Abstract |
Tegafur- uracil (UFT) plus leucovorin (LV, folinic acid) with alternating irinotecan and oxaliplatin were effective and well tolerated in patients with metastatic colorectal cancer (mCRC) in a phase I study. This study expanded the maximum tolerated dose group. Patients aged >or=18 years had histologically confirmed, inoperable, previously untreated, measurable mCRC. Patients received irinotecan 180 mg m(-2) on day 1, oxaliplatin 100 mg m(-2) on day 15 and UFT 250 mg m(-2) plus LV 90 mg on days 1-21 every 28 days. The phase I/II study comprised 45 patients, 29 at the maximum tolerated dose (MTD). The response rate in 38 evaluable patients was 63% (95% confidence interval (CI): 49-80). Median time to progression and overall survival were 8.7 months (95% CI: 7.9-10.4) and 16.8 months (95% CI: 9.6-25.3), respectively. In the MTD group, one patient had grade 3 leucopenia; one had grade 3 neutropaenia; three had grade 3 diarrhoea; and one had grade 3 neurotoxicity. No hand-foot syndrome grade >1 was seen. In total, 67% of eligible patients received second-line therapy. UFT plus LV with alternating irinotecan and oxaliplatin is an efficacious first-line treatment for mCRC, with minimal neurotoxicity and hand-foot syndrome.
|
Authors | H Y Sheikh, J W Valle, T Waddell, K Palmer, G Wilson, A Sjursen, O Craven, R Swindell, M P Saunders |
Journal | British journal of cancer
(Br J Cancer)
Vol. 99
Issue 4
Pg. 577-83
(Aug 19 2008)
ISSN: 1532-1827 [Electronic] England |
PMID | 18682717
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Organoplatinum Compounds
- Oxaliplatin
- Tegafur
- Irinotecan
- Leucovorin
- Camptothecin
|
Topics |
- Adenocarcinoma
(drug therapy, secondary, surgery)
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Camptothecin
(administration & dosage, analogs & derivatives)
- Colorectal Neoplasms
(drug therapy, pathology, surgery)
- Female
- Humans
- Irinotecan
- Leucovorin
(administration & dosage)
- Male
- Maximum Tolerated Dose
- Middle Aged
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Survival Rate
- Tegafur
(administration & dosage)
- Treatment Outcome
|