Shimizu Y, Akiyama F, Umezawa S, Ishiya T, Utsugi K, Hasumi K
Department of Gynecology, Cancer Institute Hospital, Tokyo, Japan.
J Clin Oncol. 1998 May;16(5):1869-78. doi: 10.1200/JCO.1998.16.5.1869.
To evaluate the efficacy and toxicity of combination chemotherapy with bleomycin, vincristine, mitomycin, and consecutive low-dose (CLD) administration of cisplatin (CLD-BOMP) for patients with recurrent cervical carcinoma.
Ninety patients with recurrent cervical carcinoma and no prior chemotherapy were enrolled onto this study. The median age was 56 years. Eighty-seven of the 90 patients had received prior radiotherapy. The CLD-BOMP regimen was bleomycin 5 mg infused continuously days 1 through 7; vincristine 0.7 mg/m2 bolus day 7; mitomycin 7 mg/m2 bolus day 7; and cisplatin 10 mg/m2 infused over 4 hours days 1 through 7. The treatment was repeated at 3-week intervals.
All 90 patients were assessable for response, toxicity, and survival. After a median of four cycles (range, two to 10 cycles), we observed objective responses in 68 patients (76%), with 25 (28%) complete responses (CRs) and 43 (48%) partial responses (PRs; 95% confidence interval (CI), 66 to 85; 18 to 38; 37 to 59, respectively). Median survival for all 90 patients was 24.3 months (range, 2.3 to 100 months). The median survival for patients who achieved CR, PR, no change (NC), and progressive disease (PD) were not reached (NR), 23.6, 8.2, and 6.4 months, respectively. The median progression-free survival for patients who achieved CR and PR were NR and 12.3 months, respectively. There was no significant nausea or vomiting, nephrotoxicity, or pulmonary toxicity, which was attributable to the CLD-cisplatin and the adequate dosing schedule of bleomycin. The reduced toxicities allowed this regimen to be administered at the projected dose-intensities.
The CLD-BOMP regimen has significant antitumor activity with markedly reduced toxicity.
评估博来霉素、长春新碱、丝裂霉素联合顺铂连续低剂量(CLD)给药(CLD-BOMP)方案对复发性宫颈癌患者的疗效和毒性。
90例既往未接受过化疗的复发性宫颈癌患者纳入本研究。中位年龄为56岁。90例患者中有87例曾接受过放疗。CLD-BOMP方案为:博来霉素5mg,第1至7天持续输注;长春新碱0.7mg/m²,第7天静脉推注;丝裂霉素7mg/m²,第7天静脉推注;顺铂10mg/m²,第1至7天4小时内输注完毕。每3周重复一次治疗。
所有90例患者均可评估疗效、毒性和生存情况。中位治疗4个周期(范围2至10个周期)后,68例患者(76%)出现客观缓解,其中25例(28%)完全缓解(CR),43例(48%)部分缓解(PR;95%置信区间分别为66%至85%、18%至38%、37%至59%)。90例患者的中位生存期为24.3个月(范围2.3至100个月)。达到CR、PR、疾病稳定(NC)和疾病进展(PD)的患者中位生存期分别未达到(NR)、23.6个月、8.2个月和6.4个月。达到CR和PR的患者中位无进展生存期分别未达到和12.3个月。未出现明显的恶心或呕吐、肾毒性或肺毒性,这归因于CLD-顺铂以及博来霉素合适的给药方案。毒性降低使得该方案能够按预期的剂量强度给药。
CLD-BOMP方案具有显著的抗肿瘤活性且毒性明显降低。