P-145 Metastases resection following FOLFIRI-aflibercept in refractory patients to first-line chemotherapy: safety and efficacy analysis

Abstract

Introduction: The VELOUR trial demonstrated that FOLFIRI‐aflibercept combination as a second‐line treatment provides improvement over placebo in primary endpoint overall survival as well as secondary endpoint overall response rate. The improvement in ORR potentially can increase the eligibility and potential benefit of resection of metastases. Improvement of substantial magnitude of response rate has not been reported with other agents available for second‐line treatment. Scarce data is found in literature regarding the safety and efficacy of metastases resection after FOLFIRI‐aflibercept in refractory patients to conventional first‐line systemic chemotherapy. Methods: In 18 patients from 14 Spanish hospitals, metastases resection was performed after treatment with FOLFIRI‐aflibercept. The clinical characteristics, efficacy and the perioperative morbi‐mortality have been retrospectively analyzed in this series. Results: Clinical characteristics: Median age: 65 (43‐71). Sex: 72.2% male, 27.8% female. ECOG: 0 (55.6%), 1 (44.4%). K‐ras: wild‐type (16.7%), mutated (83.3%). Type of tumor: colon (72.2%), rectal (27.8%). Previous treatment: oxaliplatin combinations (100%), bevacizumab (38.9%), cetuximab (16.7%). All K‐ras wild‐type patients had received previously FOLFOX‐cetuximab. FOLFIRI‐aflibercept was administered as second‐line in 16 patients (88.9%) and beyond second‐line in 2 patients (11.1%). Number of FOLFIRI‐aflibercept cycles before surgery: median 6 (range 3‐12). Type of surgery: liver metastases (50%), lung metastases (11.1%), cytoreductive for peritoneal carcinomatosis (16.7%), supraadrenalectomy (5.6%), simultaneous metastases liver and cytoreductive for peritoneal carcinomatosis (16.67%). Overall response rate after FOLFIRI‐aflibercept (RECIST 1.1 criteria): partial response 10 patients (55.6%), stable disease 8 patients (44.4%). Median progression‐free survival from surgery: 10.3 m (confidence interval [CI] 95% 3.3‐17.4 m).With a median follow‐up of 11.1 m (range 1.2‐30.5 m) median overall survival from surgery has not been reached. Mean overall survival: 25.6 m (CI 95% 18.7‐32.6 m). Postoperative morbidity: 22.2% (postoperative ileus‐bacteriemia, intra‐abdominal collection, anastomosis leakage‐urinary sepsis and nosocomial pneumonia, coagulopathy and hepatic failure). Reoperation rate: 1 patient (5.6%), performing anastomosis leakage after cytoreductive surgery with HIPEC and liver resection. 30 and 90‐day mortality rate: 0%. Resection rates: R0 72.2%, R1 22.2%, R2 5.6%. 5 patients (27.78%) received aflibercept after surgery. Conclusion: Metastases resection following FOLFIRI‐aflibercept in refractory patients to conventional first‐line chemotherapy is feasible and safe with encouraging efficacy. No new or unexpected adverse events and post‐operative complications have been observed. Funding Sanofi.