PURPOSE: To compare single versus sequential high-dose chemotherapy (HDCT) as first or subsequent salvage treatment in patients with relapsed or refractory germ cell tumors (GCTs). PATIENTS AND METHODS: Between November 1999 and November 2004, 230 patients were planned to be recruited in a prospective, randomized, multicenter trial comparing one cycle of cisplatin 100 mg/m2, etoposide 375 mg/m2, and ifosfamide 6 g/m2 (VIP) plus three cycles of high-dose carboplatin 1,500 mg/m2 and etoposide 1,500 mg/m2 (CE; arm A) versus three cycles of VIP plus one cycle of high-dose carboplatin 2,200 mg/m2, etoposide 1,800 mg/m2, and cyclophosphamide 6,400 mg/m2 (CEC; arm B). RESULTS: The study was stopped prematurely after recruitment of 216 patients as a result of excess treatment-related mortality in arm B. One hundred eleven (51%) of 216 patients were randomly assigned to sequential HDCT, and 105 (47%) of 216 patients were randomly assigned to single HDCT. Five (2%) of 216 patients had to be excluded because of non-GCT histologies at review. With a median follow-up time of 36 months, 109 (52%) of 211 patients were alive, and 91 (43%) of 211 patients were progression free. At 1 year, event-free, progression-free, and overall survival rates were 40%, 53%, and 80%, respectively, in arm A compared with 37%, 49%, and 61%, respectively, in arm B (P > .05 for all comparisons). Treatment-related deaths, mainly as a result of sepsis and cardiac toxicity, were less frequent in arm A (four of 108 patients, 4%) compared with arm B (16 of 103 patients, 16%; P < .01). CONCLUSION: We found no difference in survival probabilities between single HDCT using CE and sequential HDCT using CEC. Sequential HDCT was better tolerated and resulted in fewer treatment-related deaths.
RCT Entities:
PURPOSE: To compare single versus sequential high-dose chemotherapy (HDCT) as first or subsequent salvage treatment in patients with relapsed or refractory germ cell tumors (GCTs). PATIENTS AND METHODS: Between November 1999 and November 2004, 230 patients were planned to be recruited in a prospective, randomized, multicenter trial comparing one cycle of cisplatin 100 mg/m2, etoposide 375 mg/m2, and ifosfamide 6 g/m2 (VIP) plus three cycles of high-dose carboplatin 1,500 mg/m2 and etoposide 1,500 mg/m2 (CE; arm A) versus three cycles of VIP plus one cycle of high-dose carboplatin 2,200 mg/m2, etoposide 1,800 mg/m2, and cyclophosphamide 6,400 mg/m2 (CEC; arm B). RESULTS: The study was stopped prematurely after recruitment of 216 patients as a result of excess treatment-related mortality in arm B. One hundred eleven (51%) of 216 patients were randomly assigned to sequential HDCT, and 105 (47%) of 216 patients were randomly assigned to single HDCT. Five (2%) of 216 patients had to be excluded because of non-GCT histologies at review. With a median follow-up time of 36 months, 109 (52%) of 211 patients were alive, and 91 (43%) of 211 patients were progression free. At 1 year, event-free, progression-free, and overall survival rates were 40%, 53%, and 80%, respectively, in arm A compared with 37%, 49%, and 61%, respectively, in arm B (P > .05 for all comparisons). Treatment-related deaths, mainly as a result of sepsis and cardiac toxicity, were less frequent in arm A (four of 108 patients, 4%) compared with arm B (16 of 103 patients, 16%; P < .01). CONCLUSION: We found no difference in survival probabilities between single HDCT using CE and sequential HDCT using CEC. Sequential HDCT was better tolerated and resulted in fewer treatment-related deaths.
Authors: Lori Wood; Christian Kollmannsberger; Michael Jewett; Peter Chung; Sebastian Hotte; Martin O'Malley; Joan Sweet; Lynn Anson-Cartwright; Eric Winquist; Scott North; Scott Tyldesley; Jeremy Sturgeon; Mary Gospodarowicz; Roanne Segal; Tina Cheng; Peter Venner; Malcolm Moore; Peter Albers; Robert Huddart; Craig Nichols; Padraig Warde Journal: Can Urol Assoc J Date: 2010-04 Impact factor: 1.862
Authors: F Gössi; M Spahn; M Zweifel; S Panagiotis; A Mischo; F Stenner; U Hess; D Berthold; M Bargetzi; J Schardt; T Pabst Journal: Bone Marrow Transplant Date: 2016-11-28 Impact factor: 5.483
Authors: G Daugaard; I Skoneczna; N Aass; R De Wit; M De Santis; H Dumez; S Marreaud; L Collette; J R G Lluch; C Bokemeyer; H J Schmoll Journal: Ann Oncol Date: 2010-11-08 Impact factor: 32.976
Authors: Z DeFilipp; C B Rosand; D A Goldstein; V A Master; B C Carthon; W B Harris; O Kucuk; Z Al-Kadhimi; J B Cohen; C R Flowers; M J Lechowicz; A K Nooka; J L Kaufman; A A Langston; Z Chen; J Arora; E K Waller Journal: Bone Marrow Transplant Date: 2016-07-18 Impact factor: 5.483
Authors: B Nitzsche; C Gloesenkamp; M Schrader; M Ocker; R Preissner; M Lein; A Zakrzewicz; B Hoffmann; M Höpfner Journal: Br J Cancer Date: 2010-06-15 Impact factor: 7.640