Phase II trial of gemcitabine plus UFT as salvage treatment in oxaliplatin, irinotecan and fluoropyrimidine-refractory metastatic colorectal cancer

• Published in: Cancer chemotherapy and pharmacology Vol. 74; no. 3; pp. 447 - 455
• Main Authors: Lee, Keun-Wook, Kim, Yu Jung, Lee, Kyung-Hun, Han, Sae-Won, Kim, Tae-Yong, Oh, Do-Youn, Im, Seock-Ah, Kim, Tae-You, Bang, Yung-Jue, Choi, In Sil, Kim, Jee Hyun
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.09.2014; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Cancer Research; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - mortality; Colorectal Neoplasms - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Disease-Free Survival; Drug Administration Schedule; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Neutropenia - chemically induced; Oncology; Organoplatinum Compounds - administration & dosage; Original Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Republic of Korea; Salvage Therapy; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tegafur - administration & dosage; Treatment Outcome; Tumors; Uracil - administration & dosage; Refractory; Chemotherapy; UFT; Gemcitabine; Metastatic colorectal cancer; Antineoplastic agent; Rectal disease; Toxicity; Colorectal cancer; Metastasis; Isomerases; Oxaliplatin; Phase II trial; Intestinal disease; Advanced stage; Topoisomerase I inhibitor; Pyrimidine nucleoside; Platinum II Complexes; Camptothecin derivatives; Human; Treatment resistance; Enzyme; Fluoropyrimidine derivatives; DNA topoisomerase; Enzyme inhibitor; Malignant tumor; Colonic disease; Irinotecan; Alkylating agent; Treatment; Antimetabolic; Pyrimidine derivatives; Digestive diseases; Fluorine Organic compounds; Salvage treatment; Cancer
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-014-2515-8

Purpose To investigate the efficacy of gemcitabine plus uracil–tegafur (UFT) combination chemotherapy as a salvage treatment in patients with metastatic colorectal cancer (MCRC). Methods This single-arm phase II study was conducted at three institutions in Korea. Patients with MCRC refractory to fluoropyrimidine, oxaliplatin and irinotecan were enrolled. Gemcitabine 800 mg/m 2 was administered intravenously on days 1, 8 and 15. UFT 200 mg/m 2 /day was taken orally in three divided doses on days 1–21. Cycles were repeated every 4 weeks, and tumor evaluation was carried out every 8 weeks. The primary endpoint of this study was 8-week progression-free survival (PFS) rate. Results Forty-one patients were enrolled. Fourteen patients received gemcitabine/UFT as a third-line treatment and 37 patients as a fourth-line or later-line therapy. Toxicities were easily manageable, and non-hematologic toxicities of ≥grade 3 were rare. The most common toxicity of ≥grade 3 was neutropenia (20.0 %). One patient showed partial response (response rate, 2.4 %) and 14 (34.1 %) showed stable disease. The 8-week PFS rate was 42.3 %. The median PFS was 1.7 months [95 % confidence interval (CI) 1.6–1.8 months], and the median overall survival was 9.2 months (95 % CI 5.8–12.6 months). Conclusions Overall efficacy of gemcitabine/UFT in refractory MCRC was unsatisfactory. However, we could find a minor proportion of patients who showed prolonged tumor stabilization to gemcitabine/UFT. Further studies are warranted to identify a patient subgroup that might have benefits from gemcitabine/UFT therapy.