A Phase II Study of Weekly Docetaxel in Combination with Capecitabine in Advanced Gastric and Gastroesophageal AdenocarcinomasLo S.S. · Khorana A.A. · Javle M. · Simon S. · Kiefer G. · Rajasenan K. · Wang H. · Hantel A. · Shayne M. · Hwang J. · Schmotzer A. · Ramanathan R.K.
aLoyola University Stritch School of Medicine, Maywood, Ill., bUniversity of Rochester School of Medicine and Dentistry, Rochester, N.Y., cRoswell Park Cancer Institute, Buffalo, N.Y., dUniversity of Pittsburgh Cancer Institute, Pittsburgh, Pa., eEdward Hospital, Naperville, Ill., and fLombardi Cancer Center, Georgetown University, Washington, D.C., USA
Objective: Docetaxel and capecitabine are active agents in advanced gastric and gastroesophageal (GE) carcinomas. This multi-institutional phase II trial evaluates the combination of docetaxel and capecitabine as first- or second-line treatment in patients with advanced gastric and GE adenocarcinomas. Methods: Patients who had received 1 or no prior chemotherapy regimens were eligible. The chemotherapy regimen consisted of a 21-day cycle with docetaxel 30 mg/m2 administered on days 1 and 8 and capecitabine 825 mg/m2 administered twice daily on days 1–14. The primary end point of the study was overall survival (OS). Results: Forty patients were enrolled in the study; 39 received treatment and were evaluable for response and toxicity. The median patient age was 61 years (range 21–84); 8 patients had received prior chemotherapy in the advanced or metastatic setting. Grade 3/4 adverse events occurred in 15 patients (38%), including diarrhea in 5 patients (13%) and hand-foot syndrome in 5 patients (13%). The overall response rate was 32% [95% confidence interval (CI) 16.7–51.4]. The median time to progression and OS were 3.4 months (95% CI 2.7–5.8) and 10.7 months (95% CI 6.1–12.1), respectively. Conclusions: The regimen of docetaxel and capecitabine is a well-tolerated, easily administered and active outpatient regimen for advanced gastric and GE adenocarcinoma.
Shelly S. Lo, MD
Loyola University Medical Center
Cardinal Bernardin Cancer Center, 2160 S. First Ave.
Maywood, IL 60153 (USA)
Tel. +1 708 327 3154, Fax +1 708 327 3219, E-Mail firstname.lastname@example.org
Presented in part at the 43rd Annual Meeting of the American College of Clinical Oncology, Chicago, Ill., USA, in June 2007.
Received: May 8, 2009
Accepted after revision: July 16, 2009
Published online: April 13, 2010
Number of Print Pages : 5
Number of Figures : 1, Number of Tables : 2, Number of References : 20
Oncology (International Journal of Cancer Research and Treatment)
Vol. 78, No. 2, Year 2010 (Cover Date: April 2010)
Journal Editor: Markman M. (Houston, Tex.)
ISSN: 0030-2414 (Print), eISSN: 1423-0232 (Online)
For additional information: http://www.karger.com/OCL