Chambers S K, Lamb L, Kohorn E I, Schwartz P E, Chambers J T
Division of Gynecologic Oncology, Yale University Comprehensive Cancer Center, New Haven, Connecticut 06520-8063.
Gynecol Oncol. 1994 May;53(2):161-9. doi: 10.1006/gyno.1994.1110.
Chemotherapy for cervical cancer patients with recurrent and/or advanced disease has been complicated by excessive toxicity and short duration of responses, leading to little or no improvement in survival. Modification of drug scheduling and delivery of platinum, bleomycin, methotrexate, and 5-FU has resulted in a new combination regimen with little toxicity and a survival advantage for responders. PBM (platinum 80 mg/m2 D1, bleomycin 10 mu/m2/day D3-6, methotrexate 150 mg/m2 D15, 22 with leucovorin) is alternated with PFU (platinum 100 mg/m2 D1, 5-FU 1000 mg/m2/day D2-5) q 4 weeks for 3-6 months. The platinum, bleomycin, and 5-FU were delivered by continuous infusion. Twenty-three patients with recurrent and 17 with advanced cervical cancer are evaluable; 91% of patients with recurrent disease had received prior radiation therapy. The response rate was 30.4% in those with recurrent disease, and 41.2% in those with advanced disease, with 86 and 42.9% of responders respectively achieving a CR. Survival data were analyzed for each group separately, as well as for the combined recurrent/advanced disease group (N = 40). The results and significance were not changed by the groupings. In the combined recurrent/advanced group, median duration of response was 10.5 months, mean 20.1, and the median overall survival was 11 months, mean 20.5 +/- 3.5. There was a survival advantage accrued to the responders (median, 28 months) vs the nonresponders (10 months) (P = 0.0005 by log rank test). Moreover, there was a significant difference in progression-free interval between responders vs nonresponders (P = 0.0001), as well as between responders and those with stable disease (P = 0.001). This regimen was very well tolerated and there was no significant pulmonary toxicity. Furthermore, in the subset of 23 patients who had recurrent disease, 67% achieved palliation of pain. Experience with this protocol supports the continuing use of chemotherapy in the management of cervical cancer patients.
对于患有复发性和/或晚期疾病的宫颈癌患者，化疗一直存在毒性过大和缓解期短的问题，导致生存率几乎没有提高或根本没有提高。对铂类、博来霉素、甲氨蝶呤和5-氟尿嘧啶的给药方案和给药方式进行调整后，形成了一种新的联合治疗方案，该方案毒性小，对有反应者有生存优势。PBM方案（铂80mg/m²第1天，博来霉素10U/m²/天第3 - 6天，甲氨蝶呤150mg/m²第15、22天，同时给予亚叶酸钙）与PFU方案（铂100mg/m²第1天，5-氟尿嘧啶1000mg/m²/天第2 - 5天）每4周交替进行，持续3 - 6个月。铂类、博来霉素和5-氟尿嘧啶通过持续静脉输注给药。23例复发性宫颈癌患者和17例晚期宫颈癌患者可进行评估；91%的复发性疾病患者曾接受过放疗。复发性疾病患者的缓解率为30.4%，晚期疾病患者的缓解率为41.2%，分别有86%和42.9%的有反应者达到完全缓解（CR）。对每组患者以及复发性/晚期疾病合并组（N = 40）分别进行生存数据分析。分组并未改变结果及其显著性。在复发性/晚期疾病合并组中，中位缓解期为10.5个月，平均为20.1个月，中位总生存期为11个月，平均为20.5±3.5个月。有反应者（中位生存期28个月）与无反应者（10个月）相比有生存优势（对数秩检验P = 0.0005）。此外，有反应者与无反应者之间以及有反应者与病情稳定者之间的无进展生存期存在显著差异（P = 0.0001和P = 0.001）。该方案耐受性良好，无明显肺部毒性。此外，在23例复发性疾病患者亚组中，67%的患者疼痛得到缓解。该方案的经验支持在宫颈癌患者的治疗中继续使用化疗。
