Randomized phase II study of two different schedules of gemcitabine and oral S-1 in chemo-naïve patients with advanced non-small cell lung cancer.

Abstract

INTRODUCTION:

This study was conducted to evaluate the efficacy and safety and to compare dosing schedules of gemcitabine combined with S-1 in chemo-naïve non-small cell lung cancer patients.

METHODS:

Patients with chemo-naïve stage IIIB/IV non-small cell lung cancer were randomized into two treatment arms. Patients were given oral S-1 (60 mg/m/d, twice a day) from days 1 to 14 with gemcitabine (1000 mg/m/d) on days 1 and 8 (arm A) or on days 8 and 15 (arm B). This cycle was repeated every 21 days.

RESULTS:

A total of 80 patients were entered in this trial. The primary end point of this study was response rate. The response rates of arm A and arm B were 22.0 and 28.9%, respectively (p = 0.606). Median time to treatment failure in arm A was 3.6 months and 4.8 months in arm B. Median time to progression in arm A was 4.1 months and 5.5 months in arm B. Median survival time in arm A and arm B was 15.5 months and 18.8 months, respectively. The toxicity profile was relatively mild and did not differ very much between two arms.

CONCLUSION:

The combination of gemcitabine and S-1 was determined to be feasible and effective for advanced non-small cell lung cancer. We selected arm B for further studies because of its higher response rate and survival data.

• Authors: Miyako Satouchi, Yoshikazu Kotani, Nobuyuki Katakami, Temiko Shimada, Yoshiko Urata, Sho Yoshimura, Yasuhiro Funada, Akito Hata, Masahiko Ando, Shunichi Negoro
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 5 Issue 5 Pg. 696-701 (May 2010) ISSN: 1556-1380 [Electronic] United States
• PMID: 20147856 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Drug Combinations
• Deoxycytidine
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, pathology)
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Carcinoma, Squamous Cell (drug therapy, pathology)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Drug Combinations
• Female
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Neoplasm Staging
• Oxonic Acid (administration & dosage)
• Safety
• Survival Rate
• Tegafur (administration & dosage)
• Treatment Outcome
• Gemcitabine