-specific type 1 T-cell immunity and imiquimod treatment was examined in a group of 17 of 29 patients.
  • In eight of these patients, T-cell reactivity was associated with IFNgamma production.
  • Fifteen of the women treated with imiquimod were HPV16+, of whom eight displayed HPV16 E2- and E6-specific T-cell immunity before treatment.
  • Of these 11 responders, eight patients displayed HPV16-specific type 1 CD4+ T-cell immunity, whereas three lacked reactivity.
  • Notably, the four patients without an objective clinical response also lacked HPV16-specific type 1 T-cell immunity.
  • CONCLUSIONS: HPV16-specific IFNgamma-associated CD4+ T-cell immunity, although not essential for imiquimod-induced regression of VIN lesions, may increase the likelihood of a strong clinical response (P = 0.03).
  • [MeSH-major] Carcinoma in Situ / drug therapy. Carcinoma in Situ / virology. Vulvar Neoplasms / drug therapy. Vulvar Neoplasms / virology
  • [MeSH-minor] Adjuvants, Immunologic. Adult. Aged. Aminoquinolines. CD4-Positive T-Lymphocytes. Female. Humans. Immunity, Cellular. Interferon-gamma / immunology. Middle Aged. Papillomaviridae. Treatment Outcome

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  • (PMID = 16033846.001).
  • [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] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Aminoquinolines; 82115-62-6 / Interferon-gamma; 99011-02-6 / imiquimod
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3. Winters U, Daayana S, Lear JT, Tomlinson AE, Elkord E, Stern PL, Kitchener HC: Clinical and immunologic results of a phase II trial of sequential imiquimod and photodynamic therapy for vulval intraepithelial neoplasia. Clin Cancer Res; 2008 Aug 15;14(16):5292-9
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  • [Title] Clinical and immunologic results of a phase II trial of sequential imiquimod and photodynamic therapy for vulval intraepithelial neoplasia.
  • PURPOSE: High-risk human papillomavirus (HPV)-associated vulval intraepithelial neoplasia (VIN) is difficult to treat by excision or ablation because of high recurrence rates.
  • Small studies of photodynamic therapy (PDT) and imiquimod treatments have shown some success and function at least in part through stimulation of local immune responses.
  • Indeed, there is evidence that immunosuppressed individuals have higher rates of VIN, suggesting immune control is relevant.
  • EXPERIMENTAL DESIGN: In the study, 20 women with high-grade VIN were treated with topical imiquimod and the PDT sequentially.
  • Vulval biopsy and blood were taken pretreatment and, after imiquimod and PDT, with follow up for 1 year.
  • RESULTS: The treatment was well-tolerated.
  • The nonresponders showed a significantly higher level of T regulatory cells in the lesions after imiquimod treatment.
  • CONCLUSIONS: The response rates are clinically relevant, and the treatment regimen was feasible for the majority.
  • Initial nonresponders to imiquimod seem to be relatively refractory, and this may derive from their unfavorable local immune environment, in particular, the increased proportions of T regulatory cells, possibly the limiting action and/or development of any HPV T-cell immunity.
  • The potential benefit of this treatment is its ability to treat multifocal disease.
  • [MeSH-major] Aminoquinolines / administration & dosage. Antineoplastic Agents / administration & dosage. Carcinoma in Situ / drug therapy. Photochemotherapy. Vulvar Neoplasms / drug therapy
  • [MeSH-minor] Administration, Topical. Adult. Antigens, CD / metabolism. Combined Modality Therapy. Female. Fluorescent Antibody Technique. Humans. Immunohistochemistry. Lymphocytes, Tumor-Infiltrating / drug effects. Lymphocytes, Tumor-Infiltrating / immunology. Middle Aged. T-Lymphocytes, Regulatory

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  • (PMID = 18698049.001).
  • [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
  • [Grant] United Kingdom / Cancer Research UK / /
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antigens, CD; 0 / Antineoplastic Agents; 99011-02-6 / imiquimod
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4. Sewak S, Kosmider S, Ganju V, Woollett A, Yeow EG, Le B, Henry M, Debrincat MA, Bell R: Phase II study of paclitaxel and vinorelbine (Pacl-Vin) in hormone-refractory metastatic prostate cancer: double tubulin targeting. Intern Med J; 2010 Mar;40(3):201-8
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  • [Title] Phase II study of paclitaxel and vinorelbine (Pacl-Vin) in hormone-refractory metastatic prostate cancer: double tubulin targeting.
  • BACKGROUND: Androgen ablation is the standard treatment for advanced prostate cancer.
  • The aim of the Pacl-Vin study was to determine the efficacy and safety of paclitaxel in combination with vinorelbine in patients with HRPC, following from a phase I trial.
  • Improvement in quality of life measures was noted after three cycles of therapy.
  • Grade 3 and 4 toxicities were: neutropenia 8%, febrile neutropenia 4%, infection 2%, anaemia 3%, lethargy 1% and somnolescence 1%.
  • However, the low level of activity of this regimen precludes its further testing.
  • [MeSH-major] Drug Delivery Systems / methods. Paclitaxel / administration & dosage. Prostatic Neoplasms / drug therapy. Prostatic Neoplasms / pathology. Tubulin / blood. Vinblastine / analogs & derivatives
  • [MeSH-minor] Adenocarcinoma / drug therapy. Adenocarcinoma / pathology. Adenocarcinoma / secondary. Aged. Aged, 80 and over. Cohort Studies. Drug Administration Schedule. Drug Therapy, Combination. Humans. Male. Middle Aged. Prostate-Specific Antigen / blood

