OBJECTIVES: To assess the impact on survival of high-dose chemotherapy with haematopoietic support in patients with high-volume, metastatic nonseminomatous germ cell tumours. METHODS:One hundred fifteen patients were randomised to receive either four cycles every 21 d of vinblastine (0.2 mg/kg on day 1), etoposide (100 mg/m2/d on days 1 through 5), cisplatin (40 mg/m2/d on days 1 through 5), and bleomycin (30 mg on days 1, 8, and 15) (arm A), or a slightly modified regimen followed by a high-dose chemotherapy including etoposide (350 mg/m2/d on days 1 through 5), cisplatin (40 mg/m2/d on days 1 through 5), and cyclophosphamide (1600 mg/m2/d on days 2 through 5) (arm B). RESULTS: In an intent-to-treat analysis, there were 32 (56%) and 24 (42%) complete responses in arms A and B, respectively (p=0.099). After a median follow-up of 9.7 yr, 31 and 27 patients have continuously shown no evidence of disease in arms A and B, respectively. There was no significant difference between the overall survival curves (p=0.167). According to the International Germ Cell Cancer Collaborative Group prognostic classification, the 5-yr survival rates were 88% and 82% in the intermediate group and 69% and 44% in the poor group (p=0.045) in arms A and B, respectively. CONCLUSIONS: This trial failed to demonstrate an impact on response and survival of high-dose chemotherapy with haematopoietic support in first-line treatment of patients with high-volume, metastatic nonseminomatous germ cell tumours.
RCT Entities:
OBJECTIVES: To assess the impact on survival of high-dose chemotherapy with haematopoietic support in patients with high-volume, metastatic nonseminomatous germ cell tumours. METHODS: One hundred fifteen patients were randomised to receive either four cycles every 21 d of vinblastine (0.2 mg/kg on day 1), etoposide (100 mg/m2/d on days 1 through 5), cisplatin (40 mg/m2/d on days 1 through 5), and bleomycin (30 mg on days 1, 8, and 15) (arm A), or a slightly modified regimen followed by a high-dose chemotherapy including etoposide (350 mg/m2/d on days 1 through 5), cisplatin (40 mg/m2/d on days 1 through 5), and cyclophosphamide (1600 mg/m2/d on days 2 through 5) (arm B). RESULTS: In an intent-to-treat analysis, there were 32 (56%) and 24 (42%) complete responses in arms A and B, respectively (p=0.099). After a median follow-up of 9.7 yr, 31 and 27 patients have continuously shown no evidence of disease in arms A and B, respectively. There was no significant difference between the overall survival curves (p=0.167). According to the International Germ Cell Cancer Collaborative Group prognostic classification, the 5-yr survival rates were 88% and 82% in the intermediate group and 69% and 44% in the poor group (p=0.045) in arms A and B, respectively. CONCLUSIONS: This trial failed to demonstrate an impact on response and survival of high-dose chemotherapy with haematopoietic support in first-line treatment of patients with high-volume, metastatic nonseminomatous germ cell tumours.
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: Irbaz Bin Riaz; Muhammad Umar; Umar Zahid; Muhammad Husnain; Ahmad Iftikhar; Ali McBride; Jawad Bilal; Asad Javed; Sara Akbar; Parminder Singh; Zeeshan Ali; Qurat Ul Ain Riaz Sipra; Farva Razia Gondal; Frederick Ahman; Faiz Anwer Journal: Bone Marrow Transplant Date: 2018-04-27 Impact factor: 5.483
Authors: Robert J Hamilton; Christina Canil; Noa Shani Shrem; Kopika Kuhathaas; Maria Di Jiang; Peter Chung; Scott North; Piotr Czaykowski; Sebastien Hotte; Eric Winquist; Christian Kollmannsberger; Armen Aprikian; Denis Soulières; Scott Tyldesley; Alan I So; Nicholas Power; Ricardo A Rendon; Martin O'Malley; Lori Wood; Michael A S Jewett Journal: Can Urol Assoc J Date: 2022-06 Impact factor: 2.052