Nogami Naoyuki, Nishio Makoto, Okamoto Isamu, Enatsu Sotaro, Suzukawa Kazumi, Takai Hiroki, Nakagawa Kazuhiko, Tamura Tomohide
Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto-machi, Matsuyama, Ehime 791-0280, Japan.
Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.
Respir Investig. 2019 Jan;57(1):27-33. doi: 10.1016/j.resinv.2018.09.003. Epub 2018 Oct 4.
The combination of pemetrexed and carboplatin is commonly used for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC), mainly because it is comparatively effective and less toxic than other platinum-doublet therapies. Using the JMII (JACAL) study, we report the efficacy and safety of this treatment followed by pemetrexed maintenance in the elderly population (≥70 years of age).
The JMII study was a multicenter, post-marketing study that assessed the efficacy and safety of carboplatin (AUC6) and pemetrexed (500 mg/m, given on Day 1 of a 21-day cycle, 4 cycles) followed by pemetrexed (500 mg/m) maintenance in advanced non-squamous NSCLC patients (n = 109). Retrospective subgroup analyses were performed in elderly patients aged ≥70.
The study includes younger (<70 years, n = 84) and elderly (≥70 years, n = 25) patients who received induction therapy. Median progression-free survival and overall survival from the start of the induction phase were 5.2 (95% CI: 3.5, 8.2) and 16.8 (95% CI: 10.3, NC) months for the elderly patients compared with 5.8 (95% CI: 4.3, 7.4) and 20.5 (95% CI: 16.7, NC) months for the younger patients, respectively. Grade 3/4 hematologic toxicities were more frequent in the elderly patients. Non-hematologic toxicities in the elderly patients were comparable to those in younger patients. Dose reduction was more common in the elderly (44% vs 23%), due to hematologic toxicities.
There was no difference in efficacy (evaluated by progression-free survival) between elderly and younger patients. Although grade 3/4 hematologic toxicities were frequently observed in the elderly patients, they were easily managed with dose adjustment.
培美曲塞与卡铂联合常用于治疗晚期非鳞状非小细胞肺癌（NSCLC），主要是因为它比其他铂类双联疗法相对更有效且毒性更小。通过JMII（JACAL）研究，我们报告了这种治疗方案随后进行培美曲塞维持治疗在老年人群（≥70岁）中的疗效和安全性。
JMII研究是一项多中心上市后研究，评估了卡铂（AUC6）和培美曲塞（500mg/m²，在21天周期的第1天给药，共4个周期）随后进行培美曲塞（500mg/m²）维持治疗在晚期非鳞状NSCLC患者（n = 109）中的疗效和安全性。对年龄≥70岁的老年患者进行了回顾性亚组分析。
该研究纳入了接受诱导治疗的年轻患者（<70岁，n = 84）和老年患者（≥70岁，n = 25）。老年患者从诱导期开始的中位无进展生存期和总生存期分别为5.2个月（95%CI：3.5，8.2）和16.8个月（95%CI：10.3，NC），而年轻患者分别为5.8个月（95%CI：4.3，7.4）和20.5个月（95%CI：16.7，NC）。3/4级血液学毒性在老年患者中更常见。老年患者的非血液学毒性与年轻患者相当。由于血液学毒性，剂量减少在老年患者中更常见（44%对23%）。
老年患者和年轻患者在疗效（通过无进展生存期评估）上没有差异。虽然老年患者经常观察到3/4级血液学毒性，但通过剂量调整很容易处理。
