Dose-dense TPF induction chemotherapy for locally advanced head and neck cancer: a phase II study
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RESEARCH ARTICLE
Open Access
Dose-dense TPF induction chemotherapy for locally advanced head and neck cancer: a phase II study Ching-Yun Hsieh1, Ming-Yuh Lein1, Shih-Neng Yang2, Yao-Ching Wang2, Yin-Jun Lin2, Chen-Yuan Lin1, Chun-Hung Hua3, Ming-Hsul Tsai3 and Ching-Chan Lin1,4*
Abstract Background: Phase 3 studies suggest that induction chemotherapy (ICT) of cisplatin and 5-fluorouracil plus docetaxel (TPF) is effective but toxic for patients with squamous-cell carcinoma of the head and neck (SCCHN). Dose-dense chemotherapy may yield favorable outcomes compared with standard-dose chemotherapy, yet the optimal induction regimen remains undefined. We assessed the efficacy and tolerability of biweekly dose-dense TPF ICT in patients with SCCHN. Methods: In this prospective phase II study, We enrolled patients with stage III/IV (AJCC 7th edition) unresectable squamous cell carcinoma of head and neck cancer. Patients received dose-dense TPF (ddTPF) with cisplatin and docetaxel 50 mg/m2 on day 1, leucovorin 250 mg/m2 on day1, followed by 48-h continuous infusion of 2500 mg/ m2 of 5-fluorouracil on day 1 and 2, every 2 weeks for 6 cycles followed by radiotherapy. The primary endpoint was the response rate (RR) after ICT. Results: Fifty-eight patients were enrolled from June 2014 to September 2015. Overall RR after ICT was 89.6% [complete response (CR), 31%; partial response (PR), 58.6%]. Grade 3/4 neutropenia, mucositis, and diarrhea incidences were 25.9, 1.7, and 1.7%, respectively. 94.8% of patients completed all treatment courses of ICT without dose reduction. The 3-year overall survival (OS) was 54.3% (95%CI: 39.7 to 66.8%) and progression-free survival (PFS) was 34.3% (95%CI: 22.0 to 46.9%). Multivariate analysis showed that CR after ICT is an independent prognostic factor for OS and PFS. Conclusions: Six cycles of ddTPF is an active, well-tolerated induction regimen for patients with SCCHN. The presence of CR after ICT predicted long-term survival. Trial registration: ClinicalTrials.gov Identifier: NCT04397341, May 21, 2020, retrospectively registered. Keywords: Head and neck cancer, Docetaxel, Cisplatin, Fluorouracil, Dose-dense chemotherapy, Induction chemotherapy
* Correspondence: [email protected] 1 Division of Hematology and Oncology, Department of internal medicine, China Medical University Hospital, China Medical University, 2 Yude Rd, North District, Taichung 404, Taiwan 4 Graduate Institute of Biomedical Sciences, China Medical University, Taichung 404, Taiwan Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative
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