Akerley Wallace, McCoy Jason, Hesketh Paul J, Goodwin J Wendall, Bearden James D, Atkins James N, Chansky Kari, Crowley John J, Gandara David R
University of Utah Health Science Center, Huntsman Cancer Institute, Salt Lake City, Utah 84112, USA.
J Thorac Oncol. 2007 Jun;2(6):526-30. doi: 10.1097/JTO.0b013e318060d2dc.
To evaluate the activity of a nonplatinum-, nonetoposide-containing regimen for patients with extensive stage small cell lung cancer.
Patients with untreated extensive stage small cell lung cancer were treated with gemcitabine 1000 mg/m2 and irinotecan 100 mg/m2 on days 1 and 8 of a 21-day cycle for a maximum of six cycles. Patients with brain metastases were eligible if asymptomatic or controlled after radiation.
Eighty-four eligible patients with untreated extensive stage small cell lung cancer with adequate organ function and a performance status of 0-2 were accrued. The median age was 64 years (range, 42-85) and 45 (54%) were women. Six cycles were completed by 28 (33%) patients. Some degree of diarrhea occurred in 57% (grade 3/4, 18%). Other grade 3/4 toxicities were neutropenia (26%), anemia (10%), thrombocytopenia (8%), febrile neutropenia (5%), fatigue (11%), nausea (10%), and vomiting (8%). The response rate was 32% (95% confidence interval: 22%-43%) among the 81 patients with measurable disease. The median survival was 8.5 months (95% confidence interval: 7.0-9.8) with 1- and 2-year survival rates of 26% and 7%, respectively. Salvage therapy data were captured by prospective collection, and only 50% of patients were treated secondarily.
The overall response rate with the combination of gemcitabine and irinotecan was disappointing, and the median survival rate was lower than expected. Further development of this combination in small cell lung cancer is not recommended.
评估一种不含铂类和依托泊苷的方案对广泛期小细胞肺癌患者的疗效。
未经治疗的广泛期小细胞肺癌患者在21天周期的第1天和第8天接受吉西他滨1000mg/m²和伊立替康100mg/m²治疗，最多6个周期。脑转移患者若无症状或放疗后病情得到控制则符合入组条件。
共纳入84例符合条件、未经治疗、广泛期小细胞肺癌且器官功能良好、体能状态为0 - 2的患者。中位年龄为64岁（范围42 - 85岁），45例（54%）为女性。28例（33%）患者完成了6个周期的治疗。57%的患者出现了某种程度的腹泻（3/4级，18%）。其他3/4级毒性反应包括中性粒细胞减少（26%）、贫血（10%）、血小板减少（8%）、发热性中性粒细胞减少（5%）、疲劳（11%）、恶心（10%）和呕吐（8%）。81例可测量疾病患者的缓解率为32%（95%置信区间：22% - 43%）。中位生存期为8.5个月（95%置信区间：7.0 - 9.8），1年和2年生存率分别为26%和7%。挽救治疗数据通过前瞻性收集获得，仅有50%的患者接受了二线治疗。
吉西他滨和伊立替康联合方案的总体缓解率令人失望，中位生存率低于预期。不建议在小细胞肺癌中进一步开发此联合方案。
