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Phase II study of S-1, a novel oral fluoropyrimidine, and biweekly administration of docetaxel for previously treated advanced non-small-cell lung cancer.

Oki Y, Hirose T, Yamaoka T, Kusumoto S, Shirai T, Sugiyama T, Okuda K, Nakashima M, Murata Y, Ohmori T, Adachi M - Cancer Chemother. Pharmacol. (2010)

Bottom Line: Response rates and survival times did not differ significantly according to the histological type.Grade 3-5 toxicities included neutropenia in 51.0% of patients, thrombocytopenia in 2.0%, anemia in 20.4%, infection in 24.5%, anorexia in 12.2%, diarrhea in 14.3%, nausea in 6.1%, and dehydration in 4.2%.There was 1 treatment-related death due to severe anorexia, stomatitis, diarrhea, and, as consequence, dehydration.

View Article: PubMed Central - PubMed

Affiliation: Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan.

ABSTRACT

Purpose: We examined the safety and efficacy of the combination of S-1 and biweekly docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC).

Methods: Patients with previously treated advanced NSCLC were eligible if they had a performance status of 2 or less, were 80 years or younger, and had adequate organ function. Forty-nine patients (38 men and 11 women; median age, 66 years; range 43-79 years) were enrolled. Patients were treated with the combination of 80 mg/m(2) per day of S-1 for 14 consecutive days and 35 mg/m(2) of docetaxel on days 1 and 15 every 4 weeks.

Results: The overall response rate was 16.3% (95% confidence interval, 7.6-30.5%). The disease-control rate was 49.0% (95% confidence interval, 34.4-63.7%). The median survival time after this treatment was 9 months (range 1-22 months). The median progression-free survival time was 3 months (range 1-11 months). Response rates and survival times did not differ significantly according to the histological type. Grade 3-5 toxicities included neutropenia in 51.0% of patients, thrombocytopenia in 2.0%, anemia in 20.4%, infection in 24.5%, anorexia in 12.2%, diarrhea in 14.3%, nausea in 6.1%, and dehydration in 4.2%. There was 1 treatment-related death due to severe anorexia, stomatitis, diarrhea, and, as consequence, dehydration.

Conclusions: The combination of S-1 and biweekly docetaxel is an acceptable therapeutic option in patients with previously treated advanced NSCLC regardless of the histological type.

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Related in: MedlinePlus

The figure shows progression-free survival time from this treatment estimated with the Kaplan–Meier method. The median progression-free survival time was 3 months (range 1–11 months)
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Fig2: The figure shows progression-free survival time from this treatment estimated with the Kaplan–Meier method. The median progression-free survival time was 3 months (range 1–11 months)

Mentions: Survival analysis was performed when the median follow-up time of all evaluable patients was 9 months. At the time of analysis, nine patients (18.4%) were alive and none had been lost to follow-up. The MST from the start of this regimen was 9 months (range 1–22 months; Fig. 1). The 1-year survival rate from the start of this regimen was 42%. The MST did not differ significantly according to the histological type (p = 0.28). The MST did not differ significantly between patients who had received paclitaxel pretreatment and patients who had not (p = 0.35). The median PFS time was 3 months (range 1–15 months; Fig. 2).Fig. 1


Phase II study of S-1, a novel oral fluoropyrimidine, and biweekly administration of docetaxel for previously treated advanced non-small-cell lung cancer.

Oki Y, Hirose T, Yamaoka T, Kusumoto S, Shirai T, Sugiyama T, Okuda K, Nakashima M, Murata Y, Ohmori T, Adachi M - Cancer Chemother. Pharmacol. (2010)

The figure shows progression-free survival time from this treatment estimated with the Kaplan–Meier method. The median progression-free survival time was 3 months (range 1–11 months)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3064900&req=5

Fig2: The figure shows progression-free survival time from this treatment estimated with the Kaplan–Meier method. The median progression-free survival time was 3 months (range 1–11 months)
Mentions: Survival analysis was performed when the median follow-up time of all evaluable patients was 9 months. At the time of analysis, nine patients (18.4%) were alive and none had been lost to follow-up. The MST from the start of this regimen was 9 months (range 1–22 months; Fig. 1). The 1-year survival rate from the start of this regimen was 42%. The MST did not differ significantly according to the histological type (p = 0.28). The MST did not differ significantly between patients who had received paclitaxel pretreatment and patients who had not (p = 0.35). The median PFS time was 3 months (range 1–15 months; Fig. 2).Fig. 1

Bottom Line: Response rates and survival times did not differ significantly according to the histological type.Grade 3-5 toxicities included neutropenia in 51.0% of patients, thrombocytopenia in 2.0%, anemia in 20.4%, infection in 24.5%, anorexia in 12.2%, diarrhea in 14.3%, nausea in 6.1%, and dehydration in 4.2%.There was 1 treatment-related death due to severe anorexia, stomatitis, diarrhea, and, as consequence, dehydration.

View Article: PubMed Central - PubMed

Affiliation: Division of Respiratory Medicine and Allergology, Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan.

ABSTRACT

Purpose: We examined the safety and efficacy of the combination of S-1 and biweekly docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC).

Methods: Patients with previously treated advanced NSCLC were eligible if they had a performance status of 2 or less, were 80 years or younger, and had adequate organ function. Forty-nine patients (38 men and 11 women; median age, 66 years; range 43-79 years) were enrolled. Patients were treated with the combination of 80 mg/m(2) per day of S-1 for 14 consecutive days and 35 mg/m(2) of docetaxel on days 1 and 15 every 4 weeks.

Results: The overall response rate was 16.3% (95% confidence interval, 7.6-30.5%). The disease-control rate was 49.0% (95% confidence interval, 34.4-63.7%). The median survival time after this treatment was 9 months (range 1-22 months). The median progression-free survival time was 3 months (range 1-11 months). Response rates and survival times did not differ significantly according to the histological type. Grade 3-5 toxicities included neutropenia in 51.0% of patients, thrombocytopenia in 2.0%, anemia in 20.4%, infection in 24.5%, anorexia in 12.2%, diarrhea in 14.3%, nausea in 6.1%, and dehydration in 4.2%. There was 1 treatment-related death due to severe anorexia, stomatitis, diarrhea, and, as consequence, dehydration.

Conclusions: The combination of S-1 and biweekly docetaxel is an acceptable therapeutic option in patients with previously treated advanced NSCLC regardless of the histological type.

Show MeSH
Related in: MedlinePlus