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  • [CommentIn] Intern Med J. 2010 Dec;40(12):864-5 [21199229.001]
  • (PMID = 19460063.001).
  • [ISSN] 1445-5994
  • [Journal-full-title] Internal medicine journal
  • [ISO-abbreviation] Intern Med J
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Australia
  • [Chemical-registry-number] 0 / Tubulin; 5V9KLZ54CY / Vinblastine; EC 3.4.21.77 / Prostate-Specific Antigen; P88XT4IS4D / Paclitaxel; Q6C979R91Y / vinorelbine
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5. Razis E, Kosmidis P, Aravantinos G, Bakoyiannis C, Janinis J, Timotheadou H, Christodoulou C, Fountzilas G: Second line chemotherapy with 5 fluorouracil and vinorelbine in anthracycline and taxane pretreated patients with metastatic breast cancer. Cancer Invest; 2004;22(1):10-5
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  • [Title] Second line chemotherapy with 5 fluorouracil and vinorelbine in anthracycline and taxane pretreated patients with metastatic breast cancer.
  • PURPOSE: 5-Fluorouracil (5-FU) and Vinorelbine (Vin) are active in the second line therapy of metastatic breast cancer (MBC).
  • We conducted a multi-institutional phase II study to assess the activity of the combination of 5-FU and Vin in anthracycline and taxane pretreated patients with MBC.
  • PATIENTS AND METHODS: Patients with MBC previously treated with anthracyclines and taxanes, who had measurable or evaluable disease, were treated with folinic acid 200 mg/m2 IV, 5-FU 400 mg/m2 IV bolus, and 5-FU 600 mg/m2 continuous infusion over 24 hours on days 1, 2, 15, and 16 and Vin 25 mg/m2 on days 1 and 15 of a 28-day cycle, for six cycles.
  • Response rate, time to disease progression, overall survival, and toxicity were evaluated.
  • Grade III and IV neutropenia was seen in four and three patients, respectively.
  • At a median follow-up of 19.5 months, 33 patients have progressed, 14 during treatment and 19 during the follow-up period, and 23 have died for an overall survival of 12.3 months.
  • The time to progression was six months.
  • CONCLUSION: The combination of 5-FU and Vin is well tolerated and is a good option for the palliative care of patients with MBC.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Breast Neoplasms / drug therapy. Breast Neoplasms / pathology. Vinblastine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Drug Resistance, Neoplasm. Female. Fluorouracil / administration & dosage. Humans. Infusions, Intravenous. Injections, Intravenous. Middle Aged. Neoplasm Metastasis. Salvage Therapy. Survival Analysis. Treatment Outcome

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  • (PMID = 15069759.001).
  • [ISSN] 0735-7907
  • [Journal-full-title] Cancer investigation
  • [ISO-abbreviation] Cancer Invest.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 5V9KLZ54CY / Vinblastine; Q6C979R91Y / vinorelbine; U3P01618RT / Fluorouracil
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6. Di Lorenzo G, Pizza C, Autorino R, De Laurentiis M, Marano O, D'Alessio A, Cancello G, Altieri V, Tortora G, Perdonà S, Bianco AR, De Placido S: Weekly docetaxel and vinorelbine (VIN-DOX) as first line treatment in patients with hormone refractory prostate cancer. Eur Urol; 2004 Dec;46(6):712-6
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  • [Title] Weekly docetaxel and vinorelbine (VIN-DOX) as first line treatment in patients with hormone refractory prostate cancer.
  • BACKGROUND: The current study investigated the clinical benefit, the impact on biochemical and objective response and tolerability of weekly docetaxel with vinorelbine (VIN-DOX) in symptomatic patients with hormone refractory prostate cancer (HRPC).
  • Clinical benefit evaluations, based on Karnofsky performance status (KPS) and pain measure, were assessed weekly during therapy.
  • The most important toxicity was neutropenia (Grade 3 = 32%).
  • CONCLUSIONS: The combination of weekly VIN-DOX appears to be feasible.
  • VIN-DOX was found to be associated with improvement in clinical benefit response and biochemical response and well tolerated as first line treatment in HRPC.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Prostatic Neoplasms / drug therapy. Vinblastine / analogs & derivatives
  • [MeSH-minor] Aged. Aged, 80 and over. Antineoplastic Agents, Hormonal / therapeutic use. Antineoplastic Agents, Phytogenic / administration & dosage. Humans. Male. Middle Aged. Taxoids / administration & dosage. Treatment Failure

