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Titolo:
Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study
Autore:
Hoff, PM; Ansari, R; Batist, G; Cox, J; Kocha, W; Kuperminc, M; Maroun, J; Walde, D; Weaver, C; Harrison, E; Burger, HU; Osterwalder, B; Wang, AO; Wong, R;
Indirizzi:
Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA Univ Texas Houston TX USA 77030 Anderson Canc Ctr, Houston, TX 77030 USA Phys Reliance Network Inc, Dallas, TX USA Phys Reliance Network Inc Dallas TX USA ance Network Inc, Dallas, TX USA Michiana Hematol Oncol, South Bend, IN USA Michiana Hematol Oncol South Bend IN USA matol Oncol, South Bend, IN USA Hematol & Oncol Assoc Virginia, Richmond, VA USA Hematol & Oncol Assoc Virginia Richmond VA USA irginia, Richmond, VA USA Response Oncol, Memphis, TN USA Response Oncol Memphis TN USAResponse Oncol, Memphis, TN USA Hoffmann La Roche Inc, Nutley, NJ 07110 USA Hoffmann La Roche Inc Nutley NJ USA 07110 Roche Inc, Nutley, NJ 07110 USA McGill Univ, Dept Oncol, Montreal, PQ, Canada McGill Univ Montreal PQ Canada ll Univ, Dept Oncol, Montreal, PQ, Canada London Reg Canc Ctr, London, ON N6A 4L6, Canada London Reg Canc Ctr London ON Canada N6A 4L6 , London, ON N6A 4L6, Canada Ottawa Reg Canc Ctr, Ottawa, ON K1Y 4K7, Canada Ottawa Reg Canc Ctr Ottawa ON Canada K1Y 4K7 , Ottawa, ON K1Y 4K7, Canada Grp Hlth Ctr, Sault St Marie, ON, Canada Grp Hlth Ctr Sault St Marie ON Canada th Ctr, Sault St Marie, ON, Canada Tom Baker Canc Ctr, Calgary, AB, Canada Tom Baker Canc Ctr Calgary AB Canada Baker Canc Ctr, Calgary, AB, Canada H Bliss Canc Ctr, St Johns, NF, Canada H Bliss Canc Ctr St Johns NF Canada Bliss Canc Ctr, St Johns, NF, Canada F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland F Hoffmann La Roche & Co Ltd Basel Switzerland CH-4002 asel, Switzerland
Titolo Testata:
JOURNAL OF CLINICAL ONCOLOGY
fascicolo: 8, volume: 19, anno: 2001,
pagine: 2282 - 2292
SICI:
0732-183X(20010415)19:8<2282:COOCVI>2.0.ZU;2-S
Fonte:
ISI
Lingua:
ENG
Soggetto:
FLUOROPYRIMIDINE CARBAMATE; CONTINUOUS-INFUSION; PALLIATIVE CHEMOTHERAPY; IRINOTECAN; CARCINOMA; TRIAL; 5-FLUOROURACIL; SURVIVAL; BOLUS; MODULATION;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
56
Recensione:
Indirizzi per estratti:
Indirizzo: Hoff, PM Univ Texas, MD Anderson Canc Ctr, 1515 Holcombe Blvd,Box 426, Houston, TX 77030 USA Univ Texas 1515 Holcombe Blvd,Box 426 Houston TX USA 77030 30 USA
Citazione:
P.M. Hoff et al., "Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study", J CL ONCOL, 19(8), 2001, pp. 2282-2292

Abstract

Purpose: To compare the response rate, efficacy parameters, and toxicity profile of oral capecitabine with bolus intravenous (IV) fluorouracil plus leucovorin (5-FU/LV) as first-line treatment in patients with metastatic colorectal cancer. Patients and Methods: We prospectively randomized 605 patients to treatment with oral capecitabine for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily for 5 days in 4-week cycles. Results: The overall objective tumor response rate among all randomized patients was significantly higher in the capecitabine group (24.8%) than in the 5-FU/LV group (15.5%; P =.005). In the capecitabine and 5-FU/LV groups, median times to disease progression were 4.3 and 4.7 months (log-rank P =.72), median times to treatment failure were 4.1 and 3.1 months (P =.19), andmedian overall survival times were 12.5 and 13.3 months (P =.974), respectively. Capecitabine, compared with bolus 5-FU/LV treatment, produced a significantly lower incidence (P <.0002) of diarrhea, stomatitis, nausea, and alopecia, Patients treated with capecitabine also displayed lower incidencesof grade 3/4 stomatitis and grade 3/4 neutropenia (P <.0001) leading to significantly less neutropenic fever/sepsis. Grade 3 hand-foot syndrome (P <.00001) and grade 3/4 hyperbilirubinemia were the only toxicities more frequently associated with capecitabine than with 5-FU/LV treatment. Conclusion: Oral capecitabine was mare active than 5-FU/LV in the induction of objective tumor responses. Time to disease progression and survival were at least equivalent for capecitabine compared with the 5-FU/LV arm. Capecitabine also demonstrated clinically meaningful benefits over bolus 5-FU/LV in terms of tolerability. <(c)> 2001 by American Society of Clinical Oncology.

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Documento generato il 23/01/20 alle ore 03:37:23