IAHCT is used in the treatment of LMCRC. Regarding its anti-angiogenic effect bevacizumab (B) is a good candidate for IAH treatment. This phase II evaluate IAH administration of B in second line treatment of LMCRC combined with systemic treatment. We report here the results of the planned interim analysis on toxicity plus those on efficacy as the trial closed prematurely.
Inclusion criteria: patients (pts) with LMCRC after failure to a 1st line of IV CT; ECOG performance status (PS) 0 or 1; at least one liver lesion evaluable by RECIST; extra-hepatic disease acceptable when limited to one or two lung metastases or lymph nodes potentially accessible to a curative treatment. They had to receive IAH treatment with B, 7.5 mg/kg every 3 weeks, and systemic CT with capecitabine (2 g/m2/day (d) 14 d, followed by 7 d rest) + irinotecan (200 mg/m2 every 21d) or oxaliplatin (130 mg/m2 every 21 d) depending on the 1st line received.
Between 06:2013 and 02/2015, 10 pts from 5 centers were included: 6 men, 4 women (median age 61 years); ECOG PS0 (7) and PS1 (3); limited extra-hepatic disease in 4 pts. Median duration of 1st line treatment was 6 months. IAH catheter was implanted surgically in one pt and radiologically in 9. Pts had an average of 6 cycles of IAH B, 3 received oxaliplatin and 7 irinotecan concomitantly. There was one grade (G) 3 allergic reaction to IAH B, one G3 abdominal pain, one G3 mucositis, one G3 nausea and one G3 vomiting events. Related to the use of B, 2 G3 thromboembolic events and 3 G3 hypertension were observed. The arterial catheter has to be replaced in one pt and a thrombosis of hepatic artery was observed in a second one preventing continuation of IAH treatment after one cycle. In the 9 evaluable pts, 2 had partial response (22%), 5 stable disease (56%) and 2 progressive disease (22%). The median progression-free and overall survival were 5.2 months 95%CI [1.6 – 6.2] and 13.5 months [4.8 – NR].
IAH administration of bevacizumab in pts with LMCRC seems to be feasible with no major side effect. The efficacy reported did not suggest a major effect of this treatment that should rather be used in combination with IAHCT with oxaliplatin. We thank the PHRC for its financial support
Clinical trial identification
Legal entity responsible for the study
Gustave Roussy, Villejuif, France
Programme Hospitalier de Recherche Clinique
M.P. Ducreux: Receipt of grants/research supports: Roche, Chugai, Pfizer. Receipt of honoraria or consultation fees: Roche, Celgene, Merck Serono. Amgen, Novartis, Sanofi, Pfizer, Lilly, Servier. Spouse: Head of Business Unit, Sandoz. V. Boige: Advisory boards: Bayer, Symposium participation: Bayer, Amgen. D. Malka: Symposium participations: Roche, Amgen, Lilly, Merck Serono, Research funding: Merck Serono, Roche, Amgen Advisory boards: Roche, Amgen. All other authors have declared no conflicts of interest.