Results of a Southwest Oncology Group Phase III Trial of Carboplatin plus Cyclophosphamide versus Cisplatin plus Cyclophosphamide in Advanced Ovarian Cancer

Oncology ◽  
1993 ◽  
Vol 50 (2) ◽  
pp. 2-9 ◽  
Author(s):  
Edward V. Hannigan ◽  
Stephanie Green ◽  
David S. Alberts ◽  
Robert O’Toole ◽  
Earl Surwit
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Oncology Group ◽  
Phase Iii Trial ◽  
Southwest Oncology Group

Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial

2003 ◽  
Vol 21 (13) ◽  
pp. 2460-2465 ◽  
Author(s):  
Maurie Markman ◽  
P.Y. Liu ◽  
Sharon Wilczynski ◽  
Bradley Monk ◽  
Larry J. Copeland ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Cox Model ◽  
Single Agent ◽  
Advanced Ovarian Cancer ◽  
Complete Response ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Southwest Oncology Group

Purpose: To determine whether continuing paclitaxel for an extended time period in women with advanced ovarian cancer who had achieved a clinically defined complete response to a platinum/paclitaxel-based chemotherapy could prolong subsequent progression-free survival (PFS) and affect ultimate survival. Patients and Methods: Patients were randomly assigned to either three or 12 cycles of single-agent paclitaxel administered every 28 days and were then followed up for progression-free and overall survival. Results: As of September 6, 2001, 277 patients (262 assessable) had entered the trial, with a total of 54 PFS events having developed among 222 patients with follow-up data. With the exception of peripheral neuropathy, there were no major differences in toxicity between the regimens. The median PFS was 21 and 28 months in the three-cycle and 12-cycle paclitaxel arms, respectively. One-sided P values from an unadjusted log-rank test and an adjusted Cox model analysis (for stratification factors) were .0035 and .0023, respectively, both in favor of the 12-cycle arm. The Cox model-adjusted three-cycle versus the 12-cycle progression hazard ratio was estimated to be 2.31 (99% confidence interval, 1.08 to 4.94). With a protocol-specified early termination boundary of P = .005, these findings led the Southwest Oncology Group Data Safety Monitoring Committee to discontinue the trial. As of the date of study closure, there was no difference in overall survival between the treatment arms. Conclusion: Twelve cycles of single-agent paclitaxel administered to women with advanced ovarian cancer who attain a clinically defined complete response to initial platinum/paclitaxel-based chemotherapy significantly prolongs the duration of PFS.

A randomized, double-blind phase III trial of niraparib maintenance treatment in patients with HRD+ advanced ovarian cancer after response to front-line platinum-based chemotherapy.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. TPS5606-TPS5606 ◽  
Author(s):  
Antonio Gonzalez-Martin ◽  
Floor Jennishens Backes ◽  
Klaus H. Baumann ◽  
Dana Meredith Chase ◽  
Mathias Konrad Fehr ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Treatment ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Front Line ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Platinum Based Chemotherapy

Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel versus cisplatin and paclitaxel (GOG158) and an update on GOG0182-ICON5

2003 ◽  
Vol 13 (Suppl 2) ◽  
pp. 149-155 ◽  
Author(s):  
M. A. Bookman ◽  
B. E. Greer ◽  
R. F. Ozols
Keyword(s):  
Ovarian Cancer ◽  
Surgical Outcomes ◽  
Gynecologic Cancer ◽  
Advanced Ovarian Cancer ◽  
Cytotoxic Agents ◽  
Phase Iii ◽  
Current Status ◽  
Standard Regimen ◽  
Phase Iii Trial ◽  
Optimal Therapy

Mature results from GOG158 have clearly established carboplatin and paclitaxel as an effective and well-tolerated standard regimen, providing a basis for the reference arm in GOG0182-ICON5, an ongoing multiarmed phase III trial of the Gynecologic Cancer InterGroup (GCIG) evaluating the incorporation of newer cytotoxic agents. Results from GOG158 will be reviewed, including an analysis of second-look surgical outcomes, followed by an update on the current status of GOG0182-ICON5.

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