Dose-dense TPF induction chemotherapy for locally advanced head and neck cancer: a phase II study

Autor: Yao Ching Wang, Shih Neng Yang, Ming-Yuh Lein, Yin-Jun Lin, Chun Hung Hua, Ching Yun Hsieh, Ching Chan Lin, Ming-Hsul Tsai, Chen Yuan Lin
Jazyk: angličtina
Rok vydání: 2020
Předmět:
0301 basic medicine
Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Antimetabolites
Antineoplastic
Dose-dense chemotherapy
medicine.medical_treatment
Leucovorin
Phases of clinical research
Docetaxel
lcsh:RC254-282
03 medical and health sciences
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Genetics
medicine
Mucositis
Humans
Prospective Studies
Head and neck cancer
Aged
Chemotherapy
business.industry
Squamous Cell Carcinoma of Head and Neck
Induction chemotherapy
Induction Chemotherapy
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
medicine.disease
Combined Modality Therapy
Progression-Free Survival
Regimen
030104 developmental biology
Head and Neck Neoplasms
030220 oncology & carcinogenesis
Female
Fluorouracil
Cisplatin
business
medicine.drug
Research Article
Zdroj: BMC Cancer
BMC Cancer, Vol 20, Iss 1, Pp 1-9 (2020)
ISSN: 1471-2407
Popis: 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.
Databáze: OpenAIRE
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