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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

5551 - Outcomes of anti-PD1 antibodies for advanced melanoma in real-world population

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

Topics

Immunotherapy

Tumour Site

Melanoma

Presenters

Michiel van Zeijl

Citation

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

Authors

M.C.T. van Zeijl1, M.W.J.M. Wouters2, A.J. van den Eertwegh3, M.J. Aarts4, A.C.J. van Akkooi2, F.W.P.J. van den Berkmortel5, M.G. Franken6, J.W.B. de Groot7, K.H. Herbschleb8, J.J.M. van der Hoeven8, G.A.P. Hospers9, E. Kapiteijn10, D. Piersma11, R.S. van Rijn12, K.P.M. Suijkerbuijk13, A.J. Ten Tije14, A.A.M. Van der Veldt15, G. Vreugdenhil16, J.B.A.G. Haanen17

Author affiliations

  • 1 Medical Oncology, Leiden University Medical Centre, 2333ZA - Leiden/NL
  • 2 Surgical oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 3 Medical Oncology, Vrije University Medical Centre, 1081HZ - Amsterdam/NL
  • 4 Medical Oncology, Maastricht University Medical Centre, 6229HX - Maastricht/NL
  • 5 Medical Oncology, Zuyderland Medical Centre, 6419 PC - Heerlen/NL
  • 6 Institute For Medical Technology Assessment, Erasmus University, 3062PA - Rotterdam/NL
  • 7 Medical Oncology, Isala Hospital, Zwolle/NL
  • 8 Medical Oncology, Radboud University Medical Centre, Nijmegen/NL
  • 9 Medical Oncology, University Medical Centre Groningen, Groningen/NL
  • 10 Medical Oncology, Leiden University Medical Centre, 2300 RC - Leiden/NL
  • 11 Medical Oncology, Medisch Spectrum Twente, 7500 KA - Enschede/NL
  • 12 Medical Oncology, Medical Centre Leeuwarden, Leeuwarden/NL
  • 13 Medical Oncology, University Medical Centre Utrecht, 3508 GA - Utrecht/NL
  • 14 Medical Oncology, Amphia Ziekenhuis, 4818 CK - Breda/NL
  • 15 Medical Oncology, Erasmus University Medical Center, 3015 CE - Rotterdam/NL
  • 16 Medical Oncology, Maxima Medisch Centrum, 5500 MB - Veldhoven/NL
  • 17 Medical Oncology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
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Resources

Abstract 5551

Background

Anti-PD1 antibodies (aPD1s) for advanced melanoma have proven their superiority over chemotherapy and ipilimumab in phase III trials. However, in real-world many patients were not represented in these trials. We report real-world outcomes of aPD1 for advanced melanoma.

Methods

Pts with advanced (non-uveal) melanoma from 2014 to 2016 who received 1st line aPD1 were selected from the Dutch Melanoma Treatment Registry - a population based registry in the Netherlands. Outcomes of pts normally eligible (ELI) for trial participation (ECOG PS of 0-1, no brain metastasis, auto-immune disease, HIV, psychiatric disorder or corticosteroid use) were compared to pts normally non-eligible (N-ELI) for trial participation. Time to event was estimated with Kaplan-Meier method and overall survival (OS) with cox regression analysis.

Results

In total 552 patients with advanced melanoma received 1st line aPD1. Median age was 65yrs (range 21-94). At baseline 28% had elevated LDH, 90% ECOG PS of 0-1, 19% brain metastases, 65% stage IV-M1c disease and 41% had a BRAF mutation. Toxicity grade 3-4 occurred in 68 pts (12.3%). Median follow-up estimated with reverse Kaplan-Meier method was 18.8 mo (95%CI: 18-20). 1- and 2-yr OS (95%CI) was 72% (68-76%) and 59% (55-65%) and median OS was not reached. Median time to next treatment (TTNT) for ELI pts was not reached and TTNT for N-ELI pts was 10.6 mo (95%CI: 8.3-14.7). Median time of treatment duration was 8.8 mo (95%CI: 6.9-10.5) for ELI pts and 5.3 mo (95%CI: 4.1-7.1) for N-ELI pts. 1- and 2-yr OS were respectively 76% (72-81%) and 63% (57-70%) versus 65% (95%CI: 59-72%) and 53 (95%CI: 45-61% (log-rank test p-value: 0.003). Unadjusted hazard ratio (HR) for OS was 1.57 (95%CI: 1.17-2.09) for N-ELI compared to ELI pts and adjusted HR was 1.28 (95%CI: 0.94-1.73). HR for LDH >500 UI/L was 2.10 (95%CI: 1.23-3.58) and HR for BRAF neg. pts 1.74 (95%CI: 1.26-2.41).

Conclusions

Real-world outcomes of 1st line aPD1s in patients with advanced melanoma seem to be in accordance to results observed in phase III trials. These data support that N-ELI pts normally not represented in phase III trials may benefit from aPD1 treatment. LDH >500 UI/L and BRAF neg. status were associated with poorer survival.

Clinical trial identification

Legal entity responsible for the study

Authors.

Funding

The Dutch Melanoma Treatment Registry is funded by Bristol-Myers Squibb, Merck Sharpe & Dohme, Novartis and Roche.

Editorial Acknowledgement

Disclosure

A.C.J. van Akkooi: Advisory boards, Consulting: Amgen, BMS, Novartis, MSD, Merck, Pfizer. J.W.B. de Groot: Advisory boards: BMS, Merck. G.A.P. Hospers, E. Kapiteijn: Advisory boards: BMS, Merck. K.P.M. Suijkerbuijk: Consulting/advisory relationship: Bristol-Myers Squibb, MSD; Honoraria: Novartis, Roche. A.A.M. Van der Veldt: Advisory boards: BMS, MSD, Roche, Novartis. All other authors have declared no conflicts of interest.

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