{"title":"康瑞珠单抗联合同期化放疗作为槟榔相关局部晚期口腔鳞状细胞癌一线治疗的 II 期试验","authors":"","doi":"10.1016/j.ijrobp.2024.07.049","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.</div></div><div><h3>Materials/Methods</h3><div>This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m<sup>2</sup> Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).</div></div><div><h3>Results</h3><div>Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, <em>P</em> = 0.001), DFS (92.2% vs 55.5%, <em>P</em> = 0.003), and OS (98.0% vs 77.8%, <em>P</em> = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.</div></div><div><h3>Conclusion</h3><div>Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstrated significant efficacy in patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma, with tolerable toxicity profiles.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Phase II Trial of Camrelizumab in Combination with Concurrent Chemoradiotherapy as First-Line Treatment for Betel Nut-Related Locally Advanced Oral Squamous Cell Carcinoma\",\"authors\":\"\",\"doi\":\"10.1016/j.ijrobp.2024.07.049\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose/Objective(s)</h3><div>Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.</div></div><div><h3>Materials/Methods</h3><div>This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m<sup>2</sup> Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).</div></div><div><h3>Results</h3><div>Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, <em>P</em> = 0.001), DFS (92.2% vs 55.5%, <em>P</em> = 0.003), and OS (98.0% vs 77.8%, <em>P</em> = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.</div></div><div><h3>Conclusion</h3><div>Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstrated significant efficacy in patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma, with tolerable toxicity profiles.</div></div>\",\"PeriodicalId\":14215,\"journal\":{\"name\":\"International Journal of Radiation Oncology Biology Physics\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Radiation Oncology Biology Physics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0360301624008113\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Radiation Oncology Biology Physics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0360301624008113","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
A Phase II Trial of Camrelizumab in Combination with Concurrent Chemoradiotherapy as First-Line Treatment for Betel Nut-Related Locally Advanced Oral Squamous Cell Carcinoma
Purpose/Objective(s)
Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.
Materials/Methods
This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m2 Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).
Results
Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, P = 0.001), DFS (92.2% vs 55.5%, P = 0.003), and OS (98.0% vs 77.8%, P = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.
Conclusion
Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstrated significant efficacy in patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma, with tolerable toxicity profiles.
期刊介绍:
International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field.
This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.