Final Results of a Randomized Phase 2 Trial Investigating the Addition of Cetuximab to Induction Chemotherapy and Accelerated or Hyperfractionated Chemoradiation for Locoregionally Advanced Head and Neck Cancer
| Autor: | Victoria M. Villaflor, Everett E. Vokes, Ryan J. Brisson, Masha Kocherginsky, Tanguy Y. Seiwert, Mary Ellyn Witt, Apoorva Chawla, Daniel J. Haraf, Kerstin M. Stenson, Allison Dekker, Joseph K. Salama, Mark W. Lingen, Elizabeth A. Blair, J.M. Melotek, Ezra E.W. Cohen |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 0301 basic medicine Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Cetuximab Disease-Free Survival 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols Humans Medicine Radiology Nuclear Medicine and imaging neoplasms Survival rate Aged Aged 80 and over Radiation Squamous Cell Carcinoma of Head and Neck business.industry Head and neck cancer Dose fractionation Induction chemotherapy Radiotherapy Dosage Chemoradiotherapy Induction Chemotherapy Middle Aged medicine.disease Carboplatin Survival Rate Radiation therapy Treatment Outcome 030104 developmental biology chemistry Head and Neck Neoplasms 030220 oncology & carcinogenesis Carcinoma Squamous Cell Female Dose Fractionation Radiation Neoplasm Recurrence Local Accelerated Radiation Therapy business medicine.drug |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 96:21-29 |
| ISSN: | 0360-3016 |
| Popis: | The role of cetuximab in the treatment of locoregionally advanced head and neck squamous cell cancer (LA-HNSCC) remains poorly defined. In this phase 2 randomized study, we investigated the addition of cetuximab to both induction chemotherapy (IC) and hyperfractionated or accelerated chemoradiation.Patients with LA-HNSCC were randomized to receive 2 cycles of weekly IC (cetuximab, paclitaxel, carboplatin) and either Cetux-FHX (concurrent cetuximab, 5-fluorouracil, hydroxyurea, and 1.5 Gy twice-daily radiation therapy every other week to 75 Gy) or Cetux-PX (cetuximab, cisplatin, and accelerated radiation therapy with delayed concomitant boost to 72 Gy in 42 fractions). The primary endpoint was progression-free survival (PFS), with superiority compared with historical control achieved if either arm had 2-year PFS ≥70%.110 patients were randomly assigned to either Cetux-FHX (n=57) or Cetux-PX (n=53). The overall response rate to IC was 91%. Severe toxicity on IC was limited to rash (23% grade ≥3) and myelosuppression (38% grade ≥3 neutropenia). The 2-year rates of PFS for both Cetux-FHX (82.5%) and Cetux-PX (84.9%) were significantly higher than for historical control (P.001). The 2-year overall survival (OS) was 91.2% for Cetux-FHX and 94.3% for Cetux-PX. With a median follow-up time of 72 months, there were no significant differences in PFS (P=.35) or OS (P=.15) between the treatment arms. The late outcomes for the entire cohort included 5-year PFS, OS, locoregional failure, and distant metastasis rates of 74.1%, 80.3%, 15.7%, and 7.4%, respectively. The 5-year PFS and OS were 84.4% and 91.3%, respectively, among human papillomavirus (HPV)-positive patients and 65.9% and 72.5%, respectively, among HPV-negative patients.The addition of cetuximab to IC and chemoradiation was tolerable and produced long-term control of LA-HNSCC, particularly among poor-prognosis HPV-negative patients. Further investigation of cetuximab may be warranted in the neoadjuvant setting and with non-platinum-based chemoradiation. |
| Databáze: | OpenAIRE |
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