Patient profiles, treatment patterns, and outcomes among persistent, recurrent, or metastatic cervical cancer patients under routine care in the United States.

OBJECTIVE: Patients with persistent, recurrent, or metastatic cervical cancer have poor prognosis. While recent advances have expanded treatment options, real-world data on treatment patterns and outcomes in this population are lacking. METHODS: This retrospective study identified adult females with persistent, recurrent, or metastatic cervical cancer from the ConcertAI Oncology Dataset who received systemic therapy on or after August 15, 2014. Patients were followed from persistent, recurrent, or metastatic diagnosis through third-line (3 L) therapy, death, end of record, or study end (June 2021). Data collection included patient characteristics, treatment patterns, and clinical outcomes. Kaplan-Meier methods were used for the three most common first-line (1 L) regimens to analyze real-world time on treatment (rwToT), real-world progression-free survival (rwPFS), and real-world overall survival (rwOS). Analyses were stratified by bevacizumab receipt by treatment line. RESULTS: 307 patients were included (mean [standard deviation] age 51.5 [13.2] years, 70.7% White). 91.2% of patients had metastatic disease, 8.5% had persistent disease, and <1% had recurrent disease. The most common 1 L regimen was carboplatin+paclitaxel+bevacizumab (40.7%) with median (95% confidence interval [CI]) rwToT of 3.5 (2.9-4.4) months. 57.0% of patients proceeded to second line (2 L), and 25.7% went to 3 L. Median (95% CI) rwPFS was 7.2 (6.4-8.1) months, and median (95% CI) rwOS was 16.5 (14.2-19.9) months, from initiation of 1 L. CONCLUSIONS: 1 L regimens received in patients with persistent, recurrent, or metastatic cervical cancer generally followed clinical guidelines, and the rwOS agrees with clinical trials. This study highlights the burden of disease and unmet need for specific treatments in these patients.

Comparison of advanced ovarian cancer patients treated with or without bevacizumab in the US Community Oncology Clinics.

Aim: Real-world data on treatment patterns and outcomes of advanced ovarian cancer (OC) patients since bevacizumab approval in first-line (1L) OC treatment were assessed. Materials & methods: In this descriptive retrospective study using the ConcertAI Oncology Dataset, patient characteristics, treatment patterns and real-world progression-free survival (rwPFS) from start of 1L were evaluated among patients diagnosed with advanced OC between 2011-2020. Treatment data from structured sources were confirmed and/or supplemented by human review of unstructured data. Results: Median rwPFS for bevacizumab and non bevacizumab cohorts was 17.3 months (95% CI: 14.9, 20.4) and 15.7 months (95% CI: 12.3, 29.1), respectively. Patients with ≥10 doses during 1L had higher median rwPFS compared with patients receiving 3-9 doses. Conclusion: This real-world study suggests benefits of bevacizumab treatment in advanced OC were primarily experienced by patients who received ≥10 doses in 1L.

What is this article about? Bevacizumab (Avastin) is a medicine that treats cancer. It makes it harder for the cancer to get nutrients from blood. At first, you could only use it after other cancer medicine did not work. From 2018, bevacizumab could be used with cancer medicine as the first treatment. Experts said it should continue for a year after cancer medicine stopped. This would make it harder for the cancer to come back. What did we do? We checked if more patients got bevacizumab as their first medicine after 2018 approval. We also saw how long it took for the cancer to come back. We did this by looking at electronic medical records between January 2011 and August 2020. We looked for women who had cancer that was staring to spread or had spread. We compared women who got bevacizumab to women who only got other cancer medicines. What were the results? After 2018, more women got bevacizumab early. We saw that the cancer did not take longer to come back. We noticed that half the women took bevacizumab less than ten-times out of up to 22-times. The cancer took longer to come back for women who took bevacizumab ten or more times. What do the result mean? We do not know why so many women stopped treatment early. Other studies in different countries also showed better results for women who got more bevacizumab. This study can help doctors and patients decide how much bevacizumab to give when they might be thinking of stopping treatment.

Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer.

Aim: Evaluated real world use of bevacizumab-awwb (MVASI®), a bevacizumab biosimilar, for treating metastatic colorectal cancer (mCRC). Materials & methods: Adult mCRC patients who received bevacizumab-awwb during the first year after market availability were identified from the ConcertAI oncology dataset. Results: Of 304 patients, 47% initiated bevacizumab-awwb as reference product (RP) naive patients and 53% received bevacizumab-awwb with prior exposure to RP. Overall, 78% received bevacizumab-awwb as first-line therapy; the proportion was higher (91%) in RP-naive patients. Among RP-experienced patients, 83% were transitioned from RP to bevacizumab-awwb in the same line without disease progression; of those, the majority (83%) were transitioned within 28 days. Conclusion: Early evidence from US oncology practices suggests clinical adoption of bevacizumab-awwb in treating mCRC patients.

