학술논문
The evolution of precision oncology: The ongoing impact of the Drug Rediscovery Protocol (DRUP).
Document Type
Academic Journal
Author
Haj Mohammad SF; Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands. s.f.haj_mohammad@lumc.nl.; Timmer HJL; Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Zeverijn LJ; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Geurts BS; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Spiekman IAC; Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.; Verkerk K; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Verbeek FAJ; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Verheul HMW; Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.; Voest EE; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Gelderblom H; Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.
Source
Publisher: Medical Journals Sweden AB Country of Publication: Sweden NLM ID: 8709065 Publication Model: Electronic Cited Medium: Internet ISSN: 1651-226X (Electronic) Linking ISSN: 0284186X NLM ISO Abbreviation: Acta Oncol Subsets: MEDLINE
Subject
Language
English
Abstract
Background and Purpose: The Drug Rediscovery Protocol (DRUP) is a Dutch, pan-cancer, nonrandomized clinical trial that aims to investigate the efficacy and safety of targeted and immunotherapies outside their registered indication in patients with advanced or metastatic cancer.
Patients: Patients with advanced or metastatic cancer are eligible when there are no standard of care treatment options left and the tumor possesses a molecular genomic variant for which commercially available anticancer treatment is accessible off-label in DRUP. Clinical benefit is the study's primary endpoint, characterized by a confirmed objective response or stable disease after at least 16 weeks of treatment.
Results: More than 2,500 patients have undergone evaluation, of which over 1,500 have started treatment in DRUP. The overall clinical benefit rate (CBR) remains 33%. The nivolumab cohort for patients with microsatellite instable metastatic tumors proved highly successful with a CBR of 63%, while palbociclib or ribociclib in patients with tumors harboring CDK4/6 pathway alterations showed limited efficacy, with a CBR of 15%. The formation of two European initiatives (PCM4EU and PRIME-ROSE) strives to accelerate implementation and enhance data collection to broaden equitable access to anticancer treatments and gather more evidence.
Conclusion: DRUP persists in improving patients access to off-label targeted or immunotherapy in the Netherlands and beyond. The expansion of DRUP-like clinical trials across Europe provides countless opportunities for broadening the horizon of precision oncology.
Patients: Patients with advanced or metastatic cancer are eligible when there are no standard of care treatment options left and the tumor possesses a molecular genomic variant for which commercially available anticancer treatment is accessible off-label in DRUP. Clinical benefit is the study's primary endpoint, characterized by a confirmed objective response or stable disease after at least 16 weeks of treatment.
Results: More than 2,500 patients have undergone evaluation, of which over 1,500 have started treatment in DRUP. The overall clinical benefit rate (CBR) remains 33%. The nivolumab cohort for patients with microsatellite instable metastatic tumors proved highly successful with a CBR of 63%, while palbociclib or ribociclib in patients with tumors harboring CDK4/6 pathway alterations showed limited efficacy, with a CBR of 15%. The formation of two European initiatives (PCM4EU and PRIME-ROSE) strives to accelerate implementation and enhance data collection to broaden equitable access to anticancer treatments and gather more evidence.
Conclusion: DRUP persists in improving patients access to off-label targeted or immunotherapy in the Netherlands and beyond. The expansion of DRUP-like clinical trials across Europe provides countless opportunities for broadening the horizon of precision oncology.