Abstract
PurposeThe strategy of precision medicine has been widely adopted in the practice of oncology, although the efficacy remains unclear. This study assesses clinical outcomes in patients with an actionable alteration found during FoundationOne CDx™ (F1CDx) testing and who received a targeted therapy based on the results.Materials and MethodsThis is a retrospective cohort study of patients with tumors that underwent F1CDx from September 2012 to July 2018. F1CDx provided actionable alterations for patients to select appropriate therapies. The primary objective was to estimate the objective response rate (ORR) at 3 months from the start of study treatment. The secondary objectives were to estimate progression-free survival (PFS) and overall survival (OS).ResultsOne thousand patients underwent F1CDx testing. Six hundred fifty-two patients were identified as having actionable mutations. Thirty-eight patients (18 males and 20 females) received targeted therapy and were included in the study. The most common alterations were PD-1/PDL-1, high-TMB, P13K, and HER2/ERBB2. Patients received various treatments including nivolumab, pembrolizumab, trastuzumab, and everolimus. Eight (23.5%) and six (17.7%) patients achieved partial response (PR) and stable disease (SD), respectively; 20 (58.8%) had progression of disease (PD). The disease control rate was 41.2% (95% CI: 24.7% to 59.3%). The median PFS was 2.7 months (95% CI: 2.3 to 5.4 months), and median OS was 9.9 months (95% CI: 4.5 to 33.7 months).ConclusionOur results demonstrate promising data in precision medicine in real community oncology practice. It warrants further large and prospective studies in patients with actionable alterations.
Highlights
Advances in genomics and next-generation sequencing (NGS) have revolutionized the field of oncology by allowing precisionbased approaches in management of cancer
Precision oncology looks at genetic and molecular characteristics of tumors instead of traditional histology to match treatment strategies [1]. This strategy has been applied in the management of many types of cancers including testing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, Btype Raf kinase (BRAF) mutation, c-Ros oncogene 1 (ROS1), and programmed death ligand-1 (PD-L1) in nonsmall-cell lung cancer (NSCLC); human epidermal growth factor receptor 2 (HER2) in breast and gastric cancer; Kirsten rat sarcoma viral oncogene homolog (K-RAS), neuroblastoma ras viral oncogene homolog (N-RAS), and BRAF mutation in colon cancer; and tumor mutational burden, NTRK fusions, and microsatellite instability (MSI) status in all solid tumors [2,3,4,5,6,7,8]
We calculated the growth modulation index (GMI) for each patient that had a prior line of therapy by calculating the ratio of progression-free survival (PFS) on targeted therapy (PFSn) vs. PFS on prior line of treatment (PFSn-1).We used the electronic medical record to determine if patients received the targeted treatment suggested by the F1CDx report; if they did not receive targeted treatment, we recorded the treatment received after F1CDx testing if available
Summary
Advances in genomics and next-generation sequencing (NGS) have revolutionized the field of oncology by allowing precisionbased approaches in management of cancer. Precision oncology looks at genetic and molecular characteristics of tumors instead of traditional histology to match treatment strategies [1] This strategy has been applied in the management of many types of cancers including testing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, Btype Raf kinase (BRAF) mutation, c-Ros oncogene 1 (ROS1), and programmed death ligand-1 (PD-L1) in nonsmall-cell lung cancer (NSCLC); human epidermal growth factor receptor 2 (HER2) in breast and gastric cancer; Kirsten rat sarcoma viral oncogene homolog (K-RAS), neuroblastoma ras viral oncogene homolog (N-RAS), and BRAF mutation in colon cancer; and tumor mutational burden, NTRK fusions, and microsatellite instability (MSI) status in all solid tumors [2,3,4,5,6,7,8]. The biomarkers PDL-1 and tumor mutation burden (TMB) have been shown to predict responses to immunotherapy in several cancers and are included in our study as “targeted treatment”
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