مورد إلكتروني

Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: A phase III trial of the gynecologic cancer intergroup

التفاصيل البيبلوغرافية
العنوان: Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: A phase III trial of the gynecologic cancer intergroup
المؤلفون: Bookman, M, Brady, M, Mcguire, W, Harper, P, Alberts, D, Friedlander, M, Colombo, N, Fowler, J, Argenta, P, De Geest, K, Mutch, D, Burger, R, Swart, A, Trimble, E, Accario Winslow, C, Roth, L, Bookman, MA, Brady, MF, McGuire, WP, Harper, PG, Alberts, DS, Fowler, JM, Argenta, PA, Mutch, DG, Burger, RA, Swart, AM, Trimble, EL, Roth, LM, COLOMBO, NICOLETTA
بيانات النشر: 2009
نوع الوثيقة: Electronic Resource
مستخلص: PURPOSE: To determine if incorporation of an additional cytotoxic agent improves overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma who receive carboplatin and paclitaxel. PATIENTS AND METHODS: Women with stages III to IV disease were stratified by coordinating center, maximal diameter of residual tumor, and intent for interval cytoreduction and were then randomly assigned among five arms that incorporated gemcitabine, methoxypolyethylene glycosylated liposomal doxorubicin, or topotecan compared with carboplatin and paclitaxel. The primary end point was OS and was determined by pairwise comparison to the reference arm, with a 90% chance of detecting a true hazard ratio of 1.33 that limited type I error to 5% (two-tail) for the four comparisons. RESULTS: Accrual exceeded 1,200 patients per year. An event-triggered interim analysis occurred after 272 events on the reference arm, and the study closed with 4,312 women enrolled. Arms were well balanced for demographic and prognostic factors, and 79% of patients completed eight cycles of therapy. There were no improvements in either PFS or OS associated with any experimental regimen. Survival analyses of groups defined by size of residual disease also failed to show experimental benefit in any subgroup. CONCLUSION: Compared with standard paclitaxel and carboplatin, addition of a third cytotoxic agent provided no benefit in PFS or OS after optimal or suboptimal cytoreduction. Dual-stage, multiarm, phase III trials can efficiently evaluate multiple experimental regimens against a single reference arm. The development of new interventions beyond surgery and conventional platinum-based chemotherapy is required to additionally improve outcomes for women with advanced EOC.
مصطلحات الفهرس: Advanced-Stage Ovarian Cancer, info:eu-repo/semantics/article
URL: http://hdl.handle.net/10281/14601
info:eu-repo/semantics/altIdentifier/wos/WOS:000266194000014
volume:27
firstpage:1355
lastpage:1358
journal:JOURNAL OF CLINICAL ONCOLOGY
الإتاحة: Open access content. Open access content
ملاحظة: English
أرقام أخرى: ITBAO oai:boa.unimib.it:10281/14601
info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-63049115790
1308896813
المصدر المساهم: BICOCCA OPEN ARCH
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رقم الأكسشن: edsoai.on1308896813
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