IMpower132: Atezolizumab plus platinum-based chemotherapy vs chemotherapy for advanced NSCLC in Japanese patients.
IMpower132: Atezolizumab plus platinum-based chemotherapy vs chemotherapy for advanced NSCLC in Japanese patients.
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DOI：
10.1111/cas.14817
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发表时间：
2021-04
期刊：
影响因子：
5.7
通讯作者：
Kawakami T
中科院分区：
文献类型：
--
作者：
Nishio M;Saito H;Goto K;Watanabe S;Sueoka-Aragane N;Okuma Y;Kasahara K;Chikamori K;Nakagawa Y;Kawakami T
IMpower 132探讨了atezolizumab联合培美曲塞和含铂化疗作为晚期非小细胞肺癌（NSCLC）一线治疗的安全性和疗效。III期、开放标签、IMpower 132研究的关键合格性标准包括年龄≥18岁，根据实体瘤疗效评价标准（RECIST）第1.1版，经组织学或细胞学证实的晚期非鳞状NSCLC，东部肿瘤协作组体能状态为0/1，既往未接受过IV期NSCLC的全身治疗。患者接受atezolizumab（1200 mg）+培美曲塞（500 mg/m2）和顺铂（75 mg/m2）或卡铂（浓度曲线下面积，6 mg/mL/min）（APP组）或单独化疗（PP组）。联合主要研究终点为意向治疗人群中的总生存期（OS）和研究者评估的无进展生存期（PFS）（根据RECIST 1.1）。在日本患者中进行了亚组分析。在日本亚组（n = 101）中，APP组（n = 48）的中位OS为30. 8（95% CI，24. 3至不可估计）个月，PP组为22. 2（95% CI，15. 7 - 30. 8）个月（n = 53;风险比[HR]，0. 63 [95% CI，0. 36 - 1. 14]）。APP组的PFS为12.8（95% CI，8.6 - 16.6）个月，PP组为4.5（95% CI，4.1 - 6.7）个月（HR，0.33 [95% CI，0.21 - 0.58]）。68.8%的APP组患者和44.2%的PP组患者发生3/4级治疗相关不良事件（TRAE）。与全球研究结果一致，atezolizumab联合培美曲塞和含铂化疗改善了日本晚期NSCLC患者的疗效，且耐受性良好，尽管3/4级TRAE的发生率较高。全球III期IMpower 132研究评价了atezolizumab联合培美曲塞和含铂化疗与单药化疗作为晚期非鳞状NSCLC一线治疗的对比。对101例日本患者进行的亚组分析显示，atezolizumab联合化疗在这些患者中耐受良好，与单独化疗相比提供了总体治疗获益。这些结果与全球研究一致。
IMpower132 explored the safety and efficacy of atezolizumab plus pemetrexed and platinum‐based chemotherapy as first‐line treatment for advanced non‐small‐cell lung cancer (NSCLC). Key eligibility criteria for the phase 3, open‐label, IMpower132 study included age ≥18 y, histologically or cytologically confirmed advanced non‐squamous NSCLC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status of 0/1, and no prior systemic treatment for stage IV NSCLC. Patients received atezolizumab (1200 mg) plus pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) or carboplatin (area under the concentration curve, 6 mg/mL/min) (APP arm) or chemotherapy alone (PP arm). The co‐primary study endpoints were overall survival (OS) and investigator‐assessed progression‐free survival (PFS) per RECIST 1.1 in the intention‐to‐treat population. A subgroup analysis was conducted in Japanese patients. In the Japanese subgroup (n = 101), median OS was 30.8 (95% CI, 24.3 to not estimable) mo in the APP arm (n = 48) and 22.2 (95% CI, 15.7‐30.8) mo in the PP arm (n = 53; hazard ratio [HR], 0.63 [95% CI, 0.36‐1.14]). PFS was 12.8 (95% CI, 8.6‐16.6) mo in the APP arm vs 4.5 (95% CI, 4.1‐6.7) mo in the PP arm (HR, 0.33 [95% CI, 0.21‐0.58]). Grade 3/4 treatment‐related adverse events (TRAEs) occurred in 68.8% of APP arm patients and 44.2% of PP arm patients. Consistent with global study results, atezolizumab plus pemetrexed and platinum‐based chemotherapy improved efficacy and was well tolerated in Japanese patients with advanced NSCLC despite a higher incidence of grade 3/4 TRAEs. The global phase 3 IMpower132 study evaluated atezolizumab plus pemetrexed and platinum‐based chemotherapy vs chemotherapy alone for first‐line treatment of advanced non‐squamous NSCLC. A subgroup analysis of 101 Japanese patients showed that atezolizumab plus chemotherapy was well tolerated in these patients and provided overall treatment benefit vs chemotherapy alone. These results are consistent with the global study.
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影响因子：
9.6
作者：
Detterbeck, Frank C.;Boffa, Daniel J.;Tanoue, Lynn T.
通讯作者：
Tanoue, Lynn T.
DOI：
10.1016/s0140-6736(16)32517-x
发表时间：
2017-01-21
期刊：
Lancet (London, England)
影响因子：
--
作者：
Rittmeyer A;Barlesi F;Waterkamp D;Park K;Ciardiello F;von Pawel J;Gadgeel SM;Hida T;Kowalski DM;Dols MC;Cortinovis DL;Leach J;Polikoff J;Barrios C;Kabbinavar F;Frontera OA;De Marinis F;Turna H;Lee JS;Ballinger M;Kowanetz M;He P;Chen DS;Sandler A;Gandara DR;OAK Study Group
通讯作者：
OAK Study Group
影响因子：
64.8
作者：
Herbst RS;Soria JC;Kowanetz M;Fine GD;Hamid O;Gordon MS;Sosman JA;McDermott DF;Powderly JD;Gettinger SN;Kohrt HE;Horn L;Lawrence DP;Rost S;Leabman M;Xiao Y;Mokatrin A;Koeppen H;Hegde PS;Mellman I;Chen DS;Hodi FS
通讯作者：
Hodi FS
影响因子：
3.6
作者：
Hida, Toyoaki;Kaji, Reiko;Kubo, Toshio
通讯作者：
Kubo, Toshio
Nivolumab多中心II期研究对日本晚期或复发性非小细胞肺癌的日本患者。
影响因子：
7.3
作者：
Nishio M;Hida T;Atagi S;Sakai H;Nakagawa K;Takahashi T;Nogami N;Saka H;Takenoyama M;Maemondo M;Ohe Y;Nokihara H;Hirashima T;Tanaka H;Fujita S;Takeda K;Goto K;Satouchi M;Isobe H;Minato K;Sumiyoshi N;Tamura T
通讯作者：
Tamura T