An Overview of Trilaciclib Safety and Patient QOL Outcomes


Focusing the discussion on the clinical trials that led to the FDA approval of trilaciclib, experts in ES-SCLC share key insights into the drug’s safety and its effect on patient quality of life.


Martin Dietrich, MD, PhD: One of the biggest aspects of this ASCO [American Society of Clinical Oncology] meeting was patient-reported outcomes and quality of life-related issues. I think those were studied in this trial. We’ve seen that]patients are more content avoiding hospitalizations and avoiding time spent in our treatment areas for supportive care and transfusions. Those are important factors that we should consider. It’s a 30-minute infusion prior to each day of therapy, so we are looking at this from a whole experience perspective—not only from numerical markers, but also from subjective, graspable patient-reported outcomes that are seemingly improving the patient’s journey. That is very difficult with extensive-stage small-cell lung cancer. The chemotherapy is very effective in the first-line setting but is very harsh. It’s interesting to see that we’re not only affecting numerical toxicities, but objective experience for patients as well.

Edgardo Santos, MD, FACP: Correct. You mentioned quality of life, Martin. When you see the toxicity profile or adverse reactions from trilaciclib, the therapy is very well tolerated. Perhaps the most common effect that you see with trilaciclib is irritation where we give the infusion. Usually, it is a discomfort or pain where the medication is passing through, perhaps with some erythema or redness. When that happens, we start the infusion and flush the catheter with either normal saline or dextrose 5 normal saline. That should take care of the problem. Interstitial tissue has been reported with this disease. Thoracic oncology is very important, especially when the patient is going to be exposed to immunotherapy—such as atezolizumab or durvalumab—which is another standard of care worldwide, or here in the United States. This issue of ILD [interstitial lung disease] is important to us. The report has been only 1 case, but we need also to mention that it’s very well tolerated. The most common adverse effects we have seen with trilaciclib are that more than 10% of the patient population has been fatigued, had hypocalcemia, hypoglycemia, or some elevation of the aspartate transaminase. Those are the things we see with trilaciclib.

Martin Dietrich, MD, PhD: I don’t think it’s a new side effect. We’ve seen the CDK4/6 [cyclin-dependent kinase 4/6] inhibitor showing low levels of ILD, but I think, overall, they are very manageable. In the bigger context of immunotherapy, it’s a problem that we’re monitoring for very closely in the clinic.

Edgardo Santos, MD, FACP: Absolutely.

Martin Dietrich, MD, PhD: What patients are you choosing for trilaciclib? For which patients would you say this is appropriate? Are there any patients for whom you say it is not appropriate?

Edgardo Santos, MD, FACP: At this moment, the indication that we have for trilaciclib is for extensive-disease small cell lung cancer, first-line or second-line therapy. I treat all my patients with trilaciclib as a myeloprotectant. As you know, we give trilaciclib within 4 hours prior to the infusion of chemotherapy. You do that, the classic regimen for small cell lung cancer, on day 1, day 2, and day 3. Similarly, for topotecan, there is an infusion every day. The issue here is that when trilaciclib, that myeloprotectant, is given, within a window of 1 to 4 hours before you start infusion of chemotherapy. I made my decision a long time ago to use this myeloprotectant and be proactive more than reactive.

Martin Dietrich, MD, PhD: I can second that. I think we have looked at this from many angles. We have discussed the treatment outcomes and the patient experience, but we also evaluated the internal cost of care delivery. The question that may come up is about adding another drug. Is this going to increase the budget of the cost of care delivery? As it turns out, it actually saves money. Hospitalization is expensive. We all know the cost of emergency room visits. Transfusions are exorbitantly high. We not only provide a smoother journey for the patient, but we also save money by being proactive in the protection of this bone marrow situation.

Edgardo Santos, MD, FACP: I completely agree with you, Martin. You mentioned the issue of what happened with COVID-19. With the system so overwhelmed, we need to be prepared for the future. Perhaps, hopefully, it’s the last pandemic, but you never know what could happen. When you have something like trilaciclib that can avoid those hospitalizations—because of neutropenia—to avoid a transfusion and those kinds of things will significantly help the health care system. We need to be prepared for that. As I said, as long as the patient can stay at home with their family and their loved ones, that is a plus. That's exactly what we want to see regarding quality of life in the health care system.

Martin Dietrich, MD, PhD: Absolutely. I would definitely second that.

Transcript edited for clarity.

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