Clinical benefit of a precision medicine based approach for guiding treatment of refractory cancers.

Radovich M1,2, Kiel PJ1,2, Nance SM1, Niland EE1, Parsley ME1, Ferguson ME1, Jiang G2, Ammakkanavar NR2, Einhorn LH2, Cheng L2, Nassiri M2,Davidson DD2, Rushing DA2, Loehrer PJ2, Pili R2, Hanna N2, Callaghan JT2, Skaar TC2, Helft PR2, Shahda S2, O'Neil BH2, Schneider BP1,2.

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Abstract

PATIENTS AND METHODS:

Patients with metastatic solid tumors who had progressed on at least one line of standard of care therapy were referred to the Indiana University Health Precision Genomics Program. Tumor samples were submitted for DNA & RNA next-generation sequencing, fluorescence in situ hybridization, and immunohistochemistry for actionable targets. A multi-disciplinary tumor board reviewed all results. For each patient, the ratio of progression-free survival (PFS) of the genomically guided line of therapy divided by the PFS of their prior line was calculated. Patients whose PFS ratio was ≥ 1.3 were deemed to have a meaningful improvement in PFS.

RESULTS:

From April 2014-October 2015, 168 patients were evaluated and 101 patients achieved adequate clinical follow-up for analysis. 19 of 44 (43.2%) patients treated with genomically guided therapy attained a PFS ratio ≥ 1.3 vs. 3 of 57 (5.3%) treated with non-genomically guided therapy (p < 0.0001). Similarly, overall PFS ratios (irrespective of cutoff) were higher for patients with genomically guided therapy vs non-genomically guided therapy (p = 0.05). Further, patients treated with genomically guided therapy had a superior median PFS compared to those treated with non-genomically guided therapy (86 days vs. 49 days, p = 0.005, H.R. = 0.55, 95% C.I.:0.37-0.84).

CONCLUSION:

Patients with refractory metastatic cancer who receive genomically guided therapy have improved PFS ratios and longer median PFS compared to patients who do not receive genomically guided therapy.