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Frequently asked questions about COSELA

Listed below are answers to some commonly asked questions about COSELA.

You can also always contact us directly at www.COSELAhcp.com/request-information if you have additional questions or would like more information.

What is the impact of COSELA on long-term clinical outcomes, including progression-free survival (PFS) and overall survival (OS)?
In the clinical trials, PFS and OS were evaluated as secondary and exploratory endpoints. No statistically significant differences in PFS or OS were observed between the trilaciclib and placebo groups; however, the studies were not powered to detect differences in these outcomes.1
How does COSELA influence the ability to maintain planned treatment schedules?
Based on clinical studies and some real-world evidence, COSELA has lowered the incidence of neutropenia, anemia, and thrombocytopenia from chemotherapy, and also lowered the occurrence of chemotherapy dose delays/reductions and hospitalizations in patients with ES-SCLC.1,2
What is the impact of COSELA on long-term clinical outcomes, including antitumor efficacy?
In the clinical trials, PFS and OS were evaluated as secondary and exploratory endpoints. No statistically significant differences in PFS or OS were observed between the trilaciclib and placebo groups; however, the studies were not powered to detect differences in these outcomes.1
What patient subgroups may derive the greatest benefit (e.g., older adults, poor performance status,
comorbidities affecting marrow reserve)?

The clinical studies for COSELA were not designed to assess a comparative benefit across subgroups of patients.

Patients were not stratified by risk of myelosuppression or other baseline risk factors. COSELA may be given to any appropriate patient with ES-SCLC at risk of chemotherapy-induced myelosuppression and is not solely indicated for high-risk patients or any particular subgroup.1

What clinical factors or biomarkers—if any—predict degree of myeloprotection or identify individuals less likely to respond?
COSELA is a transient CDK 4/6 inhibitor studied in patients with ES-SCLC, a tumor type largely insensitive to CDK4/6 inhibition.1
What monitoring schedule (labs, clinical assessments) is recommended to guide safe use and detect potential adverse events related to COSELA?
According to the COSELA Prescribing Information, patients should be monitored for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including infusion-site pain and erythema during infusion.1
Can I use granulocyte-colony stimulating factors (G-CSFs) and erythropoiesis-stimulating agents (ESAs) after I administer COSELA?
In clinical studies, use of G-CSFs and ESAs was allowed from Cycle 2 onwards, as clinically indicated. Therapeutic G-CSF was allowed at any time during the studies as clinically indicated. Prophylactic use of G-CSFs and ESAs was prohibited during Cycle 1.1
Do I need to administer COSELA every time I administer an appropriate chemotherapy regimen, regardless of line or cycle?
COSELA should be administered and completed within 4 hours of the start of chemotherapy on each day chemotherapy is given.
COSELA is given as an infusion, and patients typically receive it right before their chemotherapy in the same infusion chair.1
What tumor types can COSELA be used with?
COSELA was specifically studied in patients with ES-SCLC and is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients with ES-SCLC. 1
Is COSELA safe and effective when used with modified chemotherapy schedules, such as dose-dense regimens, split dosing, or non-standard cycle lengths?
The clinical studies for COSELA did not include assessments of safety and efficacy across modified chemotherapy schedules.1
CDK=cyclin-dependent kinase; ES-SCLC=extensive-stage small cell lung cancer; ESA=erythropoiesis-stimulating agent; G-CSF=granulocyte colony-stimulating factor.