Harstrick A, Schmoll H J, Wilke H, Köhne-Wömpner C H, Stahl M, Schöber C, Casper J, Bruderek L, Schmoll E, Bokemeyer C
Department of Hematology and Oncology, University of Hannover Medical School, Germany.
J Clin Oncol. 1991 Sep;9(9):1549-55. doi: 10.1200/JCO.1991.9.9.1549.
Thirty patients with metastatic progressive germ cell carcinoma who failed to be cured with first-line cisplatin chemotherapy were treated with a salvage regimen consisting of cisplatin 20 mg/m2, etoposide 100 mg/m2, and ifosfamide 1.2 g/m2 (PEI) intravenously (IV), days 1 to 5 every 3 weeks. Ten patients (33%) were tumor-free at the end of therapy. Complete response (CR) was achieved with chemotherapy alone in four patients and with additional surgery in six patients (two necroses, two mature teratomas, two carcinomas). Six patients (20%) had normalization of tumor markers but unresectable residual disease (Rm-), and the remaining 14 patients (46%) failed to respond. Of 10 patients with CR, nine (90%) relapsed again (eight carcinomas, one mature teratoma). The median duration of CR was 3.5 months. The median survival of the whole group was 311 days (range, 110 to 996+). Currently, seven of 30 patients are alive, and five of them are without signs of progressive tumor. The response to prior cisplatin therapy predicted for response and survival after PEI salvage therapy. Of 14 patients with prior CR, eight (57%) achieved a second CR compared with one of 11 (9%) with prior unfavorable response (P = .039). The median survival for patients with prior favorable response was 400 days, compared with 251 days for patients with prior unfavorable response (P less than .001). Myelosuppression was dose-limiting, with leukopenia greater than grade 2 in 84% and thrombocytopenia greater than grade 2 in 51% of all cycles. This three-drug regimen can induce a second CR in one third of patients with relapsed or refractory germ cell carcinoma. Only those patients with prior favorable responses can expect to be cured by this salvage regimen, while patients with prior unfavorable response should be considered for alternative salvage approaches.
30例一线顺铂化疗未能治愈的转移性进展性生殖细胞癌患者接受了挽救方案治疗，该方案为顺铂20mg/m²、依托泊苷100mg/m²和异环磷酰胺1.2g/m²（PEI）静脉滴注，第1至5天，每3周重复一次。10例患者（33%）在治疗结束时无肿瘤。4例患者单纯化疗达到完全缓解（CR），6例患者（2例坏死、2例成熟畸胎瘤、2例癌）在化疗基础上接受额外手术达到CR。6例患者（20%）肿瘤标志物恢复正常但有不可切除的残留病灶（Rm-），其余14例患者（46%）无反应。10例CR患者中，9例（90%）再次复发（8例癌、1例成熟畸胎瘤）。CR的中位持续时间为3.5个月。全组的中位生存期为311天（范围110至996+）。目前，30例患者中有7例存活，其中5例无肿瘤进展迹象。对既往顺铂治疗的反应可预测PEI挽救治疗后的反应和生存情况。既往CR的14例患者中，8例（57%）获得第二次CR，而既往反应不佳的11例患者中只有1例（9%）获得第二次CR（P=0.039）。既往反应良好患者的中位生存期为400天，既往反应不佳患者为251天（P＜0.001）。骨髓抑制是剂量限制性毒性，所有周期中84%出现2级以上白细胞减少，51%出现2级以上血小板减少。这种三药方案可使三分之一复发或难治性生殖细胞癌患者获得第二次CR。只有既往反应良好的患者有望通过这种挽救方案治愈，而既往反应不佳的患者应考虑采用其他挽救方法。
