Weekly Docetaxel in Combination With Capecitabine in Patients With Metastatic Gastric Cancer

Abstract

Docetaxel (T) and capecitabine (X) are active agents against gastric cancer with synergistic antitumor effects. We conducted the current phase II study to assess the response rate and toxicity of combination TX regimen in patients with metastatic gastric cancer. Eligible patients were treated with docetaxel (36 mg/m2 intravenously) on days 1 and 8 and capecitabine (1000 mg/m2 orally twice a day) on days 1-14 of a 3-week schedule until progression occurred. From December 2001 to May 2003, 55 patients with median age of 54 years (range, 22-73 years) were enrolled; 47 patients had measurable lesions. A total of 358 courses of treatment were given, with a median of 5 (range, 1-22+) per patient. Objective responses were documented in 19 of 47 patients with measurable lesions (response rate, 40.4%; 95% confidence interval [CI], 25.9-54.9), with the median response duration of 5.6 months (range, 2.1-13.6+). At a median follow up of 15.9 months for all of 55 study patients, the median time to progression and survival were 4.5 months (95% CI, 3.4-5.6) and 12.0 months (95% CI, 7.5-16.6), respectively. Hematologic toxicities were mild to moderate, and the observed grade 3 nonhematologic toxicities, the most frequent of which was stomatitis, were generally manageable. Four patients experienced pneumonitis, but all of them responded to steroid treatment. The TX regimen was relatively well tolerated and effective against metastatic gastric cancer, with the added advantage of being an outpatient regimen.

Randomised, non-comparative phase II study of weekly docetaxel with cisplatin and 5-fluorouracil or with capecitabine in oesophagogastric cancer: the AGITG ATTAX trial

“…Palliative benefit was also shown by the improvement in relevant disease-related symptoms, as determined by QLQs. Several studies in advanced oesophagogastric cancer have shown the activity of docetaxel and capecitabine doublets (Chun et al, 2005;Kim et al, 2005;Lorenzen et al, 2005), although this is not universal (Orditura et al, 2006). As a randomised phase II study, our protocol was not powered for direct efficacy comparisons between the two arms.…”

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

“…This toxicity profile is similar to weekly docetaxel plus capecitabine, which proved to be promising in gastric cancer, as shown by some phase 2 trials. 24,25 Although the incidence is not high, this toxicity may be troublesome for patients. Docetaxel-induced hand-and-foot syndrome is known to be related to the cumulative dose and occur more frequently in a weekly schedule.…”

Review of capecitabine as oral treatment of gastric, gastroesophageal, and esophageal cancers

“…[32][33][34] Capecitabine-Taxane Combination Therapies Gastric and gastroesophageal cancer Tables 2 and 3 summarize the trials of combination of capecitabine and a taxane. [40][41][42][43][44][45][46] The labeled dose of capecitabine and docetaxel 75 mg on Day 1 in 3-week cycles 44,45 and a variety of lower doses of capecitabine with various doses and schedules of docetaxel or paclitaxel [40][41][42][43]46 have been reported, with RRs rates ranging from 37% to 67%. In those trials, the median TTP and overall survival ranged from 4.5 months to 5.3 months and from 10.5 months to 17.2 months, respectively.…”