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 Anti-Cancer Agents & Biologic Therapy
Germ Cell Tumours
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.