Einhorn L H, Williams S D, Loehrer P J, Birch R, Drasga R, Omura G, Greco F A
Department of Medicine, Indiana University, Indianapolis.
J Clin Oncol. 1989 Mar;7(3):387-91. doi: 10.1200/JCO.1989.7.3.387.
Four courses of PVP16B (cisplatin plus etoposide [VP-16] plus bleomycin) has been standard chemotherapy for disseminated germ cell tumors at Indiana University and the Southeastern Cancer Study Group (SECSG) since 1984. We began a random prospective phase III study in patients with favorable-prognosis (minimal and moderate extent) disseminated germ cell tumors comparing four courses of PVP16B over 12 weeks to the identical dose PVP16B administered in three courses over 9 weeks. The categories of minimal and moderate disease constitute approximately two thirds of all disseminated germ cell tumors that require chemotherapy. One hundred eighty-four patients entered this trial, and all patients have a minimal follow-up of 1 year. Overall, 106 of 107 (99%) minimal extent and 73 of 77 moderate patients (95%) achieved an initial disease-free status (NED), confirming the favorable prognostic categories. Eighty-six of 88 patients (98%) randomized to three courses and 93 of 96 randomized to four courses (97%) of PVP16B achieved disease-free status. There have been ten relapses (5%), with five on each arm. Currently, 81 of 88 (92%) and 88 of 96 (92%) patients randomized to three v four courses of PVP16B are continuously disease-free. This study confirms the high cure rate with PVP16B in favorable-prognosis germ cell tumors. The deletion of the fourth course of PVP16B significantly reduces the toxicity, cost, and inconvenience of this curative regimen. We conclude that three courses of PVP16B is the preferred regimen for favorable-prognosis germ cell tumors.
自1984年以来，四疗程的PVP16B（顺铂加依托泊苷[VP - 16]加博来霉素）一直是印第安纳大学和东南癌症研究组（SECSG）针对播散性生殖细胞肿瘤的标准化疗方案。我们开展了一项随机前瞻性III期研究，针对预后良好（轻度和中度播散）的播散性生殖细胞肿瘤患者，比较12周内进行四疗程PVP16B与9周内进行三疗程相同剂量PVP16B的疗效。轻度和中度疾病类别约占所有需要化疗的播散性生殖细胞肿瘤的三分之二。184名患者进入该试验，所有患者的最短随访期为1年。总体而言，107例轻度患者中的106例（99%）和77例中度患者中的73例（95%）达到了初始无病状态（NED），证实了这些预后良好的类别。随机接受三疗程PVP16B的88例患者中的86例（98%）和随机接受四疗程PVP16B的96例患者中的93例（97%）达到了无病状态。出现了10例复发（5%），每组各有5例。目前，随机接受三疗程或四疗程PVP16B的88例患者中的81例（92%）和96例患者中的88例（92%）仍持续无病。本研究证实了PVP16B对预后良好的生殖细胞肿瘤具有高治愈率。删除PVP16B的第四疗程可显著降低这种治愈性方案的毒性、成本和不便之处。我们得出结论，三疗程的PVP16B是预后良好的生殖细胞肿瘤的首选方案。
