Avtor/Urednik		Scheithauer, W; McKendrick, J; Begbie, S; Borner, M; Burns, WI; Burris, HA; Cassidy, J; Jodrell, D; Koralewski, P; Štabuc, B
Naslov		Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial
Tip		članek
Vir		Ann Oncol
Vol. in št.		Letnik 14, št. 12
Leto izdaje		2003
Obseg		str. 1735-43
Jezik		eng
Abstrakt		Background: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil-leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes' C colon cancer. Patients and methods: Patients aged 18-75 years with resected Dukes' C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m2 twice daily, days 1-14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m2 with i.v. leucovorin 20 mg/m2 on days 1-5, repeated every 28 days (n = 974). Results: Patients receiving capecitabine experienced significantly (P <0.001) less diarrhea, stomatitis, nausea/ vomiting, alopecia and neutropenia, but more hand-foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenialsepsis and stomatitis (P <0.001), although more experienced grade 3 hand-foot syndrome than those treated with 5-FU/LV (P <0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged <65 years or >65 years old. Conclusions: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in 2004.
Deskriptorji		COLONIC NEOPLASMS ANTIMETABOLITES, ANTINEOPLASTIC DEOXYCYTIDINE DIARRHEA FLUOROURACIL AGE FACTORS SEX FACTORS SAFETY PERIPHERAL NERVOUS SYSTEM DISEASES NEUTROPENIA NEOPLASM METASTASIS COMBINED MODALITY THERAPY LEUCOVORIN