Real-World Outcomes of Trilaciclib Among Patients with Extensive-Stage Small Cell Lung Cancer Receiving Chemotherapy.

INTRODUCTION: Trilaciclib was recently approved in the USA for reducing chemotherapy-induced myelosuppression (CIM) among adults with extensive-stage small cell lung cancer (ES-SCLC) when administered prior to chemotherapy. There is limited understanding of real-world outcomes of trilaciclib. METHODS: A comprehensive literature review was conducted using a keyword search in the MEDLINE, Embase, and conference abstracts. Additional studies were identified through communications with the authors of relevant studies. Published and unpublished real-world studies of trilaciclib- and comparable non-trilaciclib-treated patients with ES-SCLC were included. Evidence on myelosuppressive hematologic adverse events (HAEs), cytopenia-related healthcare utilization, and other reported outcomes (e.g., hospitalizations, dose reduction, and treatment delay) were synthesized. If feasible, outcomes were compared qualitatively between the trilaciclib and historical reference groups, and between first-line trilaciclib initiators and the overall trilaciclib population. Weighted averages were estimated for selected outcomes using sample size as the weight. RESULTS: The literature search identified five unique studies based on eight records-two included trilaciclib only, two non-trilaciclib only, and one both. In trilaciclib cohorts, the weighted average prevalence of grade ≥ 3 myelosuppressive HAEs in ≥ 1 lineage, ≥ 2 lineages, and all three lineages was 40.5%, 14.5%, and 7.5%, respectively. All rates were numerically lower compared to the historical non-trilaciclib cohorts (58.8%, 28.0%, 13.0% respectively). Cytopenia-related healthcare utilization was also lower in the trilaciclib cohorts. In general, first-line trilaciclib initiators had numerically lower myelosuppressive HAEs and cytopenia-related healthcare utilization than the overall trilaciclib patients. CONCLUSIONS: The existing evidence suggests that trilaciclib may reduce single and multilineage grade ≥ 3 myelosuppressive HAEs and cytopenia-related healthcare utilization among patients with ES-SCLC in the real world. It is a promising new treatment for CIM prevention in ES-SCLC and may bring greater benefits to first-line trilaciclib initiators. Future studies are recommended to further evaluate the real-world effectiveness of trilaciclib.

Burden of chemotherapy-induced myelosuppression among patients with extensive-stage small cell lung cancer: A retrospective study from community oncology practices.

BACKGROUND: Myelosuppression is a major dose-limiting complication of chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC). The objective was to describe the burden of myelosuppression, treatment patterns, and supportive care use among patients with ES-SCLC treated with chemotherapy in a US community oncology setting. METHODS: This retrospective cohort study used structured electronic medical record (EMR) data from the Florida Cancer Specialists & Research Institute between January 2013 and December 2020. Adult patients with ES-SCLC who were treated with chemotherapy between September 2013 and November 2020 were identified. The index date was the date of the first chemotherapy-containing line of therapy (LOT). Patients were followed for a minimum of 30 days after index (unless patient died) until December 31, 2020, or end of activity in the EMR data, whichever occurred first. Incidence and frequency of myelosuppressive episodes/events, treatment patterns, eligibility for red blood cell (RBC) or platelet transfusions, and supportive care use (granulocyte colony-stimulating factor [G-CSF], erythropoiesis-stimulating agents [ESAs], intravenous [IV] hydration) during the follow-up period were reported. RESULTS: The study population included 1239 patients. Most (94.0%) patients started first-line chemotherapy at index. During follow-up and across all chemotherapy-containing LOTs, 1222 (98.6%) patients had at least 1 myelosuppressive episode; 62.1% of patients had grade ≥ 3 myelosuppressive episodes in at least one lineage, 33.9% had grade ≥ 3 myelosuppressive episodes in at least two lineages, and 15.5% had grade ≥ 3 myelosuppressive episodes in all three lineages. Supportive care use included 89.7% of patients who received G-CSF, 24.4% who received ESAs, and 52.1% who received IV volume expansion. Almost one-third (32.6%) of patients were eligible to receive RBC transfusions based on lab values (hemoglobin < 8 g/dL). CONCLUSION: There is a high burden related to multilineage myelosuppression among chemotherapy-treated patients with ES-SCLC in the community oncology setting. Reducing myelosuppression could make chemotherapy treatment safer, reduce the need for supportive care, and potentially prevent the treatment of complications.

Defining appropriate quality performance metrics for pharmacies dispensing oral oncology therapies.

Pharmacy benefit managers use measures like the medication possession ratio (MPR) as a performance/quality metric to evaluate specialty pharmacies and assess direct and indirect remuneration clawback fees. Abundant evidence shows that measuring MPR does not correlate with patients' experiences while on oral cancer oncolytics and does not accurately reflect their clinical outcomes. The authors demonstrate that as an alternative to MPR, the Florida Cancer Specialists & Research Institute's Rx To Go in-house pharmacy offers value; it uses a multifaceted approach to comprehensively evaluate the services that specialty oncology pharmacies provide to patients with cancer who are being treated with oral oncolytics.

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting.

PURPOSE: To describe the outcomes of a pharmacist-led multi-center, collaborative patient education and proactive adverse event management program in a community-based oncology setting. METHODS: Patients with EGFR mutation-positive (EGFRm+) non-small cell lung cancer, newly prescribed with oral afatinib, and monitored as part of the Florida Cancer Specialists patient management program, were included in a retrospective, observational analysis. During follow-up, data were collected on adverse event frequency, and changes in afatinib dosing. Data analyses were descriptive and exploratory in nature. RESULTS: The mean age of the 123 patients included in the analysis was 69 years, and 78% were female. At the time of the analysis, 3 patients had discontinued before receiving treatment, 89 patients had discontinued afatinib treatment, and 31 patients were continuing to receive afatinib treatment. The most common afatinib-related adverse events were diarrhea (85%), rash/skin reactions (58%), stomatitis/mucositis (19%), and paronychia (16%). Overall, 13% of patients discontinued due to afatinib-related adverse events. The median duration of treatment was 4 months in patients who discontinued due to adverse events, 6 months in those who discontinued for other reasons, and 18 months in those who were continuing to receive therapy. Afatinib dose-reductions were more frequent in patients continuing treatment versus those who discontinued due to adverse events (77% vs. 42%, respectively). CONCLUSIONS: Findings suggest that adverse events in patients with EGFRm + non-small cell lung cancer receiving afatinib can be successfully managed in a community-based, real-world setting with the help of collaborative pharmacist-led patient education, adverse event monitoring, and continuous support.