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ECOG 1308: A phase II trial of induction chemotherapy followed by cetuximab with low dose versus standard dose IMRT in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx (OP).
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2012
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Surgical OncologyPathologyTumor BiologyOral CancerCancer-associated VirusRadiation MedicineOncologyHuman Papillomavirus VaccinesPublic HealthNeck OncologyClinical Radiation OncologyRadiation OncologyCancer ResearchPhase Ii TrialRadiation TherapyEcog 1308Cancer TreatmentLower Dose RadiationHuman PapillomavirusCervical Cancer ManagementCervical CancerMedicineCorrelative StudiesInduction Chemotherapy
5566 Background: Human papillomavirus (HPV) infection is now recognized as a risk factor of oropharyngeal squamous cell carcinoma (OPSCC) and approximately 60% of OPSCC are HPV positive (+). ECOG 2399 using induction chemotherapy (IC) followed by chemoradiation demonstrated significantly improved 2-yr progression-free survival (PFS; 85% vs. 50%, p=0.05) and overall survival (OS; 94% vs. 58%p=0.004). These results have generated interest in development of less toxic regimens for HPV(+) patients with lower dose radiation. Methods: Design: This is a phase II clinical trial .The primary objective is the estimation of the 2-year PFS in the reduced dose RT arm. Secondary objectives include toxicity, OS, objective response, quality of life (QOL) and correlative studies of biomarkers. Eligibility Criteria: Patients with Stage III or IV resectable HPV(+) OPSCC. HPV(+) disease is defined as p16 IHC strongly (+) on at least 70% of cells, and/or HPV-16 ISH (+).Treatment : Patients received IC with a combination of paclitaxel 90mg/m 2 on days 1,8, and 15, cisplatin 75mg/m 2 on day 1, and cetuximab loading dose of 400 mg/m 2 on day 1, cycle 1 followed by cetuximab 250 mg/m 2 weekly, thereafter. Each cycle was 21 days for a total of 3 cycles. After completion of IC, patients were assessed clinically with a complete head and neck exam and imaging studies. Those with clinical CR at primary site received radiation to 54Gy plus cetuximab. Patients with clinical PR or SD at primary site received standard dose RT with cetuximab. Correlative Studies: The expression of biomarkers on tumor and blood samples and QOL parameters will be correlated with the clinical outcomes. Results: Current enrollment: Target accrual was 83 patients. The study accrued 90 patients from March 17, 2010 to accrual on October 19, 2011. Baseline characteristics reveal; median age 57 years, 94% male, 95% white, 47% never smokers, 10% <10 pack year (pyr) smoking, 38% >10 pyr smoking, 84% not current smokers, 39% node (N) stage N2b and 29% N2c, 22% tumor (T) stage T1, 52% T2, 16% T3, and 10% T4. Conclusions: Enrollment has just completed with no data analysis available.