To evaluate the potential effect of patient selection on chemotherapy trials for patients with advanced germ cell tumors (GCT), four sets of eligibility criteria for poor risk trials were compared in 118 patients. A significant difference was found in the number of patients designated poor risk by the various criteria (P less than .005). Disagreement in the risk assignment by the various selection criteria was seen in 44% of patients. Initial complete response (CR) rates in patients designated poor risk by the various criteria ranged from 38% to 62%. Initial CR rates as high as 94% were seen in patients considered to be poor risk by one set of criteria, but good risk by another. Substantial differences in sensitivity, specificity, overall predictive value, and survival distributions were observed for the various selection criteria. Randomized trials will be necessary to reduce the influence of eligibility criteria on trial outcome and conclusions.

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A phase II trial of 6 months of alternating etoposide plus cisplatin (EP) and cyclophosphamide, vinblastine, actinomycin D, bleomycin, cisplatin (VAB-6) was conducted in 41 evaluable patients in an attempt to improve the treatment results in those patients considered to have "poor-risk" germ cell tumors (GCT). Eight of 14 (57%) patients with mediastinal and retroperitoneal GCTs achieved complete remission (CR), and five (36%) remain alive and free of disease. Fourteen of 27 patients (52%) with poor-risk testicular cancer achieved CR, and ten (37%) remain alive and free of disease. Two patients with seminoma, one each with a testicular and extragonadal primary tumor, achieved durable CRs. Toxicity was tolerable, but greater than that of VAB-6 alone. The response and survival of the 39 patients with nonseminomatous tumors were found to be identical to the results of 29 patients with nonseminomatous GCTs and poor-risk characteristics who were treated with VAB-6 alone. Thus, this 6-month schedule of alternating months of chemotherapy is not recommended for patients with poor-risk GCTs. Patients with such tumors should be referred to centers conducting prospective trials, so that research seeking better therapy may continue.

Among 216 patients with metastatic germ cell tumors who achieved a complete response (CR) to cisplatin-based chemotherapy (CT), 38 have experienced a relapse. Prognostic factors for time to relapse from time of response were considered using the Cox proportional hazards model. Compared with patients who responded to CT and did not require surgery and patients whose surgery showed only either necrotic debris or mature teratoma, those who required surgery for residual tumor after CT were at much higher risk for relapse, although their residual tumor was totally resected. Of the 19 patients who required this surgery, eight have experienced a relapse. Other prognostic factors for relapse included lactate dehydro-genase (LDH) and human chorionic gonadatropin (hCG) at the time of initial CT. Although those who require surgery for residual tumor after CT receive additional CT, there is still a high risk of relapse. Cancer 63440-445, 1989.

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To determine whether transurethral prostatectomy results in higher long-term mortality rates than open prostatectomy, we reviewed retrospectively 1,125 patients treated by transurethral and 190 treated by nonperineal open prostatectomy for benign disease at 1 institution from 1978 through 1987. Patients in whom prostatic cancer was found were excluded. We identified age, preoperative medical illnesses and urinary retention, American Society of Anesthesiologists category, type of anesthesia, length of followup, health status and cause of death. For statistical analysis the study cohort consisted of 527 patients in whom the charts were complete and followup was adequate (421 in the transurethral prostatectomy and 106 in the open prostatectomy groups). Mean age for the 2 groups was 66.3 and 67.5 years, respectively. With an average followup of 70.7 months 77% of the transurethral prostatectomy group were alive, compared to 78% of the open prostatectomy group at an average followup of 71.4 months. We found no supportive evidence that transurethral prostatectomy results in higher long-term mortality rates than does an open operation (log-rank test p = 0.74). Also, there was no significant survival difference in patients who required a preoperative Foley catheter. We also examined a subset of patients with adequate followup who had no significant medical history (for example hypertension, diabetes, heart disease and so forth) and compared them to patients with medical illnesses at prostatectomy. There was a significant survival difference between those with and without preoperative medical conditions (Wilcoxon test p = 0.047) in the transurethral prostatectomy group but not in the open group (p = 0.58). However, there was no significant survival difference between procedures among the healthiest subset of patients (p = 0.16).

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