A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974).

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.

• 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: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 5 Pg. 1054-1061 (May 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 21059637 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• AFP protein, human
• Biomarkers, Tumor
• Chorionic Gonadotropin
• alpha-Fetoproteins
• Bleomycin
• Etoposide
• L-Lactate Dehydrogenase
• Cisplatin
• Ifosfamide

Topics

• Adolescent
• Adult
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biomarkers, Tumor (blood)
• Bleomycin (adverse effects, therapeutic use)
• Chorionic Gonadotropin (blood)
• Cisplatin (adverse effects, therapeutic use)
• Disease-Free Survival
• Etoposide (adverse effects, therapeutic use)
• Humans
• Ifosfamide (adverse effects, therapeutic use)
• Kaplan-Meier Estimate
• L-Lactate Dehydrogenase (blood)
• Male
• Mediastinal Neoplasms (diagnosis, mortality, therapy)
• Middle Aged
• Neoplasm Metastasis
• Neoplasms, Germ Cell and Embryonal (diagnosis, mortality, therapy)
• Prognosis
• Retroperitoneal Neoplasms (diagnosis, mortality, therapy)
• Stem Cell Transplantation
• Testicular Neoplasms (diagnosis, mortality, therapy)
• Young Adult
• alpha-Fetoproteins (metabolism)