(P-229) Adverse Events in NSCLC Patients Treated with Docetaxel Monotherapy

Background: A docetaxel monotherapy is a treatment regimen used to treat patients diagnosed with non-small cell lung cancer (NSCLC). This study aimed to assess the adverse events (AEs) profile among patients treated with this treatment regimen.

Objectives: To assess the safety profile of NSCLC patients treated with docetaxel monotherapy, overall, by age, by gender, and by lines of therapy (LoT).

Methods: A retrospective observational cohort of adult patients with metastatic NSCLC on Docetaxel monotherapy between 2016 and 2018 was assembled from the Optum Clinformatics® database. Eligible patients had: at least two diagnoses at different dates of lung cancer (ICD-9: 162.xx; ICD-10: C34.xx ), active health plan enrollment, no prior cancer diagnosis (except non-melanoma skin cancer), or chemotherapy within six months prior to the earliest lung cancer diagnosis; with secondary malignancy diagnosis and at least one lung cancer chemotherapy treatment after the earliest lung cancer diagnosis; received Docetaxel monotherapy in any LoT. Patients with any record of SCLC-specific treatments were excluded. A grace period of 28 days and a gap of ≥ 90-day were used to define LoT. Adverse events (AEs) were identified using ICD-9 or ICD-10 codes and were reported overall, by age, by gender, and by LoT. All statistical analysis was conducted using SAS 9.4.

Results: There were 120 NSCLC patients (71 males and 49 females) in the analytic cohort who received docetaxel monotherapy treatment. The mean age was 65.4 years (SD=9.5), 65.8 (9.8) and 65.9 (9.1) in males and females, respectively. The median duration of treatment was 84 days for LoT1, 48 days for LoT2, and 54 days for LoT3. Among patients treated with any number of LoTs the most frequent AEs were anemias (25.0%), abnormalities of heart beat (24.2%), respiratory failure (23.3%). The most frequent types of AEs were similar in males and females. In males, the most frequently noted AEs were volume depletion (23.9%), respiratory failure (22.5%), abnormalities of heart beat (22.5%), and anemias (21.1%). In females, the most common AEs were anemias (30.6%), abnormalities of heart beat (26.5%), respiratory failure (24.5%), and hypotension (24.5%). The frequencies and types of AEs differed by age as well.

Conclusions: Compared to the docetaxel label, the frequency of cardiac events is higher and the frequency of thrombocytopenia lower in this real-world data (RWD) than in the prospective clinical trials. The analysis shows the additional value of RWD analysis after clinical trials have been completed. Cardiac events might deserve specific attention in docetaxel treated patients.