Which regimen should be considered standard of care for goodrisk metastatic germ cell tumor

The clinician treating the patient who has good-risk metastatic GCT has an initial decision to make: should the patient be treated with BEP for three cycles or EP for four cycles? At the 2003 meeting of the American Society of Clinical Oncology (ASCO), Culine and colleagues [16] presented a randomized trial comparing three cycles of BEP to four cycles of EP in patients who had good-risk metastatic GCT. The primary endpoint of the trial was a ''favorable response rate'' (FRR), defined as chemotherapy complete response, surgical complete response, or markernegative partial response. The trial was designed to demonstrate less than 10% difference in FRR between the two arms. A total of 270 patients were randomized and 258 patients were eligible. The FRR was 92% for the BEP arm versus 91% for the EP arm (P = .6). No statistically significant differences in 4-year event-free survival or 4-year overall survival were reported. The final results of this trial have not been published in a peer-reviewed journal. In this author's opinion, either three cycles of BEP or four cycles of EP should be considered standard of care in the management of good-risk metastatic GCT.

Which of these two regimens should be preferred? The treating physician and patient need to individualize the choice of treatment and discuss the relative pros and cons of each. Given that risk factors for BIP in patients who have GCT include age greater than 40 years, renal dysfunction, underlying pulmonary disease, smoking, and cumulative bleomycin dose, there may be reason to choose four cycles of EP and avoid bleomycin. It should be remembered, however, that the overall risk for BIP with 270 units of bleomycin is low, so avoidance of bleomycin in young individuals who have normal renal and pulmonary function is not warranted. In patients who have underlying peripheral neuropathy or hearing loss in whom minimizing cisplatin exposure might be advantageous, three cycles of BEP may be preferred to avoid the extra cycle of cisplatin.

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