'A Breath of Fresh Air': FDA's Cosela Approval May Improve Quality of Life in Lung Cancer


The FDA’s recent approval of Cosela to reduce the frequency of chemotherapy-induced bone marrow suppression in adults who are receiving certain types of chemotherapy for extensive-stage small cell lung cancer is a “breath of fresh air,” according to an expert.

The Food and Drug Administration’s (FDA) recent approval of a first-in-its-class drug, Cosela (trilaciclib), is refreshing for patients and providers, according to a lung cancer expert.

Cosela is indicated to reduce the frequency of chemotherapy-induced bone marrow suppression in adults who are receiving certain types of chemotherapy for extensive-stage small cell lung cancer that has spread beyond the lungs.

One of the most common side effects of chemotherapy, according to Dr. Jared Weiss, is myelosuppression – or bone marrow suppression. Essentially what happens, he explained, is that the poisonous effect of chemotherapy can damage a person’s bone marrow cells while attacking the cancer cells. As a result, bone marrow suppression can lead to low white blood cell, red blood cell and platelet counts. If red blood cell counts decrease, patients can become fatigued and have trouble breathing. Moreover, decreases in white blood cell and platelet counts may cause patients to be predisposed to life-threatening infections and an increased risk of bleeding.

“Fatigue is one of the things that my patients suffer from the most,” Weiss, an associate professor of medicine at University of North Carolina Lineberger Comprehensive Cancer Center, said in an interview with CURE®. “It's one of the things that, until now, I've been least able to do anything about. There are things that we do, frankly, (that) don't work that well. And it's a massive breath of fresh air for me as a doctor to be able to prevent side effects like fatigue and improve quality of life.”

Traditionally, Weiss noted, oncologists have accepted the side effect because there wasn’t much that could be done to treat it. However, the FDA’s approval of Cosela helps change that.

“(Myelosuppression is) a part of the price of business of giving life-extending chemotherapy,” he said. “Now things are finally changing (since) there's an approved agent that can actually prevent this problem.”

The agency based its decision on results of three randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer, which enrolled a total of 245 patients to receive either an infusion of Cosela or a placebo before chemotherapy. Researchers then compared the number of patients who experienced severe neutropenia (a very low white blood cell, or neutrophil, count) in the first cycle of chemotherapy, and examined how long the neutropenia lasted.

Patients who received Cosela had a lower risk of severe neutropenia compared to placebo in all three trials, and those who had severe neutropenia and received Cosela, had it for a shorter amount of time than those who received a placebo.

According to Weiss, however, the most important thing about the results was that treatment with Cosela was associated with an improvement in quality of life.

“I think most of my patients would endorse that duration (of life) only matters if it is also with quality,” he said. “There are two major cancer-related themes that harm my patients’ quality of life — the side effects of a growing cancer, which is why we give them treatment (and) the side effects of the treatment itself.”

The problem, Weiss stressed, is that the doctor-patient team doesn’t have the luxury to ignore either of those harms as for treatment to work, there needs to be that balance.

Critical point to understand

It’s important to note, Weiss mentioned, that Cosela was developed to solely preserve a patient’s quality of life by helping to prevent some of the side effects associated with chemotherapy.

The goal when developing the drug was not to improve disease control duration or survival in those with extensive-stage small cell lung cancer.

“That's a critical point to understand here,” he said. “This drug was first studied in small cell (lung cancer) because (these) cancer cells are not sensitive to (how the drug works).”

For instance, there isn’t a fear that the cancer cells will be protected from chemotherapy if Cosela is added to the treatment regimen. But it is necessary to note that adding Cosela to a chemotherapy regimen did not have a negative effect on survival.

“This is certainly a new standard of care in small cell lung cancer,” highlighted Weiss. “It is my intention, in my practice, that every patient with extensive-stage small cell lung cancer, who gets one of three (chemotherapy) regimens, will have (Cosela) added to it for myelopreservation and preservation of quality of life.”

Advocating for the drug

Patients need to be cognizant, Weiss said, of the fact that some oncologists may not be as interested with this agent as it wasn’t shown to extend survival.

“We don't tend to pay as much attention, and this is admitting a fault, not an endorsement to quality of life,” he said. “This drug hasn't made quite the splash in the doctor community that a drug that creates even a small improvement in survival would have.”

As a result, patients may need to approach their doctor and ask about this drug and advocate for getting it.

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