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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 13/2022

12-09-2022 | NSCLC | Thoracic Oncology

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

Authors: Kazuya Takamochi, MD, PhD, Masahiro Tsuboi, MD, PhD, Morihito Okada, MD, PhD, Seiji Niho, MD, PhD, Satoshi Ishikura, MD, PhD, Shunsuke Oyamada, PhD, Takuhiro Yamaguchi, PhD, Kenji Suzuki, MD, PhD, the Advanced Clinical Trial Chest Surgery Group (ACTG)

Published in: Annals of Surgical Oncology | Issue 13/2022

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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.
Appendix
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Metadata
Title
S-1 + Cisplatin with Concurrent Radiotherapy Followed by Surgery for Stage IIIA (N2) Lung Squamous Cell Carcinoma: Results of a Phase II Trial
Authors
Kazuya Takamochi, MD, PhD
Masahiro Tsuboi, MD, PhD
Morihito Okada, MD, PhD
Seiji Niho, MD, PhD
Satoshi Ishikura, MD, PhD
Shunsuke Oyamada, PhD
Takuhiro Yamaguchi, PhD
Kenji Suzuki, MD, PhD
the Advanced Clinical Trial Chest Surgery Group (ACTG)
Publication date
12-09-2022
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 13/2022
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-022-12490-4

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