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Figure S2 from Copenhagen Prospective Personalized Oncology (CoPPO)—Clinical Utility of Using Molecular Profiling to Select Patients to Phase I Trials

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posted on 2023-03-31, 20:25 authored by Ida Viller Tuxen, Kristoffer Staal Rohrberg, Olga Oestrup, Lise Barlebo Ahlborn, Ane Yde Schmidt, Iben Spanggaard, Jane P. Hasselby, Eric Santoni-Rugiu, Christina Westmose Yde, Morten Mau-Sørensen, Finn Cilius Nielsen, Ulrik Lassen

Kaplan-Meier PFS

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Capital Region of Copenhagen

Arvid Nilson Foundation

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ARTICLE ABSTRACT

We evaluated the clinical benefit of tumor molecular profiling to select treatment in the phase I setting. Patients with advanced solid cancers and exhausted treatment options referred to a phase I unit were included in a prospective, single-center, single-arm open-label study (NCT02290522). Tumor biopsies were obtained for comprehensive genomic analysis including whole-exome sequencing and RNA sequencing. When possible, patients were treated with regimen matched to the genomic profile. Primary endpoint was progression-free survival (PFS). From May 2013 to January 2017, a total of 591 patients were enrolled, with 500 patients undergoing biopsy. Genomic profiles were obtained in 460 patients and a potential actionable target was identified in 352 (70%) of 500 biopsied patients. A total of 101 patients (20%) received matched treatment based on either gene mutations or RNA expression levels of targets available in early clinical trials or off-label treatment. Objective response according to RECIST1.1 was observed in 15 of 101 patients (0% complete response, 15% partial response), with a median PFS of 12 weeks (95% confidence interval, 9.9–14.4). Our study supports the feasibility of genomic profiling to select patients in the phase I setting and suggests that genomic matching can be beneficial for a minor subset of patients with no other treatment options. Randomized studies may validate this assumption.See related commentary by Ratain, p. 1136

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