Dr. Kathryn Gold discusses the latest insights on small-cell lung cancer guidelines from the National Comprehensive Cancer Network.
Discussion on the latest insights on small-cell lung cancer guidelines from the National Comprehensive Cancer Network.
Small-cell lung cancer (SCLC) remains a challenging diagnosis for patients and physicians despite the progress made in more common non-small cell lung cancer (NSCLC) in recent years. With fewer targets and therapeutics available, mortality rates are low in SCLC compared with NSCLC.
Given the slower progress and fewer approvals, it is imperative that when there are updates on the research and regulatory side, physicians and patients are made aware of the options. The National Comprehensive Cancer Network (NCCN) produces guidelines across cancer types to help keep providers and even payers current on the drug armamentarium and optimal approaches for each patient.
The American Journal of Managed Care® (AJMC®) spoke with Kathryn Gold, MD, medical oncologist and associate professor of medicine at UC San Diego, who is a member of the NCCN guidelines panel for small-cell lung cancer, for insight into the guidelines and the importance of frequent updates.
The following has been edited lightly for clarity.
AJMC®: Can you discuss the need for frequent updates to NCCN guidelines as new therapies emerge in SCLC?
Gold: As a committee, we really think it’s important to update the guidelines frequently with the latest information. Our standard procedure is an annual meeting where we really go over the entire set of guidelines from page 1 until the end, look at all the details, and see if there’s any irrelevant things that need to be removed, discuss if there are any new things that need to be added. But between those annual meetings, we also have ad hoc discussions whenever important new data comes available—either a phase 3 trial, exciting phase 2 trial with really promising results, a new FDA approval, or an FDA withdrawal of approval, as has happened recently with several drugs. We’ll meet in between those annual meetings to update the guidelines about that. Those can be emails, they can be conference calls, but we do think it’s really important to keep that up to date, because we know that busy clinicians are making decisions for their patients based on the information in there. I’m fortunate that I get to focus on only a couple tumor types. I focus on lung, head, and neck cancer, so that’s all the data I need to know. But many doctors in practice have to focus on all different tumor types, so they may not be able to stay quite as involved in the research on any one tumor type, especially relatively rare tumor like small-cell lung cancer. So we know that people are relying on us to get the most up to date data for their patients to be able to figure out how to treat them. We also know that some insurers use our guidelines, as part of their decision making regarding coverage decisions, we do try to keep it updated for that reason, as well.
AJMC®: What are your thoughts on the recent withdrawals?
Gold: Yeah, so this is related to the FDA’s desire to get things approved quickly if they look really promising based on early data, but sometimes that early data doesn’t pan out. So the 2 recent examples in small-cell lung cancer were nivolumab and pembrolizumab. And they both got accelerated approvals based on phase 1 and 2 data showing promising response rates for small-cell lung cancer. Both those FDA approvals required them to do larger confirmatory phase 3 trials with overall survival endpoints. And on those phase 3 trials, the survival endpoints were not met. Therefore, the FDA approval was withdrawn. Now, those are still listed on the NCCN guidelines, both nivolumab and pembrolizumab, kind of with a lower preference ranking to reflect that withdrawal of FDA approval.