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First-line (1-L) bevacizumab plus chemotherapy (Bev/CT) in colorectal cancer (CRC) patients with potentially resectable liver only (LM) or liver and lung metastases (LLM): KRAS mutation analysis of the non-interventional PICASSO study

Date

08 Oct 2016

Session

Poster Display

Presenters

David Malka

Citation

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

Authors

D. Malka1, J. Metges2, D. Elias3, J. Bennouna1, F. Bonnetain4, L. Dourthe5, M. Ben Abdelghani6, A. Radji7, P. Laplaige8, F. Petit Laurent9, J. Telliez10, S. Bakiri11, M. Rivoire12

Author affiliations

  • 1 Digestive Oncology, Institut de Cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 2 Digestive Oncology, C.H.U. Brest - Hôpital Morvan, Brest/FR
  • 3 Chirurgie Digestive Et Hépato-biliaire, Institut de Cancérologie Gustave Roussy, Villejuif/FR
  • 4 Methodology And Quality Of Life In Oncology Unit, CHU Besançon, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 5 Oncology, Clinique Sainte Anne, Strasbourg/FR
  • 6 Oncology, Centre Paul Strauss Centre de Lutte contre le Cancer, Strasbourg/FR
  • 7 Radiotherapy, Clinique Saint Hilaire, Rouen/FR
  • 8 Oncology, Polyclinique de Blois, La Chaussee St. Victor/FR
  • 9 Gastro-enterology, Centre Hospitalier, Gleizé/FR
  • 10 Digestive Oncology, Roche France, Boulogne-Billancourt/FR
  • 11 Biostatistics, Roche France, Boulogne-Billancourt/FR
  • 12 Digestive Oncology, Centre Léon Bérard, Lyon/FR
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Resources

Abstract 2382

Background

The management of pts with CRC and LM only evolves with the progress in liver surgery and improved activity of anti-tumor agents. Criteria for the definition of unresectable and potentially resectable LM may vary among onco-surgical physicians. PICASSO was designed to describe the outcomes and management of CRC pts with potentially resectable LM or LLM, and treated 1-L Bev/CT in real-life setting.

Methods

PICASSO was a French prospective non-interventional cohort study. Eligible pts with potential conversion to resectability of initially unresectable LM or LLM were included consecutively and treated with 1-L Bev/CT. Planned pts follow-up was 36 months (mo). The primary endpoint was the rate of patients with no detectable metastatic disease (DMD) after 1-L Bev/CT with/without metastases resection (MR). The results according to KRAS mutational status are presented here.

Results

Out of the 205 evaluable patients (efficacy population), a total of 153 pts included in the PICASSO study had known KRAS status: 60.8% had wild-type status (WT) and 39.2% had a mutated status (MT). Mean age was 66 years (SD =10), 64% were men and 96% had ECOG 0/1. Overall, 73% had synchronous metastases. The rate of pts without DMD after 1st-line Bev/CT with/without MR was 51% in KRAS WT pts and 36% in KRAS MT pts. Median PFS was 10.6 mo [95%CI: 8.8; 12.9] and 11.0 mo [8.9; 13.2] in the KRAS WT and KRAS MT pts respectively. Median PFS in pts without DMD was 14.8 mo [11.7- 17.1] for KRAS WT pts and 16.0 mo [10.6; 24.4] for KRAS MT pts. Median OS was not reached (NR) for KRAS WT pts and was 29.8 mo [25.8; NR] for KRAS MT pts. OS rate at 36 mo was 51.1% [39.0; 62.0] for KRAS WT pts and 44.3% [30.0; 57.7] for KRAS MT pts. for KRAS WT and MT pts without DMD, the OS rate at 36 mo was 79.3% [60.8; 89.7] and 73.1% [46.8; 87.9], respectively. Bev safety in the total population was comparable to its well-known safety profile.

Conclusions

In real-life setting, 51% and 36% of KRAS WT and MT CRC pts with potentially resectable LM or LLM had no DMD after 1sl-L Bev/CT. Median PFS and OS rate at 36 months were comparable in both KRAS subgroups.

Clinical trial identification

Clinicaltrials.gov : NCT01343901

Legal entity responsible for the study

N/A

Funding

Roche

Disclosure

D. Malka, J. Telliez, S. Bakiri: Roche. J-P. Metges: Roche, Merck, Sanofi, Bayer. J. Bennouna: Roche, Boehringer, Astra-Zeneca, MSD. F. Bonnetain: Novartis, Celgene, Roche, Merck, Amgen, Chugai. L-M. Dourthe: Roche, Novartis, Astellas. M. Ben Abdelghani, A. Radji: Sanofi, Ipsen. P. Laplaige: Roche, Pfizer, Sanofi, Genomic Health, Pierre Fabre. All other authors have declared no conflicts of interest.

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