Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer

We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients. Patients wh...

Full description

Saved in:
Bibliographic Details
Published inBritish journal of cancer Vol. 94; no. 11; pp. 1575 - 1579
Main Authors Nakamura, K, Yamaguchi, T, Ishihara, T, Sudo, K, Kato, H, Saisho, H
Format Journal Article
LanguageEnglish
Published England Nature Publishing Group 05.06.2006
Subjects
Aged
Clinical Study
Deoxycytidine - analogs & derivatives
Deoxycytidine - therapeutic use
Deoxycytidine - toxicity
Drug Combinations
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neoplasm Metastasis
Oxonic Acid - therapeutic use
Oxonic Acid - toxicity
Pancreatic cancer
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - mortality
Pancreatic Neoplasms - pathology
Survival Analysis
Tegafur - therapeutic use
Tegafur - toxicity
Time Factors
Online AccessGet full text

Cover

More Information
Summary:We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients. Patients who had pathologically proven pancreatic cancer with metastatic lesions were eligible candidates for entry into the study. S-1 was given orally (30 mg m(-2)) b.i.d. for 14 consecutive days and gemcitabine (1000 mg m(-2)) was given on days 8 and 15. The cycle was repeated every 21 days. We enrolled 33 MPC patients. The median number of cycles was eight (range 1-20). Grade 3-4 toxicities were leucopenia (33%), neutropenia (55%), anaemia (9%), thrombocytopenia (15%), anorexia (6%), fever (9%), and interstitial pneumonia (6%). Objective responses were obtained in 16 patients (one complete response and 15 partial responses; response rate, 48%; 95% confidence interval (CI), 33-65). Median survival and 1-year survival rate were 12.5 months (95% CI, 5.9-19.1) and 54% (95% CI, 36-72), respectively. Combination chemotherapy with GEM and S-1 was well tolerated and yielded a significantly high response rate.
ISSN:0007-0920
1532-1827
DOI:10.1038/sj.bjc.6603168