Adding immunotherapy to chemotherapy greatly improved the odds of survival among patients with the most common type of lung cancer, according to a study published Monday in the New England Journal of Medicine.
Leena Gandhi, the study's lead author and director of the Thoracic Medical Oncology Program at the Perlmutter Cancer Center at New York University Langone Health, said the findings "sugges[t] … that chemotherapy alone is no longer a standard of care."
Background on immunotherapy
According to the Times, the findings represent another advance for immunotherapies, which use an individual's immune system to attack abnormal cells in the body, such as cancer cells. Immunotherapies are costly, with treatments totaling more than $100,000 annually, and can have serious side effects. However, the drugs also can have long-lasting benefits.
FDA has approved four immunotherapies to treat cancer, and researchers are examining ways to combine immunotherapies with other treatments to see how they can improve the treatments' effects and determine the appropriate formulations for patients, according to the Times.
For the study, researchers randomly assigned patients with metastatic non-squamous advanced non–small-cell lung cancer (NSCLC) to one of two separate groups:
- One with patients who would take the standard treatment, chemotherapy pemetrexed, in combination with a placebo; and
- One with patients who would take the standard chemotherapy treatment in combination with pembrolizumab, an immunotherapy manufactured by Merck that is commonly known as Keytruda.
The study involved a total of 616 participants from medical centers in 15 countries.
According to the researchers, patients in the placebo group saw a "modest benefit," with a few months added to their lives. However, patients in the Keytruda group saw a significant improvement. According to the researchers, after a median follow-up of 10.5 months, participants who received the immunotherapy were half as likely to die when compared with individuals who did not receive the treatment.
The researchers found that the survival rate at 12 month among participants who did not receive Keytruda was 49.4%, compared with an estimated 69.2% among those who had received the treatment. However, the researchers found that participants who received Keytruda had problems with their kidneys and more immune-related adverse reactions. As a result, some of the participants stopped taking Keytruda.
Gandhi said the findings "represent[t] a sea change in the way we think about treating lung cancer." She added, "I think we were all surprised at the magnitude of benefit and how clear the difference was at an early analysis, and that we could tell there was an overall survival difference."
Roy Herbst, chief of medical oncology at the Yale Cancer Center, said, "I've been treating lung cancer for 25 years now, and I've never seen such a big paradigm shift as we're seeing with immunotherapy." He said, "If you want to see long-term survival, you've got to give immunotherapy as soon as possible." He continued, "Chemotherapy has limitations. Immunotherapy has the ability to cure."
Separately, Jorge Gomez—a spokesperson for the American Lung Association and director of thoracic oncology at Mount Sinai Hospital, who was not involved in the study—said the combined treatment appears, so far, to have nearly doubled participants' median survival, a measure that's met when 50% of patients die. According to Gomez, the median survival for patients with non-squamous non-small cell lung cancer who receive chemotherapy alone is about 11 or 12 months; in comparison, among study participants who also received immunotherapy, median survival has not yet been met. "It's already been 21 months," Gomez said. "The differences are big enough now that you know it's going to be a very big number and it's important to get this information to people so they can start using this regimen" (Grady, New York Times, 4/16; Scutti, CNN, 4/16).
Advisory Board's take
Deirdre Saulet, Practice Manager, Oncology Roundtable
As evidence of immunotherapy's effectiveness builds, nearly every health system is trying to provide these groundbreaking treatments to patients. But it's important to remember that immunotherapies, including checkpoint inhibitors, can cause severe adverse events and side effects. Because these drugs are usually given to very ill patients and are still relatively new in practice, many providers may not recognize that symptoms are related to immunotherapy drugs—and so may not be prepared to manage symptoms swiftly and effectively.
In our recent survey of 170 cancer programs, we found that nearly all programs are prescribing immunotherapy agents. However, only one-third of respondents told us their oncologists felt "very comfortable" managing immunotherapy-related side effects. Just as many respondents said their providers were "very uncomfortable" managing side effects.
To ensure high-quality care, health systems need to invest in robust and ongoing patient and provider education and support. For instance, many organizations are creating molecular tumor boards to enable oncologists to confer about potential side effects of their patients' treatment regimens and share best practices for preventing and managing these events.
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