Real-world treatment patterns and outcomes in PD-L1-positive non-small cell lung cancer.

Aim: We report real-world treatment patterns and outcomes in patients with PD-L1+ non-small-cell lung cancer (NSCLC). Methods: This retrospective, observational study using the ConcertAI Oncology Dataset (Symphony AI, CA, USA), included patients with PD-L1+ (≥1% expression) metastatic NSCLC who began first-line (1L) treatment between 2016 and 2019. Treatment outcomes were assessed by treatment class (immune checkpoint inhibitor [ICI] monotherapy, ICI combinations or chemotherapy). Results: In total, 128 (25.5%), 237 (47.3%) and 136 patients (27.1%) received 1L chemotherapy, 1L ICI monotherapy and 1L ICI combinations, respectively. ICI combinations and monotherapy had improved clinical outcomes versus chemotherapy. Adjusted analyses showed no significant difference in outcome between ICI monotherapy and ICI combinations. Conclusion: ICI-based treatments are being increasingly adopted into clinical practice and were associated with better outcomes versus chemotherapy.

Clinical and utilization outcomes associated with tumor mutational burden in a real-world pan-tumor population.

Aim & methods: This real-world study examined the association of tumor mutational burden (TMB) with clinical and healthcare utilization in adults diagnosed with advanced solid tumor 1 January 2015- 31 January 2019. Results: There were 170 patients in low-TMB group (TMB<10 mut/Mb) and 32 in high-TMB group (TMB ≥10 mut/Mb). Median overall survival was 18.8 (95% CI: 17.3-28.8) and 15.9 months (95% CI: 11.3-18.0) whereas median progression-free survival was 9.9 (95% CI: 8.6-11.4) and 7.8 months (95% CI: 3.8-12.5) for the low- and high-TMB groups, respectively. Hospitalization (49.4 vs 37.5%), emergency visit (25.3 vs 21.9%), and median overall cost of care (US$135,403 vs 87,570) were all lower in low-TMB group. Conclusion: Despite the limited sample, these data provide a historical perspective for examining real-world outcomes associated with TMB.

Lay abstract Tumor mutational burden (TMB) is the total number of mutations found in the DNA of cancer cells. Knowing the TMB may help plan the best treatment. The goal of this study was to examine whether higher TMB is directly associated with clinical outcomes or healthcare use and costs in patients who have not received immuno-oncology treatment. This study included 202 adult patients who were diagnosed with advanced solid tumors between January 2015 and January 2019. Patients were divided into two groups based on their TMB level. The study results indicate some relationship between TMB level and real-world outcomes. Future studies with a larger sample size are needed to confirm these results.

Real-world patterns on tumor mutation burden testing in a pan-tumor population.

Background: There is limited real-world information on use of tumor mutational burden (TMB) testing and characteristics of patients receiving it. Materials & methods: Patients ≥18 years old and diagnosed with advanced solid tumors between 1 January 2015 and 31 January 2019 with TMB testing (TMB cohort) and without it (non-TMB) were included in this retrospective, observational study. Results: The TMB cohort (n = 202) was younger than non-TMB (n = 212) (mean age: 62.1 vs 65.6 at diagnosis; p = 0.005). There were more Black patients in the TMB cohort (21.3 vs 11.8% in non-TMB; p = 0.004). Clinical characteristics were comparable between the two cohorts; however, systemic anticancer treatment was higher among TMB cohort (91.6 vs 77.8% in non-TMB). Conclusion: Notable differences were observed between patients receiving TMB test and those not receiving it.

Claims identification of patients with severe cancer-related symptoms.

