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Clinical Trial
. 2011 Aug 9;105(4):505-12.
doi: 10.1038/bjc.2011.278. Epub 2011 Jul 26.

Docetaxel and capecitabine for advanced gastric cancer: investigating dose-dependent efficacy in two patient cohorts

P C Thuss-Patience  1 , A Kretzschmar, Y Dogan, F Rothmann, I Blau, I Schwaner, K Breithaupt, D Bichev, M Grothoff, C Grieser, P Reichardt
Affiliations
Clinical Trial

Docetaxel and capecitabine for advanced gastric cancer: investigating dose-dependent efficacy in two patient cohorts

P C Thuss-Patience et al. Br J Cancer. .

Abstract

Background: No comparisons of different doses of docetaxel-capecitabine in patients with advanced gastric cancer have been performed.

Methods: Patients with previously untreated metastatic/locally advanced gastro-oesophageal or gastric adenocarcinoma were enrolled in a prospective multicentre phase II trial. Two sequential cohorts received docetaxel 75 mg m(-2) (day 1) plus capecitabine 1000 mg m(-2) twice daily (days 1-14) (cohort I) or docetaxel 60 mg m(-2) (day 1) plus capecitabine 800 mg m(-2) twice daily (days 1-14) (cohort II) every 3 weeks. The primary end point was confirmed overall response rate.

Results: In all, 91 patients were enrolled (cohort I, n=40; cohort II, n=51) and 87 were evaluable for efficacy (n=38, 49, respectively). Overall response rate was 50.0% in cohort I and 23.5% in cohort II (exploratory analysis, P=0.014). Median times to tumour progression and overall survival were 5.6 and 10.1 months in cohort I and 3.7 and 7.2 months in cohort II, respectively. Dose reductions for docetaxel and capecitabine were required in 50.0% and 57.5% of patients in cohort I and 11.8% and 15.7% in cohort II, respectively.

Conclusion: Starting treatment with full doses and reducing promptly seems to be the more promisingly effective strategy than starting cautiously with lower doses. Docetaxel/capecitabine 75/2000 mg m(-2) is a manageable, convenient outpatient combination with promising efficacy against advanced gastric cancer.

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Figures

Figure 1
Figure 1
Patient flowchart. *Reasons for exclusion: no gastric cancer (n=3) and patient gave wrong identity (n=1). **Because there were no drop outs, patient number exceeds that required statistically (n=44).
Figure 2
Figure 2
Time to tumour progression (A) and overall survival (B) in cohort I (higher dose, n=40) and cohort II (lower dose, n=51) treated with docetaxel and capecitabine. (A) Median time to tumour progression: cohort I, 5.6 months (95% CI: 3.9–7.3), cohort II, 3.7 months (95% CI: 2.5–5.0), P=0.10 (log-rank test). (B) Median overall survival: cohort I, 10.1 months (95% CI: 7.3–13.0), cohort II, 7.2 months (95% CI: 4.1–10.2), P=0.20 (log-rank test).
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