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Phase I study of induction chemotherapy with afatinib, ribavirin, and weekly carboplatin and paclitaxel for stage IVA/IVB human papillomavirus‐associated oropharyngeal squamous cell cancer
Author(s) -
Dunn Lara A.,
Fury Matthew G.,
Sherman Eric J.,
Ho Alan A.,
Katabi Nora,
Haque Sofia S.,
Pfister David G.
Publication year - 2018
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.24938
Subject(s) - carboplatin , afatinib , medicine , ribavirin , regimen , paclitaxel , oncology , chemotherapy , cancer , cisplatin , immunology , epidermal growth factor receptor , gefitinib , hepatitis c virus , virus
Background The human papillomavirus (HPV) E6 oncoprotein enhances the oncogenic potential of ErbB proteins in HPV‐related malignancies. This phase I study evaluates the addition of afatinib, an ErbB family inhibitor, and ribavirin to paclitaxel and carboplatin induction chemotherapy in HPV‐associated, locally advanced oropharyngeal squamous cell carcinoma (SCC). Methods This dose escalation study included 2 doses of oral afatinib: 30 and 40 mg daily. Ribavirin dosing was weight based. Paclitaxel (80 mg/m 2 ) and carboplatin (area under the curve [AUC] 1.5) were administered on days 1 and 8 of each 21‐day cycle. After 3 cycles, patients were removed from protocol to receive definitive treatment. Results Among 10 patients, there were no dose‐limiting toxicities. Six patients (67%) had unconfirmed objective partial responses. The 2‐year progression‐free survival rate was 75%. Conclusion Afatinib, ribavirin, paclitaxel, and carboplatin induction chemotherapy is safe and well tolerated. The phase II recommended dose of afatinib is 40 mg oral daily in this combination regimen.