PMID- 36097299 OWN - NLM STAT- MEDLINE DCOM- 20221110 LR - 20221110 IS - 1534-4681 (Electronic) IS - 1068-9265 (Linking) VI - 29 IP - 13 DP - 2022 Dec TI - S-1 + Cisplatin with Concurrent Radiotherapy Followed by Surgery for Stage IIIA (N2) Lung Squamous Cell Carcinoma: Results of a Phase II Trial. PG - 8198-8206 LID - 10.1245/s10434-022-12490-4 [doi] AB - BACKGROUND: 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. METHODS: 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(2) twice daily on days 1-14, in addition to intravenous infusion of cisplatin (60 mg/m(2)) on day 1. The primary endpoint was 2-year progression-free survival (PFS) rate. RESULTS: 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. CONCLUSIONS: Induction therapy using S-1 + cisplatin with concurrent TRT followed by surgery is a feasible and promising treatment approach for stage IIIA (N2) LSCC. CI - (c) 2022. Society of Surgical Oncology. FAU - Takamochi, Kazuya AU - Takamochi K AD - Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan. ktakamo@juntendo.ac.jp. FAU - Tsuboi, Masahiro AU - Tsuboi M AD - Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan. FAU - Okada, Morihito AU - Okada M AD - Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan. FAU - Niho, Seiji AU - Niho S AD - Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. FAU - Ishikura, Satoshi AU - Ishikura S AD - Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. FAU - Oyamada, Shunsuke AU - Oyamada S AD - Department of Biostatistics, JORTC Data Center, Tokyo, Japan. FAU - Yamaguchi, Takuhiro AU - Yamaguchi T AD - Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan. FAU - Suzuki, Kenji AU - Suzuki K AD - Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan. CN - Advanced Clinical Trial Chest Surgery Group (ACTG) LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20220912 PL - United States TA - Ann Surg Oncol JT - Annals of surgical oncology JID - 9420840 RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Male MH - Humans MH - Cisplatin MH - *Lung Neoplasms MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Combined Modality Therapy MH - Treatment Outcome MH - *Carcinoma, Non-Small-Cell Lung/pathology MH - *Carcinoma, Squamous Cell/drug therapy MH - *Testicular Neoplasms/drug therapy MH - Lung/pathology MH - Neoplasm Staging FIR - Tanaka, Fumihiro IR - Tanaka F FIR - Tsuchida, Masanori IR - Tsuchida M FIR - Yoshino, Ichiro IR - Yoshino I FIR - Shiono, Satoshi IR - Shiono S FIR - Oizumi, Hiroyuki IR - Oizumi H FIR - Haruki, Tomohiro IR - Haruki T FIR - Okumura, Norihito IR - Okumura N FIR - Kazuhito, Funai IR - Kazuhito F FIR - Ito, Hiroyuki IR - Ito H FIR - Horio, Hirotoshi IR - Horio H FIR - Matsuura, Motoki IR - Matsuura M FIR - Ueno, Tsuyoshi IR - Ueno T FIR - Tagawa, Tetsuzo IR - Tagawa T EDAT- 2022/09/14 06:00 MHDA- 2022/11/11 06:00 CRDT- 2022/09/13 00:13 PHST- 2022/06/29 00:00 [received] PHST- 2022/08/17 00:00 [accepted] PHST- 2022/09/14 06:00 [pubmed] PHST- 2022/11/11 06:00 [medline] PHST- 2022/09/13 00:13 [entrez] AID - 10.1245/s10434-022-12490-4 [pii] AID - 10.1245/s10434-022-12490-4 [doi] PST - ppublish SO - Ann Surg Oncol. 2022 Dec;29(13):8198-8206. doi: 10.1245/s10434-022-12490-4. Epub 2022 Sep 12.