Williams S, Blessing J A, Liao S Y, Ball H, Hanjani P
Department of Medicine, Indiana University Cancer Center, Indianapolis.
J Clin Oncol. 1994 Apr;12(4):701-6. doi: 10.1200/JCO.1994.12.4.701.
This study was performed to determine the effectiveness of postoperative adjuvant chemotherapy in patients with surgically resected ovarian germ cell tumors.
After tumor removal and thorough surgical staging, patients were enrolled on this study and treated with three courses of cisplatin, etoposide, and bleomycin (BEP). Reassessment laparotomy was required of consenting, appropriate patients initially, but became an optional procedure in 1989.
Of 93 patients assessable on this trial, 89 are continuously free of germ cell cancer. At second-look laparotomy, two other patients were found to have small foci of immature teratoma; both remain clinically free of recurrence. One received subsequent alternate chemotherapy and one did not. Thus, 91 of 93 patients are currently free of germ cell cancer. Follow-up duration ranges from 4.0 to 90.3 months, with 67 patients monitored for longer than 2 years. Acute toxicity was moderate. One patient developed acute myelomonocytic leukemia 22 months after diagnosis. Another patient was noted to have a malignant lymphoma 69 months after protocol treatment.
Three courses of BEP will nearly always prevent recurrence in well-staged patients with completely resected ovarian germ cell tumors and should be given to all such patients. The development of acute leukemia as a complication of treatment is disturbing and mandates careful long-term follow-up, but is unusual and does not alter the risk-to-benefit ratio of treatment.
本研究旨在确定术后辅助化疗对接受手术切除的卵巢生殖细胞肿瘤患者的疗效。
肿瘤切除及全面手术分期后，患者入组本研究并接受三个疗程的顺铂、依托泊苷和博来霉素（BEP）治疗。最初，需对同意且合适的患者进行再次剖腹探查，但在1989年这成为了可选程序。
在本试验可评估的93例患者中，89例持续无生殖细胞癌。在二次剖腹探查时，发现另外两名患者有未成熟畸胎瘤小病灶；两人临床上均无复发。一人接受了后续的替代化疗，一人未接受。因此，93例患者中有91例目前无生殖细胞癌。随访时间为4.0至90.3个月，67例患者监测时间超过2年。急性毒性为中度。一名患者在诊断后22个月发生急性粒单核细胞白血病。另一名患者在方案治疗后69个月被发现患有恶性淋巴瘤。
三个疗程的BEP几乎总能预防分期良好、卵巢生殖细胞肿瘤完全切除患者的复发，所有此类患者均应接受该治疗。治疗后出现急性白血病作为并发症令人不安，需要仔细的长期随访，但并不常见，也不会改变治疗的风险效益比。
