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Survey Shows More NSCLC Patients Getting EGFR Testing, but Results Often Don't Inform Care


NEW YORK (GenomeWeb) – Although more newly diagnosed non-small cell lung cancer patients are receiving EGFR mutation testing as recommended by guidelines, a significant proportion of oncologists aren't basing patients' treatment decisions on test results, a global survey conducted by drugmaker Boehringer Ingelheim has shown.

The survey results point to a potential barrier for the uptake of personalized therapies such as Boehringer Ingelheim's Gilotrif (afatinib) and Roche/Genentech's Tarceva (erlotinib), which are the frontline options for advanced non-small cell lung cancer patients with EGFR mutations. The US Food and Drug Administration approved Gilotrif two years ago alongside Qiagen's Therascreen EGFR RGQ PCR kit as a companion diagnostic for advanced NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions.

Recognizing the importance of EGFR testing to Gilotrif's use, in late 2012, a few months before the drug's approval, Boehringer launched the Let's Test campaign to educate healthcare providers about the importance of biomarker testing in lung cancer. In the campaign, the firm highlighted that EGFR mutations show up in approximately 15 percent of Caucasians with NSCLC and with much higher frequency among East Asians. The website also guides physicians on how to decide which advanced NSCLC patients to offer genetic testing.

Around the launch of the Let's Test campaign, the company cited data collected by Ipsos US Oncology Monitor that showed around 50 percent of NSCLC patients were being tested for EGFR mutations. Boehringer noted at the time that even when patients are tested for EGFR mutations, it was happening too late to make a difference in terms of treatment strategy.

Now, the latest survey sponsored by Boehringer shows more patients are getting tested, but in many cases doctors are still not using test results to personalize therapeutic decisions. Researchers led by James Spicer of Kings College London presented the findings from the global survey involving more than 550 oncologists from 10 countries earlier this month at the 2015 European Lung Cancer Conference in Geneva, Switzerland.

The survey, which took place between December 2014 and January 2015, included oncologists from Canada, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, the UK, and the US. Boehringer's Gilotrif is approved in more than 50 countries around the world.

Overall, 81 percent of newly diagnosed advanced NSCLC patients received testing for EGFR mutations, according to the survey. However, oncologists started one in four advanced NSCLC patients on first-line treatment before they received results on patients' mutations status. Moreover, 51 percent of oncologists indicated that patients' EGFR mutation status did not impact their therapeutic strategy for those patients.  

Compared to previous years, it's a positive sign that gradually, more and more newly diagnosed advance NSCLC patients are getting tested. Market data cited by Boehringer showed that in the fourth quarter of 2012 – before the market availability of Gilotrif – EGFR mutation testing was being performed for approximately 70 percent of advanced non-squamous NSCLC patients. This was a marked improvement from the year-ago period when only around 40 percent were getting tested. Now, according to the latest survey from Boehringer, 80 percent of newly diagnosed advanced NSCLC patients are getting EGFR testing.

The continued growth in testing rates is likely helped by guidelines issued two years ago (by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology) that recommended testing all advanced adenocarcinoma patients for alterations in EGFR and ALK genes. But the latest survey also reveals that sometimes the patient's health status gets in the way of testing, and other times the deterrent is more logistical, such as lengthy turnaround times for test results.

Surveyed doctors cited a range of reasons — including tumor histology, insufficient tumor samples, poor health status of the patient, and long turnaround times for tests — for not testing all lung cancer patients. According to Spicer, oncologists' reasons for not testing patients were for the most part in line with best practices when it concerned tumor histology or health status. "We know that patients with particular kinds of lung cancer, mainly squamous cell cancer, are very unlikely to have such a mutation," he noted. "So, perhaps it's not justified to expend the resources to test those patients."

But then, Spicer pointed out that some surveyed oncologists also cited smoking status and patients' age as factors determining whether or not to order testing — "neither of which really should be taken into account when offering this test," he said.

The dearth of tissue samples has been a longstanding problem hindering invasive diagnostic testing in lung cancer. As a result, a number of test developers are working to refine and launch liquid biopsy tests that gauge circulating tumor DNA.

Additionally, the turnaround times for genetic tests are usually between one and two weeks, but may be longer depending on the lab, Spicer noted. "Remember these patients are newly diagnosed and are waiting to start their first ever treatment," he said. "There is pressure on the prescriber and on the patient to get going on something."

According to Boehringer spokesperson Susanne Granold, around 25 percent of US oncologists surveyed said they aren't using EGFR status to guide first-line treatment decisions because results take too long to come back. "Long turnaround time is a major obstacle for NSCLC patients to receive optimal therapy," Granold told GenomeWeb. "Future technology, including an eventual blood test to identify EGFR mutations, will help improve turnaround times."

The survey showed that more doctors in the US and in Europe, compared to those in Asia, didn't personalize therapeutic strategies based on patients' EGFR status. Around 60 percent of US oncologists indicated in the survey that they didn’t make treatment decisions based on patients' mutation status, while 50 percent of oncologists in Canada and 23 percent in Asia said the same. Specifically, 26 percent of US doctors decided which treatments to give patients before they had test results, compared to 12 percent of physicians in Asia and 30 percent in Europe.

The survey highlights the need for physician education, Spicer observed. Doctors need to be reminded that "yes, in some cases, there is a very real clinical need to get on with treatment," he said. "But usually this kind of lung cancer has been developing for many months before a diagnosis is made, so another few days to wait for a test result that can make quite a big difference in patient outcome is an appropriate time to wait."

Researchers presented data last year showing that patients harboring the more common Del19 EGFR mutations live more than a year longer on Gilotrif compared to standard chemo. Based on this data, investigators led by Massachusetts General Hospital's Lecia Sequist said Gilotrif should become the standard of care for this subset of lung cancer patients.

The survey also showed that overall EGFR testing rates differed regionally in advanced NSCLC, with oncologists in the US and in Europe performing fewer tests compared to those in Asian countries. Among surveyed Asian oncologists, 92 percent said they order testing before starting first-line therapy. Meanwhile, around 77 percent of US and European oncologists said they ordered EGFR mutation tests in this setting (see US infographic).

The regional differences in EGFR testing and in use of results to guide treatment decisions may be attributable to the fact that EGFR mutations show up in much higher rates (up to 30 percent of NSCLC patients) in the Asian community. "So, if I'm sitting in a clinic in Tokyo, then I would expect about a third of my patients with lung cancer to have a mutation," Spicer said. "In my clinic in London, that percentage is much lower, around 10 percent. So, EGFR mutations are much more part of the agenda for lung cancer doctors in East Asia just because of the biology and local population."

It's not clear the extent to which the issues related to testing may be impacting Gilotrif sales. In its 2014 annual report, Boehringer didn't break out sales for Gilotrif, which competes on the market with Tarceva. Last year, worldwide sales of Tarceva — approved in first-line EGFR mutated NSCLC and those with or without mutations in later stages of disease, as well as for advanced pancreatic cancer patients — dipped 1 percent to CHF 1.29 billion ($1.35 billion).

Boehringer's Granold noted in an email that the company is planning to discuss the survey findings with the lung cancer community in different countries and garner feedback from patient advocacy groups, doctors, and policy makers. "Our ultimate goal would be to develop country-specific action plans (because the survey results varied between regions and countries) to help support advanced NSCLC patients," she said.