Increasing use of oral anticancer treatments (OATs) in oncology is modifying the treatment paradigm for cancer. Nonetheless, available data on the pattern of use of OATs and its evolution over time are limited. The objective of this study was to describe the patterns of use of OATs in France from 2004 to 2012.A retrospective analysis was performed using Oncology Analyzer, a physician survey database. All patients actively treated by an oral or an intravenous anticancer treatment between October 2004 and September 2012 were enrolled in the database. Descriptive analyses were performed by treatment category with a focus on the last year of collection and the evolution across the study period.From October 2011 to September 2012, a sample of 7426 patients treated by oral or intravenous active anticancer treatments was analyzed: 74% of patients receiving an OAT were diagnosed with a solid tumor, 52% of whom had a stage IV cancer. The use of OATs increased with age and was the highest in patients over 80 years. From 2004 to 2012, the proportion of cancer patients receiving OATs increased by four percentage points (from 28.4% to 32.5%). Additionally, for treatments available in both forms, a marked preference for oral formulations was observed.The patterns and trend of use prior to 2004 were not addressed due to lack of information in the database. The use of a market research database is relevant for highly prevalent cancers but for rare cancers the sample size is limited, underlining the utility of using other data sources such as cancer registries.The Re-ACTOR study provides an overview of OAT use in France, which was prescribed to 32% of cancer patients in France in 2012, principally to older patients and to those with solid tumors and with metastatic disease.
The aim of this study was to estimate the cost-of-illness associated with completely resected stage IIIB/IIIC melanoma with macroscopic lymph node involvement, overall and by disease phase, in France, Germany and the UK. This retrospective observational study included patients aged older than or equal to 18 years first diagnosed with stage IIIB/IIIC cutaneous melanoma between 1 January 2009 and 31 December 2011. Data were obtained from medical records and a patient survey. Direct costs, indirect costs and patient out-of-pocket expenses were estimated in euros (€) (and British pounds, £) by collecting resource use and multiplying by country-specific unit costs. National annual costs were estimated using national disease prevalence from the European cancer registry and other published data. Forty-nine centres provided data on 558 patients (58.2% aged <65 years, 53.6% stage IIIB disease at diagnosis). The mean follow-up duration was 27 months (France), 26 months (Germany) and 22 months (UK). The mean total direct cost per patient during follow-up was €23 582 in France, €32 058 in Germany and €37 970 (£31 123) in the UK. The largest cost drivers were melanoma drugs [mean €14 004, €21 269, €29 750 (£24 385), respectively] and hospitalization/emergency treatment [mean: €6634, €6950, €3449 (£2827), respectively]. The total mean indirect costs per patient were €129 (France), €4,441 (Germany) and €1712 (£1427) (UK). Estimates for annual national direct cost were €13.1 million (France), €30.2 million (Germany) and €27.8 (£22.8) million (UK). The economic burden of stage IIIB/IIIC melanoma with macroscopic lymph node involvement was substantial in all three countries. Total direct costs were the highest during the period with distant metastasis/terminal illness.
Aims Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is standard care for neovascular age-related macular degeneration (nAMD), but the recommended monthly injection regimen is burdensome. Evidence suggests low injection/monitoring frequencies in clinical practice and suboptimal vision outcomes. This observational cohort study uses administrative claims data from the French national healthcare system to assess anti-VEGF treatment patterns and nAMD-specific healthcare resource demands and costs.Patients and methods nAMD patients ≥50 years initiating intravitreal ranibizumab, aflibercept or bevacizumab treatment (2014‒2015), and propensity score-matched non-nAMD patients (controls), were identified from the Echantillon Généraliste de Bénéficiaires database. Outcomes of interest included anti-VEGF treatment patterns, and healthcare resource utilization and associated costs of patients vis-à-vis controls over 24 months.Results Study patients (n = 355) received (mean) 5.2 and 2.4 anti-VEGF injections over 0‒12 and 12‒24 months, respectively. Most patients (79.0%) remained on their initial anti-VEGF agent; among treatment switchers, the most common transition was from ranibizumab to aflibercept. During follow-up, nAMD patients were more likely than controls to require ophthalmology visits (99.7% vs. 44.8%), ocular procedures (optical coherence tomography/angiography/fundoscopy) (96.9% vs. 27.2%), cataract surgery (13.0% vs. 6.7%), and medical transports (38.0% vs. 31.9%). Mean numbers of ophthalmology visits (25.1 vs. 1.2) and medical transports (6.0 vs. 3.5) were higher (p<.01) among nAMD patients. Total reimbursed costs were two-fold higher for nAMD patients than controls (mean €16,799 vs. €8,255) due to higher treatment costs (€6,847 vs. €1,156), medical fees (€1,858 vs. €295), hospital fees (€6,396 vs. €5,235), and transport costs (€358 vs. €259). Excess total healthcare cost was (mean) €5,279 and €7,918 over the first 12 and 24 months of treatment, respectively.Conclusions Current intravitreal anti-VEGF treatment and monitoring requirements place a considerable economic burden on the French healthcare system. New intravitreal therapies with extended dosing intervals and predictable efficacy might reduce demand for ophthalmology services.
No biomarkers have been established yet to predict response to anti-angiogenic treatment. To test whether the Xerna™ TME Panel, a novel biomarker, is predictive of anti-angiogenic treatment outcome, an exploratory, retrospective analysis of the Phase 1b study of navicixizumab in combination with paclitaxel in platinum resistant ovarian cancer was performed. Navicixizumab is a bispecific anti-angiogenic antibody to vascular endothelial growth factor (VEGF) and delta-like ligand 4. The Xerna™ TME Panel evaluates RNA gene expression data of ~100 genes defining the immune and angiogenic biologies that dominate the tumor microenvironment (TME). This novel diagnostic employs a machine learning model to classify a patient's TME along immune and angiogenic axes, resulting in classification into one of four TME subtypes—Angiogenic (A), Immune Suppressed (IS), Immune Active (IA) and Immune Desert (ID). We hypothesized that patient TME subtypes classified with angiogenic dominant biology (A/IS) are more likely to benefit from treatment with navicixizimab relative to those in the biomarker negative subgroup (IA/ID).
Methodology
The Phase 1b study of navicixizumab (3 mg/kg or 4 mg/k, IV, q2w) in combination with paclitaxel (80 mg/m2 IV on D0, D7, and D14 of 28-day cycle) was an open-label, non-randomized study that included 44 patients with platinum-resistant, grade 2/3 ovarian cancer. Patients received a median of 4 prior treatments (63% prior bevacizumab, 45% prior PARP). Pre-treatment tumor tissue was analyzed retrospectively using the Xerna™ TME Panel.
Result(s)*
The objective response rate per RECIST 1.1 was 43.2% in the overall patient population (n=44). Responses were durable (median 6 months [95% CI, 5.4 months, not estimable]). Pre-treatment tumor tissue was available for 33 patients. In the B-positive subgroup (A/IS, n=13), 62% of patients had an objective response, compared to 25%, in the B-negative subgroup (IA/ID, n=20). PFS was 9.2 months in the B-positive subgroup vs. 3.9 months in the B-negative subgroup, HR = 0.43 [95% CI 0.188 to 0.999]).
Conclusion*
Navicixizumab plus paclitaxel demonstrated promising clinical activity in this heavily pretreated patient population. The Xerna™ TME Panel may identify patients more likely to benefit from treatment with navicixizumab and should be prospectively evaluated in a future study.
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