Investigational New Drugs

, Volume 23, Issue 3, pp 243–251 | Cite as

Weekly irinotecan plus UFT and leucovorin as first-line chemotherapy of patients with advanced colorectal cancer

  • M. Méndez
  • P. G. Alfonso
  • E. Pujol
  • E. González
  • C. Castañon
  • P. Cerezuela
  • Y. López-Mateos
  • J. J. CruzEmail author


We evaluated the antitumoral efficacy and safety of CPT-11 125 mg/m2 (weekly 90 min i.v. infusion; days 1, 8 and 15) combined with UFT (oral combination of tegafur and uracil) 200 mg/m2/day plus leucovorin (LV) 45 mg/m2/day (both divided into three separate oral doses every 8 h, days 1–21) every 4 weeks as first-line chemotherapy of metastatic colorectal cancer (CRC). Fifty-three patients ≧18 years old with histologically confirmed diagnosis of advanced CRC and bidimensionally measurable disease were enrolled. Three patients (6%) showed CR and 8 patients (15%) showed PR (ORR = 21% (95% CI, 10–32). Stable disease was reported in 19 patients (36%) [tumor control rate = 57% (95% CI, 43–70)]. The median time to progression and overall survival were 7.9 and 18.2 months, respectively (1-year rate = 74%; 2-years rate = 26%). CPT-11/UFT/LV treatment was well tolerated: the most reported grade 3/4 toxicities were neutropenia (11% of patients) and delayed diarrhea (28% of patients). No significant differences in response rate, survival or toxicity were found between younger (≤65 years) and older patients (> 65 years). Weekly CPT-11 plus UFT/LV was found effective and safe as first-line chemotherapy for metastatic CRC. The addition of CPT-11 to UFT/LV doubled the response rate compared to the results previously reported with UFT/LV, while myelosuppression remained low.

Key words

tegafur uracil CPT-11 colorectal cancer elderly 


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Copyright information

© Springer Science + Business Media, Inc. 2005

Authors and Affiliations

  • M. Méndez
    • 1
  • P. G. Alfonso
    • 2
  • E. Pujol
    • 3
  • E. González
    • 4
  • C. Castañon
    • 5
  • P. Cerezuela
    • 6
  • Y. López-Mateos
    • 7
  • J. J. Cruz
    • 8
    • 9
    Email author
  1. 1.Hospital de MóstolesMadrid
  2. 2.Hospital Gregorio MarañónMadrid
  3. 3.Hospital Río HortegaValladolid
  4. 4.Hospital Virgen de las NievesGranada
  5. 5.Hospital Virgen BlancaLeón
  6. 6.Hospital Naval del MediterráneoMurcia
  7. 7.Hospital Virgen del PuertoPlasencia
  8. 8.Hospital Clínico UniversitarioSalamancaSpain
  9. 9.Servicio de Oncología MédicaHospital Clínico UniversitarioSalamancaSpain

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