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We investigated the efficacy and safety of a combination of oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) as first-line palliative chemotherapy for elderly patients with metastatic or recurrent gastric cancer.
The study patients were chemotherapy-naïve patients (> 65 years old) with histologically confirmed, metastatic or recurrent gastric cancer. Chemotherapy consisted of oxaliplatin 100 mg/m2 and FA 100 mg/m2 (2-hour infusion), and then 5-FU 2400 mg/m2 (46-hour continuous infusion) every 2 weeks.
A total of 37 patients were studied between April 2004 and October 2006. Of the 34 evaluable patients, none achieved a complete response (CR) and 14 achieved a partial response (PR), resulting in an overall response rate of 41.2%. The median time to progression (TTP) was 5.7 months (95% CI: 4.2~6.3 months) and the median overall survival (OS) was 9.8 months (95% CI: 4.4~12.0 months). The main hematologic toxicities were anemia and neutropenia, which were observed in 56.7% and 32.4% of the patients, respectively. Grade 3/4 neutropenia was observed in 8.1% of the patients. None of the patients experienced febrile neutropenia. Peripheral neuropathy occurred in 35.1% of the patients and all were grade 1/2.
This oxaliplatin/5-FU/FA regimen showed good efficacy and an acceptable toxicity profile in elderly patients with metastatic or recurrent gastric cancer.
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The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed emesis.
From April 2002 through October 2002, a total of 112 patients receiving cisplatin- based combination chemotherapy were randomized to receive a single i.v. dose of dolasetron 100 mg or ondansetron 8 mg, 30 minutes before the initiation of chemotherapy. In the ondansetron group, two additional doses of ondansetron 8 mg were given at intervals of 2 to 4 hours. To prevent delayed emesis, dolasetron 200 mg p.o. daily or ondansetron 8 mg p.o. bid was administered from the 2nd days to a maximum of 5 days. The primary end point was the proportion of patients that experienced no emetic episodes and required no rescue medication (complete response, CR) during the 24 hours (acute period) and during Day 2 to Day 5±2 days (delayed period), after chemotherapy. The secondary end points included the incidence and severity of emesis.
105 patients were evaluable for efficacy. CR rates during the acute period were 36.0% for a single dose of dolasetron 100 mg, and 43.6% for three doses of ondansetron 8 mg. CR rates during the delayed period were 8.0% and 10.9%, respectively. There was no significant difference in the efficacy between the two groups. Adverse effects were mostly mild to moderate and not related to study medication.
A single i.v. dose of dolasetron 100 mg is as effective as three i.v. doses of ondansetron 8 mg in preventing acute and delayed emesis after cisplatin-based chemotherapy, with a comparable safety profile.
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