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Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial
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Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial
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Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial
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Journal Article
Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial
2022
Overview
Background
The treatment of recurrent or metastatic head and neck squamous-cell carcinoma (R/M HNSCC) remains challenging. Preclinical studies revealed that B cell depletion could modulate the microenvironment and overcome chemoresistance. We conducted a phase I study to evaluate the feasibility and safety of B cell depletion using the anti-CD20 antibody rituximab to treat HNSCC.
Methods
Ten patients were enrolled in two protocols. The first four patients treated using protocol 1 received rituximab 1000 mg on days −14 and −7, followed by gemcitabine/cisplatin every 3 weeks, and rituximab was administered every 6 months thereafter. Because of disease hyperprogression, protocol 1 was amended to protocol 2, which consisted of the concomitant administration of rituximab 375 mg/m
2
and gemcitabine/cisplatin every 3 weeks. Another six patients were enrolled and treated using protocol 2.
Results
Three patients treated using protocol 1 exhibited rapid disease progression, and the remaining patient could not undergo evaluation after rituximab treatment. Conversely, no unpredicted harm was observed in the six patients treated using protocol 2. Among these patients, one achieved complete response, and two had partial responses. The disease-free durations in these patients were 7.0, 6.2, and 7.1 months, respectively. Immune cell analysis revealed a higher ratio of cytotoxic T cells to regulatory T cells in responders than in non-responders.
Conclusions
B cell depletion using rituximab alone in patients with HNSCC can cause hyperprogressive disease. Contrarily, the co-administration of rituximab and cisplatin/gemcitabine was feasible and safe.
Trial registration
ClinicalTrials.gov Identifier:
NCT04361409
, 24 April 2020, retrospectively registered
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Antineoplastic Combined Chemotherapy Protocols - administration & dosage
/ Biomedical and Life Sciences
/ Cancer
/ Cisplatin - administration & dosage
/ Deoxycytidine - administration & dosage
/ Deoxycytidine - analogs & derivatives
/ Disease
/ Drug Administration Schedule
/ Head and Neck Neoplasms - drug therapy
/ Head and neck squamous-cell carcinoma
/ Health Promotion and Disease Prevention
/ Humans
/ Male
/ Neoplasm Recurrence, Local - drug therapy
/ Oncology
/ Patients
/ Relapse
/ Rituximab - administration & dosage
/ Software
/ Squamous Cell Carcinoma of Head and Neck - drug therapy
/ Tongue
