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Quality of Life in Good Prognosis Patients With Metastatic Germ Cell Cancer: A Prospective Study of the European Organization for Research and Treatment of Cancer Genitourinary Group/Medical Research Council Testicular Cancer Study Group (30941/TE20)

Sophie D. Fosså, Ronald de Wit, J. Trevor Roberts, Peter M. Wilkinson, Pieter H.M. de Mulder, Graham M. Mead, Pat Cook, Linda de Prijck, Sally Stenning, Neil K. Aaronson, Andrew Bottomley, Laurence Collette

From the Norwegian Radium Hospital, Oslo, Norway; Rotterdam Cancer Institute and University Hospital, Rotterdam; University Hospital, Nijmegen; and The Netherlands Cancer Institute, Amsterdam, the Netherlands; Northern Centre for Cancer Treatment, Newcastle upon Tyne; Christie Hospital, Manchester; Royal South Hants Hospital, Southampton; and Medical Research Council Cancer Trials Unit, London, United Kingdom; and European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium.

Address reprint requests to Sophie D. Fosså, MD, Norwegian Radium Hospital, Montebello, 0310 Oslo, Norway; email: s.d.fossa{at}klinmed.uio.no.

Purpose: To describe global quality of life (GLQL) in patients with metastatic testicular cancer (TC) treated with four different schedules of bleomycin, etoposide, and cisplatin (BEP) chemotherapy (four v three cycles given over 5 v 3 days).

Patients and Methods: Quality-of-life data were prospectively collected in 666 patients with metastatic TC entered into the European Organization for Research and Treatment of Cancer (EORTC) Trial 30941/United Kingdom Medical Research Council Trial TE20, using the EORTC Quality-of-Life Questionnaire C30 and a TC module. Data were analyzed by a mixed effects model and by evaluation of clinically relevant changes at 2 years.

Results: The pattern of GLQL changes was similar in the four groups. Two years after chemotherapy, 36% of patients displayed improved GLQL as compared with baseline, whereas GLQL had deteriorated in 13%. At 3 months, patients receiving the 3-day regimen experienced increased gastrointestinal (GI) toxicity more than those receiving the 5-day regimen, with the difference reaching the level of clinical relevance ( 10-point change) if four cycles were given. The 3-day schedule increased the 2-year risk of tinnitus, with clinical relevance demonstrated after four cycles. Long-term peripheral neuropathy and Raynaud-like phenomena were not associated with the number of cycles or days per cycle. At 2 years, Raynaud-like phenomena, tinnitus, or reduced hearing were reported by 21% to 26% of the patients.

Conclusion: Because of the excess of acute GI toxicity and the increased risk of tinnitus after the 3-day regimen, we recommend the 5-day regimen if four cycles of BEP are planned. If only three cycles are to be given, then the 3-day regimen is acceptable, even given the increased risk of nausea/vomiting at 3 months.

Supported by grants 5U10 CA11488-24 through 2U10 CA11488-31 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.

The contents of this article are the sole responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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