Standards of care for lung cancer have improved dramatically in recent decades, but improving outcomes is a function of both improved treatment and earlier diagnosis. The journey to improved survival includes diagnosis, access to molecular testing, and access to the most effective drugs through an improved regulatory process.
“If we find disease, we want to find early-stage disease,” said Giorgio Scagliotti, MD, PhD, Professor and Chief of Medical Oncology, University of Turin, Turin, Italy. “When we diagnose lung cancer through screening, 70-80% of the disease we find is stage I or II. If we wait for a clinical diagnosis, it is the opposite. We have an opportunity to make a difference with low-dose CT (LDCT) lung cancer screening, yet screening rates are low. In the United States, fewer than 4% of smokers eligible for screening underwent LDCT screening in 2017, the most recent data we have.”
Dr. Scagliotti opened the final plenary session of WCLC 2022 with a call to double lung cancer survival within five years. Improved screening is the key. More effective screening could help prevent 12,000 premature lung cancer deaths annually in the US alone, he said.
The benefits of lung cancer screening have been grossly underestimated, but multiple challenges and consequences persist, including inadequate lung cancer awareness and access to information. These lead to reduced opportunities and motivation for screening; delayed and later-stage diagnoses; lower treatment rates; poorer quality of life; and shorter survival.
He indicated that barriers to lung cancer screening can be approached and lowered across three domains: capabilities, motivation, and opportunity.
In Italy, for example, appropriate candidates receive personalized invitations to screening from family physicians with mail, text, and telephone reminders. At the same time, messaging campaigns enlist community and faith leaders to support screening and help motivate participants. The UK deploys mobile LDCT units to shopping malls and other population centers to make screening easier and more convenient.
“We know that screening is both effective and cost-effective,” Dr. Scagliotti said. “And we have real-world data to show it.”
Revised eligibility criteria that expand screening to younger smokers and former smokers and those with other clinical warning signs could make screening even more cost effective, he said. Cost effectiveness would also be increased with better integration of screening into healthcare workflows and systems.
Looking to the future, biomarker-based screening could increase early detection and risk stratification as it has in breast cancer.
“We need to create a new ecosystem of data to separate low-risk and high-risk individuals and we need to integrate screening into healthcare systems,” Dr. Scagliotti concluded. “The European Commission is looking into ways to better include screening in standards of care.”
Improved access to screening is just one part of the solution. Those who have lung cancer need improved access to drug treatments.
Watch On-Demand: Closing Plenary—Access to Drugs
In-person and virtual attendees can watch WCLC 2022 sessions on-demand through December 31, 2022. If you couldn’t make the meeting, it’s not too late to register and enjoy on-demand content through the end of the year.
“We see more and more patients with advanced disease,” said Nir Peled, MD, PhD, head of the Cancer Institute, Shaare Zedek Medical Center, The Hebrew University, Jerusalem, Israel. “There is more and more need to access drugs.”
Beyond screening, multiple other breakthroughs have reduced lung cancer mortality, including better prognostic markers, the approval of immunotherapy for all lines of treatment from neoadjuvant through rescue, and the development of tyrosine kinase inhibitors and other agents that can penetrate the blood-brain barrier.
The pace of lung cancer drug approvals has accelerated in recent years and the development of ALK (anaplastic lymphoma kinase) inhibitors has extended survival to about seven years in those with ALK rearrangements.
“Those benefits all depend on access to the relevant drugs,” Dr. Peled said. “We should always be thinking about the drugs we would like to have for our patients and the drugs that we actually have available. There are countries and areas that cannot conduct gene analysis on a regular basis. As an organization, we need to think about solutions and improving access to drugs.”
Drug access is a combination of regulatory approval for a specific indication, availability of reimbursement, cost, and general availability. Lack of approval, off-label use, reimbursement barriers, high out-of-pocket costs, and lack of drug product can all be problems, depending on the local situation. An approved drug that is not eligible for reimbursement or requires excessive administrative overhead is a common scenario worldwide.
“An appropriate diagnosis is the first step in drug access,” Dr. Peled said. “Assuring access steals a lot of time from clinicians. We need administrative support to ensure our patients get the drugs they need.”
Drug approval is an additional step in providing patients access to new drugs. Regulators play key roles in drug access, both in approving new agents and labeling requirements. But neither drug approvals nor indications or other conditions of use are simple “yes” or “no” decisions.
“The complexity of the system is mind boggling,” said Francesco Pignatti, MD, Head of Oncology and Haematology and Diagnostics, Human Medicines Evaluation Division, European Medicines Agency, Amsterdam, The Netherlands. “You are talking about hundreds of different organizations just in Europe, all doing slightly different things in reaching for the same goal.”
In theory, he continued, regulatory processes are intended to benefit patients. And while patient voices have seldom had a seat at the table in the past, regulators are currently moving toward systemic engagement of patients in regulatory decisions and other aspects of the drug development process.
Drug approvals are based on assessments of quality, safety, efficacy, and benefits versus harms.
“When you talk about benefits and harms, perspective matters,” Dr. Pignatti said. “My perspective may not be the same as yours. Fortunately, there are systematic ways to assess how patients and others trade off different values and preferences.”
Preferences and perspectives are even more important as drug evaluations rely more on surrogate endpoints and less on long term patient outcomes. About half of our recent approvals are based on early endpoints, including biomarker-driven treatments that have led to important improvements in outcomes.
“We need to think more systematically about involving patients in regulatory decisions,” Dr. Pignatti said. “And we need to consider access outside approved drugs to optimize treatment decisions. The new European Medicines Agency’s Cancer Medicines Forum hopes to outline priorities to tackle these issues in the interests of patients.”
