A randomized trial of standard chemotherapy v a high-dose chemotherapy regimen in the treatment of poor prognosis nonseminomatous germ-cell tumors.

摘要: We performed a prospective randomized trial of high-dose chemotherapy regimen v standard cisplatin-based in poor prognosis nonseminomatous germ-cell cancer patients. The consisting twice the dose cisplatin (P), along with vinblastine (Ve), bleomycin (B), and epipodophylotoxin etoposide (VP-16) (V) (PVeBV) was compared to classic normal cisplatin, vinblastine, (PVeB). Eligibility criteria included large abdominal masses, liver metastases, multiple pulmonary brain marked elevations serum tumor markers (alpha-fetoprotein greater than 1,000 ng/mL or beta-subunit human chorionic gonadotropin 10,000 mIU), unfavorable histology (pure choriocarcinoma), extragonadal tumors. Fifty-two consecutive patients prognostic features were receive either PVeBV PVeB. median follow-up is 4 years. Treatment increased complete remission rate (88% 67%, P = .14) associated lower relapse (17% 41%, .2). survival receiving therapy 30 months, while for has not been reached. Actuarial 5-year treated 78%, 48% (two-sided Mantel-Cox test .06). Disease-free also superior (P .03). Sixty-eight percent (23 34) are alive continuously disease-free, 33% (six 18) PVeB .02). major difference toxicity between severity myelosuppression incidence severe hearing loss. Ninety-one had WBC count less 1,000/microL, 50% .05). Hearing aids recommended 12 who received two effectiveness may relate double-dose addition VP-16, synergistic effect these drugs.