A Phase 2 Open Label, Single-Arm Trial to Evaluate the Combination of Cetuximab Plus Taxotere, Cisplatin, and 5-Flurouracil as an Induction Regimen in Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck

Journal Article · Mon Feb 01 04:00:00 EST 2016 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2015.10.019· OSTI ID:22645077

Mesía, Ricard ^[1]; Vázquez, Silvia ^[1]; Grau, Juan J. ^[2]; García-Sáenz, Jose A. ^[3]; Lozano, Alicia ^[4]; García, Carlos ^[5]; Carles, Joan ^[6]; Irigoyen, Antonio ^[7]; Mañós, Manel ^[8]; García-Paredes, Beatriz ^[3]; Barco, Elvira del ^[9]; Taberna, Miren ^[1]; Escobar, Yolanda ^[9]; others, and

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1. Medical Oncology Department, Institut Català d'Oncologia L'Hospitalet, Barcelona (Spain)
2. Medical Oncology Department, Hospital Clínic i Provincial, Barcelona (Spain)
3. Medical Oncology Department, Hospital Clínico San Carlos, Madrid (Spain)
4. Radiation Oncology Department, Institut Català d'Oncologia L'Hospitalet, Barcelona (Spain)
5. Medical Oncology Department, Hospital General Yagüe, Burgos (Spain)
6. Medical Oncology Department, Hospital del Mar, Barcelona (Spain)
7. Medical Oncology Department, Hospital Virgen de las Nieves, Granada (Spain)
8. Department of Otorhinolaryngology, Hospital de Bellvitge, Barcelona (Spain)
9. Medical Oncology Department, Gregorio Marañón University Hospital, Madrid (Spain)

Purpose: Despite treatment, prognosis of unresectable squamous cell carcinoma of the head and neck (SCCHC) is dismal. Cetuximab therapy has proven to increase the clinical activity of radiation therapy and chemotherapy in patients with locoregional advanced disease with an acceptable toxicity profile. We designed a phase 2 trial to evaluate the efficacy of docetaxel, cisplatin, and 5-fluorouracil (TPF) plus cetuximab (C-TPF) as an induction regimen in patients with unresectable SCCHN. Methods and Materials: A single-arm phase 2 trial was conducted. Eligible patients included those with untreated unresectable SCCHC, World Health Organization performance status of 0 to 1, 18 to 70 years of age. Treatment consisted of four 21-day cycles of TPF (docetaxel, 75 mg/m{sup 2} day 1; cisplatin, 75 mg/m{sup 2} day 1; 5-fluorouracil [5-FU], 750 mg/m{sup 2} day 1-5) and cetuximab, 250 mg/m{sup 2} weekly (loading dose of 400 mg/m{sup 2}). Prophylactic granulocyte colony-stimulating factor and antibiotic support were given. After induction, sequential accelerated radiation therapy with concomitant boost (69.9 Gy) and weekly cetuximab therapy were delivered in the absence of disease progression. The primary endpoint was objective response rate (ORR) to C-TPF. Results: Fifty patients were enrolled across 8 centers. Median age was 54 years; disease was stage IV; oropharynx and hypopharynx were the most common primary sites. Eighty-two percent received 4 cycles of C-TPF, and 86% started sequential treatment based on radiation therapy and cetuximab. ORR after C-TPF was 86% (95% confidence interval [CI]: 73%-94%) and 24% had complete response (CR). With a median follow-up of 40.7 months, median overall survival (OS) was 40.7 months. The 2-year actuarial locoregional control (LRC) rate was 57%. The most common drug-related grade 3 or 4 toxicities during induction were neutropenia (24%), neutropenic fever (24%), and diarrhea (20%). There were 3 treatment-related deaths (6%). Conclusions: C-TPF yields high ORR and CR as induction treatment in unresectable SCCHN. However, hematologic toxicity is too high to recommend this regimen at the current dose.

• OSTI ID: 22645077
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 2 Vol. 94; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CHEMOTHERAPY
FLUORINE COMPOUNDS
GY RANGE 10-100
HEAD
INDUCTION
NECK
PATIENTS
RADIOTHERAPY
TOXICITY