Developing a score system to predict therapeutic outcomes to anti-PD-1 immunotherapy in metastatic melanoma

Tumori. 2019 Dec;105(6):465-473. doi: 10.1177/0300891619868009. Epub 2019 Aug 26.

Abstract

Background: Prognosis of patients with metastatic melanoma has improved due to the advent of antibodies targeting the programmed cell death protein-1 (PD-1). However, therapeutic outcomes from anti-PD-1 therapy widely differ among patients. Biomarkers for outcome are needed as these may influence patient selection and treatment decision.

Methods: Data of patients with metastatic melanoma treated with anti-PD-1 were retrospectively reviewed. Baseline biochemical (serum lactate dehydrogenase [LDH] levels, complete blood count) and clinical characteristics were evaluated to identify predictors of progression-free survival (PFS) and overall survival (OS). PFS and OS were assessed using Kaplan-Meier and Cox models. The comparison of predictive power of independent predictors for response to anti-PD-1 was evaluated by receiver operating characteristic (ROC) curves.

Results: Overall, 173 patients were included. Low metastases burden, normal baseline LDH levels, and high relative lymphocyte count (RLC) were associated with favorable outcomes (p < 0.01). According to ROC curves, RLC >17.5% improved survival outcomes. PFS was 3.7 and 15.8 months for patients with RLC <17.5% and >17.5%, respectively (p = 0.004); OS was 5.0 and 33.6 months for patients with RLC <17.5% and >17.5%, respectively (p < 0.001). Stratification of patients according to these variables showed that survival outcomes strongly differ in patients with 3 of 3 compared to those with 2, 1, and none of these 3 factors present (p < 0.001).

Conclusions: Metastases burden, LDH levels, and RLC are independent baseline characteristics associated with outcome in patients with melanoma receiving anti-PD-1. Further investigations are needed to clarify if evaluation of these parameters can translate into clinical strategy and apply to patient selection.

Keywords: LDH; Melanoma; anti-PD-1; immunotherapy; leukocytes; prognosis.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Animals
  • Antineoplastic Agents, Immunological / administration & dosage
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Biomarkers, Tumor*
  • Female
  • Humans
  • Leukocytes / metabolism
  • Male
  • Melanoma / diagnosis*
  • Melanoma / drug therapy*
  • Melanoma / etiology
  • Melanoma / metabolism
  • Middle Aged
  • Molecular Targeted Therapy*
  • Mutation
  • Prognosis
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors*
  • ROC Curve
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Immunological
  • Biomarkers, Tumor
  • PDCD1 protein, human
  • Programmed Cell Death 1 Receptor