Comparison of combination therapy with paclitaxel Taxol® and cisplatin versus cyclophosphamide and cisplatin in patients with suboptimal stage III and stage IV ovarian cancer: A Gynecologic Oncology Group study Journal Article

  


Authors: McGuire, W. P.; Hoskins, W. J.; Brady, M. F.; Kucera, P. R.; Partridge, E. E.; Look, K. Y.; Clarke-Pearson, D. L.; Davidson, M.
Article Title: Comparison of combination therapy with paclitaxel Taxol® and cisplatin versus cyclophosphamide and cisplatin in patients with suboptimal stage III and stage IV ovarian cancer: A Gynecologic Oncology Group study
Abstract: In patients with advanced ovarian cancer, high response rates are achieved with chemotherapy combinations that include alkylating agents and platinum coordination complexes. However, few patients experience long-term control of disease, especially when primary resection leaves substantial residual mass. Paclitaxel (Taxol R), a new agent with documented activity in platinum-refractory ovarian cancer, has been shown to be well tolerated when given in combination with cisplatin. In this prospective study, we compared the combination of paclitaxel-cisplatin with a standard therapy of cyclophosphamide-cisplatin in patients with suboptimal stage III and stage IV disease. Of 410 patients with advanced ovarian cancer and >1-cm residual masses following initial surgery, 386 met all eligibility criteria. These patients were randomly assigned to receive a regimen of cisplatin (75 mg m-2) and cyclophosphamide (750mg m-2) or cisplatin (75 mg m-2) and paclitaxel (135 mg m-2) delivered over 24 h. Dosage reductions in cyclophosphamide or paclitaxel were permitted for significant toxicity. Among 216 patients with measurable disease, responses were reported in 73% of those randomized to receive cisplatin-paclitaxel and in 60% of those who received cisplatin-cyclophosphamide. Median progression-free survival was significantly longer (P < 0.001) with the cisplatin-paclitaxel combination compared with cisplatin-cyclophosphamide (17.9 vs 12.9 months, respectively). Median overall survival also was significantly longer (P < 0.001) with cisplatin-paclitaxel (37.5 vs 24.4 months). Thus, this study provides compelling evidence that giving the paclitaxel-cisplatin combination as first-line therapy for suboptimally debulked stage III or any stage IV ovarian cancer can increase both the duration of the progression-free interval and the overall survival while maintaining an acceptable toxicity profile. © 1996 IGCS,.
Keywords: adult; cancer survival; controlled study; aged; major clinical study; clinical trial; cisplatin; cancer combination chemotherapy; conference paper; paclitaxel; cancer staging; neurotoxicity; ovarian cancer; controlled clinical trial; nephrotoxicity; ovary cancer; bone marrow suppression; randomized controlled trial; cyclophosphamide; dexamethasone; gastrointestinal toxicity; multicenter study; drug response; alopecia; allergic reaction; intravenous drug administration; oral drug administration; diphenhydramine; taxol; histamine h2 receptor antagonist; human; female; priority journal
Journal Title: International Journal of Gynecological Cancer
Volume: 6
Issue: Suppl. 1
ISSN: 1048-891X
Publisher: Lippincott Williams & Wilkins  
Date Published: 1996-09-01
Start Page: 2
End Page: 8
Language: English
PROVIDER: scopus
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-0029779020&partnerID=40&md5=bb0d2d277754a9f8710f7b93b4c9695e
Notes: Article -- Export Date: 22 November 2017 -- Source: Scopus