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Annals of Oncology Advance Access originally published online on September 25, 2007
Annals of Oncology 2008 19(1):104-108; doi:10.1093/annonc/mdm449
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© 2007 European Society for Medical Oncology. For Permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Phase II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer and/or adenocarcinoma of the gastroesophageal junction

D. Richards1,2,*, D. McCollum1,3, L. Wilfong1,4, M. Sborov5, K. A. Boehm1, F. Zhan1 and L. Asmar1

1 US Oncology Research, Inc., Houston
2 Tyler Cancer Center, Tyler
3 Baylor Charles Sammons Cancer Center, Dallas
4 Texas Oncology, PA, Presbyterian, Dallas
5 Minnesota Oncology Hematology, Edina, USA

* Correspondence to: Dr D. Richards, US Oncology Research, Tyler Cancer Center, 910 East Houston Street, Suite 100, Tyler, TX 75702, USA. Tel: +1-903-579-9800; Fax: +1-903-579-9935; E-mail: donald.richards{at}usoncology.com

Background: Platinum-based chemotherapy is the standard treatment for advanced gastric cancer (GC). This trial explored the efficacy and tolerability of combined docetaxel (Taxotere) + oxaliplatin (DOCOX) in GC patients.

Patients and methods: Patients with untreated stage IV GC or adenocarcinoma of the gastroesophageal junction (AGEJ) received docetaxel 60 mg/m2 followed by oxaliplatin 130 mg/m2 on day 1 of each 21-day cycle until progression or unacceptable toxicity. The primary end points were response rate (RR), toxicity, progression-free survival (PFS), and overall survival (OS).

Results: Baseline characteristics (N = 71): median age 59 years, 72% male, 51% esophagogastric junction cancer, and Eastern Cooperative Oncology Group performance status of zero, one, two were 42%, 51%, 7%, respectively. The median number of cycles was 6 (range, 1–19). Grades 3–4 toxic effects: neutropenia (70%); vomiting (17%); nausea (16%); dehydration, fatigue, or diarrhea (13%, each); and thrombocytopenia or febrile neutropenia (7%, each). Sixty-six patients completed ≥2 cycles. The RR was 36% with 25 partial response (PR) and no complete responses (CRs); stable disease (SD) was 49%. Clinical benefit rate (CBR = CR + PR + SD ≥6 months) was 40%; median PFS was 4.3 months, and OS was 8.5 months.

Conclusions: DOCOX produced manageable toxicity in patients with advanced GC and AGEJ. The confirmed RR of 36%, CBR of 40%, and median survival of 8.5 months are encouraging and comparable to standard front-line regimens.

Key words: docetaxel, gastropesophageal junction, gastric, oxaliplatin, phase II

Received for publication May 25, 2007. Revision received August 9, 2007. Accepted for publication August 13, 2007.


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