Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Ann Surg Oncol. 2022 Dec;29(13):8198-8206. doi: 10.1245/s10434-022-12490-4. Epub 2022 Sep 12.
To date, no clinical trials on the use of induction therapy before surgery have focused solely on lung squamous cell carcinoma (LSCC). We report the results of the Personalized Induction Therapy-2 (PIT-2) trial, a multicenter phase II study, performed to investigate the efficacy and safety of S-1 + cisplatin with concurrent thoracic radiotherapy (TRT) followed by surgery in patients with stage IIIA (N2) LSCC.
Patients with pathologically proven stage IIIA (N2) LSCC received induction therapy comprising three cycles of S-1 + cisplatin with concurrent TRT (45 Gy in 25 fractions) followed by surgery. S-1 was administered orally at a dose of 40 mg/m twice daily on days 1-14, in addition to intravenous infusion of cisplatin (60 mg/m) on day 1. The primary endpoint was 2-year progression-free survival (PFS) rate.
Of 45 registered patients, 43 underwent induction therapy. Of the 43 patients, 39 (91%) underwent surgery (35 lobectomies, 3 pneumonectomies, and 1 wedge resection). The 2-year PFS, 2-year overall survival, objective response rate, and pathological complete response rates were 67% (90% confidence interval [CI] 54-78%), 70% (95% CI 53-81%), 86% (95% CI 76-96%), and 39% (95% CI 23-54%), respectively. No new treatment-related adverse events occurred during the induction therapy. One case of 90-day postoperative mortality involving a patient who underwent right pneumonectomy and developed pneumonia after discharge occurred.
Induction therapy using S-1 + cisplatin with concurrent TRT followed by surgery is a feasible and promising treatment approach for stage IIIA (N2) LSCC.
迄今为止，尚无专门针对肺鳞癌（LSCC）的手术前诱导治疗临床试验。我们报告了多中心 II 期 Personalized Induction Therapy-2（PIT-2）试验的结果，该试验旨在研究 S-1 + 顺铂联合同期胸部放疗（TRT）继以手术治疗 IIIA（N2）期 LSCC 患者的疗效和安全性。
经病理证实为 IIIA（N2）期 LSCC 的患者接受诱导治疗，包括 3 个周期的 S-1 + 顺铂联合同期 TRT（45 Gy，25 次分割），继以手术。S-1 口服，剂量为 40 mg/m2，每日 2 次，第 1-14 天；顺铂静脉输注，剂量为 60 mg/m2，第 1 天。主要终点为 2 年无进展生存率（PFS）。
45 例注册患者中，43 例接受了诱导治疗。43 例患者中，39 例（91%）接受了手术（35 例肺叶切除术、3 例全肺切除术和 1 例楔形切除术）。2 年 PFS、2 年总生存率、客观缓解率和病理完全缓解率分别为 67%（90%置信区间[CI]：54-78%）、70%（95% CI：53-81%）、86%（95% CI：76-96%）和 39%（95% CI：23-54%）。诱导治疗期间未发生新的与治疗相关的不良事件。1 例患者在右全肺切除术后发生肺炎，术后 90 天死亡。
S-1 + 顺铂联合同期 TRT 继以手术治疗 IIIA（N2）期 LSCC 是一种可行且有前途的治疗方法。
