OBJECTIVE: To compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated withintravenous (IV) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24 weeks. METHODS: Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m² q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m²/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor. RESULTS: 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 dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p<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. CONCLUSION:Maintenance paclitaxel at 40 mg/m²/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m² × 3 doses provides no significant increase in RFI.
RCT Entities:
OBJECTIVE: 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) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24 weeks. METHODS: Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m² q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m²/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor. RESULTS: 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 dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p<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. CONCLUSION: Maintenance paclitaxel at 40 mg/m²/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m² × 3 doses provides no significant increase in RFI.
Authors: Michael P Stany; Tomas Bonome; Fred Wamunyokoli; Kristen Zorn; Laurent Ozbun; Dong-Choon Park; Ke Hao; Jeff Boyd; Anil K Sood; David M Gershenson; Ross S Berkowitz; Samuel C Mok; Michael J Birrer Journal: Adv Exp Med Biol Date: 2008 Impact factor: 2.622
Authors: Jeffrey Bell; Mark F Brady; Robert C Young; Janice Lage; Joan L Walker; Katherine Y Look; G Scott Rose; Nick M Spirtos Journal: Gynecol Oncol Date: 2006-07-24 Impact factor: 5.482
Authors: John K Chan; Chunqiao Tian; Gini F Fleming; Bradley J Monk; Thomas J Herzog; Daniel S Kapp; Jeffrey Bell Journal: Gynecol Oncol Date: 2009-11-28 Impact factor: 5.482
Authors: Michael A Bookman; Mark F Brady; William P McGuire; Peter G Harper; David S Alberts; Michael Friedlander; Nicoletta Colombo; Jeffrey M Fowler; Peter A Argenta; Koen De Geest; David G Mutch; Robert A Burger; Ann Marie Swart; Edward L Trimble; Chrisann Accario-Winslow; Lawrence M Roth Journal: J Clin Oncol Date: 2009-02-17 Impact factor: 44.544
Authors: J Baptist Trimbos; Mahesh Parmar; Ignace Vergote; David Guthrie; Giorgio Bolis; Nicoletta Colombo; Jan B Vermorken; Valter Torri; Constantino Mangioni; Sergio Pecorelli; Andrea Lissoni; Ann Marie Swart Journal: J Natl Cancer Inst Date: 2003-01-15 Impact factor: 13.506
Authors: Katherine C Fuh; James J Java; John K Chan; Daniel S Kapp; Bradley J Monk; Robert A Burger; Robert C Young; David S Alberts; William P McGuire; Maurie Markman; Jeffrey Bell; Robert F Ozols; Deborah K Armstrong; Carol Aghajanian; Michael A Bookman; Robert S Mannel Journal: Gynecol Oncol Date: 2019-06-19 Impact factor: 5.482
Authors: Heidi S Donovan; Sandra E Ward; Susan M Sereika; Judith E Knapp; Paula R Sherwood; Catherine M Bender; Robert P Edwards; Margaret Fields; Renee Ingel Journal: J Pain Symptom Manage Date: 2013-09-07 Impact factor: 3.612
Authors: U Wagner; P Harter; F Hilpert; S Mahner; A Reuß; A du Bois; E Petru; W Meier; P Ortner; K König; K Lindel; D Grab; P Piso; O Ortmann; I Runnebaum; J Pfisterer; D Lüftner; N Frickhofen; F Grünwald; B O Maier; J Diebold; S Hauptmann; F Kommoss; G Emons; B Radeleff; M Gebhardt; N Arnold; G Calaminus; I Weisse; J Weis; J Sehouli; D Fink; A Burges; A Hasenburg; C Eggert Journal: Geburtshilfe Frauenheilkd Date: 2013-09 Impact factor: 2.915
Authors: Robertson Mackenzie; Aline Talhouk; Sima Eshragh; Sherman Lau; Daphne Cheung; Christine Chow; Nhu Le; Linda S Cook; Nafisa Wilkinson; Jacqueline McDermott; Naveena Singh; Friedrich Kommoss; Jacobus Pfisterer; David G Huntsman; Martin Köbel; Stefan Kommoss; C Blake Gilks; Michael S Anglesio Journal: Am J Surg Pathol Date: 2015-11 Impact factor: 6.394