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  • [CommentIn] Eur Urol. 2004 Dec;46(6):709-11 [15548436.001]
  • (PMID = 15548437.001).
  • [ISSN] 0302-2838
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 0 / Antineoplastic Agents, Phytogenic; 0 / Taxoids; 15H5577CQD / docetaxel; 5V9KLZ54CY / Vinblastine; Q6C979R91Y / vinorelbine
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7. Bifulco G, Mandato VD, Piccoli R, Giampaolino P, Mignogna C, Mignogna MD, Costagliola L, Nappi C: Early invasive vulvar squamous cell carcinoma arising in a woman with vulvar pemphigus vulgaris and systemic lupus erythematosus. BMC Cancer; 2010;10:324
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  • [Title] Early invasive vulvar squamous cell carcinoma arising in a woman with vulvar pemphigus vulgaris and systemic lupus erythematosus.
  • Here, we report the first case of a woman affected with SLE presenting with early invasive squamous cell carcinoma (SCC) arising from Pemphigus Vulgaris of the vulva.
  • CASE PRESENTATION: A 27-year-old Caucasian woman was admitted to our Gynaecology Unit for bleeding vegetant lesions of the vulva.
  • Biopsy showed concomitant PV and vulvar intraepithelial neoplasia (VIN) grade 3.
  • One month later a new biopsy revealed progression from VIN 3 to early SCC.
  • Despite chemotherapy, no remission of disease was observed.
  • She died six months after diagnosis CONCLUSION: Our case underlines PV as another chronic inflammatory disease of the lower genital tract predisposing to VIN-SCC.
  • [MeSH-major] Carcinoma in Situ / etiology. Carcinoma, Squamous Cell / etiology. Lupus Erythematosus, Systemic / complications. Pemphigus / complications. Vulvar Diseases / complications. Vulvar Neoplasms / etiology
  • [MeSH-minor] Adult. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Biopsy. Disease Progression. Fatal Outcome. Female. Humans. Neoplasm Invasiveness. Neoplasm Staging. Time Factors


8. Hillemanns P, Wang X, Staehle S, Michels W, Dannecker C: Evaluation of different treatment modalities for vulvar intraepithelial neoplasia (VIN): CO(2) laser vaporization, photodynamic therapy, excision and vulvectomy. Gynecol Oncol; 2006 Feb;100(2):271-5
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  • [Title] Evaluation of different treatment modalities for vulvar intraepithelial neoplasia (VIN): CO(2) laser vaporization, photodynamic therapy, excision and vulvectomy.
  • OBJECTIVES: To evaluate various treatment modalities for vulvar intraepithelial neoplasia (VIN) in relation to possible risk factors for recurrence.
  • METHODS: Retrospective review of 93 patients with VIN treated by CO(2) laser vaporization, photodynamic therapy with aminolevulinic acid (PDT), excision or vulvectomy.
  • The risk for recurrence significantly increased with VIN grade (P = 0.02), multifocal VIN disease (P = 0.01), multicentric intraepithelial neoplasia (P = 0.05) and high-risk HPV infection (P < 0.001).
  • There was one (1%) case of progression to vulvar cancer.
  • CONCLUSIONS: Vulva preserving treatment methods for VIN have high recurrence rates, especially in patients with HPV infection and multifocal disease.
  • [MeSH-major] Carcinoma in Situ / drug therapy. Carcinoma in Situ / surgery. Vulvar Neoplasms / drug therapy. Vulvar Neoplasms / surgery
  • [MeSH-minor] Adult. Aminolevulinic Acid / therapeutic use. Female. Gynecologic Surgical Procedures / methods. Humans. Laser Therapy / methods. Middle Aged. Neoplasm Recurrence, Local. Papillomaviridae. Papillomavirus Infections / complications. Photochemotherapy. Photosensitizing Agents / therapeutic use. Retrospective Studies. Risk Factors. Treatment Outcome

