Alternating irinotecan with oxaliplatin combined with UFT plus leucovorin (SCOUT) in metastatic colorectal cancer

摘要

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 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 leucopaenia; 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.