A phase II trial of biweekly gemcitabine and paclitaxel (GEMTAX) combination in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN): A Southwest Oncology Group study.

Abstract

5555 Background: Combinations of gemcitabine (G) and paclitaxel (P) have documented efficacy in lung, bladder, and breast cancer. Based on prior phase I data and pilot data of this regimen in advanced SCCHN, we conducted a multicenter phase II study to assess the efficacy and safety of biweekly GEMTAX in patients (pts) with recurrent or metastatic SCCHN. Methods: Eligible pts had biopsy proven SCCHN, either metastatic or persistent/recurrent after definitive surgery or radiation therapy. Pts also had Zubrod PS ≤ 1, sensory neuropathy < grade (Gr) 2, no serious organ dysfunction or CNS metastases. One prior induction or adjuvant regimen was allowed, with no G or taxanes, completed at least 6 months prior to enrollment. Treatment was G 3,000 mg/m2 and P 150 mg/m2 on days 1 and 15 of a 28 day cycle. Response to treatment was evaluated every 2 cycles. Treatment continued for 4 cycles after confirmed complete response or until disease progression. Results: 63 eligible pts (50 males, 13 females), median age 63.1 (range 40.7-82.9), were enrolled from 19 SWOG institutions. Major primary sites: 20 lip/oral cavity, 13 oropharynx, and 16 larynx. Status at enrollment: 50 recurrent, 7 persistent, 5 newly diagnosed. Response in 57 pts with measurable disease was 2 complete and 13 partial responses, for an estimated response rate of 26% (95% CI 16-40). The median times to overall and progression free survival were 8 months (95% CI 7-11) and 4 months (95% CI 3-6), respectively. Among 8 pts alive at last contact the median follow-up was 39 months (range 26-54). There were no treatment related deaths. Twelve (19%) patients had Gr 4 events, and 40 (63%) had Gr 3 events, with 8 hematologic events in each of Gr 3 and Gr 4. The most common Gr 3/4 events were fatigue 8 (13%), neutropenia 5 (8%), and neuropathy 4 (6%). Conclusions: GEMTAX appears to have activity similar to other doublets in metastatic and recurrent SCCHN, with somewhat less toxicity. The tolerability and activity, despite lack of a platinum, suggests that biweekly GEMTAX is a useful combination, warranting further study. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly Lilly