G Daugaard1, I Skoneczna2, N Aass3, R De Wit4, M De Santis5, H Dumez6, S Marreaud7, L Collette7, J R G Lluch8, C Bokemeyer9, H J Schmoll10. 1. Department of Oncology, Rigshospitalet, Copenhagen, Denmark. Electronic address: gedske.daugaard@rh.regionh.dk. 2. Department of Urology, Chemotherapy Unit, Maria Sklodowska-Curie Memorial Center, Warsaw, Poland. 3. Department of Oncology, Oslo University Hospital and University of Oslo, Oslo, Norway. 4. Department Medical Oncology, Erasmus University Hospital, Rotterdam, The Netherlands. 5. LBI-ACR VIEnna and ACR-ITR VIEnna/CEADDP-Kaiser Franz Josef-Spital, Vienna, Austria. 6. Department of Oncology, University Hospitals, Leuven, Belgium. 7. European Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium. 8. Institut Català d'Oncologia, Htal. Duran i Reynals, Hòspitalet Barcelona, Barcelona, Spain. 9. Department of Oncology, Hematology and Bone Marrow Transplantation with Section Pneumology, Hubertus Wald Cancer Center (UCCH), University Medical Center Hamburg Eppendorf, Hamburg. 10. Department of Oncology and Hematology, Martin Luther University, Halle, Germany.
Abstract
BACKGROUND: To compare the efficacy of one cycle of standard dose cisplatin, etoposide, and ifosfamide (VIP) plus three cycles of high-dose VIP followed by stem-cell infusion [high-dose chemotherapy (HD-CT arm)] to four cycles of standard cisplatin, etoposide, and bleomycin (BEP) in patients with poor-prognosis germ-cell cancer (GCC). PATIENT AND METHODS: Patients with poor-prognosis GCC were assigned to receive either BEP or VIP followed by HD-CT. To show a 15% improvement in a 1-year failure-free survival (FFS), the study aimed to recruit 222 patients but closed with 137, due to slow accrual. RESULTS:One hundred thirty-one patients were included in this analysis. The complete response rates in the HD-CT and in the BEP arm did not differ: (intention to treat) 44.6% versus 33.3% (P = 0.18). There was no difference in FFS between the two treatment arms (P = 0.057, 66 events). At 2 years, the FFS rate was 44.8% [95% confidence interval (CI) 32.5-56.4] and 58.2%, respectively (95% CI 48.0-71.9); but this 16.3% (standard deviation 7.5%) difference was not statistically significant (P = 0.060). Overall survival did not differ between the two groups (log-rank P > 0.1, 47 deaths). CONCLUSION: This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC.
RCT Entities:
BACKGROUND: To compare the efficacy of one cycle of standard dose cisplatin, etoposide, and ifosfamide (VIP) plus three cycles of high-dose VIP followed by stem-cell infusion [high-dose chemotherapy (HD-CT arm)] to four cycles of standard cisplatin, etoposide, and bleomycin (BEP) in patients with poor-prognosis germ-cell cancer (GCC). PATIENT AND METHODS: Patients with poor-prognosis GCC were assigned to receive either BEP or VIP followed by HD-CT. To show a 15% improvement in a 1-year failure-free survival (FFS), the study aimed to recruit 222 patients but closed with 137, due to slow accrual. RESULTS: One hundred thirty-one patients were included in this analysis. The complete response rates in the HD-CT and in the BEP arm did not differ: (intention to treat) 44.6% versus 33.3% (P = 0.18). There was no difference in FFS between the two treatment arms (P = 0.057, 66 events). At 2 years, the FFS rate was 44.8% [95% confidence interval (CI) 32.5-56.4] and 58.2%, respectively (95% CI 48.0-71.9); but this 16.3% (standard deviation 7.5%) difference was not statistically significant (P = 0.060). Overall survival did not differ between the two groups (log-rank P > 0.1, 47 deaths). CONCLUSION: This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC.
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