Investigation of the Association Between Treatment Effects On Progression Free Survival and Overall Survival in Multiple Myeloma Using Data From Published Literature
| العنوان: | Investigation of the Association Between Treatment Effects On Progression Free Survival and Overall Survival in Multiple Myeloma Using Data From Published Literature |
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| المؤلفون: | April Teitelbaum, Shannon Cartier, Samuel Wagner, Glenn S. Kroog, Ying Zhang, Virginia M. Rosen, Bin Zhang, Blake J Bartlett, Pralay Mukhopadhyay |
| المصدر: | Blood. 120:4241-4241 |
| بيانات النشر: | American Society of Hematology, 2012. |
| سنة النشر: | 2012 |
| مصطلحات موضوعية: | Oncology, medicine.medical_specialty, education.field_of_study, business.industry, Immunology, Hazard ratio, Population, Regression analysis, Cell Biology, Hematology, Biochemistry, Confidence interval, Standard error, Sample size determination, Internal medicine, Linear regression, medicine, Progression-free survival, business, education |
| الوصف: | Abstract 4241 Background: The primary goals in the development of new oncology therapies are treatments that improve quality of life and overall survival (OS). In recent years, advances in the treatment of multiple myeloma (MM) have led to improvements in OS. However, with improved treatment options and multiple rounds of therapy it is becoming an increasing challenge to demonstrate OS improvements in clinical trials. Thus, progression free survival (PFS) is widely used as a surrogate endpoint to demonstrate long term clinical benefit. However, to our knowledge, there has been very limited analysis of the association between treatment effects on PFS and treatment effects on OS in patients with multiple myeloma (MM). Purpose: To evaluate whether observed treatment effects on PFS are positively associated with treatment effects on OS in MM based on published data from clinical trials in patients with MM. Methods: A systematic literature review of MM identified 13 published clinical trials that reported HRs for the effects of treatment on PFS and separately on OS. The patients in 12 of the studies were previously untreated, and one study included patients with relapsed/refractory disease. The Pearson correlation coefficient (Pearson r) was used to estimate the association between the reported hazard ratios (HRPFS and HROS), as well as the log-transformed HRs (log(HRPFS) and log(HROS)), for the treatment effects on PFS and OS. Linear regression models were used to evaluate the relationship between the HR, and log(HR), of PFS and OS. A log transformation of the HRs for PFS and OS was used in order to minimize any skewness and normalize the data. R-squared values were estimated from the regression models. 95% Confidence intervals around the R-squared values were estimated using Olkin and Finn's approximation (I. Olkin and J. D. Finn, Psychological Bulletin, Vol 118(1), Jul 1995, 155–164) of the standard error and Student's T distribution. Sensitivity analyses included the estimation of additional weighted regression models to investigate the robustness of the R-squared estimates using two weighting methods. Individual study sample sizes were used as weights in one method to allocate more precision to studies with larger sample sizes. Estimates of the geometric mean of the variance of the HRs were also utilized as weights to account for the multi-directional error around the two HRs. The geometric mean estimates were calculated as the inverse of the product of the width of the two HRs. Results: Pearson r estimates between the HRs for the treatment effects on PFS and OS showed a strong positive correlation between HRPFS and HROS r=0.815 (CI: 0.53–0.93; p Conclusion: This analysis based on published MM clinical trial results indicate that treatment effects on PFS may be positively associated with treatment effects on OS. Further studies involving patient-level data would be necessary to confirm these results. Disclosures: Zhang: BMS: Employment. Cartier:OptumInsight: Consultancy. Rosen:BMS: Consultancy. Teitelbaum:Optum Insight was hired to do literature review: Employment. Bartlett:Bristol-Myers Squibb: Employment. Kroog:Bristol-Myers Squibb: Employment. Mukhopadhyay:BMS: Employment. Wagner:Bristol-Myers Squibb: Employment. |
| تدمد: | 1528-0020 0006-4971 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::9b9133a59ebe4c59b950aeb246a981c6Test https://doi.org/10.1182/blood.v120.21.4241.4241Test |
| رقم الانضمام: | edsair.doi...........9b9133a59ebe4c59b950aeb246a981c6 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15280020 00064971 |
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