BACKGROUND:Reports have demonstrated the superior activity of combining both irinotecan and oxaliplatin (FOLFOXIRI) therapy. An option for gaining similar benefits with less toxicity would be the administration of irinotecan through a hepatic artery approach. The aim of this study was to assess the response and adverse event rates for irinotecan drug-eluting beads (DEBIRI) with folinic acid, 5-fluorouracil, and oxaliplatin (FOLFOX) and bevacizumab as a first-line treatment for unresectable colorectal liver metastasis. METH-ODS: Patients with colorectal liver metastases were randomly assigned to modified FOLFOX (mFOLFOX) and bevacizumab or mFOL-FOX6, bevacizumab, and DEBIRI (FOLFOX-DEBIRI). The primary endpoint was the response rate. The secondary endpoints were adverse events, the rate of conversion to resection, and progression-free survival. RESULTS: The intention-to-treat population comprised 70 patients: 10 patients in the pilot and then 30 patients randomly assigned to the FOLFOX-DEBIRI arm and 30 patients randomly assigned to the FOLFOX/bevacizumab arm. The 2 groups were similar with respect to the extent of liver involvement (30% vs 30%), but a greater percentage of patients in the FOLFOX-DEBIRI arm had an Eastern Cooperative Oncology Group performance status of 1 or 2 (57% vs 31%) and extrahepatic disease (56% vs 32%, P 5.02). The median numbers of chemotherapy cycles were similar (10 vs 9), and there were similar rates of grade 3/4 adverse events (54% for the FOLFOX-DEBIRI group vs 46% for the FOLFOX/ bevacizumab group). The overall response rate was significantly greater in the FOLFOX-DEBIRI arm versus the FOLFOX/bevacizumab arm at 2 (78% vs 54%, P 5.02), 4 (95% vs 70%, P 5.03), and 6 months (76% vs 60%, P 5.05). There was significantly more downsizing to resection in the FOLFOX-DEBIRI arm versus the FOLFOX/bevacizumab arm (35% vs 16%, P 5.05), and there was improved median progression-free survival (15.3 vs 7.6 months). CONCLUSIONS: The simultaneous administration of mFOLFOX6 (with or without bevacizumab) and DEBIRI through the hepatic artery (FOLFOX-DEBIRI) is safe and does not cause treatment delays or increase the systemic toxicity of chemotherapy. This strategy leads to improved overall response rates, improved hepatic progression-free survival, and more durable overall progression-free survival in patients downsized to resection. Cancer 2015;121:3649-58.

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Oral propranolol (OP) has been shown to be effective in the treatment of complicated infantile hemangiomas (IHs), but optimal treatment duration to avoid relapses after stopping OP treatment has not been established. The objective of this study was to compare the frequency of relapses in long-term OP treatment with that of short-term OP treatment. This was a retrospective cohort study of 30 patients with complicated IHs who received treatment with OP. Patients were divided into two groups: OP treatment of 8 months or less and OP treatment of longer than 8 months. OP was started at 1 mg/kg/day in three doses every 8 hours for 1 week and increased to 1.5 to 4 mg/kg/day afterward. Ultrasound was used to objectively measure the response to treatment. Clinical and ultrasound assessment showed a decrease in IH size and resolution of complications in all patients (n = 30). In the short-term group (n = 10), nine patients (90%) relapsed after stopping treatment. In the long-term group (n = 20), the duration of treatment was 12 months in all patients, and only 1 patient out of the 20 treated (5%) showed relapse 2 months after finishing the full treatment (odds ratio = 18, 95% confidence interval 2.6, 123, p < 0.001. Twelve months of treatment of IH with OP is associated with a significantly lower rate of relapse than with shorter treatment.

Purpose: The primary objective of this study was to assess the progression-free survival (PFS) rate at 9 months (Fleming design, H0: 55%, H1: 75%) after mFOLFOX6 plus DEBIRI in liver metastases of colorectal cancer (LMCRC) chemo-naive patient. Materials: In this study LMCRC chemo-naïve patient (no prior chemotherapy for metastatic disease) with non-resectable liverdominant disease, liver involvement <60%, adequate organ function, age 18 years, PS 2 were included and received mFOLFOX6 every 2 weeks plus 4 courses of DEBIRI. DEBIRI were performed with 100mg of irinotecan per lobe, every 2 weeks, alternating right and left lobe. Results: 57 patients (63 years ) PS 0-1: 95%were enrolled with a median number of liver metastases 9.5 [1-20]. 49% of patients received the full schedule treatment. Main grade 3-4 toxicities were neutropenia (24.6%), diarrhea (12.3%), abdominal pain (10.5%), and pancreatitis/cholecystitis (8.8%/5.3%). One toxic death occurred. PFS rate at 9 months was 53.6% (95% CI, 41.8%-65.1%). Disease control rate (RECIST) was 92.8% (CR 3.6%, PR 69.6%, SD 19.6%). Tumor shrinkage (>20%) occurred in 85.7% and median depth response was -47% (-100% to +38%). 19 (33%) patients had a R0 surgery with or without ablative therapy. With a median follow-up of 27.5 months (95% CI, 21.0; 30.6), median OS was 33.1 months (95% CI, 25.7; 46.1) and median PFS 10.8 months (95% CI, 8.18; 12.32). Conclusions: Despite the primary endpoint was not met, mFOLFOX6 + DEBIRI as front line treatment allow an excellent disease control rate in non-resectable LMCRC with deep responses, leading to secondary resection in 1/3 of patients.