Winegarden J D, Mauer A M, Otterson G A, Rudin C M, Villalona-Calero M A, Lanzotti V J, Szeto L, Kasza K, Hoffman P C, Vokes E E
University of Chicago Section of Hematology/Oncology and University of Chicago Cancer Research Center, Chicago, IL 60637, USA.
Ann Oncol. 2004 Jun;15(6):915-20. doi: 10.1093/annonc/mdh215.
To evaluate the efficacy and toxicity of oxaliplatin and paclitaxel as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC).
The treatment regimen was given as defined in a phase I investigation in patients with previously treated ovarian cancer. It consisted of paclitaxel 175 mg/m(2) (1-h infusion) and oxaliplatin 130 mg/m(2) (2-h infusion) given every 21 days. Eligible patients had stage IIIB (pleural effusion)/IV NSCLC, measurable disease, no prior chemotherapy, Eastern Cooperative Oncology Group performance status 0-2, and adequate hematological, renal and hepatic function.
A total of 38 patients were enrolled with the following characteristics: 29% male (n = 11); 71% female (n = 27); median age 64.5 years (range 37-78); performance status of 0-1 84% (n = 32); stage IIIB 8% (n = 3); stage IV 92% (n = 35). One hundred and eighty-one cycles were administered, with a median of four per patient (range one to 12). The overall objective response rate for all 38 patients was 34.2% [95% confidence interval (CI) 19.6% to 51.4%]. This response rate includes 13 patients who met criteria for a partial response. No complete responses were observed. Median overall survival time was 9.2 months (95% CI 6-12.4) and median progression-free survival time was 4.3 months (95% CI 2.1-6.5). The 1- and 2-year overall survival rates were 37% and 21%, respectively. Hematological toxicity included six patients with grade 4 neutropenia. Non-hematological toxicity consisted mainly of grades 1 and 2 neurosensory toxicity. Laryngodysesthesia was observed in two patients following oxaliplatin infusion. No grade 4 non-hematological toxicities were encountered.
This regimen is well tolerated, and demonstrates activity in patients with advanced NSCLC.
评估奥沙利铂和紫杉醇作为晚期非小细胞肺癌（NSCLC）患者一线治疗方案的疗效和毒性。
治疗方案按照先前接受治疗的卵巢癌患者的I期研究中的定义给予。方案包括每21天给予紫杉醇175mg/m²（静脉输注1小时）和奥沙利铂130mg/m²（静脉输注2小时）。符合条件的患者为IIIB期（有胸腔积液）/IV期NSCLC，有可测量病灶，未曾接受过化疗，东部肿瘤协作组（ECOG）体能状态评分为0 - 2，且血液学、肾脏和肝脏功能良好。
共纳入38例患者，其特征如下：男性占29%（n = 11）；女性占71%（n = 27）；中位年龄64.5岁（范围37 - 78岁）；体能状态评分为0 - 1的占84%（n = 32）；IIIB期占8%（n = 3）；IV期占92%（n = 35）。共进行了181个周期的治疗，每位患者中位治疗周期数为4个（范围1 - 12个）。38例患者的总体客观缓解率为34.2% [95%置信区间（CI）19.6%至51.4%]。该缓解率包括13例达到部分缓解标准的患者。未观察到完全缓解。中位总生存时间为9.2个月（95% CI为6 - 12.4），中位无进展生存时间为4.3个月（95% CI为2.1 - 6.5）。1年和2年总生存率分别为37%和21%。血液学毒性包括6例4级中性粒细胞减少症患者。非血液学毒性主要为1级和2级神经感觉毒性。2例患者在输注奥沙利铂后出现喉感觉异常。未出现4级非血液学毒性。
该方案耐受性良好，对晚期NSCLC患者显示出活性。
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