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A phase 2 study of pemetrexed plus gemcitabine every 2 weeks for patients with recurrent or metastatic head and neck squamous cell cancer
Article first published online: 4 OCT 2010
Copyright © 2010 American Cancer Society
Volume 117, Issue 4, pages 795–801, 15 February 2011
How to Cite
Fury, M. G., Haque, S., Stambuk, H., Shen, R., Carlson, D. and Pfister, D. (2011), A phase 2 study of pemetrexed plus gemcitabine every 2 weeks for patients with recurrent or metastatic head and neck squamous cell cancer. Cancer, 117: 795–801. doi: 10.1002/cncr.25464
- Issue published online: 3 FEB 2011
- Article first published online: 4 OCT 2010
- Manuscript Accepted: 28 APR 2010
- Manuscript Revised: 16 APR 2010
- Manuscript Received: 23 DEC 2009
- head and neck;
- phase 2;
Preclinical studies suggest that additive or synergistic effects are achieved with the combination of pemetrexed plus gemcitabine. A phase 1 study of pemetrexed plus gemcitabine given every 2 weeks demonstrated encouraging preliminary efficacy against head and neck squamous cell cancer (HNSCC).
This was an open-label, single-institution, single-arm, phase 2 study for patients who had received no more than 2 cytotoxic regimens for recurrent and/or metastatic HNSCC. All patients received pemetrexed 500 mg/m2 intravenously plus gemcitabine 1250 mg/m2 intravenously every 2 weeks with vitamin B12 and folate support. The primary endpoint was the objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST); secondary endpoints were to estimate overall survival and to evaluate safety and tolerability.
Twenty-five patients received therapy. All patients had received prior radiotherapy, and half had received prior cytotoxic chemotherapy for recurrent and/or metastatic disease. Neutropenia (grade ≥3) occurred in 24% of patients. Four patients (16%) had a partial response (PR) according to RECIST, and 5 additional patients (20%) had objective tumor reductions of >20 but <30% did not meet RECIST criteria for a PR. The median overall survival for all treated patients was 8.8 months.
Treatment with pemetrexed plus gemcitabine every 2 weeks with vitamin support generally was well tolerated. The results of this study provided further evidence that pemetrexed may have significant palliative activity against advanced HNSCC. Cancer 2011. © 2010 American Cancer Society.