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International Journal of Clinical Oncology

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16-10-2023 | Radiotherapy | Original Article

Multicenter prospective phase II trial of concurrent chemoradiotherapy with weekly low-dose carboplatin for cisplatin-ineligible patients with advanced head and neck squamous cell carcinoma

Authors: Yushi Ueki, Shusuke Ohshima, Yusuke Yokoyama, Takeshi Takahashi, Ryusuke Shodo, Keisuke Yamazaki, Kohei Ohtaki, Kohei Saijo, Ryoko Tanaka, Takafumi Togashi, Yuichiro Sato, Satoshi Takano, Jo Omata, Nao Takahashi, Ryuichi Okabe, Arata Horii

Published in: International Journal of Clinical Oncology | Issue 1/2024

Abstract

Background

The optimal chemotherapy regimen in concurrent chemoradiotherapy (CCRT) for cisplatin-ineligible head and neck squamous cell carcinoma (HNSCC) has not been established. We aimed to evaluate the feasibility, efficacy, and safety of CCRT with weekly low-dose carboplatin for the treatment of advanced HNSCC in patients who are cisplatin-ineligible.

Methods

This prospective phase II study enrolled adult patients (age ≥ 20 years) with HNSCC receiving whole-neck irradiation including bilateral levels II–IV and who were aged (≥ 75-year-old patients with 40 mL/min estimated glomerular filtration rate [eGFR] or better) or had renal dysfunction (< 75-year-old patients with 30–60 mL/min eGFR). Carboplatin was administered weekly (area under the plasma concentration–time curve = 2.0) for up to seven cycles during concurrent radiotherapy (70 Gy/35 Fr). The primary endpoint was the completion rate of CCRT. Secondary endpoints included overall response rate and incidence of adverse events.

Results

Among the 30 patients enrolled, 28 were men. The median age was 73.5 years. Seventeen patients were < 75 years whereas 13 were ≥ 75 years old. The completion rate of CCRT was 90%. The overall response rate was 90%. Grade 3 adverse events that occurred in 10% or more patients were oral/pharyngeal mucositis (47%), leukocytopenia (20%), and neutropenia (10%). Grade 4 adverse events occurred in one patient (elevation of alanine aminotransferase level). No treatment-related deaths occurred.

Conclusion

CCRT with weekly low-dose carboplatin is a promising treatment option, with favorable feasibility, efficacy, and acceptable toxicity, for patients who are cisplatin-ineligible with advanced HNSCC.

Clinical Trial Registration Number

jRCTs031190028.

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Title: Multicenter prospective phase II trial of concurrent chemoradiotherapy with weekly low-dose carboplatin for cisplatin-ineligible patients with advanced head and neck squamous cell carcinoma
Authors: Yushi Ueki
Shusuke Ohshima
Yusuke Yokoyama
Takeshi Takahashi
Ryusuke Shodo
Keisuke Yamazaki
Kohei Ohtaki
Kohei Saijo
Ryoko Tanaka
Takafumi Togashi
Yuichiro Sato
Satoshi Takano
Jo Omata
Nao Takahashi
Ryuichi Okabe
Arata Horii
Publication date: 16-10-2023
Publisher: Springer Nature Singapore
Keyword: Radiotherapy
Published in: International Journal of Clinical Oncology / Issue 1/2024
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-023-02423-w

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Abstract

Background

Methods

Results

Conclusion

Clinical Trial Registration Number

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