A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma

Cisplatin is a cornerstone chemotherapy for nasopharyngeal carcinoma (NPC); however, certain patients are ineligible for cisplatin-based regimens. This phase 2 trial (NCT04405622) evaluated the efficacy and safety of gemcitabine and toripalimab in previously untreated patients with recurrent or metastatic NPC who were either ineligible for cisplatin or had experienced severe adverse events from prior cisplatin-based treatments. Patients received gemcitabine (1,000 mg/m<sup>2</sup>) and toripalimab (240 mg) every three weeks for six cycles, followed by toripalimab monotherapy for up to two years. The primary endpoint was the incidence of grade ≥3 adverse events, while secondary endpoints included objective response rate (ORR) and overall survival (OS). Of 30 screened patients, 21 were enrolled. No treatment-related fatalities occurred, with the most frequent adverse events being headache and nausea. The ORR was 61.9%, coupled with a disease control rate of 100%. Overall, gemcitabine plus toripalimab demonstrated low toxicity and promising efficacy for this specific patient cohort.

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Publication Details

Journal
Cell Reports Medicine
Published
2024-10-01
DOI
https://doi.org/10.1016/j.xcrm.2024.101779
Citations
6
Primary Topic
Lung Cancer Treatments and Mutations
Type
article
Field-Weighted Citation Impact
2.51

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article

A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma

Yan‐Feng Ouyang, Zheng‐Kai Feng, Kai Wen, Chen-Mei Gu et al.
6 citations
Cell Reports Medicine
Lung Cancer Treatments and Mutations
2.51
article

A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma

Yan‐Feng Ouyang, Zheng‐Kai Feng, Kai Wen, Chen-Mei Gu, Huifeng Li, Ruo-Qi Xie, Chao Lin, Ming‐Yuan Chen, Rui You, Yi-Jun Hua, You‐Ping Liu, Xiong Zou, Yong‐Long Liu, Siyuan Chen, Rui Sun, Weijing Zhang, Qi Yang, Yu‐Long Xie, Pei‐Yu Huang, Xi Ding, Zhiqiang Wang
article en
6 citations

Abstract

Cisplatin is a cornerstone chemotherapy for nasopharyngeal carcinoma (NPC); however, certain patients are ineligible for cisplatin-based regimens. This phase 2 trial (NCT04405622) evaluated the efficacy and safety of gemcitabine and toripalimab in previously untreated patients with recurrent or metastatic NPC who were either ineligible for cisplatin or had experienced severe adverse events from prior cisplatin-based treatments. Patients received gemcitabine (1,000 mg/m<sup>2</sup>) and toripalimab (240 mg) every three weeks for six cycles, followed by toripalimab monotherapy for up to two years. The primary endpoint was the incidence of grade ≥3 adverse events, while secondary endpoints included objective response rate (ORR) and overall survival (OS). Of 30 screened patients, 21 were enrolled. No treatment-related fatalities occurred, with the most frequent adverse events being headache and nausea. The ORR was 61.9%, coupled with a disease control rate of 100%. Overall, gemcitabine plus toripalimab demonstrated low toxicity and promising efficacy for this specific patient cohort.

Cell Reports MedicineVol. 5(10)
Sun Yat-sen University (CN), Kunming Medical University (CN), Fifth Affiliated Hospital of Sun Yat-sen University (CN), First Affiliated Hospital of Kunming Medical University (CN), Sun Yat-sen University Cancer Center (CN)
National Natural Science Foundation of China, Sun Yat-sen University, Recruitment Program of Global Experts, Guangzhou Municipal Science and Technology Project, National Ten Thousand Talent Program, Sun Yat-sen University Cancer Center
Openalex Percentile: Top 10%
Lung Cancer Treatments and Mutations
2.51
DOIOpen Access PDFOpenAlex
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