101PClinical application of routine comprehensive tumour molecular profiling in the management of cancer patients. (7th November 2019)

• Record Type: Journal Article
• Authors: Mileyko, V; Veselovsky, E; Rozhavskaya, E; Ignatova, E; Kovtun, A; Sharova, M; Ivanov, M
• Is Part Of: Annals of oncology. Volume 30(2019)Supplement 7
• Publication Date: 2019-11-07
• Subjects: Oncology -- Periodicals; 616.992
• DOI: 10.1093/annonc/mdz413.105
• Languages: English
• ISSNs: 0923-7534

Abstract

Abstract: Background: Along with the extension of the FDA approved molecular matched therapies, the evidence is building to support molecular profile-based off-label drug prescription or inclusion in a clinical trial. We report the findings from our real-world comprehensive molecular tumor profiling (CMTP) practice to assess how CMTP extends treatment options within and beyond standards of care. Methods: Pts with a confirmed diagnosis of advanced cancers are eligible. DNA was extracted from either archival or fresh collected tumor samples. Blood plasma was used for sequencing if the tumor sample was unavailable. CMTP included next generation sequencing. A panel of 409, 50 or 17 genes was used based on multidisciplinary molecular tumor board (MMTB) recommendations. Additional tests (IHC, FISH, MSI testing) were performed if recommended by MMTB. Results: 155 patients were eligible for the analysis (63% female, median age 57, range 17-90). Tumor types were gyneco (19%), colorectal (18%), lung (14%), pancreatic (10%), breast (9%), stomach (5%). A total of 94% actionable biomarker (AB) associated with potential benefit from approved therapy were identified across 68(44%) pts. 49 (72%) pts had only one AB while 19 had 2 or more AB (up to 5). The most common AB were BRCA1/2 mutation/deletion (14%), PIK3CA mutations (13%), PD-L1 overexpression (12.7%), microsatellite instability (11%) and ERBB2 mutation/amplification/overexpression (7%). 29/155 (19%) pts received in-label therapy recommendations (TR) (38% pts - lung, 31% pts – gyneco, 10% pts - colorectal). 28/126 (23%) pts without in-label TR received off-label TR (18% pts – gyneco, 18% pts colorectal, 14% pts – pancreatic, 10% pts – stomach) with a total of 56 TR (20% immunotherapy, 13% PARPi, 7% MEKi, 5% ERBB2i). 12/98 (12%) pts without in-label or off-label TR received profile-matched TR within a clinical trial. Across 19/155 (12%) pts we identified biomarkers associated with the resistance to standard therapy. Conclusions: CMTP was informative for 72/155 (46%) pts. 69/155(44%) pts received TR. Across tumor types least % of pts received TR with prostate (0/5, 0%), pancreatic (4/15, 26%) and breast (5/14, 36%) cancer, suggesting the need to define pts population who may benefit from CMTP. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: V. Mileyko: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. E. Veselovsky: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. E. Rozhavskaya: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. A. Kovtun: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. M. Sharova: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. M. Ivanov: Full / Part-time employment: Atlas Oncology Diagnostics, ltd. All other authors have declared no conflicts of interest.