Kogure Yoshihito, Kada Akiko, Hashimoto Hiroya, Atagi Shinji, Takiguchi Yuichi, Saka Hideo, Ebi Noriyuki, Inoue Akira, Kurata Takayasu, Fujita Yuka, Nishii Yoichi, Itani Hidetoshi, Endo Takeo, Saito Akiko M, Shibayama Takuo, Yamamoto Nobuyuki, Gemma Akihiko
Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
JTO Clin Res Rep. 2023 Apr 6;4(6):100514. doi: 10.1016/j.jtocrr.2023.100514. eCollection 2023 Jun.
In the CAPITAL study, a randomized phase 3 study, wherein carboplatin plus nab-paclitaxel treatment was compared with docetaxel treatment for older patients with squamous-cell lung cancer, the former became the new standard of care for such patients. Our study aimed to evaluate whether the efficacy of second-line immune checkpoint inhibitors (ICIs) affected the primary analysis of overall survival (OS).
Herein, we performed a post hoc analysis of the impact of second-line ICIs on OS, safety in each group of participants aged more than 75 years, and intracycle nab-paclitaxel skip status.
Patients were randomly allocated to the carboplatin plus nab-paclitaxel (nab-PC) arm (n = 95) or the docetaxel (D) arm (n = 95). Of these patients, 74 of 190 (38.9%) were transferred to ICIs for second-line treatment (nab-PC arm: 36, D arm: 38). A survival benefit was numerically observed only for patients for whom first-line therapy was terminated owing to disease progression (median OS [nab-PC arm]: with and without ICIs, 321 and 142 d, respectively; median OS [D arm]: with and without ICIs, 311 and 256 d, respectively). The OS among patients who received ICI after adverse events was similar in the two arms. In the D arm, a significantly higher frequency of grade greater than or equal to 3 adverse events was observed among patients aged more than or equal to 75 years (86.2%) than among those aged less than 75 years (65.6%, = 0.041), including a significantly higher frequency of neutropenia (84.6% versus 62.5%, = 0.032); no such differences were observed in the nab-PC arm.
We found that second-line ICI treatment seemed to have a little impact on OS.
在CAPITAL研究（一项随机3期研究，其中比较了卡铂联合白蛋白结合型紫杉醇治疗与多西他赛治疗老年鳞状细胞肺癌患者的疗效）中，前者成为了此类患者新的标准治疗方案。我们的研究旨在评估二线免疫检查点抑制剂（ICI）的疗效是否会影响总生存期（OS）的主要分析。
在此，我们对二线ICI对OS的影响、每组75岁以上参与者的安全性以及白蛋白结合型紫杉醇周期内漏用情况进行了事后分析。
患者被随机分配至卡铂联合白蛋白结合型紫杉醇（nab-PC）组（n = 95）或多西他赛（D）组（n = 95）。在这些患者中，190例中有74例（38.9%）转至ICI进行二线治疗（nab-PC组：36例，D组：38例）。仅在因疾病进展而终止一线治疗的患者中观察到了生存获益（中位OS[nab-PC组]：使用和未使用ICI时，分别为321天和142天；中位OS[D组]：使用和未使用ICI时，分别为311天和256天）。在不良事件后接受ICI治疗的患者中，两组的OS相似。在D组中，75岁及以上患者中≥3级不良事件的发生率（86.2%）显著高于75岁以下患者（65.6%，P = 0.041），包括中性粒细胞减少症的发生率显著更高（84.6%对62.5%，P = 0.032）；在nab-PC组中未观察到此类差异。
我们发现二线ICI治疗似乎对OS影响不大。
