Sheikh Usman Iqbal

Mean overall survival gain with aflibercept plus FOLFIRI vs placebo plus FOLFIRI in patients with previously treated metastatic colorectal cancer

Background:Mean survival in cancer trials can be estimated with statistical techniques to extrapolate study survival curves. This methodology was applied to data from the VELOUR trial, where use of the novel biologic aflibercept (ziv-aflibercept in the United States) in combination with fluorouracil+leucovorin+irinotecan (FOLFIRI), had significantly increased median overall survival (OS) by 1.44 months, vs placebo plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) resistant to, or that had progressed following, an oxaliplatin-containing regimen.Methods:Parametric survival analyses were used to identify distributions with the best fit to the empirical VELOUR data. Mean OS for the two treatment groups (and pre-defined subgroups) was calculated from the fitted curves over a 15-year survival period.Results:Overall, the log-logistic distribution was the best-fitting for both treatment arms and, with it, the estimated difference in mean OS over 15 years between aflibercept+FOLFIRI and placebo+FOLFIRI was 4.7 months. In addition, the survival advantage with aflibercept was at least 3 months for the ITT population, whichever distribution was used to extrapolate survival.Conclusion:Extrapolation of survival curves suggests the mean OS difference for aflibercept in the VELOUR trial is at least 3 months in the ITT population and selected subgroups.

A hospital budget impact model to compare stem cell mobilisation strategies: impact of primary research and direct stakeholder engagement

Objectives There is a dearth of published health economic evidence on stem cell mobilisation (SCM) that can be leveraged effectively for decision making. Our objective was to develop a budget impact model (BIM) that accurately represented the preferences of key decision makers in estimating the total financial impact of adopting plerixafor for patients undergoing autologous peripheral stem cell transplantation for multiple myeloma and lymphoma. The BIMs were developed for France, Germany, Italy, Spain, UK and USA. Methods Prior to BIM development, a targeted literature review to identify key aspects of the SCM process was conducted in addition to in-depth interviews in Europe (n=33) and the USA (n=20), to determine the most influential decision maker(s) for choosing a mobilisation regimen. Inputs and outputs that are critical for decision making at the hospital level were determined. Results Primary research revealed that the centre director and treating physician are the most influential decision makers, while hospital administrators, transplant coordinators, pharmacy and apheresis directors have a more limited role. Clinical inputs most critical for assessment were drug/regimen use, apheresis days and success/failure rates, and economic inputs were costs of mobilisation, drug, apheresis and hospitalisation. Model outputs include first mobilisation success and total mobilisation budget impact. The model has flexibility to assess costs of multiple regimens including granulocyte-colony stimulating factor (G-CSF), G-CSF+plerixafor, G-CSF+chemotherapy and G-CSF+chemotherapy+plerixafor. Conclusions Conducting interviews with key stakeholders and using the latest clinical practice information to identify model inputs and outputs is useful for developing a representative BIM that is likely to be accepted by hospital decision makers evaluating adoption of plerixafor for SCM.