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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3427 - The real-world impact of modern treatments on the survival of patients with metastatic melanoma

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Marco Donia

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

M. Donia1, E. Ellebaek2, T.H. Øllegaard3, L. Duval3, J.B. Aaby4, L. Højberg4, U.H. Køhler5, H. Schmidt3, L. Bastholt4, I. Svane1

Author affiliations

  • 1 Center For Cancer Immune Therapy And Department Of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, 2730 - Herlev/DK
  • 2 Department Of Oncology, Herlev and Gentofte Hospital, 2730 - Herlev/DK
  • 3 Department Of Oncology, Aarhus University Hospital, 8000 - Aarhus C/DK
  • 4 Medical Oncology, Odense University Hospital, 5000 - Odense C/DK
  • 5 Braintrust Consult, Braintrust Consult, 52700 - Odense/DK
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Resources

Abstract 3427

Background

Phase III trials with strict enrolment criteria led to the approval of several new treatments for unresectable or metastatic melanoma (MM) between 2010 and 2015. The impact of modern treatments on the overall survival of the whole “real world” population of MM is unknown.

Methods

The Danish MM database contains data on the entire, unselected population diagnosed with MM within a nationwide area. To evaluate the impact of novel treatments, all MM cases diagnosed in three non-consecutive years marked by major changes in the availability of 1st line treatments (2012: i.v. IL-2 and BRAFi; 2014: anti-CTLA-4; 2016: anti-PD-1 and MEKi) were retrieved. Patients were grouped into “trial-like” and “trial-excluded” based on seven predefined eligibility criteria used in all MM registration immunotherapy clinical trials, including CNS metastases and PS ≥ 2. The database was locked on February 1st 2018.

Results

We retrieved the data of all 838 patients diagnosed with MM (excluding ocular melanoma) in Denmark during 2012, 2014 and 2016. The baseline characteristics of patients diagnosed in 2012, 2014 and 2016 were similar. In the “trial-like” population (39% of all MM), which met all seven eligibility criteria for trial participation, the median overall survival (OS) was not yet reached in the 2016 group versus 20.1 months in 2014 (hazard ratio [HR] for death 0.57, 95% CI 0.38-0.84; p = 0.0049) and 16.5 months in 2012 (HR 0.47, 95% CI 0.30-0.73; p = 0.0008). No major survival differences were observed in 2014 versus 2012 (HR 0.77, 95% CI 0.55-1.08; p = 0.1354). In the “trial-excluded” population (61% of all MM), 75% of patients had known CNS metastases and/or PS ≥ 2. Here, the median OS was improved to 6.8 months in the 2016 group versus 5.2 months in 2014 (HR 0.67, 95% CI 0.52-0.86; p = 0.0013) and 4.3 months in 2012 (HR 0.67, 95% CI 0.53-0.86; p = 0.0016), with no difference between 2012 and 2014 (p = 0.65).

Conclusions

“Trial-like” patients represent only 39% of the total MM population in the real world. Our data show that the introduction of modern treatments led to an improved survival of real world patients with MM, regardless of their clinical trial eligibility.

Clinical trial identification

Legal entity responsible for the study

Danish Melanoma Oncology Group.

Funding

Herlev and Gentofte Research Council.

Editorial Acknowledgement

Disclosure

M. Donia: Honoraria for lectures: Bristol-Myers Squibb, Sanofi-Genzyme, MSD, AstraZeneca. H. Schmidt: Advisory board: MSD, Incyte, BMS; Limited grants for research: MSD. L. Bastholt: Advisory board: MSD, Incyte, BMS, Roche, Eisai, Novartis. I-M. Svane: Advisory board, Lectured: Roche, Novartis, MSD, Celgene, Incyte, TILT Bio, Pfizer, BMS, AstraZeneca, IO Biotech; Limited grants for translational research: BMS, Roche, Novartis, Incyte; Stock owner: IO biotech. All other authors have declared no conflicts of interest.

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