Real-world challenges for patients with breast cancer in sub-Saharan Africa: a retrospective observational study of access to care in Ghana, Kenya and Nigeria.

OBJECTIVE: To evaluate medical resource utilisation and timeliness of access to specific aspects of a standard care pathway for breast cancer at tertiary centres in sub-Saharan Africa. DESIGN: Data were retrospectively abstracted from records of patients with breast cancer treated within a prespecified 2-year period between 2014 and 2017. The study protocol was approved by local institutional review boards. SETTING: Six tertiary care institutions in Ghana, Kenya and Nigeria were included. PARTICIPANTS: Health records of 862 patients with breast cancer were analysed: 299 in Ghana; 314 in Kenya; and 249 in Nigeria. INTERVENTIONS: As directed by the treating physician. OUTCOME MEASURES: Parameters selected for evaluation included healthcare resource and use, medical procedure turnaround times and out-of-pocket (OOP) payment patterns. RESULTS: Use of mammography or breast ultrasonography was <45% in all three countries. Across the three countries, 78%-88% of patients completed tests for hormone receptors and human epidermal growth factor receptor 2 (HER2). Most patients underwent mastectomy (64%-67%) or breast-conserving surgery (15%-26%). Turnaround times for key procedures, such as pathology, surgery and systemic therapy, ranged from 1 to 5 months. In Ghana and Nigeria, most patients (87%-93%) paid for diagnostic tests entirely OOP versus 30%-32% in Kenya. Similarly, proportions of patients paying OOP only for treatments were high: 45%-79% in Ghana, 8%-20% in Kenya and 72%-89% in Nigeria. Among patients receiving HER2-targeted therapy, the average number of cycles was five for those paying OOP only versus 14 for those with some insurance coverage. CONCLUSIONS: Patients with breast cancer treated in tertiary facilities in sub-Saharan Africa lack access to timely diagnosis and modern systemic therapies. Most patients in Ghana and Nigeria bore the full cost of their healthcare and were more likely to be employed and have secondary or postsecondary education. Access to screening/diagnosis and appropriate care is likely to be substantively lower for the general population.

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.

BACKGROUND: Rituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings. METHODS: This non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions). RESULTS: Mean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days. CONCLUSIONS: Compared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units. TRIAL REGISTRATION: ClinicalTrials.gov NCT01200758.

Simulation and comparison of progression-free survival among patients with non-squamous non-small-cell lung cancer receiving sequential therapy.

OBJECTIVES: In recent years, the treatment landscape in advanced non-squamous non-small-cell lung cancer (nsNSCLC) has changed. New therapies (e.g., bevacizumab indicated in first line) have become available and other therapies (e.g., pemetrexed in first line and second line) moved into earlier lines in the treatment paradigm. While there has been an expansion of the available treatment options, it is still a key research question which therapy sequence results in the best survival outcomes for patients with nsNSCLC. METHODS: A therapy-sequencing disease model that approximates treatment outcomes in up to five lines of treatment was developed for patients with nsNSCLC. The primary source of data for progression-free survival (PFS) and time to death was published pivotal trial data. All patients were treatment-naïve and in the PFS state, received first-line treatment with either bevacizumab-based therapy or doublet chemotherapy (including the option of pemetrexed + cisplatin). Patients would then progress to a subsequent line of therapy, remain in PFS or die. In case of progression, it was assumed that each survivor would receive a subsequent line of therapy, based on EMA licensed therapies. Weibull distribution curves were fitted to the data. RESULTS: All bevacizumab-based first-line therapy sequences analyzed achieved total PFS of around 15 months. Bevacizumab + carboplatin + paclitaxel (first line) → pemetrexed (second line) → erlotinib (third line) → docetaxel (fourth line) resulted in total mean PFS time of 15.7 months, for instance. Sequences with pemetrexed in combination with cisplatin in first line achieved total PFS times between 12.6 and 12.8 months with a slightly higher total PFS time achieved when assuming pemetrexed continuation therapy in maintenance after pemetrexed + cisplatin in first-line induction. Overall survival results followed the same trend as PFS. CONCLUSION: The model suggests that treatment-sequencing strategies starting with a bevacizumab-based combination in first line yield better survival outcomes than those starting with pemetrexed-based combinations, a result that is attributable to the possibility of one further line of treatment with first-line bevacizumab-based treatment sequences.

Clinical and cost effectiveness of bevacizumab + FOLFIRI combination versus FOLFIRI alone as first-line treatment of metastatic colorectal cancer in South Korea.

BACKGROUND: Bevacizumab has been extensively investigated in combination with various standard chemotherapies in the treatment of metastatic colorectal cancer (mCRC). However, a comparison to irinotecan + infusional 5-fluorouracil/leucovorin (FOLFIRI) is lacking. OBJECTIVE: To explore clinical effectiveness and cost-effectiveness of adding bevacizumab to a regimen of FOLFIRI for the first-line treatment of mCRC in the Republic of Korea by conducting an indirect treatment comparison. METHODS: A health-economic model was developed to investigate the possible health outcomes (life-years gained [LYG]), direct costs, and incremental cost-effectiveness ratio (ICER) of adding bevacizumab to a FOLFIRI regimen. Data on progression-free and overall survival were derived from randomized clinical trials and were used in the indirect treatment comparison. The annual discount rate for costs and outcomes was 5%. A lifetime horizon of 8 years was used. Sensitivity analyses were carried out on all pivotal model assumptions. RESULTS: Incremental mean overall survival among patients treated with bevacizumab + FOLFIRI varied between 8.6 and 15.7 months compared with patients treated with FOLFIRI alone. The deterministic base-case result was 1.177 LYG. The discounted ICERs ranged from µ31.8 to µ39.5 million/LYG, with the base-case result being µ34.5 million/LYG. Treatment effect had the most impact on the outcomes in this model. CONCLUSIONS: Although there is no formal threshold for ICER per LYG in Korea, funding may be considered for bevacizumab + FOLFIRI, particularly if the severity and end-of-life nature of mCRC is taken into account.