FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases (RCSM): Final results of the FFCD 1102 phase II trial

摘要: Background: Optimal therapeutic strategy in patients (pts) with RCSM remains discussed and many front-line options can be discussed to best treat primary tumor and metastatic disease: surgery (S), radiotherapy (RT), chemoradiotherapy (CRT) or chemotherapy (CT). The FFCD 1102 trial evaluated the efficacy of upfront FOLFIRINOX in this setting.Methods: Chemotherapy-naïve pts with RCSM received FOLFIRINOX: oxaliplatin 85 mg/m 2 d1+ irinotecan 180 mg/m 2 D1+ leucovorin 400 mg/m 2 d1 followed by 5FU 400 mg/m 2 bolus d1 and 2,400 mg/m 2 46h continuous infusion biweekly; 8 cycles were mandatory. CT-scan and MRI at baseline, 2 and 4 months (m) were centrally reviewed. The objective responses were assessed on CT-scan for metastases (RECIST criteria) and MRI for rectal tumor (volume decrease≥ 70%). The primary endpoint was disease control rate at 4 m (4m DC). With a Simon 2-stage design …