Yamamoto Nobuyuki, Harada Hideyuki, Okamoto Isamu, Masuda Noriyuki, Hayakawa Kazushige, Satouchi Miyako, Soejima Toshinori, Nishio Makoto, Kozuka Takuyo, Takeda Koji, Tanaka Masahiro, Seto Takashi, Sasaki Tomonari, Tsubouchi Hiroshi, Kakurai Yasuyuki, Nishimura Yasumasa, Nakagawa Kazuhiko
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Division of Radiation Therapy, Shizuoka Cancer Center, Shizuoka, Japan.
Clin Lung Cancer. 2021 Mar;22(2):134-141. doi: 10.1016/j.cllc.2020.12.012. Epub 2020 Dec 26.
We evaluated the tolerability and efficacy of nimotuzumab, a humanized IgG1 monoclonal anti-epidermal growth factor receptor antibody, with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small-cell lung cancer.
In this multicenter, single-arm, open-label, phase 2 trial conducted in Japan (JapicCTI-090825), patients received thoracic radiotherapy (60 Gy, 2 Gy per fraction, 6 weeks) and four 4-week cycles of chemotherapy (day 1, cisplatin 80 mg/m; days 1 and 8, vinorelbine 20 mg/m). Nimotuzumab 200 mg was administrated weekly for 16 weeks. The primary endpoint was treatment completion rate, defined as the percentage of patients completing 60 Gy of radiotherapy within 8 weeks, 2 cycles of chemotherapy, and at least 75% of the required nimotuzumab dose during the initial 2-cycle concurrent chemoradiotherapy period.
Of 40 patients enrolled, 39 received the study treatment, which was well tolerated, with a completion rate of 87.2%. Thirty-eight patients completed 60 Gy of radiotherapy within 8 weeks. Infusion reaction, grade 3 or higher rash, grade 3 or higher radiation pneumonitis, or grade 4 or higher nonhematologic toxicity were not observed. The objective response rate was 69.2%. The median progression-free survival (PFS) and 5-year PFS rate were 508 days and 29.0%, respectively. The 5-year PFS rate in patients with non-squamous cell carcinoma (n = 23) was 13.7% and in patients with squamous cell carcinoma (n = 16) was 50.0%. The 5-year overall survival rate was 58.4%.
Addition of nimotuzumab to the concurrent chemoradiotherapy regimen was well tolerated and showed potential for treating patients with locally advanced non-small-cell lung cancer, particularly squamous cell carcinoma.
我们评估了尼妥珠单抗（一种人源化IgG1单克隆抗表皮生长因子受体抗体）联合放化疗用于不可切除的局部晚期非小细胞肺癌患者的耐受性和疗效。
在日本进行的这项多中心、单臂、开放标签的2期试验（JapicCTI-090825）中，患者接受胸部放疗（60 Gy，每次2 Gy，共6周）以及4个为期4周的化疗周期（第1天，顺铂80 mg/m²；第1天和第8天，长春瑞滨20 mg/m²）。尼妥珠单抗200 mg每周给药一次，共16周。主要终点为治疗完成率，定义为在最初2周期同步放化疗期间，在8周内完成60 Gy放疗、2周期化疗以及至少75%所需尼妥珠单抗剂量的患者百分比。
40名入组患者中，39名接受了研究治疗，耐受性良好，完成率为87.2%。38名患者在8周内完成了60 Gy放疗。未观察到3级或更高等级的输注反应、皮疹、放射性肺炎或4级或更高等级的非血液学毒性。客观缓解率为69.2%。中位无进展生存期（PFS）和5年PFS率分别为508天和29.0%。非鳞状细胞癌患者（n = 23）的5年PFS率为13.7%，鳞状细胞癌患者（n = 16）的5年PFS率为50.0%。5年总生存率为58.4%。
在同步放化疗方案中添加尼妥珠单抗耐受性良好，显示出治疗局部晚期非小细胞肺癌患者，尤其是鳞状细胞癌患者的潜力。
