Brustugun O T, Sprauten M, Helland Å
a Department of Oncology , Oslo University Hospital The Norwegian Radium Hospital , Oslo , Norway.
b Department of Cancer Genetics , Oslo University Hospital - The Norwegian Radium Hospital , Oslo , Norway.
Acta Oncol. 2017 Mar;56(3):438-440. doi: 10.1080/0284186X.2016.1253865. Epub 2016 Nov 28.
Checkpoint inhibitors have proven effectiveness in clinical trials for non-small cell lung cancer (NSCLC) patients, but if this is congruent with routine patient care is discussed. We present real-world experience with the PD1-inhibitor nivolumab in NSCLC.
Patients with NSCLC were considered eligible for nivolumab treatment after one or more lines of chemotherapy, and when in reasonable performance status (PS) [Eastern Cooperative Oncology Group (ECOG) < 3]. Treatment was given according to guidelines in the two phase III studies, CA209017 and CA209057. Response evaluation was done according to Recist 1.1, and treatment given until unequivocal progression or intolerable toxicity.
Fifty-eight patients (30 females) commenced therapy in the period June-August 2015. Median age was 64.6 years (range 32.3-88.2). Twenty-four patients had squamous cell carcinoma and 32 adenocarcinoma, 38 had received two or more prior lines of therapy. Fourteen cases (24%) were in ECOG PS 2. After a medium observation time of 14.3 months, 13 (22%) are still in treatment. Median time to treatment failure (TTF) was 4.0 months, 34% were off treatment during the first two months. Median overall survival (OS) is 11.7 months. There was no difference in TTF or OS among patients with squamous versus non-squamous histology or between 1 versus >1 prior line of therapy. Four patients (7%) were off treatment due to toxicity, none were grade 4 or 5.
Nivolumab treatment outside clinical trials seems to perform as expected.
在非小细胞肺癌（NSCLC）患者的临床试验中，检查点抑制剂已被证明有效，但这是否与常规患者护理相一致仍存在争议。我们介绍了PD1抑制剂纳武单抗治疗NSCLC的真实世界经验。
NSCLC患者在接受一线或多线化疗后，且体能状态（PS）良好[东部肿瘤协作组（ECOG）＜3]时，被认为适合接受纳武单抗治疗。治疗按照两项III期研究CA209017和CA209057的指南进行。根据实体瘤疗效评价标准（RECIST）1.1进行疗效评估，治疗持续至明确进展或出现不可耐受的毒性。
2015年6月至8月期间，58例患者（30例女性）开始接受治疗。中位年龄为64.6岁（范围32.3 - 88.2岁）。24例患者为鳞状细胞癌，32例为腺癌，38例接受过两线或更多线的先前治疗。14例（24%）患者的ECOG PS评分为2分。经过14.3个月的中位观察期后，13例（22%）仍在接受治疗。中位治疗失败时间（TTF）为4.0个月，34%的患者在前两个月内停止治疗。中位总生存期（OS）为11.7个月。鳞状组织学与非鳞状组织学患者之间或接受1线与>1线先前治疗的患者之间，TTF或OS无差异。4例（7%）患者因毒性停止治疗，均无4级或5级毒性。
临床试验之外的纳武单抗治疗似乎表现如预期。
