Phase 2 of intra-arterial hepatic (IAH) bevacizumab with systemic chemotherapy (CT) in second line treatment of liver metastases of colorectal cancer (LMCRC)

Date

08 Oct 2016

Session

Poster Display

Presenters

Michel Ducreux

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

M.P. Ducreux1, O. Glehen2, G. Tergemina-Clain3, D. Smith4, B. Lacas5, V. Boige1, D. Malka1, J. Pignon3, E. Dupont-Bierre6, R. Guimbaud7

Author affiliations

  • 1 Département De Médecine, Gustave Roussy, Université Paris-Saclay, 94805 - Villejuif/FR
  • 2 Chirurgie, Centre Hospitalier Lyon-Sud, Lyon/FR
  • 3 Service De Biostatistiques Et D'epidémiologie, Gustave Roussy, Université Paris-Saclay, Villejuif/FR
  • 4 Digestive Oncology, CHU Bordeaux Hopital St. André, Bordeaux/FR
  • 5 Service De Biostatistique Et D’epidemiologie, Gustave Roussy, Université Paris-Saclay, FR-94805 - Villejuif/FR
  • 6 Département De Chirurgie Digestive, CHP Saint-Grégoire, St. Grégoire/FR
  • 7 Digestive Oncology, CHU Toulouse, Hôpital de Rangueil, Toulouse/FR
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Background

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.

Methods

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.

Results

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].

Conclusions

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

ClinicalTrials.gov: NCT01677884

Legal entity responsible for the study

Gustave Roussy, Villejuif, France

Funding

Programme Hospitalier de Recherche Clinique

Disclosure

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.

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