BACKGROUND: There is no clear data on the optimum number of courses of platinum chemotherapy required for treating advanced ovarian cancer. A prospective randomised trial was performed to compare five with eight courses of either carboplatin 400 mg/m2 or cisplatin 75 mg/m2 given four-weekly to patients with stage IC-IV ovarian cancer. PATIENTS AND METHODS: 225 patients were entered into the study and 233 were eligible for randomisation: 118 to five courses and 115 to eight courses. In each randomisation, half the patients received carboplatin and half received cisplatin. RESULTS: The mean number of courses received on the five arm was 4.74 and on the eight arm, 6.42, an increase of 35%. The median survival for all patients was 24 months with the median survival for the 156 patients with stage 3 disease being 21 months. No difference was detected in survival (P = 0.53) or time to progression from initial surgery (P = 0.29) between the two arms of the trial. False-negative calculations based on a multivariate analysis show that the trial currently has 95% power for excluding a difference of 10% in favour of the eight course arm at three years. CONCLUSION: There is insufficient evidence at the present time to justify more than five courses of first-line single agent platinum chemotherapy in the management of advanced ovarian cancer.
RCT Entities:
BACKGROUND: There is no clear data on the optimum number of courses of platinum chemotherapy required for treating advanced ovarian cancer. A prospective randomised trial was performed to compare five with eight courses of either carboplatin 400 mg/m2 or cisplatin 75 mg/m2 given four-weekly to patients with stage IC-IV ovarian cancer. PATIENTS AND METHODS: 225 patients were entered into the study and 233 were eligible for randomisation: 118 to five courses and 115 to eight courses. In each randomisation, half the patients received carboplatin and half received cisplatin. RESULTS: The mean number of courses received on the five arm was 4.74 and on the eight arm, 6.42, an increase of 35%. The median survival for all patients was 24 months with the median survival for the 156 patients with stage 3 disease being 21 months. No difference was detected in survival (P = 0.53) or time to progression from initial surgery (P = 0.29) between the two arms of the trial. False-negative calculations based on a multivariate analysis show that the trial currently has 95% power for excluding a difference of 10% in favour of the eight course arm at three years. CONCLUSION: There is insufficient evidence at the present time to justify more than five courses of first-line single agent platinum chemotherapy in the management of advanced ovarian cancer.
Authors: M A L van Lankveld; P H M Peeters; M A van Eijkeren; V C M Koot; P O Witteveen; W P Th M Mali Journal: Med Oncol Date: 2004 Impact factor: 3.064
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: Alexander B Olawaiye; James J Java; Thomas C Krivak; Michael Friedlander; David G Mutch; Gretchen Glaser; Melissa Geller; David M O'Malley; Robert M Wenham; Roger B Lee; Diane C Bodurka; Thomas J Herzog; Michael A Bookman Journal: Gynecol Oncol Date: 2018-08-19 Impact factor: 5.482
Authors: Maurie Markman; P Y Liu; James Moon; Bradley J Monk; Larry Copeland; Sharon Wilczynski; David Alberts Journal: Gynecol Oncol Date: 2009-05-17 Impact factor: 5.482