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  • (PMID = 16169064.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Photosensitizing Agents; 88755TAZ87 / Aminolevulinic Acid
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9. Le T, Hicks W, Menard C, Hopkins L, Fung MF: Preliminary results of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia grade 2/3. Am J Obstet Gynecol; 2006 Feb;194(2):377-80
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  • [Title] Preliminary results of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia grade 2/3.
  • OBJECTIVE: This study was undertaken to study the tolerability and efficacy of 5% imiquimod cream in the primary treatment of vulva intraepithelial neoplasia (VIN) grade 2/3.
  • STUDY DESIGN: VIN grade 2/3 patients were recruited from regional colposcopy units.
  • Imiquimod cream was applied over the abnormal area by the patient using an escalating dose regime for total treatment duration of 16 weeks.
  • Twenty patients (87%) had VIN grade 3.
  • Therapy was well tolerated with the most commonly observed side effects being irritation at the application site.
  • The median time to response was 7 weeks.
  • CONCLUSION: Imiquimod cream can induce histologic regression of high-grade VIN lesions and is well tolerated using a slow dose-escalating regime.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Aminoquinolines / therapeutic use. Carcinoma in Situ / drug therapy. Vulvar Neoplasms / drug therapy

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  • (PMID = 16458632.001).
  • [ISSN] 1097-6868
  • [Journal-full-title] American journal of obstetrics and gynecology
  • [ISO-abbreviation] Am. J. Obstet. Gynecol.
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Aminoquinolines; 99011-02-6 / imiquimod
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10. Sewak S, Chachoua A, Hamilton A, Taneja S, Lee J, Utate M, Sorich J, Muggia FM: A phase I study of paclitaxel, estramustine phosphate and vinorelbine (Pacl-E-Vin) in advanced malignancies: triple tubulin targeting. Anticancer Drugs; 2003 Jan;14(1):67-72
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  • [Title] A phase I study of paclitaxel, estramustine phosphate and vinorelbine (Pacl-E-Vin) in advanced malignancies: triple tubulin targeting.
  • This study was designed to define the dose-limiting toxicity (DLT) and recommended phase II dose (RPTD) of the unique triplet combination of paclitaxel, estramustine phosphate (EMP) and vinorelbine (Pacl-E-Vin).
  • Patients with advanced malignancies who had failed standard therapy, ECOG performance status (PS 0-2) and adequate organ function were included.
  • Nine patients had received no prior chemotherapy, one had received a prior regimen and two had received two or more prior regimens.
  • Of four evaluable patients at dose level 1, one patient had grade 3 neutropenia leading to the day 10 dose being withheld.
  • Of five evaluable patients at dose level 2, there was one DLT (febrile neutropenia) and two grade 3 neutropenias leading to the day 10 dose being withheld.
  • Other side effects were mild and reversible.
  • We conclude that the DLT of Pacl-E-Vin is neutropenia.
  • Dose omission at day 10 followed by 20% dose reduction of paclitaxel and vinorelbine is recommended in the event of grade 3 neutropenia.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Drug Delivery Systems / methods. Neoplasms / drug therapy. Tubulin. Vinblastine / analogs & derivatives

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  • [Copyright] Copyright 2003 Lippincott Williams & Wilkins
  • (PMID = 12544260.001).
  • [ISSN] 0959-4973
  • [Journal-full-title] Anti-cancer drugs
  • [ISO-abbreviation] Anticancer Drugs
  • [Language] eng
  • [Grant] United States / NCRR NIH HHS / RR / M-01 RR00096; United States / NCI NIH HHS / CA / P30 CA 16087
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Tubulin; 35LT29625A / Estramustine; 5V9KLZ54CY / Vinblastine; P88XT4IS4D / Paclitaxel; Q6C979R91Y / vinorelbine
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11. Todd RW, Etherington IJ, Luesley DM: The effects of 5% imiquimod cream on high-grade vulval intraepithelial neoplasia. Gynecol Oncol; 2002 Apr;85(1):67-70
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The effects of 5% imiquimod cream on high-grade vulval intraepithelial neoplasia.
  • OBJECTIVES: The aim of this study was to investigate the effects of topical 5% Imiquimod (3M Pharmaceuticals, St. Paul, Minnessota) on high-grade vulval intraepithelial neoplasia (VIN).
  • Fifteen patients with histologically confirmed VIN 3 were asked to self-administer 5% Imiquimod cream to their vulval lesions up to three times weekly for 16 weeks.
  • Local side effects limited the frequency of application such that 7 patients applied the cream once weekly, 6 twice weekly, and 2 three times weekly.
  • CONCLUSIONS: 5% Imiquimod cream appears to have an effect when used on high-grade VIN.
  • [MeSH-major] Aminoquinolines / administration & dosage. Antineoplastic Agents / administration & dosage. Precancerous Conditions / drug therapy. Vulvar Neoplasms / drug therapy

