Pioneering the implementation of a precision oncology strategy in Portugal: the Precision Oncology Platform trial

Authors

  • Beatrice Mainoli Clinical Research Unit, Research Center of IPO Porto (CI-IPOP) / RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal https://orcid.org/0000-0002-5295-4346
  • Joana Assis Clinical Research Unit, Research Center of IPO Porto (CI-IPOP) / RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal. https://orcid.org/0000-0002-9234-7161
  • José Dinis Clinical Research Unit, Research Center of IPO Porto (CI-IPOP) / RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, Porto, Portugal; Department of Medical Oncology, Portuguese Oncology Institute of Porto (IPO-Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal https://orcid.org/0000-0002-2684-8283
  • Rui Henrique Department of Pathology and Cancer Biology & Epigenetics Group, Research Center of IPO Porto (CI-IPOP)/ CI-IPOP @RISE (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto)/Porto Comprehensive Cancer Centre Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal; Department of Pathology and Molecular Immunology, ICBAS-School of Medicine & Biomedical Sciences, University of Porto (ICBAS-UP), Rua Jorge Viterbo Ferreira 228, 4050-513 Porto, Portugal. https://orcid.org/0000-0003-3171-4666
  • Júlio Oliveira Clinical Research Unit, Research Center of IPO Porto (CI-IPOP) / RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal; Department of Medical Oncology, Portuguese Oncology Institute of Porto (IPO-Porto) / Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal; Experimental Pathology and Therapeutics Group, Research Center (CI-IPOP)/RISE@CI-IPOP (Health Research Network), Portuguese Oncology Institute of Porto (IPO-Porto)/Porto Comprehensive Cancer Center Raquel Seruca (Porto.CCC Raquel Seruca), R. Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal. https://orcid.org/0000-0002-9576-3486

DOI:

https://doi.org/10.2340/1651-226X.2023.33322

Keywords:

Precision Oncology, targeted treatment, DRUP-like Clinical Trials (DLCTs), Precision Oncology Platform (POP) trial

Abstract

Background and purpose: The Precision Oncology Platform (POP) trial represents the effort of the Portuguese Oncology Institute of Porto (IPO Porto) for joining other leading European institutions in both ‘Personalised Cancer Medicine for all EU citizens’ (PCM4EU), and ‘PRecisIon Cancer MEdicine RepurpOsing SystEm Using Pragmatic Clinical Trials’ (PRIME-ROSE) consortia, enabling the development of the Portuguese version of the Drug Rediscovery Protocol (DRUP)-like Clinical Trial (DLCT), based on the experience of the DRUP trial developed in The Netherlands.

Patients/material and methods: The POP trial is a phase II, pragmatic multicentric, non-randomised, open-label study, designed entirely like the other DLCTs. Its primary objective is to describe anti-tumour activity of targeted anticancer drugs in patients with advanced malignancies harbouring actionable molecular alterations. The primary endpoint is disease control rate (DCR). Secondary endpoints encompass treatment-related grade ≥3 adverse events, objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will assess biomarkers, resource use and costs, and patient-reported outcome measures (PROMs).

Interpretation: The POP trial will offer access to innovative treatments for patients without further therapeutic options and provide evidence on efficacy and safety of molecularly-guided treatments. Methodologically, it represents a pioneer approach in Portugal, including a pay-for-performance model embedded in the clinical trial. The POP trial represents a unique opportunity to integrate clinical research within cancer care, pursuing an evidence-based precision oncology strategy, and facilitating its rational and cost-effective implementation into the Portuguese healthcare system.

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Published

2024-06-23

How to Cite

Mainoli, B., Assis, J., Dinis, J., Henrique, R., & Oliveira, J. (2024). Pioneering the implementation of a precision oncology strategy in Portugal: the Precision Oncology Platform trial. Acta Oncologica, 63(1), 482–486. https://doi.org/10.2340/1651-226X.2023.33322