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133 results on '"Pandite L"'

4. Overall Survival Endpoint in Oncology Clinical Trials: Addressing the Effect of Crossover - The Case of Pazopanib in Advanced Renal Cell Carcinoma

Author

Diaz, J., Sternberg, C.N., Mehmud, F., Delea, T.E., Latimer, N., Pandite, L., and Motzer, R.J.

Abstract

Objective: To identify the issues of using overall survival (OS) as a primary endpoint in the presence of crossover and the statistical analyses available to adjust for confounded OS due to crossover in oncology clinical trials. Methods: An indirect comparison was conducted between pazopanib and sunitinib in advanced renal cell carcinoma. Statistical adjustment methods were used to estimate the true comparative effectiveness of these treatments. Recently, a head-to-head trial comparing pazopanib and sunitinib was completed. This provided the opportunity to compare the OS treatment effect estimated for pazopanib versus sunitinib using indirect comparison and statistical adjustment techniques with that observed in the head-to-head trial. Results: Using a rank-preserving structural failure time model to adjust for crossover in the pazopanib registration trial, the indirect comparison of pazopanib versus sunitinib resulted in an OS hazard ratio (HR) of 0.97, while an unadjusted analysis resulted in an OS HR of 1.96. The head-to-head trial reported a final OS HR of 0.92 for pazopanib versus sunitinib. Conclusion: This case study supports the need to adjust for confounded OS due to crossover, which enables trials to meet ethical standards and provides decision makers with a more accurate estimate of treatment benefit.

Published
2016

6. Open label non-randomized multi-cohort pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1c259 SPEAR T-cellsTM in HLA-A*02+ patients with synovial sarcoma (NCT01343043)

Author

Mackall, C., primary, D'Angelo, S., additional, Grupp, S., additional, Glod, J., additional, Druta, M., additional, Chow, W., additional, Chagin, K., additional, Mehler, M., additional, Kari, G., additional, Trivedi, T., additional, Holdich, T., additional, Pandite, L., additional, and Amado, R., additional

Published
2016
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7. IL8 polymorphisms and overall survival in pazopanib- or sunitinib-treated patients with renal cell carcinoma

Author

Xu, C-F, primary, Johnson, T, additional, Garcia-Donas, J, additional, Choueiri, T K, additional, Sternberg, C N, additional, Davis, I D, additional, Bing, N, additional, Deen, K C, additional, Xue, Z, additional, McCann, L, additional, Esteban, E, additional, Whittaker, J C, additional, Spraggs, C F, additional, Rodríguez-Antona, C, additional, Pandite, L N, additional, and Motzer, R J, additional

Published
2015
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10. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study

Author

Sleijfer, Stefan, Gorlia, T, Lamers, Cor, Burger, H (Hens), Blay, JY, le Cesne, A, Scurr, M, Collin, F, Pandite, L, Marreaud, S, Hohenberger, P, Sleijfer, Stefan, Gorlia, T, Lamers, Cor, Burger, H (Hens), Blay, JY, le Cesne, A, Scurr, M, Collin, F, Pandite, L, Marreaud, S, and Hohenberger, P

Abstract

BACKGROUND: Pazopanib has activity in relapsed non-adipocytic soft-tissue sarcomas (STS). A series of serum cytokines and angiogenic factors (CAFs) at baseline and changes in soluble vascular endothelial growth factor receptor-2 (sVEGFR2) or placental-derived growth factor (PlGF) levels during treatment were explored for their association with outcome. METHODS: Twenty-three baseline CAFs, and sVEGFR2 and PlGF changes were measured in 85 and 32 patients, respectively. Associations between baseline CAF levels and efficacy parameters, plus between-week 12 sVEGFR2 and PlGF levels and pazopanib-specific toxicities were investigated. RESULTS: At baseline, low interleukin (IL)-12 p40 subunit and MPC3 levels were associated with better progression-free survival (PFS) at 12 weeks (PFS12wks), low basic nerve growth factor and hepatocyte growth factor with a better PFS, and low inter-cellular adhesion molecule-1 and IL-2 receptor alpha with prolonged overall survival (OS; all P<0.05). Pazopanib decreased sVEGFR2 and increased PlGF levels. Low sVEGFR2 and high PlGF levels at week 12 were associated with higher-grade hypertension, CONCLUSION: Several baseline CAFs were related to outcome parameters. Low sVEGFR2 and high PlGF at week 12 associate with several pazopanib-specific toxicities and poorer efficacy. If confirmed, these factors may be used as early markers for response to and toxicity from pazopanib, enabling further individualisation of STS treatment. British Journal of Cancer (2012) 107, 639-645. doi:10.1038/bjc.2012.328 www.bjcancer.com Published online 17 July 2012 (C) 2012 Cancer Research UK

Published
2012

13. 9400 ORAL Prognostic and Predictive Factors in Advanced Soft Tissue Sarcoma Patients Treated in an EORTC STBSG Global Network Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo (EORTC 62072, PALETTE)

Author

Van der Graaf, W.T.A., primary, Blay, J.Y., additional, Chawla, S., additional, Kim, D.W., additional, Bui-Nguyen, B., additional, Van Glabbeke, M., additional, Marreaud, S., additional, Pandite, L., additional, Dei Tos, P., additional, and berger, P. Hohen, additional

Published
2011
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