S-1 + Cisplatin with Concurrent Radiotherapy Followed by Surgery for Stage IIIA (N2) Lung Squamous Cell Carcinoma: Results of a Phase II Trial.

Abstract

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/m2 twice daily on days 1-14, in addition to intravenous infusion of cisplatin (60 mg/m2) 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.

• Authors: Kazuya Takamochi, Masahiro Tsuboi, Morihito Okada, Seiji Niho, Satoshi Ishikura, Shunsuke Oyamada, Takuhiro Yamaguchi, Kenji Suzuki, Advanced Clinical Trial Chest Surgery Group (ACTG)
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 29 Issue 13 Pg. 8198-8206 (Dec 2022) ISSN: 1534-4681 [Electronic] United States
• PMID: 36097299 (Publication Type: Clinical Trial, Phase II, Multicenter Study, Journal Article)
• Copyright: © 2022. Society of Surgical Oncology.

Chemical References

• Cisplatin

Topics

• Male
• Humans
• Cisplatin
• Lung Neoplasms
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Combined Modality Therapy
• Treatment Outcome
• Carcinoma, Non-Small-Cell Lung (pathology)
• Carcinoma, Squamous Cell (drug therapy)
• Testicular Neoplasms (drug therapy)
• Lung (pathology)
• Neoplasm Staging