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  • (PMID = 11925122.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antineoplastic Agents; 0 / Ointments; 99011-02-6 / imiquimod
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12. Fehr MK, Hornung R, Degen A, Schwarz VA, Fink D, Haller U, Wyss P: Photodynamic therapy of vulvar and vaginal condyloma and intraepithelial neoplasia using topically applied 5-aminolevulinic acid. Lasers Surg Med; 2002;30(4):273-9
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  • [Title] Photodynamic therapy of vulvar and vaginal condyloma and intraepithelial neoplasia using topically applied 5-aminolevulinic acid.
  • BACKGROUND AND OBJECTIVES: To determine the feasibility of photodynamic therapy (PDT) of vulvar and vaginal condyloma and intraepithelial neoplasia (VIN, VAIN) and to compare PDT results with conventional treatments.
  • STUDY DESIGN/MATERIALS AND METHODS: Thirty-eight patients with vulvar or vaginal intraepithelial neoplasia (VIN) grade II/III (n = 22) or condyloma (n = 16) had 10% 5-aminolevulinic acid (ALA)-gel applied topically.
  • PDT was compared to conventional treatments for condyloma (CO(2) laser evaporation) and for VIN III (laser evaporation, surgical excision).
  • Of the neoplasia patients, none with hyperkeratotic VIN (n = 4) responded, and only one of four with increased pigmentation cleared.
  • Reduced disease-free survival (DFS) was associated with multifocal VIN (P = 0.02, OR 2.17, 95% CI 1.15-4.08), but DFS did not vary with treatment mode.
  • CONCLUSIONS: Although PDT is not equally efficacious for all subgroups, PDT for condyloma and intraepithelial neoplasia appears to be as effective as conventional treatments, but with shorter healing time and excellent cosmetic results.
  • [MeSH-major] Aminolevulinic Acid / administration & dosage. Condylomata Acuminata / drug therapy. Photochemotherapy. Photosensitizing Agents / administration & dosage. Precancerous Conditions / drug therapy. Vaginal Diseases / drug therapy. Vaginal Neoplasms / drug therapy. Vulvar Diseases / drug therapy. Vulvar Neoplasms / drug therapy
  • [MeSH-minor] Administration, Topical. Adolescent. Adult. Aged. Female. Humans. Laser Therapy. Middle Aged

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  • [Copyright] Copyright 2002 Wiley-Liss, Inc.
  • (PMID = 11948597.001).
  • [ISSN] 0196-8092
  • [Journal-full-title] Lasers in surgery and medicine
  • [ISO-abbreviation] Lasers Surg Med
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Photosensitizing Agents; 88755TAZ87 / Aminolevulinic Acid
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13. Winton TL, Livingston R, Johnson D, Rigas J, Cormier Y, Butts C, Ding K, Seymour L, Magoski N, Shepherd F: A prospective randomised trial of adjuvant vinorelbine (VIN) and cisplatin (CIS) in completely resected stage 1B and II non small cell lung cancer (NSCLC) Intergroup JBR.10. J Clin Oncol; 2004 Jul 15;22(14_suppl):7018

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  • [Title] A prospective randomised trial of adjuvant vinorelbine (VIN) and cisplatin (CIS) in completely resected stage 1B and II non small cell lung cancer (NSCLC) Intergroup JBR.10.
  • : 7018 Background: In meta-analyses platinum based adjuvant chemotherapy using 2<sup>nd</sup> generation regimens increased cure rate by 5% in completely resected NSCLC.
  • JBR.10 was undertaken to determine whether the 3<sup>rd</sup> generation regimen VIN/CIS prolonged survival in this clinical setting.
  • METHODS: Patients with completely resected stage 1 (T2N0) or stage 2 (excluding T3N0) NSCLC were stratified by nodal status (N0 vs. N1) and ras mutation status (present vs. absent vs. unknown) and randomised to receive 4 cycles of VIN (25mg/m<sup>2</sup> weekly x 16 weeks) plus CIS (50mg/m<sup>2</sup> days 1 and 8 q 4 weeks x 4) or follow up alone; VIN dose was reduced from 30mg/m<sup>2</sup> shortly after the study started due to unacceptable toxicity.
  • Grade 4 neutropenia, was common with febrile neutropenia in 7%, predominantly in patients receiving VIN 30mg/m<sup>2</sup>.
  • The commonest non-hematologic toxicities for VIN/CIS patients were fatigue (77%), nausea (76%), anorexia (53%), vomiting (46%), sensory neuropathy (45%) and constipation (44%).
  • Two patients died of drug-related toxicity [1 febrile neutropenia, 1 pulmonary fibrosis].
  • The most common cause of death was NSCLC (including 1 patient with 2<sup>nd</sup> primary NSCLC), while 3 patients died from toxicity related to later anti-cancer therapy, 9 patients died of other primary malignancies, and 21 from other causes.
  • Overall survival was significantly prolonged for VIN/CIS patients (94 months vs. 73 months; HR 0.69, p=0.011), as was RFS (not reached vs. 46.7 months; HR 0.6, p 0.0003).
  • 5-year survival for VIN/CIS patients was 69% compared to 54% for patients followed expectantly.
  • 38 patients developed 2<sup>nd</sup> malignancies.