OBJECTIVES: The goal of this study was to establish a claims-based mechanism for identifying patients with metastatic non-small cell lung cancer (mNSCLC) and high levels of patient-reported cancer-related symptoms who could benefit from engagement with health care programs. STUDY DESIGN: A cross-sectional survey of patients with mNSCLC was conducted from July 2017 to May 2018. Surveys were mailed to patients who were within 3 months of cancer treatment and enrolled in a Medicare Advantage health plan. METHODS: Pain, fatigue, and sleep disturbance were measured using the Patient-Reported Outcomes Measurement Information System. Depression was assessed using the Patient Health Questionnaire-2. Medical claims were linked to survey results to identify comorbidities and assess preindex health care resource utilization. Cluster analysis was used to differentiate patients based on patient-reported pain interference, pain intensity, depression, and sleep disturbance. Logistic regression was used to identify claims-based measures associated with more severe symptoms. RESULTS: For 698 respondents, 2 distinct symptom clusters were identified: a less severe (38.4%) cluster and a more severe (61.6%) cluster. Patients in the more severe cluster were younger, were more frequently dually eligible for Medicare and Medicaid, and more frequently had prescription fills for opioids. Claims-based factors associated with the more severe cluster included 2 or more 30-day fills for opioids in the prior 6 months, age younger than 75 years, depression diagnosis or antidepressants, bone metastases, and pain-related outpatient visits. CONCLUSIONS: The claims-based factors associated with the severe symptom cluster can enable identification of patients with mNSCLC who could benefit from clinical outreach programs to enhance the care and support provided to these patients.

The Relationship Between Guideline-Recommended Initiation of Therapy, Outcomes, and Cost for Patients with Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Guideline-recommended therapy for metastatic non-small cell lung cancer (mNSCLC) encourages evidence-based treatment; however, there is a knowledge gap regarding the influence of guideline-recommended initiation of therapy on outcomes and cost. OBJECTIVE: To investigate if lack of guideline-recommended initiation of first-line systemic therapy was associated with worse patient outcomes and increased costs for patients with mNSCLC. METHODS: In this retrospective analysis, 1,344 Medicare patients with mNSCLC were identified from Humana data. Performance status (PS) was imputed using procedure, diagnosis, and durable medical equipment codes pre-index. Guideline-recommended initiation of therapy was defined as ≥1 cycle of National Comprehensive Cancer Network-recommended first-line therapy based on age and PS or targeted therapies regardless of age and PS. Demographics and clinical characteristics were compared by guideline-recommended initiation of therapy. A Cox model assessed factors associated with 6-month mortality. End-of-life quality of care indicators included hospital admission and oncology infusions 30 days preceding death and were evaluated using logistic regression models. A generalized linear model assessed the relationship between guideline-recommended initiation of therapy and total health care costs in the 6 months post-index controlling for clinical, demographic, and treatment characteristics. Logistic models for inpatient stays and emergency department visits were also evaluated. RESULTS: Guideline-recommended therapy initiation was observed in 75.5% of patients. Patients not initiating guideline-recommended therapy were older, with a mean (SD) age of 72.5 (6.7) versus 71.2 (6.2) years (P = 0.001), and more frequently identified as having a low-income subsidy (30.0% vs. 16.4%; P < 0.001). Among the 24.6% of patients who died ≤ 6 months post-index, a greater percentage had not initiated guideline-recommended therapy (28.8% vs. 23.2%; P = 0.040). In adjusted models, PS (not initiation of guideline-recommended therapy) was predictive of mortality (patients with poor PS had an 84% higher probability of death [P = 0.014]). Among decedents, 64.2% were hospitalized, and 33.9% had an oncology-related infusion within 30 days of death, with no differences by guideline-recommended initiation of therapy. These end-of-life quality indicators were not associated with guideline-recommended initiation of therapy in adjusted models. Overall, 47.5% of patients who initiated guideline-recommended therapy were hospitalized compared with 55.0% of patients who did not (P = 0.026). Patients initiating guideline-recommended therapy had higher post-index total and oncology-related health care costs and fewer hospitalizations. In models, these differences in costs and hospitalizations were not associated with initiation of guideline-recommended therapy. CONCLUSIONS: Most patients initiated guideline-recommended therapy, with no differences in mortality and quality of care at the end of life by guideline-recommended initiation of therapy, though adherence beyond treatment initiation was not assessed. Unadjusted hospitalization rates were lower and costs were higher for patients who initiated guideline-recommended therapy. These differences were no longer observed after risk adjustment, suggesting that they may have been influenced by patient characteristics, disease progression, and subsequent treatment decisions. DISCLOSURES: This study was sponsored by Genentech. Khoury, Michael, Parikh, and Bunce are employed by Genentech. Casebeer, Drzayich Antol, DeClue, Hopson, Li, and Stemkowski are employed by Comprehensive Health Insights, Humana, which was contracted by Genentech to conduct this study. Sehman is employed by Humana. Based on this research, 2 posters were presented at the Academy of Managed Care Pharmacy Nexus 2017 on October 16-19, 2017, in Dallas, Texas. Another poster was also presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress on October 29-November 2, 2016, in Vienna, Austria.