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Annals of Oncology 2007 18(Supplement 6):vi128-vi132; doi:10.1093/annonc/mdm241
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© 2007 European Society for Medical Oncology

gastro-intestinal cancer

Reduced dose intensity of docetaxel plus capecitabine as second-line palliative chemotherapy in patients with metastatic gastric cancer: a phase II study

G Rosati1,*, D Bilancia1, D Germano1, A Dinota1, R Romano1, G Reggiardo2 and L Manzione1

1 Medical Oncology Unit, ‘S. Carlo’ Hospital, Potenza
2 Medi Service, Data management Unit, Genova, Italy

* Correspondence to: Dr G. Rosati, Medical Oncology Unit, ‘S. Carlo’ Hospital, Via Sanremo, 197, 85100 Potenza, Italy. Tel: +39-0971-612273; Fax: +39-0971-613000; E-mail: rosatiger{at}yahoo.com

Background: A phase II study was conducted to evaluate the efficacy and safety of a combination regimen of a reduced dose intensity of docetaxel (Taxotere) plus capecitabine in pretreated patients with metastatic gastric cancer.

Patients and methods: Twenty-eight patients with documented progression on or within 3 months of a cisplatin-based chemotherapy were enrolled between April 2004 and November 2006. Docetaxel (60 mg/m2 on day 1) plus capecitabine (1000 mg/m2 twice daily on days 1–14) were given every 3 weeks.

Results: All patients were assessable for safety and 25 (89%) for tumor response. Median age was 63 years, and median follow-up was 13.3 months. Overall response rate was 29% (95% confidence interval 11% to 46%), while an additional 36% had stable disease. The median time to progression and median overall survival was 4 and 6 months, respectively. The most common clinical adverse events (all grades) were neutropenia (78%), hand foot symdrome (HFS) (53%), fatigue and alopecia (50%) and diarrhea (43%). However, with the exception of grade 3–4 neutropenia, which was seen in 36% of patients, other severe adverse events were rare. There were no treatment-related deaths. Treatment delays or dose reductions were necessary in 18 out of 104 cycles.

Conclusions: A reduced dose intensity of docetaxel plus capecitabine is a valuable regimen for second-line treatment in this setting of patients. This approach warrants further investigation as a promising chemotherapy option for chemonaive patients with metastatic gastric cancer.

Key words: capecitabine, docetaxel, gastric cancer, second-line chemotherapy


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