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Lung cancer ‘personifies precision medicine’
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NEW YORK — Precision medicine approaches have dramatically altered treatment approaches and improved outcomes for patients with lung cancer, according to a presenter at HemOnc Today New York.
The precision medicine era in lung cancer has been defined by greater use of genomic testing, the development of novel therapeutics and reduced use of chemotherapy, meeting co-chair Edward S. Kim, MD, FACP, chair of solid tumor oncology and investigational therapeutics and medical director of the clinical trials office at Levine Cancer Institute at Atrium Health, said during a presentation.
“Lung cancer is a very exciting area to be in. It personifies precision medicine in so many ways,” said Kim, a HemOnc Today Editorial Board Member.
Lung cancer remains a major therapeutic challenge, with an estimated 234,030 new cases diagnosed in the United States in 2018. This accounted for 13% of all cancer diagnoses.
However, survival has continued to increase over time due to treatment advances.
The FDA approved 16 agents for non-small cell lung cancer since 2015. Many are intended for specific subgroup, as an estimated 50% of patients with lung cancer are candidates for targeted therapy.
“The drugs that have been approved are amazing,” Kim said. “They are costly, but I always believe it’s better to have more choices and let providers and patients dictate which ones will be used. ... These additional choices are helping us to empower patients to live longer, and I think we are seeing that in most areas of oncology.”
However, additional choices can complicate clinical decision-making.
For example, the cumulative number of new genetic tests on the market reached nearly 14,000 as of August 2017.
“This is one example of what is happening in the marketplace,” Kim said. “We also have many new drugs and additional approvals. You may think you know what a drug is approved for but then you find out it has three other indications that were just approved over the previous few months that you didn’t know about, so it really becomes a challenge.”
However, the importance of conducting genomic testing, either through tissue or blood samples, cannot be understated, Kim said.
Viable targets include EGFR, ALK and ROS1 mutations, as well as NTRK fusions. Other markers that may become useful in lung cancer include RET, MET, insertion 20 and tumor mutational burden.
“If you have a patient with breast cancer, would you ever start treatment without knowing HER2 status?” Kim said. “That is the equivalent of what we have in lung cancer. We have to know the biomarker status before we start treatment.
“If you don’t test, you’re not going to find these markers,” Kim added. “You need to test and utilize the answers to determine which treatment to use. If results are taking more than 2 weeks, you need to have a discussion with your boss so someone can ask pathology why it’s taking so long.”
Kim also emphasized the importance of optimizing clinical trials to increase the percentage of patients with cancer who enroll.
“Everyone talks about real-world evidence, but clinical trials are not real-world data,” he said. “You have to have specific criteria for trial participants and make sure they are all fit and meet certain parameters. That’s not the real world. The real world is going into the rural areas of North Carolina and finding someone in a small town who has cancer and saying, ‘How can we help you?’”
Approximately 8% of patients with cancer enroll in clinical trials.
“When we think about how to get more people on clinical trials, the solution has always been to open more clinical trials,” Kim said. “If we open 2,000 more clinical trials, we’re still enrolling that same 8% of patients. Maybe we should optimize the trials we have in hopes of enrolling 30% of our patients instead of 8%.”
Kim participated in an effort led by ASCO and Friends of Cancer Research to evaluate eligibility criteria to determine if they could be modified to broaden trial participation. Participants prioritized assessment of specific eligibility criteria — including presence of brain metastases, minimum age, HIV/AIDS, organ dysfunction, and prior cancer history or concurrent malignancy — to create a protocol template that has been accepted by NCI and is undergoing public review.
The next version of will focus on additional criteria, including washout periods and concomitant medications, prior therapies, laboratory reference ranges and test intervals, and performance status.
Clinical trial design will become more “cutting edge” over time, Kim added.
“There aren’t going to be as many randomized phase 3, placebo-controlled trials,” he said. “Many of the drugs we see getting approved are based on 30-, 40-, 50- or 60-patient experiences. If there is a biomarker and you see response rates around 70%, the drug likely will get accelerated approval.” – by Mark Leiser
Reference:
Kim ES. Treatment approaches for lung cancer: A model for precision medicine. Presented at: HemOnc Today New York; March 21-23, 2019; New York.
Disclosure : Kim reports consultant roles with AstraZeneca, Boehringer Ingelheim, Merck and Takeda; research funding from AstraZeneca, Boehringer Ingelheim, Ignyta and Merck; and a data and safety monitoring board role with Celltrion.