Ilson D H, Saltz L, Enzinger P, Huang Y, Kornblith A, Gollub M, O'Reilly E, Schwartz G, DeGroff J, Gonzalez G, Kelsen D P
Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Clin Oncol. 1999 Oct;17(10):3270-5. doi: 10.1200/JCO.1999.17.10.3270.
To evaluate the response, toxicity, survival, and quality of life in patients with unresectable or metastatic esophageal cancer treated with weekly irinotecan and cisplatin.
Thirty-five patients with metastatic or unresectable esophageal adenocarcinoma (23 patients) or squamous cell carcinoma (12 patients) were treated. No prior chemotherapy was allowed. The majority of patients had metastatic and bidimensionally measurable disease (34 patients each [97%]). Patients were treated with cisplatin 30 mg/m(2) and irinotecan 65 mg/m(2), repeated weekly for 4 weeks, followed by a 2-week rest period. Treatment was recycled every 6 weeks. Degree of dysphagia relief was monitored, and quality of life was measured prospectively using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and Functional Assessment of Cancer Therapy-General instruments.
Thirty-five patients were assessable for response and toxicity. Major objective responses were observed in 20 patients (57%; 95% confidence interval, 41% to 73%), including two complete responses (6%). Similar response rates were observed for adenocarcinoma (12 of 23 patients; 52%) and squamous carcinoma (eight of 12 patients; 66%). The median duration of response was 4.2 months (range, 1 to 8.8+ months). Median actuarial survival was 14.6 months (range, 1 to 15.2+ months). In 20 patients with dysphagia assessable at baseline, 18 (90%) noted either improvement or resolution of dysphagia on chemotherapy. Global quality of life improved in responding patients, primarily because of improvements in pain, emotional state, and relationships with family and friends. Toxicity was relatively mild and included only three patients (9%) with grade 4 neutropenia and four (11%) with grade 3 diarrhea. There were no treatment-related deaths.
The combination of weekly cisplatin plus irinotecan had significant activity in metastatic esophageal carcinoma and resulted in significant relief of dysphagia. The regimen was well tolerated, with acceptable myelosuppression and rare treatment-related diarrhea. Further evaluation of the combination of weekly irinotecan and cisplatin, including the addition of other agents to this regimen, is indicated.
评估每周使用伊立替康和顺铂治疗不可切除或转移性食管癌患者的疗效、毒性、生存率及生活质量。
35例转移性或不可切除的食管腺癌（23例）或鳞状细胞癌（12例）患者接受治疗。不允许之前接受过化疗。大多数患者有转移性且可进行二维测量的疾病（各34例[97%]）。患者接受顺铂30mg/m²和伊立替康65mg/m²治疗，每周重复1次，共4周，随后休息2周。每6周重复治疗周期。监测吞咽困难缓解程度，并使用欧洲癌症研究与治疗组织生活质量问卷C-30和癌症治疗功能评估通用量表前瞻性地测量生活质量。
35例患者可评估疗效和毒性。20例患者（57%；95%置信区间，41%至73%）观察到主要客观缓解，包括2例完全缓解（6%）。腺癌（23例中的12例；52%）和鳞状细胞癌（12例中的8例；66%）的缓解率相似。中位缓解持续时间为4.2个月（范围，1至8.8 +个月）。中位精算生存率为14.6个月（范围，1至15.2 +个月）。在20例基线时可评估吞咽困难的患者中，18例（90%）在化疗时吞咽困难有改善或缓解。缓解患者的总体生活质量有所改善，主要是因为疼痛、情绪状态以及与家人和朋友关系的改善。毒性相对较轻，仅3例患者（9%）出现4级中性粒细胞减少，4例（11%）出现3级腹泻。无治疗相关死亡。
每周顺铂加伊立替康联合方案在转移性食管癌中具有显著活性，并能显著缓解吞咽困难。该方案耐受性良好，骨髓抑制可接受，治疗相关腹泻罕见。表明需要对每周伊立替康和顺铂联合方案进行进一步评估，包括在此方案中加入其他药物。
