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

  • Thoracic Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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.

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Acknowledgments

The authors thank the patients, their families, the JORTC Data Center, and all the investigators who participated in this study. The authors also acknowledge the following representatives of the ACTG participating institutions: Fumihiro Tanaka (University of Occupational and Environmental Health), Masanori Tsuchida (Niigata University Graduate School of Medical and Dental Sciences), Ichiro Yoshino (Chiba University Graduate School of Medicine), Satoshi Shiono (Yamagata Prefectural Central Hospital), Hiroyuki Oizumi (Yamagata University), Tomohiro Haruki (Tottori University), Norihito Okumura (Kurashiki Central Hospital), Funai Kazuhito (Hamamatsu University School of Medicine), Hiroyuki Ito (Kanagawa Cancer Center), Hirotoshi Horio (Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital), Motoki Matsuura (Hiroshima City Hiroshima Citizens Hospital), Tsuyoshi Ueno (Shikoku Cancer Center), and Tetsuzo Tagawa (Kyushu University).

Funding

This study was supported by the campus research expenses of Juntendo University. The sponsor(s) had no role in the study design, collection, analysis, and interpretation of the data, writing of the report, or decision to submit the report for publication.

Author information

Authors and Affiliations

  1. Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan

    Kazuya Takamochi MD, PhD & Kenji Suzuki MD, PhD

  2. Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan

    Masahiro Tsuboi MD, PhD

  3. Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan

    Morihito Okada MD, PhD

  4. Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

    Seiji Niho MD, PhD

  5. Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

    Satoshi Ishikura MD, PhD

  6. Department of Biostatistics, JORTC Data Center, Tokyo, Japan

    Shunsuke Oyamada PhD

  7. Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan

    Takuhiro Yamaguchi PhD

Authors
  1. Kazuya Takamochi MD, PhD
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  2. Masahiro Tsuboi MD, PhD
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  3. Morihito Okada MD, PhD
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  4. Seiji Niho MD, PhD
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  5. Satoshi Ishikura MD, PhD
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  6. Shunsuke Oyamada PhD
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  7. Takuhiro Yamaguchi PhD
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  8. Kenji Suzuki MD, PhD
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Consortia

the Advanced Clinical Trial Chest Surgery Group (ACTG)

  • Fumihiro Tanaka
  • , Masanori Tsuchida
  • , Ichiro Yoshino
  • , Satoshi Shiono
  • , Hiroyuki Oizumi
  • , Tomohiro Haruki
  • , Norihito Okumura
  • , Funai Kazuhito
  • , Hiroyuki Ito
  • , Hirotoshi Horio
  • , Motoki Matsuura
  • , Tsuyoshi Ueno
  •  & Tetsuzo Tagawa

Corresponding author

Correspondence to Kazuya Takamochi MD, PhD.

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Disclosures

Kazuya Takamochi, Masahiro Tsuboi, Morihito Okada, Seiji Niho, Satoshi Ishikura, Shunsuke Oyamada, Takuhiro Yamaguchi, and Kenji Suzuki have no conflicts of interest to declare.

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Takamochi, K., Tsuboi, M., Okada, M. et al. S-1 + Cisplatin with Concurrent Radiotherapy Followed by Surgery for Stage IIIA (N2) Lung Squamous Cell Carcinoma: Results of a Phase II Trial. Ann Surg Oncol 29, 8198–8206 (2022). https://doi.org/10.1245/s10434-022-12490-4

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  • DOI: https://doi.org/10.1245/s10434-022-12490-4

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