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  • (PMID = 28016266.001).
  • [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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14. Morabito A, Carillio G, Bonginelli P, Amici S, Longo R, Sarmiento R, Fanelli M, Stani SC, Gattuso D, Gasparini G: Gemcitabine, vinorelbine and trastuzumab combination (GemVinT) as second-third line therapy for HER-2 overexpressing metastatic breast cancer (MBC). J Clin Oncol; 2004 Jul 15;22(14_suppl):759

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Gemcitabine, vinorelbine and trastuzumab combination (GemVinT) as second-third line therapy for HER-2 overexpressing metastatic breast cancer (MBC).
  • : 759 Background: The addition of Trastuzumab (T) to chemotherapy as first-line therapy is associated with significant improvement in response rate (RR), time to progression (TTP) and overall survival (OS), in HER-2 overexpressing MBC.
  • However, the efficacy of T combined with chemotherapy is presently object of evaluation in MBC pretreated with chemotherapy ± T.
  • We evaluated in this phase II study the safety and efficacy of GemVinT as second-third line therapy for HER-2 overexpressing MBC, pretreated with anthracyclines and/or taxanes and/or T.
  • Pts were treated with weekly T (4 mg/Kg on day 1 and then 2 mg/Kg), in combination with Gem (800 mg/m<sup>2</sup>) and Vin (25 mg/m<sup>2</sup>) on days 1 and 8, every 21 days.
  • RESULTS: 26 pts were enrolled onto the study, median age 58 years (range 41-74), median ECOG PS 0 (range 2-0), median number of metastatic sites 3 (range 1-8), prior first line chemotherapy 90% or second line 10%, prior T treatment (35%).
  • Treatment was well tolerated: grade 4 neutropenia in 2 pts, grade 3 thrombocytopenia in 1 pt, grade 3 anemia in 1 pt and grade 3 asthenia in 2 pts were observed.

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  • (PMID = 28014157.001).
  • [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. Meier CR, Illiger HJ, Steder M, Janssen J, Deertz H, Braun M, Oeney HT, Deuss B, Küchler T, Rotermund S: Weekly vinorelbine versus docetaxel for metastatic breast cancer after failing anthracycline treatment. Onkologie; 2008 Sep;31(8-9):447-53
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  • [Title] Weekly vinorelbine versus docetaxel for metastatic breast cancer after failing anthracycline treatment.
  • PATIENTS AND METHODS: Patients were randomized to receive weekly vinorelbine (VIN) or weekly docetaxel (DOC), 6 weekly doses per 8-week cycle, with optional crossover (X-DOC vs. X-VIN.
  • The primary end point was time to progression (TTP) on initial treatment.
  • RESULTS: Among 122 poor risk patients, a non-significant trend for better TTP was seen for DOC, both on initial and on crossover treatment.
  • Responses were seen on either treatment, but progression was more common with VIN than with DOC, while more patients had a response with X-DOC than with X-VIN.
  • Survival was identical in those receiving only the initial VIN vs. DOC and in the subgroups receiving crossover treatments.
  • Grade 3-4 toxicity, especially hematological toxicity resulting in treatment delay, was more common with VIN.
  • Quality of life scores reflected worse results in patients crossing treatment arms, in either direction.
  • CONCLUSIONS: DOC showed marginally better activity but did not improve TTP or other endpoints over VIN in this poor risk population.
  • [MeSH-major] Anthracyclines / administration & dosage. Breast Neoplasms / drug therapy. Taxoids / administration & dosage. Vinblastine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Bone Neoplasms / secondary. Female. Humans. Liver Neoplasms / secondary. Lung Neoplasms / secondary. Lymphatic Metastasis. Male. Middle Aged. Treatment Failure. Treatment Outcome

