Molecular Tumor Board–Assisted Care in an Advanced Cancer Population: Results of a Phase II Clinical Trial

Author:

Miller Rachel W.1ORCID,Hutchcraft Megan L.1ORCID,Weiss Heidi L.23,Wu Jianrong3,Wang Chi23,Liu Jinpeng2,Jayswal Rani23,Buchanan Mikayla4,Anderson Abigail4,Allison Derek B.5ORCID,El Khouli Riham H.6ORCID,Patel Reema A.7,Villano John L.7ORCID,Arnold Susanne M.7ORCID,Kolesar Jill M.148ORCID

Affiliation:

1. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Kentucky Markey Cancer Center, Lexington, KY

2. Shared Resource Facility, University of Kentucky Markey Cancer Center, Lexington, KY

3. Division of Cancer Biostatistics, Department of Internal Medicine, College of Medicine, University of Kentucky, Lexington, KY

4. Division of Precision Medicine, University of Kentucky Markey Cancer Center, Lexington, KY

5. Department of Pathology and Laboratory Medicine, University of Kentucky, Lexington, KY

6. Department of Radiology, University of Kentucky, Lexington, KY

7. Division of Medical Oncology, Department of Internal Medicine, University of Kentucky Markey Cancer Center, Lexington, KY

8. Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, KY

Abstract

PURPOSE Multidisciplinary molecular tumor boards (MTBs) interpret next-generation sequencing reports and help oncologists determine best therapeutic options; however, there is a paucity of data regarding their clinical utility. The purpose of this study was to determine if MTB-directed therapy improves progression-free survival (PFS) over immediately prior therapy in patients with advanced cancer. METHODS This single-arm, prospective phase II clinical trial enrolled patients with advanced cancer with an actionable mutation who received MTB-recommended targeted therapy between January 1, 2017, and October 31, 2020. MTB-recommended both on-label (level 1 evidence) and off-label (evidence levels 2 and 3) therapies. Of the 93 enrolled patients, 43 were treated frontline and 50 received second-line or greater-line therapy. The primary outcome was the probability of patients treated with second-line or greater-line MTB-directed therapy who achieved a PFS ratio ≥ 1.3 (PFS on MTB-directed therapy divided by PFS on the patient's immediately prior therapy). Secondary outcomes included PFS for patients treated frontline and overall survival and adverse effects for the entire study population. RESULTS The most common disease sites were lung (35 of 93, 38%), gynecologic (17 of 93, 18%), GI (16 of 93, 17%), and head and neck (7 of 93, 8%). The Kaplan-Meier estimate of the probability of PFS ratio ≥ 1.3 was 0.59 (95% CI, 0.47 to 0.75) for patients treated with second-line or greater-line MTB-directed therapy. The median PFS was 449 (range 42-1,125) days for patients treated frontline. The median overall survival was 768 (range 22-1,240) days. There were four nontreatment-related deaths. CONCLUSION When treated with MTB-directed therapy, most patients experienced improved PFS compared with immediately prior treatment. MTB-directed targeted therapy may be a strategy to improve outcomes for patients with advanced cancer.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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