862P - Continuous infusion bleomycin in the BEP regimen: a therapeutic alternative in the management of patients with germ-cell tumors?

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Germ Cell Tumours
Therapy
Biological Therapy
Presenter Carole Helissey
Authors C. Helissey1, L. Védrine2, B. Ceccaldi2, A. Houlgatte3, H. Mullot4, O. Bauduceau5, C. Chargari2, C. Massard6, K. Fizazi7, S. Le Moulec8
  • 1HIA Val de Grace, 75005 - Paris/FR
  • 2Oncology And Radiation Oncology, Hôpital d'instruction des armées du Val-de-Grâce, Paris/FR
  • 3Urology, HIA Val de Grace, 75005 - Paris/FR
  • 4Pharmacy, HIA Sainte Anne, Toulon/FR
  • 5Oncology Radiotherapy, HIA Val de Grace, 75005 - Paris/FR
  • 6Sitep, Institut Gustave Roussy, FR-94805 - Villejuif CEDEX/FR
  • 7Department Of Medical Oncology, Institute Gustave Roussy, FR-94805 - Villejuif/FR
  • 8Oncologie Medicale, Val de Grace Hospital, Paris/FR

Abstract

Introduction

Germ-cell tumors (GCTs) are highly curable with cisplatin-based chemotherapy. The BEP chemotherapy (Indianapolis) has become a standard in the management of GCT. The aim of this study was to evaluate the long-term side effects of a modified BEP regimen, with of bleomycin as a continuous infusion.

Patients and methods

The military hospital of Val de Grâce has developed a modified BEP regimen with the aim of reducing bleomycin-induced toxicity in patients with GCTs: bleomycin 15mg/d (d1-5) as an IV continuous injection, etoposide 100mg/m2 (d1-5) and cisplatin 20mg/m2 (d1-5), repeated every 3 weeks. Survivors were asked in 2011 to participate to this study on late toxicity, including assessment of laboratory tests, pulmonary function tests (PFT) and a semen analysis.

Results

Between March 1998 and January 2009, 68 patients with GCTs received first line chemotherapy with this modified BEP. Distribution of patients' was as following: Good prognosis (GP): 42, Intermediate and Poor-prognosis (IPP): 20, stage I with High risk factors (HP): 6. The median follow-up was 75 months. The 2-years overall survival was 90%. The relapse rate was 13%. The main immediate adverse events reported grade III-IV were neutropenia (25%), anemia (1%), thombopenia (1%), digestive (6%), infection (4%), decreased DLCO (4%) and tromboembolic events (3%). Thirty four patients were assessable for the late toxicity of this regimen (18 patients in GP, 14 patients in IPP and 2 patients in HP).The 5-years overall survival was 82%. The analysis of late side effects revealed one patient developed a haematologic malignancy (myelodysplasia).Abnormal PFT was observed in 4 patients, and only 1 patient was clinically symptomatic. In post-treatment analysis, we evaluated the fertility of 30 patients. The fertility was preserved in 22 patients (73%). Twenty patients have realized a semen analysis after the chemotherapy, and azoospermia was observed in only 3 pts (15%). Among 10 patients remaining, 5 patients had children after the treatment.

Conclusion

Using bleomycin as a continuous infusion is feasible and seems to produce similar results in terms of response rates and overall survival compared to the classic BEP chemotherapy regimen, with a total dose less important than standard. These results will be compared with those of conventional BEP

Disclosure

All authors have declared no conflicts of interest.