Not Just for Big Centers: Molecular Testing for Lung Cancer

Nick Mulcahy

June 06, 2012

June 6, 2012 (Chicago, Illinois) — Molecular testing of lung cancer tissue samples on a local level is feasible and enables personalized treatment, according to a study of a model testing network in Germany, presented here at the 2012 Annual Meeting of the American Society of Clinical Oncology.

The study addressed a "major challenge" in lung cancer — implementing molecular diagnostics in routine clinical practice outside of big academic centers, according to the authors, led by Thomas Zander, MD, from the University Hospital in Cologne.

"In Germany, most lung cancer patients are treated in community hospitals," explained Dr. Zander at a meeting press conference. However, the time, cost, and logistics of sending samples to distant academic centers can discourage molecular testing, he noted.

"We had minimal logistics to make it easy for people to participate," he said, referring to the regional testing network established in the Cologne/Bonn metropolitan area. The network provides centralized testing for small local hospitals and private practices and was the subject of this study.

The testing is important in lung cancer because there are now a number of systemic therapies that are most effective in patients who have nonsmall-cell lung cancer (NSCLC) with specific molecular traits. The therapies and related molecular signatures include erlotinib (Tarceva, Genentech/Astellas) for patients with EGFR mutations and crizotinib (Xalkori,Pfizer) for patients with ALK mutations.

Testing can guide treatment selection and allow clinicians "to choose the most appropriate targeted therapy," said Sylvia Adams, MD, from the New York University School of Medicine in New York City, who moderated the press conference.

In addition to providing test results, the network provides treatment advice based on the results, said Dr. Zander.

The network seems to have had an impact. About 70% of all NSCLCs in the geographic catchment area were sent to a central laboratory for testing during the study period.

The material was suitable for testing in 77% of cases. Of the tested samples, 40% had genetic mutations that could be targeted with therapy. This is a bit higher than might be expected; Dr. Zander explained that about 35% of NSCLCs harbor targetable lesions.

Personalized therapy leads to long survival.

In the study, 75% of stage III/IV patients with EGFR mutations ultimately received either erlotinib or gefitinib, and had a median overall survival of about 42 months. The outcome compares favorably to the 27- to 32-month overall survival seen in clinical trials of the drugs. The superior outcome is "probably" due to the use of the targeted therapy afatinib (Boehringer Ingelheim) in the second and third line, said Dr. Zander. "Implementation of personalized therapy leads to long survival," he told reporters.

All patients with ALK translocations received crizotinib when clinically indicated.

In patients with lung adenocarcinomas, Dr. Zander and his coauthors reported that KRAS mutations were found in 32% of samples, EGFR mutations in 13%, ALK alterations in 3%, BRAF mutations in 2%, PIK3CA mutations in 2%, and ERBB2 mutations in 2%. In patients with squamous cell cancers, 15% of the tumors had an FGFR1 amplification.

A Different Story in the United States

The Cologne/Bonn regional testing network, which was funded by a grant by the German federal government, stands in contrast to efforts in the United States, where only select major centers routinely test lung cancer patients, said Dr. Zander. In the United States, a minority of lung cancer patients have access to molecular diagnostics, he said.

Payment is an issue in Germany and elsewhere, noted a number of oncologists participating in the press conference. Dr. Zander said that in Germany, only testing for EGFR and ALK mutations is currently paid for by insurance.

The practicalities of having lung cancer tissue tested are a burden in the United States, according to previous reports.

A number of experts who spoke at the 2011 meeting of the National Comprehensive Cancer Network complained about logistic challenges. A "big issue" is getting a specimen from a pathology lab at a hospital to a molecular lab, said Mark Kris, MD, from the Memorial Sloan-Kettering Cancer Center in New York City. The practical value of testing for lung cancer is overblown, said Michael Kolodziej, MD, medical director of Innovent Oncology, a division of US Oncology, and a practicing physician specializing in lung cancer in Albany, New York. "We have the illusion we are in the era of personalized medicine," he said.

Dr. Zander reports financial ties to Roche, Eli Lily, and Boehringer Ingelheim. Dr. Adams reports financial ties to GlaxoSmithKline.

2012 Annual Meeting of the American Society of Clinical Oncology (ASCO): Abstract CRA10529. Presented June 5, 2012.

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