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BioMed Research International
Volume 2015 (2015), Article ID 681653, 9 pages
http://dx.doi.org/10.1155/2015/681653
Research Article

Molecular Profiling-Selected Therapy for Treatment of Advanced Pancreaticobiliary Cancer: A Retrospective Multicenter Study

1Department of Oncology, Rambam Health Care Campus, 3109601 Haifa, Israel
2Facutly of Medicine, Technion-Israel Institute of Technology, 3525406 Haifa, Israel
3Division of Oncology, Sheba Medical Center Tel Hashomer, 5262100 Ramat-Gan, Israel
4Sackler Medical School, Tel Aviv University, 6997801 Tel Aviv, Israel
5Department of Oncology, Assuta Hospital, 6971028 Tel Aviv, Israel
6Department of Oncology, Meir Medical Center, 4428164 Kfar Saba, Israel
7Davidoff Center, Rabin Medical Center, 4941492 Petah Tikva, Israel
8Department of Oncology, Wolfson Hospital, 5822012 Holon, Israel
9Division of Oncology, Tel-Aviv Sourasky Medical Center, 6423906 Tel Aviv, Israel
10Sharett Institute of Oncology, Hadassah Hebrew University Medical Center, 9124001 Jerusalem, Israel
11The Hebrew University Hadassah Medical School, 9112102 Jerusalem, Israel
12Caris Life Sciences, 4052 Basel, Switzerland
13Oncotest-Teva Pharmaceutical Industries, Ltd., 60850 Shoham, Israel

Received 17 December 2014; Accepted 3 March 2015

Academic Editor: Jennifer Laudadio

Copyright © 2015 Ron Epelbaum et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

This multicenter cohort study assessed the impact of molecular profiling (MP) on advanced pancreaticobiliary cancer (PBC). The study included 30 patients treated with MP-guided therapy after failing ≥1 therapy for advanced PBC. Treatment was considered as having benefit for the patient if the ratio between the longest progression-free survival (PFS) on MP-guided therapy and the PFS on the last therapy before MP was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit. Overall, ≥1 actionable (i.e., predictive of response to specific therapies) biomarker was identified/patient. Immunohistochemistry (the most commonly used method for guiding treatment decisions) identified 1–6 (median: 4) actionable biomarkers per patient. After MP, patients received 1–4 (median: 1) regimens/patient (most commonly, FOLFIRI/XELIRI). In a decision-impact analysis, of the 27 patients for whom treatment decisions before MP were available, 74.1% experienced a treatment decision change in the first line after MP. Twenty-four patients were evaluable for clinical outcome analysis; in 37.5%, the PFS ratio was ≥1.3. In one-sided exact binomial test versus the null hypothesis, P = 0.0015; therefore, the null hypothesis was rejected. In conclusion, our analysis demonstrated the feasibility, clinical decision impact, and potential clinical benefits of MP-guided therapy in advanced PBC.