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  • [Copyright] Copyright 2008 S. Karger AG, Basel.
  • (PMID = 18787352.001).
  • [ISSN] 1423-0240
  • [Journal-full-title] Onkologie
  • [ISO-abbreviation] Onkologie
  • [Language] eng
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Anthracyclines; 0 / Taxoids; 15H5577CQD / docetaxel; 5V9KLZ54CY / Vinblastine; Q6C979R91Y / vinorelbine
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16. Le T, Menard C, Hicks-Boucher W, Hopkins L, Weberpals J, Fung-Kee-Fung M: Final results of a phase 2 study using continuous 5% Imiquimod cream application in the primary treatment of high-grade vulva intraepithelial neoplasia. Gynecol Oncol; 2007 Sep;106(3):579-84
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Final results of a phase 2 study using continuous 5% Imiquimod cream application in the primary treatment of high-grade vulva intraepithelial neoplasia.
  • OBJECTIVES: To investigate the activity of 5% Imiquimod cream in the primary treatment of vulva intraepithelial neoplasia (VIN) grade 2/3.
  • METHODS: Patients with histologically confirmed VIN 2/3 were recruited from regional colposcopy units.
  • Imiquimod cream was applied over the abnormal VIN areas by the patients, using an escalating dose regimen for a total treatment duration of 16 weeks.
  • A historical cohort of VIN 2/3 patients treated with primary surgical ablation was used to compare recurrence patterns.
  • Thirty-six patients (92%) had VIN 3.
  • Therapy was well tolerated with the most common observed side effects being only minor skin irritation at the application site.
  • No VIN progression or cancer was diagnosed.
  • CONCLUSION: Imiquimod cream was well tolerated and resulted in the regression in a majority of high-grade VIN lesions.
  • [MeSH-major] Aminoquinolines / administration & dosage. Antineoplastic Agents / administration & dosage. Carcinoma in Situ / drug therapy. Vulvar Neoplasms / drug therapy

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  • (PMID = 17582474.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antineoplastic Agents; 99011-02-6 / imiquimod
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17. Morabito A, Longo R, Gattuso D, Carillio G, Massaccesi C, Mariani L, Bonginelli P, Amici S, De Sio L, Fanelli M, Torino F, Bonsignori M, Gasparini G: Trastuzumab in combination with gemcitabine and vinorelbine as second-line therapy for HER-2/neu overexpressing metastatic breast cancer. Oncol Rep; 2006 Aug;16(2):393-8
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  • [Title] Trastuzumab in combination with gemcitabine and vinorelbine as second-line therapy for HER-2/neu overexpressing metastatic breast cancer.
  • The aim of this study was to evaluate the safety and efficacy of combined treatment with trastuzumab (T), gemcitabine (gem) and vinorelbine (vin) as second-line therapy for HER-2 overexpressing metastatic breast cancer, pretreated with anthracyclines and/or taxanes and/or trastuzumab.
  • Patients were treated with weekly T (4 mg/kg on day 0, then 2 mg/kg), in combination with gem (800 mg/m(2)) and vin (25 mg/m(2)) on days 1 and 8, every 21 days.
  • Of the patients, 7 (23.3%) had received trastuzumab as first-line therapy.
  • Treatment was well-tolerated with grade 4 neutropenia in 6 patients, grade 3 thrombocytopenia and grade 3 anemia in 1 patient, and grade 3 asthenia in 4 patients.
  • T-gem-vin is a safe and active regimen in this subgroup of patients with poor prognosis, and the efficacy of such a schedule was particularly satisfactory in patients with HercepTest 3+.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Breast Neoplasms / drug therapy. Breast Neoplasms / pathology. Deoxycytidine / analogs & derivatives. Receptor, ErbB-2 / metabolism. Vinblastine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Humanized. Female. Humans. Middle Aged. Neoplasm Metastasis. Trastuzumab. Up-Regulation

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  • (PMID = 16820921.001).
  • [ISSN] 1021-335X
  • [Journal-full-title] Oncology reports
  • [ISO-abbreviation] Oncol. Rep.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0W860991D6 / Deoxycytidine; 5V9KLZ54CY / Vinblastine; B76N6SBZ8R / gemcitabine; EC 2.7.10.1 / Receptor, ErbB-2; P188ANX8CK / Trastuzumab; Q6C979R91Y / vinorelbine
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18. van Seters M, Fons G, van Beurden M: Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study. J Reprod Med; 2002 Sep;47(9):701-5
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  • [Title] Imiquimod in the treatment of multifocal vulvar intraepithelial neoplasia 2/3. Results of a pilot study.
  • OBJECTIVE: To investigate the efficacy of topical treatment with imiquimod 5% cream, an immune response modifier, in patients with vulvar intraepithelial neoplasia (VIN) 2/3.
  • STUDY DESIGN: Fifteen women (aged 35-51) with histologically proven multifocal VIN 2/3 without invasion, were entered into a prospective, observational, pilot study.
  • Imiquimod 5% cream was applied by the patient to the vulvar lesions one to three times a week at night.
  • RESULTS: Four patients achieved CR (27%) and nine patients, PR (60%) after 6-34 weeks of treatment.
  • Two patients discontinued medication.
  • CR was reached after 6, 7, 11 and 30 weeks of treatment.
  • CONCLUSION: This pilot study showed the potential beneficial effect of imiquimod 5% cream in multifocal VIN 2/3.
  • In contrast to current surgical treatment, imiquimod focuses on the cause of VIN and preserves the anatomy and function of the vulva.
  • Therefore, imiquimod may prove to be the treatment of choice in multifocal, high grade VIN.
  • [MeSH-major] Aminoquinolines / therapeutic use. Antineoplastic Agents / therapeutic use. Carcinoma in Situ / drug therapy. Vulvar Neoplasms / drug therapy
  • [MeSH-minor] Administration, Topical. Adult. Female. Humans. Middle Aged. Neoplasm Staging. Pilot Projects. Prospective Studies. Time Factors. Vaginal Creams, Foams, and Jellies

