Adjuvant PD-1 antibody in recurrent, previously irradiated oral cavity cancer treated with salvage surgery

Shengjin Dou; Lin Zhang; Rongrong Li; Yanli Yao; Wen Jiang; Lulu Ye; Jingjing Sun; Jiang Li; Sicheng Wu; Laiping Zhong; Shuyang Sun; Guopei Zhu

doi:10.1016/j.ctro.2023.100623

Adjuvant PD-1 antibody in recurrent, previously irradiated oral cavity cancer treated with salvage surgery

Clin Transl Radiat Oncol. 2023 Apr 3:40:100623. doi: 10.1016/j.ctro.2023.100623. eCollection 2023 May.

Authors

Shengjin Dou^{1

2

3

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5

6

7}, Lin Zhang^{1

2

3

4

5

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7}, Rongrong Li^{1

2

3

4

5

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7}, Yanli Yao^{1

2

3

4

5

6

7}, Wen Jiang^{1

2

3

4

5

6

7}, Lulu Ye^{1

2

3

4

5

6

7}, Jingjing Sun^{2

3

4

5

6

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7}, Jiang Li^{2

3

4

5

6

8

7}, Sicheng Wu⁹, Laiping Zhong^{1

2

3

4

5

6

7}, Shuyang Sun^{1

2

3

4

5

6

7}, Guopei Zhu^{1

2

3

4

5

6

7}

Affiliations

¹ Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² College of Stomatology, Shanghai Jiao Tong University, Shanghai, China.
³ National Center for Stomatology, Shanghai, China.
⁴ National Clinical Research Center for Oral Diseases, Shanghai, China.
⁵ Shanghai Key Laboratory of Stomatology, Shanghai, China.
⁶ Shanghai Research Institute of Stomatology, China.
⁷ Shanghai Center of Head and Neck Oncology Clinical and Translational Science.
⁸ Department of Oral Pathology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
⁹ Dental Public Health, Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.

Abstract

Objectives: The role of re-irradiation after salvage surgery for recurrent oral cavity cancer (OCC) is controversial. We evaluated the efficacy and safety of adjuvant toripalimab (PD-1 antibody) in this patient setting.

Materials and methods: In this phase II study, patients after salvage surgery with OCC occurring in an area of previously irradiated were enrolled. Patients received toripalimab 240 mg once every 3 weeks for 12 months, or combined with S-1 orally for 4-6 cycles. The primary endpoint was 1-year progression-free survival (PFS).

Results: Between April 2019 and May 2021, 20 patients were enrolled. Sixty percent patients had ENE or positive margins, 80% were restaged as stage IV, and 80% were previously treated with chemotherapy. The 1-year PFS and overall survival (OS) were 58.2%, and 93.8%, respectively, for patients with CPS ≥ 1, which was significantly better than those of the real-world reference cohort (p = 0.001 and 0.019). No grade 4-5 toxicities were reported, and only one patient experienced grade 3 immune related adrenal insufficiency and discontinued treatment. The 1-year PFS and OS were significantly different for patients with CPS < 1, CPS 1-19 and CPS ≥ 20 (p = 0.011 and 0.017, respectively). The peripheral blood B cell proportion was also correlated with PD in 6 months (p = 0.044).

Conclusion: Adjuvant toripalimab or combine with S-1 after salvage surgery showed improved PFS compared with a real-world reference cohort in recurrent, previously irradiated OCC, and favorable PFS were observed in patients with a higher CPS and peripheral B cell proportion. Further randomized trials are warranted.

Keywords: Head and neck neoplasms; Oral cancer; Programmed cell death 1 receptor; Re-irradiation; Salvage therapy.