Choong Nicholas W, Mauer Ann M, Hoffman Philip C, Rudin Charles M, Winegarden Jerome D, Villano J Lee, Kozloff Mark, Wade James L, Sciortino David F, Szeto Livia, Vokes Everett E
Section of Hematology-Oncology and Phase II Network, University of Chicago Medical Center, Chicago, Illinois 60615, USA.
J Thorac Oncol. 2006 Mar;1(3):245-51. doi: 10.1016/s1556-0864(15)31575-6.
This study was performed to evaluate the tolerability and efficacy of temozolomide and irinotecan as a second-line regimen in recurrent/metastatic non-small cell lung cancer (NSCLC).
Patients with recurrent/metastatic NSCLC, including those with treated brain metastases, following one prior platinum-based regimen received temozolomide 75 mg/m daily on days 1 through 15 and irinotecan 100 mg/m on days 8 and 15 every 21 days.
The authors treated 46 patients, of whom more that 90% had a performance status of 0 or 1. Four patients (8.7%) attained partial response and 17 (37.0%) had disease stabilization as their best response. The median time to progression was 1.8 months, median overall survival was 9.8 months, and 1-year overall survival was 34%. Grade 1/2 fatigue (63%), anemia (61%), nausea (52%), and diarrhea (44%) were the most common toxicities. Grade 3/4 leukopenia and diarrhea were each observed in 9% of patients. One unexpected death occurred, possibly related to the regimen.
Second-line treatment with temozolomide and irinotecan showed tolerable toxicities. The response rates, median survival times, and 1-year survival rates were comparable to other active NSCLC agents.
本研究旨在评估替莫唑胺和伊立替康作为复发性/转移性非小细胞肺癌（NSCLC）二线治疗方案的耐受性和疗效。
复发性/转移性NSCLC患者，包括那些已接受过脑转移治疗的患者，在接受一种含铂一线治疗方案后，每21天接受替莫唑胺75mg/m²，第1至15天每日服用，伊立替康100mg/m²，第8天和第15天服用。
作者治疗了46例患者，其中90%以上患者的体能状态为0或1。4例患者（8.7%）达到部分缓解，17例患者（37.0%）疾病稳定为最佳反应。中位疾病进展时间为1.8个月，中位总生存期为9.8个月，1年总生存率为34%。1/2级疲劳（63%）、贫血（61%）、恶心（52%）和腹泻（44%）是最常见的毒性反应。9%的患者观察到3/4级白细胞减少和腹泻。发生了1例意外死亡，可能与治疗方案有关。
替莫唑胺和伊立替康二线治疗显示出可耐受的毒性。缓解率、中位生存时间和1年生存率与其他有效的NSCLC药物相当。
