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Accelerated BEP : a phase I trial of dose-dense BEP for intermediate and poor prognosis metastatic germ cell tumour

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Rimmer, Yvonne, Chester, John, Joffe, Johnathan, Stark, Daniel, Shamash, Jonathan, Powles, Thomas, White, J., Wason, James, Parashar, D., Armstrong, G. (Georgina), Mazhar, Danish and Williams, M. V. (2011) Accelerated BEP : a phase I trial of dose-dense BEP for intermediate and poor prognosis metastatic germ cell tumour. British Journal of Cancer, 105 (6). pp. 766-772. doi:10.1038/bjc.2011.309

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Official URL: http://dx.doi.org/10.1038/bjc.2011.309

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Abstract

Background:
We used bleomycin, etoposide, cisplatin (BEP), the most effective regimen in the treatment of germ cell tumours (GCTs) and increased dose-density by using pegfilgrastim to shorten cycle length. Our aim was to assess safety and tolerability.

Methods:
Sixteen male patients with intermediate or poor prognosis metastatic GCT were treated with four cycles of 3-day BEP with G-CSF on a 14-day cycle for a planned relative dose-density of 1.5 compared with standard BEP.

Results:
Eleven intermediate and five poor prognosis patients were treated. In all, 14 of 16 patients completed the study treatment. Toxicities were comparable to previous studies using standard BEP, except for mucositis and haematological toxicity that were more severe. The overall relative dose-density for all 16 patients was mean 1.38 (range 0.72–1.5; median 1.46). Complete response was achieved after chemotherapy alone in two patients (13%) and following chemotherapy plus surgery in nine additional patients (56%). Four patients (25%) had a partial response and normalised their marker levels. At a median follow-up of 4.4 years (range 2.1–6.8) the estimated 5-year progression-free survival probability is 81% (95% CI 64–100%).

Conclusion:
Accelerated BEP is tolerable without major additional toxicity. A randomised controlled trial will be required to obtain comparative efficacy data.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Cancer -- Chemotherapy, Bleomycin
Journal or Publication Title: British Journal of Cancer
Publisher: Nature Publishing Group
ISSN: 0007-0920
Official Date: 6 September 2011
Dates:
DateEvent
6 September 2011Published
16 August 2011Available
12 July 2011Accepted
22 March 2011Submitted
Volume: 105
Number: 6
Number of Pages: 7
Page Range: pp. 766-772
DOI: 10.1038/bjc.2011.309
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: National Institute for Health Research (Great Britain) (NIHR)

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