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Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma.

Park SR, Kim HK, Kim CG, Choi IJ, Lee JS, Lee JH, Ryu KW, Kim YW, Bae JM, Kim NK - Br. J. Cancer (2008)

Bottom Line: S-1/35 mg m(-2) docetaxel.In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively.There was one treatment-related death due to pneumonitis.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastric Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu1, Ilsan, Goyang, Gyeonggi 410-769, Republic of Korea. sukryun73@hanmail.net

ABSTRACT
We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m(-2) b.i.d.) and docetaxel (25-40 mg m(-2)); MTD was 45 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel and RD was 40 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.

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Time to progression for all evaluable patients in phase II (n=51).
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fig1: Time to progression for all evaluable patients in phase II (n=51).

Mentions: Out of the 52 patients, 51 could be evaluated for response, whereas 1 patient was lost to follow-up after day 1 of the first chemotherapy cycle. Two patients (3.9%) achieved complete response and 32 (62.7%) had partial response, making the overall response rate 66.7% (95% confidence interval (CI): 53.8–79.6%). Twelve patients (23.5%) had stable disease and five (9.8%) had progressive disease. All objective responses were confirmed by follow-up computed tomography at least 4 weeks after the initial documentation of response. The median duration of response was 6.3 months (range: 1.6 to 13.8+). The median follow-up time was 13.1 months (range: 8.5–18.0), during which the median TTP was 6.5 months (95% CI: 4.9–8.1 months) (Figure 1) and the median OS was 13.7 months (95% CI: 9.9–17.5) (Figure 2). The one-year survival rate was 58.5% (95% CI: 44.2–72.8%).


Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma.

Park SR, Kim HK, Kim CG, Choi IJ, Lee JS, Lee JH, Ryu KW, Kim YW, Bae JM, Kim NK - Br. J. Cancer (2008)

Time to progression for all evaluable patients in phase II (n=51).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2361699&req=5

fig1: Time to progression for all evaluable patients in phase II (n=51).
Mentions: Out of the 52 patients, 51 could be evaluated for response, whereas 1 patient was lost to follow-up after day 1 of the first chemotherapy cycle. Two patients (3.9%) achieved complete response and 32 (62.7%) had partial response, making the overall response rate 66.7% (95% confidence interval (CI): 53.8–79.6%). Twelve patients (23.5%) had stable disease and five (9.8%) had progressive disease. All objective responses were confirmed by follow-up computed tomography at least 4 weeks after the initial documentation of response. The median duration of response was 6.3 months (range: 1.6 to 13.8+). The median follow-up time was 13.1 months (range: 8.5–18.0), during which the median TTP was 6.5 months (95% CI: 4.9–8.1 months) (Figure 1) and the median OS was 13.7 months (95% CI: 9.9–17.5) (Figure 2). The one-year survival rate was 58.5% (95% CI: 44.2–72.8%).

Bottom Line: S-1/35 mg m(-2) docetaxel.In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively.There was one treatment-related death due to pneumonitis.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastric Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu1, Ilsan, Goyang, Gyeonggi 410-769, Republic of Korea. sukryun73@hanmail.net

ABSTRACT
We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m(-2) b.i.d.) and docetaxel (25-40 mg m(-2)); MTD was 45 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel and RD was 40 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.

Show MeSH
Related in: MedlinePlus