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Poster display session

2280 - Dabrafenib and Trametinib combination in real life patients including brain metastases: French experience within MelBase.

Date

10 Sep 2017

Session

Poster display session

Presenters

Clara Allayous

Citation

Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377

Authors

C. Allayous1, B. Guillot2, S. Dalac Rat3, L. Mortier4, C. Dutriaux5, M. Leccia6, J. Lacour7, S. Dalle8, P. Saiag9, M. Beylot-Barry10, C. Lok11, J. De Quatrebarbes12, F. Aubin13, T. Lesimple14, B. Dreno15, R. Porcher16, A. Ballon1, B. Oriano16, C. Lebbe1

Author affiliations

  • 1 Dermatology, AP-HP Saint-Louis hospital, 75010 - Paris/FR
  • 2 Dermatology, CHRU Montpellier, 34295 - Montpellier/FR
  • 3 Dermatology, CHU Dijon, 21079 - Dijon/FR
  • 4 Dermatology, Hopital Claude Huriez, 59037 - Lille/FR
  • 5 Dermatology, CHU Bordeaux Hopital St. André, 33000 - Bordeaux/FR
  • 6 Dermatology, CHU Grenoble - Hopital Michallon, 38043 - La Tronche/FR
  • 7 Dermatology, Hôpital Archet 1, 06200 - Nice/FR
  • 8 Dermatology, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite/FR
  • 9 Dermatology, Hopital Ambroise Pare, 92100 - Boulogne-Billancourt/FR
  • 10 Dermatology, CHU Bordeaux Haut-Leveque, 33604 - Pessac/FR
  • 11 Dermatology, CHU Amiens Picardie Hôpital Nord, 80054 - Amiens/FR
  • 12 Dermatology, CH Annecy Genevois, 74370 - Metz-Tessy/FR
  • 13 Dermatology, CHRU Jean Minjoz, 25030 - Besançon/FR
  • 14 Oncology, Centre Eugene - Marquis, 35042 - Rennes/FR
  • 15 Dermatology, CHU de Nantes, 44093 - Nantes/FR
  • 16 Centre D'épidémiologie Clinique, AP-HP Hotel-Dieu hospital, 75004 - Paris/FR
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Resources

Abstract 2280

Background

Combining BRAF and MEK inhibitors is a standard of care in BRAF-mutated advanced melanoma patients. Dabrafenib (D) and Trametinib (T) have led to a 3-year overall survival (OS) rate around 44% in patients without active brain metastases (BMs) at enrollment. Recently, T received French Health Authority approval but little information is available in D+T combination use in real life, especially with active BMs patients. We report the first results of efficacy and tolerance in real life patients treated with D+T, including BMs, within national French MelBase cohort.

Methods

MelBase is a French multicentric clinical biobank dedicated to the prospective follow-up (FU) of adults with unresectable stage III or stage IV melanoma. Since March 2013, 1168 patients were included (26 centers). Available data were collected (April 2017) and analyzed (demography, OS, progression-free survival (PFS), response rate, safety).

Results

2 groups are presented: all patients treated with D+T (g1) and patients with BMs treated with D+T (g2). The characteristics at baseline are: - g1 (n = 135): mean age 57 years, PS 0-1 87%, elevated LDH 33%, BRAF V600E mutated 78%, brain metastases 29%, treated in first line 79%. After median FU 11.2 months, median OS and PFS were respectively 17.8 months (95%CI: 15.5-Not Reached (NR)) and 8.1 months (95%CI: 6.2-11.2). Best overall response (BORR) was 63% and disease control rate (DCR) 79%. - g2 (n = 39): mean age 55 years, PS 0-1 87%, elevated LDH 46%, BRAF V600E mutated 72%, treated in first line 73%. After median FU 10.3 months, median OS and PFS were respectively 15.5 months (95%CI: 13.3-NR) and 5.9 months (95%CI: 4.3-10.7). BORR was 56% and DCR 72%.

Conclusions

We report the first real life D+T data in France. Even though our results still need to mature with a longer FU, BORR is similar to COMBI-d updated data (63% g1 versus 69%). In addition, our results point out for the first time D+T efficacy in patients with active BMs. Indeed the combination appears more efficient in patients with BMs compared to D alone in already published clinical data (BREAK-MB).

Clinical trial identification

Legal entity responsible for the study

Assistance Publique des Hôpitaux de Paris (AP-HP), Direction Clinique de la Recherche et de l'Innovation (DRCI)

Funding

French National Cancer Institute (INCa), Novartis, Roche, Bristol-Myers Squib, MSD

Disclosure

C. Allayous: Travel, accomodations, expenses: Amgen, Bristol-Myers Squib, Roche. S. Dalac Rat: - Consulting or advisory role: Roche - Travel, accomodations, expenses: Roche, Bristol-Myers Squib, GSK, MSD, Novartis. L. Mortier: Roche, GSK, Novartis, Bristol-Myers Squib, MSD, Amgen. S. Dalle: - Research funding: Bristol-Myers Squib - Travel, accomodations, expenses: MSD, Bristol-Myers Squib P. Saiag: - Honoraria: Bristol-Myers Squib, MSD, Roche, Novartis, Amgen - consulting or advisory role: Bristol-Myers Squib, MSD, Roche, Novartis, Amgen - Research funding: Bristol-Myers Squib, Novartis, Roche - Travel, accomodations, expenses: Bristol-Myers Squib, MSD, Roche Novartis. M. Beylot-Barry: - Consulting or advisory role: Roche, Bristol-Myers Squib - Travel, accomodations, expenses: Roche. F. Aubin: - Honoraria: Abbvie, LéoPharma, MSD, Novartis, Celgène - Consulting or advisory role: Janssen, Celgène, MSD, Roche, Novartis - Travel, accomodations, expenses: Janssen, MSD, Abbvie, Novartis. T. Lesimple: - Consulting or advisory role: Roche, Bristol-Myers Squib, Novartis MSD - Research funding (Institution): Roche - Travel, accomodations, expenses: Roche, MSD. C. Lebbe: - Consultancy, Honoraria, Speakers bureau: Roche, Bristol-Myers Squib, Novartis, MSD, Amgen - Research funding (institution): Roche, Bristol-Myers Squib - Travel accomodations-Meetings: Roche, Bristol-Myers Squib, Novartis, Amgen - Advisory role: Roche, Bristol-Myers Squib, Novartis, MSD, Amgen, GSK. All other authors have declared no conflicts of interest.

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