Three-weekly docetaxel (T) plus capecitabine (X) in 1st and 2nd line metastatic esophageal cancer (MEC): Final Results of the phase II DACAPO Trial

• DOI: 10.1200/jco.2005.23.16_suppl.4142
• Publication Date: 2017-02-23T18:55:09Z
• Authors: S. Lorenzen; J. Duyster; C. Lersch; S. Delius; B. Lang; M. Hennig; R. Bredenkamp; C. Peschel; F. Lordick
• Keywords: Clinical endpoint; Tolerability; Mucositis

4142 Background: Both X and T have single agent activity in upper gastrointestinal tumors, together demonstrated preclinical synergy a survival benefit breast cancer. Phase II trials of XT shown response rates 40–53% good tolerability 1st-line metastatic gastric cancer (ASCO 04, abstracts 4051 4057). This trial assessed the efficacy feasibility combination patients (pts) with MEC. Methods: Pts received 75mg/m2 day 1 plus oral 1000mg/m2 twice d1–14 every 3 weeks. The primary endpoint was according to RECIST. Toxicity reported NCI.CTCAE v3.0. Median follow up is 16.5 (7.9–21.4) months. Results: From 02/03 until 04/04 we included 24 pts one center: 21 men, women; median age 61.5 years, range 49–72; 17 had squamous cell 7 adenocarcinomas. All disease. 16 were treated 1st-line, 8 2nd-line. 4 (0–6) cycles. Dose reductions or both agents (to <80% initial doses) 41% pts. 2/24 (8.3%) died within 60 days after inclusion: rapid tumor progression bleeding, esophageal stent dislocation subsequent mediastinitis. Severe adverse events (grade 3/4) were: neutropenia 10 (42%), febrile 2 (8%), diarrhea (13%), sensory neuropathy fatigue hand-foot syndrome (29%). Grade1/2 (29%) Intent-to-treat analysis showed 46% rate including CR, 17% SD, 29% PD 8% NE. Of 11 responses, 9/16 (56%) 2/8 (25%) 2nd-line therapy. 16.0 months (95%CI 7.9–24.2). time 6.2 4.6–7.8). Conclusions: Docetaxel capecitabine has manageable toxicity profile very promising MEC, at least comparable other doublet regimens. merits further investigation. Author Disclosure Employment Leadership Consultant Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis, Roche