Sarah Cannon Research Institute, Nashville, Tennessee.
Tennessee Oncology, PLLC, Nashville, Tennessee.
Cancer. 2018 May 1;124(9):1982-1991. doi: 10.1002/cncr.30986. Epub 2018 Feb 16.
The best treatment for patients with advanced non-small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single-agent pemetrexed or 1 of 2 combination regimens.
Patients with newly diagnosed, histologically confirmed nonsquamous NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 were stratified by age and serum albumin level and were randomized (1:1:1) to 1 of 3 regimens: pemetrexed (arm 1), pemetrexed and bevacizumab (arm 2), or pemetrexed, carboplatin, and bevacizumab (arm 3). The response to treatment was assessed every 2 cycles; responding and stable patients continued treatment until progression or unacceptable toxicity.
One hundred seventy-two patients were randomized, 162 patients began the study treatment, and 146 patients completed 2 cycles and were evaluated for their response. The median progression-free survival (PFS) was 2.8 months in arm 1, 4.0 months in arm 2, and 4.8 months in arm 3. The overall response rates were 15% in arm 1, 31% in arm 2, and 44% in arm 3. The overall survival was similar in the 3 treatment arms. All 3 regimens were relatively well tolerated. Patients receiving bevacizumab had an increased incidence of hypertension, proteinuria, and bleeding episodes, but most events were mild or moderate.
All 3 regimens were feasible for patients with advanced NSCLC and an ECOG performance status of 2. The addition of bevacizumab to pemetrexed increased the overall response rate. The efficacy of pemetrexed/carboplatin/bevacizumab (median PFS, 4.8 months) approached the prespecified study PFS goal of 5 months. Larger studies will be necessary to define the role of bevacizumab in addition to standard pemetrexed and carboplatin in this population. Cancer 2018;124:1982-91. © 2018 American Cancer Society.
对于晚期非小细胞肺癌（NSCLC）和一般状况较差的患者，最佳治疗方法尚不清楚。在这项 2 期临床试验中，患者被随机分配接受单药培美曲塞或 2 种联合方案中的 1 种治疗。
新诊断为组织学证实的非鳞状 NSCLC 和东部肿瘤协作组（ECOG）表现状态为 2 的患者按年龄和血清白蛋白水平分层，并随机（1:1:1）分为 3 种方案之一：培美曲塞（第 1 组）、培美曲塞联合贝伐珠单抗（第 2 组）或培美曲塞、卡铂和贝伐珠单抗（第 3 组）。每 2 个周期评估一次治疗反应；有反应和稳定的患者继续治疗，直到疾病进展或不可接受的毒性。
共随机分配了 172 名患者，162 名患者开始研究治疗，146 名患者完成了 2 个周期并进行了疗效评估。第 1 组的中位无进展生存期（PFS）为 2.8 个月，第 2 组为 4.0 个月，第 3 组为 4.8 个月。第 1 组的总缓解率为 15%，第 2 组为 31%，第 3 组为 44%。3 种治疗方案的总生存期相似。所有 3 种方案均具有较好的耐受性。接受贝伐珠单抗治疗的患者高血压、蛋白尿和出血事件的发生率增加，但大多数事件为轻度或中度。
对于 ECOG 表现状态为 2 的晚期 NSCLC 患者，所有 3 种方案均可行。培美曲塞联合贝伐珠单抗增加了总缓解率。培美曲塞/卡铂/贝伐珠单抗（中位 PFS，4.8 个月）接近预设的 5 个月 PFS 目标。需要更大的研究来确定贝伐珠单抗在该人群中除标准培美曲塞和卡铂之外的作用。癌症 2018；124:1982-91。© 2018 美国癌症协会。
