Journal article
GOG 175: A Randomized phase III trial of IV carboplatin (AUC 6) and paclitaxel 175 mg/m(2) Q 21 days x 3 courses plus low-dose paclitaxel 40 mg/m(2)/wk versus IV carboplatin (AUC 6) and paclitaxel 175 mg/m(2) Q 21 days x 3 courses plus observation in patients with early-stage ovarian carcinoma
Gynecologic oncology, Vol.116(3), pp.S2-S2
03/01/2010
DOI: 10.1016/j.ygyno.2009.12.013
Abstract
<p><h3>Objective</h3> <p id="x-x-sp0040">To compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated with intravenous (IV) <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/carboplatin" title="Learn more about Carboplatin from ScienceDirect's AI-generated Topic Pages">carboplatin</a> and <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/paclitaxel" title="Learn more about Paclitaxel from ScienceDirect's AI-generated Topic Pages">paclitaxel</a> with or without maintenance <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/low-drug-dose" title="Learn more about Low Drug Dose from ScienceDirect's AI-generated Topic Pages">low-dose</a> paclitaxel for 24 weeks. <h3>Methods</h3> <p id="x-x-sp0045">Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/krukenberg-tumor" title="Learn more about Krukenberg Tumor from ScienceDirect's AI-generated Topic Pages">epithelial ovarian cancer</a>. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m<sup>2</sup> q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m<sup>2</sup>/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor. <h3>Results</h3> <p id="x-x-sp0050">There were 571 patients enrolled onto this study, of whom 29 were deemed ineligible due to inappropriate stage or pathology, leaving 542 patients. At least 3 cycles of treatment were administered to 524/542 (97%) of patients, and among those assigned to maintenance paclitaxel, 80% completed the regimen. The incidence of grade 2 or worse peripheral neuropathy (15.5% vs. 6%), infection/fever (19.9% vs. 8.7%), and <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/dermatological-agent" title="Learn more about Dermatological Agent from ScienceDirect's AI-generated Topic Pages">dermatologic</a> events (70.8% vs. 52.1%) was higher on the maintenance regimen (<em>p</em> < 0.001). The cumulative probability of recurring within 5 years for the maintenance paclitaxel regimen is 20% vs. 23% for surveillance (hazard ratio 0.807; 95% CI: 0.565–1.15). The probability of surviving 5 years was 85.4% and 86.2%, respectively. <h3>Conclusion</h3> <p id="x-x-sp0055">Maintenance paclitaxel at 40 mg/m<sup>2</sup>/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m<sup>2</sup> × 3 doses provides no significant increase in RFI. <h3>Research Highlights</h3> <p id="x-x-sp0060">► Maintenance paclitaxel does not improve survival in early-stage ovarian cancer. ► Three cycles of carboplatin and paclitaxel are preferred for early-stage ovarian cancer. ► Maintenance paclitaxel given weekly is well tolerated.</p>
Details
- Title: Subtitle
- GOG 175: A Randomized phase III trial of IV carboplatin (AUC 6) and paclitaxel 175 mg/m(2) Q 21 days x 3 courses plus low-dose paclitaxel 40 mg/m(2)/wk versus IV carboplatin (AUC 6) and paclitaxel 175 mg/m(2) Q 21 days x 3 courses plus observation in patients with early-stage ovarian carcinoma
- Creators
- Robert S. Mannel - University of OklahomaMasamichi Hiura - Shikoku Cancer CenterMark F. Brady - Roswell Park Cancer InstituteElise C. Kohn - National Cancer InstituteKoen De Geest - University of IowaParviz Hanjani - Abington Memorial HospitalRoger Lee - Tacoma General HospitalDavid E. Cohn - The Ohio State UniversityBradley J. Monk - University of California, IrvineHelen Michael - Indiana University School of Medicine
- Resource Type
- Journal article
- Publication Details
- Gynecologic oncology, Vol.116(3), pp.S2-S2
- DOI
- 10.1016/j.ygyno.2009.12.013
- ISSN
- 0090-8258
- Comment
Supplementary materials available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3110746/
- Language
- English
- Date published
- 03/01/2010
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9983557795002771
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