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  • (PMID = 12380448.001).
  • [ISSN] 0024-7758
  • [Journal-full-title] The Journal of reproductive medicine
  • [ISO-abbreviation] J Reprod Med
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antineoplastic Agents; 0 / Vaginal Creams, Foams, and Jellies; 99011-02-6 / imiquimod
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19. Todd RW, Steele JC, Etherington I, Luesley DM: Detection of CD8+ T cell responses to human papillomavirus type 16 antigens in women using imiquimod as a treatment for high-grade vulval intraepithelial neoplasia. Gynecol Oncol; 2004 Jan;92(1):167-74
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Detection of CD8+ T cell responses to human papillomavirus type 16 antigens in women using imiquimod as a treatment for high-grade vulval intraepithelial neoplasia.
  • OBJECTIVES: To investigate CD8+ T cell reactivity to human papillomavirus (HPV) 16 antigens in patients with high-grade vulval intraepithelial neoplasia (VIN) before, during and after treatment with 5% imiquimod cream.
  • METHODS: CD8-enriched responder cell populations were obtained from 10 patients with high-grade VIN using imiquimod cream as a treatment.
  • Overlapping synthetic peptides covering the entire primary sequences of the HPV16 E6, E7 and E4 proteins were used to screen for CD8+ T cell responses using an ELISPOT assay of interferon (IFN)-gamma release.
  • With the exception of one patient, CD8+ T cell reactivity generally increased at some stage during treatment.
  • The magnitude and specificities of responses changed over the treatment period.
  • CD8+ T cell reactivity to HPV16 E7 appeared to be dominant amongst women with high-grade VIN.
  • CONCLUSIONS: HPV16 specific CD8+ T cell activity was detected in patients with high-grade VIN.
  • Despite the presence of these CD8+ T cells, the disease state persisted; therefore, a role for HPV-specific cytotoxic T cells (CTLs) in VIN resolution remains unproven.
  • [MeSH-major] Aminoquinolines / therapeutic use. Antigens, Viral, Tumor / immunology. Antineoplastic Agents / therapeutic use. CD8-Positive T-Lymphocytes / immunology. Papillomaviridae / immunology. Repressor Proteins. Vulvar Neoplasms / drug therapy. Vulvar Neoplasms / immunology

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  • (PMID = 14751153.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antibodies, Viral; 0 / Antigens, Viral, Tumor; 0 / Antineoplastic Agents; 0 / DNA, Viral; 0 / E6 protein, Human papillomavirus type 16; 0 / Oncogene Proteins, Viral; 0 / Papillomavirus E7 Proteins; 0 / Repressor Proteins; 0 / oncogene protein E4, Human papillomavirus type 16; 0 / oncogene protein E7, Human papillomavirus type 16; 82115-62-6 / Interferon-gamma; 99011-02-6 / imiquimod
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20. Naik R, Nixon S, Lopes A, Godfrey K, Hatem MH, Monaghan JM: A randomized phase II trial of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia. Int J Gynecol Cancer; 2006 Mar-Apr;16(2):786-90
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  • [Title] A randomized phase II trial of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia.
  • The aim of this study was to determine the potential therapeutic benefits of indole-3-carbinol (I3C) in the management of vulvar intraepithelial neoplasia (VIN).
  • Women with histologically confirmed high-grade VIN were randomized to receive 200 and 400 mg/day of I3C.
  • Tissue biopsy to determine histologic response was obtained at completion of the study period.
  • However, tissue biopsy from the worst-affected vulval areas revealed no improvement in grade of VIN during the 6-month period, P= 0.317.
  • This study has shown significant clinical improvement in symptomatology and vulvoscopic appearance of VIN with I3C therapy.
  • [MeSH-major] Carcinoma in Situ / drug therapy. Carcinoma, Squamous Cell / drug therapy. Indoles / therapeutic use. Vulvar Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Disease-Free Survival. Female. Humans. Hydroxyestrones / metabolism. Middle Aged. Neoplasm Staging. Survival Rate. Treatment Outcome

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  • (PMID = 16681761.001).
  • [ISSN] 1048-891X
  • [Journal-full-title] International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
  • [ISO-abbreviation] Int. J. Gynecol. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hydroxyestrones; 0 / Indoles; 18186-49-7 / 16-hydroxyestrone; C11E72455F / indole-3-carbinol; UQS3A06ILY / 2-hydroxyestrone
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