Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial-Reference-Cited by-同舟云学术

Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial

Published:2023-11-13 Issue:2 Volume:30 Page:344-355
ISSN:1078-0432
Container-title:Clinical Cancer Research
language:en
Short-container-title:

Author:

Ou Xiaomin¹²³^ORCID,Zhai Ruiping¹²³^ORCID,Wei Wenjun²⁴^ORCID,Chen Jiaying²⁴^ORCID,Ou Dan¹²³^ORCID,Liao Tian²⁴^ORCID,Xu Tingting¹²³^ORCID,Zhu Yongxue²⁴^ORCID,Wang Yulong²⁴^ORCID,Huang Shenglin³⁵^ORCID,Shi Rongliang²⁴^ORCID,Wu Bin²⁶⁷^ORCID,Chen Tongzhen²⁸^ORCID,Li Yuan²⁸^ORCID,Yang Zhongyi²⁹^ORCID,Zhou Changming¹⁰^ORCID,Liu Yuan¹¹^ORCID,Jiang Ziting¹¹^ORCID,Zeng Min²¹²^ORCID,Liu Xin²¹³^ORCID,Ji Dongmei²¹³^ORCID,Ying Hongmei¹²³^ORCID,Zhang Zhen¹²³^ORCID,Hu Chaosu¹²³^ORCID,Lu Xueguan¹²³^ORCID,Ji Qinghai²⁴^ORCID,He Xiayun¹²³^ORCID,Wang Yu²⁴^ORCID

Affiliation:

1. 1Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

2. 2Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

3. 3Shanghai Key Laboratory of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.

4. 4Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.

5. 5Shanghai Key Laboratory of Medical Epigenetics, Institutes of Biomedical Sciences, Fudan University, Shanghai, China.

6. 6Department of Diagnostic Radiology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.

7. 7Shanghai Engineering Research Center of Proton and Heavy Ion Radiation Therapy, Shanghai, China.

8. 8Department of Pathology, Fudan University Shanghai Cancer Center, Shanghai, China.

9. 9Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.

10. 10Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.

11. 11Department of Endoscopy, Fudan University Shanghai Cancer Center, Shanghai, China.

12. 12Department of Nursing Administration, Fudan University Shanghai Cancer Center, Shanghai, China.

13. 13Department of Head and Neck Tumors and Neuroendocrine Tumors, Fudan University Shanghai Cancer Center, Shanghai, China.

Abstract

Abstract Purpose: The aim of this study was to assess the efficacy, toxicities, and potential role of larynx preservation of induction chemotherapy combined with programmed cell death protein 1 (PD-1) inhibitor in locally advanced laryngeal and hypopharyngeal cancer. Patients and Methods: This is a single-arm phase II study. Patients with histopathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma and Eastern Cooperative Oncology Group Performance Status 0–1 were eligible. Three cycles of induction chemotherapy (paclitaxel 175 mg/m2 d1, cisplatin 25 mg/m2 d1–3) combined with PD-1 inhibitor (toripalimab 240 mg d0) were administered. Response assessment was performed after induction chemoimmunotherapy using RECIST 1.1 criteria. Patients with a complete/partial response of the primary tumor received concurrent chemoradiation, followed by maintenance therapy of toripalimab. Otherwise, patients were referred to surgery, followed by adjuvant (chemo) radiation and maintenance therapy of toripalimab. The primary endpoint is a larynx preservation rate at 3 months postradiation. Results: Twenty-seven patients were enrolled. Most cases exhibited stage IV disease (81.5%), with T4 representing 37.0%. Five patients underwent pretreatment tracheostomy because of impaired larynx function. Overall response rate of induction chemoimmunotherapy was 85.2%. At 3 months postradiation, the larynx preservation rate was 88.9%. With a median follow-up of 18.7 months, the 1-year overall survival rate, progression-free survival rate, and larynx preservation rate were 84.7%, 77.6%, and 88.7%, respectively. When excluding those with pretreatment tracheostomy, the 1-year larynx preservation rate was 95.5%. Exploratory analysis revealed that relapse correlated with enrichment of RNA signature of hypoxia and M2 macrophage–associated genes. Conclusions: Induction toripalimab combined with chemotherapy provided encouraging activity, promising larynx preservation rate and acceptable toxicity in this cohort of extensively locally advanced laryngeal and hypopharyngeal cancer.

Funder

National Natural Science Foundation of China

Science and Technology Commission Foundation of Shanghai Municipality

Shanghai Anti-Cancer Association

Chinese Society of Clinical Oncology

Publisher

American Association for Cancer Research (AACR)

Subject

Cancer Research,Oncology

Link

https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-23-2398/3381755/ccr-23-2398.pdf

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