Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3
Van Cutsem E et al. - In a trial to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in pts with stage III colon cancer, it was reported that irinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival (OS) in pts with stage III colon cancer vs LV5FU2 alone. Methods- After curatively intentioned surgery, pts with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m2 as 2-hr infusion, followed by FU; as 400 mg/m2 bolus and then 600 mg/m2 continuous infusion over 22 hrs, days 1 and 2, every 2 wks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m2 as 30- to 90-min infusion, day 1, every 2 wks).
- 260 (7.9%) of 3278 pts received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan.
Results- Principal efficacy analysis was based on 2094 treated pts with stage III disease, randomly allocated in the LV5FU2 strata.
- After median follow-up of 66.3 mos, 5-yr DFS rate was 56.7% with irinotecan/LV5FU2 and 54.3% with LV5FU2 alone.
- Combining irinotecan with LV5FU2 did not significantly improve OS in this pt group vs LV5FU2 alone (5-yr rate 73.6% vs 71.3%, respectively).
- The addition of irinotecan to LV5FU2 was associated with increased incidence of grade 3 to 4 GI events and neutropenia.
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