Germà-Lluch J R, Garcia del Muro X, Tabernero J M, Sánchez M, Aparicio J, Alba E, Barnadas A
Department of Medical Oncology, Institut Català d'Oncologia, Barcelona, Spain.
Ann Oncol. 1999 Mar;10(3):289-93. doi: 10.1023/a:1008351022211.
Patients with poor-prognosis germ-cell tumors according to the IGCCC have a poor long-term survival. This study evaluates the efficacy and toxicity of the intensive alternating chemotherapy regimen BOMP/EPI in these patients.
Patients with IGCCC poor-prognosis germ-cell tumors treated at 13 centres were studied. Treatment consisted of bleomycin 30 mg, vincristine 2 mg, methotrexate 300 mg/m2 and cisplatin 100 mg/m2 (BOMP), alternating after a 14-day interval with etoposide 120 mg/m2 day 1-4, ifosfamide 1.3 g/m2 day 1-4 and cisplatin 25 mg/m2 day 1-4 (EPI). BOMP was administered 21 days after the EPI. Bleomycin was administered weekly per 12 weeks.
Thirty-eight patients were treated. The median number of cycles administered was 7 (1-10 cycles). Eighteen patients achieved complete responses with chemotherapy alone (12 had necrosis and 2 mature teratoma at postchemotherapy resection), and four achieved complete responses with chemotherapy and surgical resection of viable cancer. Thus, an overall favorable response was achieved in 22 patients (60%). Four additional patients had marker-negative non-resected residual masses. Eleven patients were considered treatment failures, including one who died early and another who succumbed to granulocytopenic sepsis and renal failure. Hematologic toxicity was the most common, with 26 patients (70%) having grade 4 granulocytopenia. After a median follow-up of 41 months, the actuarial two-year overall survival and progression-free survival were 64% and 58%, respectively.
BOMP/EPI is active in poor-prognosis germ-cell tumors according to the IGCCC criteria. The results obtained compare favorably with those expected with conventional chemotherapy, and justify further studies.
根据国际生殖细胞癌协作组(IGCCC)标准,预后不良的生殖细胞肿瘤患者长期生存率较低。本研究评估了强化交替化疗方案BOMP/EPI对这些患者的疗效和毒性。
对在13个中心接受治疗的IGCCC预后不良生殖细胞肿瘤患者进行研究。治疗方案包括博来霉素30mg、长春新碱2mg、甲氨蝶呤300mg/m²和顺铂100mg/m²(BOMP),间隔14天后交替使用依托泊苷120mg/m²第1 - 4天、异环磷酰胺1.3g/m²第1 - 4天和顺铂25mg/m²第1 - 4天(EPI)。BOMP在EPI后21天给药。博来霉素每12周每周给药一次。
38例患者接受治疗。给药周期中位数为7个(1 - 10个周期)。18例患者单纯化疗即获得完全缓解(12例化疗后切除标本有坏死,2例为成熟畸胎瘤),4例患者化疗联合手术切除存活癌灶后获得完全缓解。因此,22例患者(60%)获得总体良好反应。另外4例患者有标志物阴性的未切除残留肿块。11例患者被视为治疗失败,包括1例早期死亡和另1例死于粒细胞缺乏性败血症及肾衰竭。血液学毒性最常见,2