Biomarker-Driven Therapy in Metastatic Gastric and Esophageal Cancer: Real-Life Clinical Experience.

Purim O1,2, Beny A3, Inbar M4, Shulman K5, Brenner B6,7, Dudnik E7, Bokstein F4, Temper M8,9, Limon D4, Matceyevsky D4, Sarid D4, Segal A10, Semenisty V3, Brenner R6,11, Peretz T8,9, Idelevich E9,12, Pelles-Avraham S4, Meirovitz A8,9, Figer A4, Russell K13, Voss A13, Dvir A14, Soussan-Gutman L14, Hubert A8,9.

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Abstract

BACKGROUND:

Precision treatment of cancer uses biomarker-driven therapy to individualize and optimize patient care.

OBJECTIVE:

To evaluate real-life clinical experience with biomarker-driven therapy in metastatic gastric and esophageal cancer in Israel.

PATIENTS AND METHODS:

This multicenter retrospective cohort study included patients with metastatic gastric or esophageal cancer who were treated in the participating institutions and underwent biomarker-driven therapy. Treatment was considered to have a benefit if the ratio between the longest progression-free survival (PFS) post biomarker-driven therapy and the last PFS before the biomarker-driven therapy was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit.

RESULTS:

The analysis included 46 patients (61% men; median age, 58 years; 57% with poorly-differentiated tumors). At least one actionable (i.e., predictive of response to a specific therapy) biomarker was identified for each patient. Immunohistochemistry was performed on all samples and identified 1-8 (median: 3) biomarkers per patient (most commonly: low TS, high TOPO1, high TOP2A). Twenty-eight patients received therapy after the biomarker analysis (1-4 lines). In the 1st line after biomarker analysis, five patients (18%) achieved a partial response and five (18%) stable disease; the median (range) PFS was 129 (12-1155) days. Twenty-four patients were evaluable for PFS ratio analysis; in seven (29.2%), the ratio was ≥1.3. In a one-sided exact binomial test vs. the null hypothesis, p = 0.019; therefore, the null hypothesis was rejected.

CONCLUSIONS:

Our findings demonstrated that implementing biomarker-driven analysis is feasible and could provide clinical benefit for a considerable proportion (~30%) of patients with metastatic gastric or esophageal cancer.