First study to evaluate treatment based on molecular profiling of advanced pancreatic cancer

The feasibility of selecting treatment based on individual molecular characteristics was demonstrated in a first-of-its kind pancreatic cancer clinical trial reported today by the Translational Genomics Research Institute (TGen) and the Virginia G. Piper Cancer Center at Scottsdale Healthcare.

The findings were announced during the American Association for Cancer Research (AACR) Annual Meeting 2012, March 31-April 4, in Chicago.

"The most important finding is that this approach is feasible and we are encouraged by preliminary evidence that this approach may benefit some patients," said Dr. Ramesh K. Ramanathan, Medical Director of the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with TGen.

The completed phase II clinical trial: Therapy Selected by Tumor Molecular Profiling in Patients with Previously Treated Metastatic Pancreatic Cancer, is part of a Stand Up To Cancer (SU2C) Pancreatic Cancer Dream Team consortium created in 2009.

Dr. Ramanathan said this is the first clinical study of pancreatic cancer in which biopsies were done of the tumors and treatments were based on the molecular profiling of pancreatic cancer tumors.

The study showed that biopsies could be safely conducted, and that multiple drug targets could be identified by IHC and DNA sequencing (Caris Target Now-), CGH and microarray.

"Survival analysis is premature, but we believe some patients have had benefit," Dr. Ramanathan said.

Forty-nine subjects were accrued between August 2010 and January 2012. Fourteen patients did not start protocol therapy either due to insufficient tumor on biopsy or due to worsening cancer related symptoms after biopsy. There were 35 evaluable patients.

In most patients - all of whom had prior chemotherapy - molecular profiling at Caris resulted in two or more IHC targets for therapy and a non-cross resistant regimen could be implemented.

The most common IHC targets were topoisomerase 1 or 2 and Thymidylatesynthase. Only commercially available agents were prescribed. Treatment recommendations were based primarily on IHC markers. Common regimens/ agents recommended were FOLFIRI, FOLFOX, irinotecan and doxorubicin.

Study has completed accrual. One patient treated with FOLFIRI is a one-year survivor.

Genomic (CGH and microarray) assays and pathway analysis are ongoing to understand response and molecular factors identified in the cancer cells..

The study's abstract will be presented at an AACR Late-Breaking Poster Session from 8 a.m.-12 p.m. today at Chicago's McCormick Place convention center.