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Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329
Author(s) -
Malhotra Binu,
Moon James,
Kucuk Omar,
Clark Joseph I.,
Urba Susan G.,
Wolf Gregory T.,
Worden Francis P.
Publication year - 2014
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.23522
Subject(s) - medicine , gemcitabine , tolerability , oncology , paclitaxel , chemotherapy , response evaluation criteria in solid tumors , phases of clinical research , head and neck cancer , radiation therapy , adverse effect
Background A phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) utilizing biweekly gemcitabine and paclitaxel (GEMTAX), showed an overall response rate of 53%. 1 This phase II trial was conducted to determine the feasibility, tolerability, and efficacy of this combination. Methods Patients with metastatic/recurrent SCCHN were treated with gemcitabine (3000 mg/m2) and paclitaxel (150 mg/m2) on days 1 and 15 of every 28‐day cycle. Results In 57 patients with measurable disease, median progression‐free survival (PFS) was 4 months and median overall survival (OS) was 8 months. Overall response rate of 28% and disease stabilization in 19% were seen. There were no treatment‐related deaths with grade 3/4 hematologic toxicity seen in 20% of the patients. Conclusion Biweekly GEMTAX is feasible, well tolerated, and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum‐based chemotherapy. © 2014 Wiley Periodicals, Inc. Head Neck 36: 1712–1717, 2014