publication . Article . 2016

Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy.

Latimer, N.R.; Bell, H.; Abrams, K.R.; Amonkar, M.M.; Casey, M.;
Open Access English
  • Published: 27 Jan 2016 Journal: Cancer Medicine, volume 5, issue 5, pages 806-815 (eissn: 2045-7634, Copyright policy)
  • Publisher: John Wiley and Sons Inc.
  • Country: United Kingdom
Abstract
Abstract Trametinib, a selective inhibitor of mitogen‐activated protein kinase kinase 1 (MEK1) and MEK2, significantly improves progression‐free survival compared with chemotherapy in patients with BRAF V600E/K mutation–positive advanced or metastatic melanoma (MM). However, the pivotal clinical trial permitted randomized chemotherapy control group patients to switch to trametinib after disease progression, which confounded estimates of the overall survival (OS) advantage of trametinib. Our purpose was to estimate the switching‐adjusted treatment effect of trametinib for OS and assess the suitability of each adjustment method in the primary efficacy population. ...
Subjects
free text keywords: Original Research, Clinical Cancer Research, BRAF protein human, clinical trial, drug therapy, melanoma, trametinib
30 references, page 1 of 2

1. Chapman, P. B., A. Hauschild, C. Robert, J. B. Haanen, P. Ascierto, J. Larkin, et al. 2011. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364:2507-2516.

2. Flaherty, K. T., C. Robert, P. Hersey, P. Nathan, C. Garbe, M. Milhem, et al. 2012. Improved survival with MEK inhibition in BRAF-mutated melanoma. N. Engl. J. Med. 367:107-114.

3. Curtin, J. A., J. Fridlyand, T. Kageshita, H. N. Patel, K. J. Busam, H. Kutzner, et al. 2005. Distinct sets of genetic alterations in melanoma. N. Engl. J. Med. 353:2135-2147. [OpenAIRE]

4. Davies, H., G. R. Bignell, C. Cox, P. Stephens, S. Edkins, S. Clegg, et al. 2002. Mutations of the BRAF gene in human cancer. Nature 417:949-954. [OpenAIRE]

5. Jakob, J. A., R. L. Jr Bassett, C. S. Ng, J. L. Curry, R. W. Joseph, G. C. Alvarado, et al. 2012. NRAS mutation status is an independent prognostic factor in metastatic melanoma. Cancer 118:4014-4023.

6. Latimer, N. R., K. R. Abrams, P. C. Lambert, M. J. Crowther, A. J. Wailoo, J. P. Morden et al. 2014. Adjusting survival time estimates to account for treatment switching in randomized controlled trials-an economic evaluation context: methods, limitations and recommendations. Med. Decis. Making 34:387-402.

7. Finkelstein, D. M., and D. A. Schoenfeld. 2011. Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 trial by using the inverse probability of censoring weighted method. J. Clin. Oncol. 29:1093-1095.

8. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal 2013. Available at: URL: http://www.nice.org.uk/article/pmg9/ resources/non-guidance-guide-to-the-methods-oftechnology-appraisal-2013-pdf [accessed 1 July 2015].

9. Briggs, A., K. Claxton, and M. Sculpher. 2006. Decision Modelling for Health Economic Evaluation. Oxford University Press Inc, New York.

10. Gold, M. R., J. E. Siegel, L. B. Russell, and M. C. Weinstein. 1996. Cost-effectiveness in health and medicine. Oxford University Press Inc, New York.

11. Canadian Agency for Drugs and Technologies in Health. 2006. Guidelines for the economic evaluation of health technologies: Canada. 3rd ed. Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada.

12. Tappenden, P., J. Chilcott, S. Ward, S. Eggington, D. Hind, and S. Hummel. 2006. Methodological issues in the economic analysis of cancer treatments. Eur. J. Cancer 42:2867-2875. [OpenAIRE]

13. Morden, J. P., P. C. Lambert, N. R. Latimer, K. R. Abrams, and A. J. Wailoo. 2011. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med. Res. Methodol. 11:4. [OpenAIRE]

14. Robins, J. M., and A. A. Tsiatis. 1991. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun. Stat. Theory Methods 20:2609-2631.

15. Robins, J. M., and D. M. Finkelstein. 2000. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 56:779-788.

30 references, page 1 of 2
Abstract
Abstract Trametinib, a selective inhibitor of mitogen‐activated protein kinase kinase 1 (MEK1) and MEK2, significantly improves progression‐free survival compared with chemotherapy in patients with BRAF V600E/K mutation–positive advanced or metastatic melanoma (MM). However, the pivotal clinical trial permitted randomized chemotherapy control group patients to switch to trametinib after disease progression, which confounded estimates of the overall survival (OS) advantage of trametinib. Our purpose was to estimate the switching‐adjusted treatment effect of trametinib for OS and assess the suitability of each adjustment method in the primary efficacy population. ...
Subjects
free text keywords: Original Research, Clinical Cancer Research, BRAF protein human, clinical trial, drug therapy, melanoma, trametinib
30 references, page 1 of 2

1. Chapman, P. B., A. Hauschild, C. Robert, J. B. Haanen, P. Ascierto, J. Larkin, et al. 2011. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364:2507-2516.

2. Flaherty, K. T., C. Robert, P. Hersey, P. Nathan, C. Garbe, M. Milhem, et al. 2012. Improved survival with MEK inhibition in BRAF-mutated melanoma. N. Engl. J. Med. 367:107-114.

3. Curtin, J. A., J. Fridlyand, T. Kageshita, H. N. Patel, K. J. Busam, H. Kutzner, et al. 2005. Distinct sets of genetic alterations in melanoma. N. Engl. J. Med. 353:2135-2147. [OpenAIRE]

4. Davies, H., G. R. Bignell, C. Cox, P. Stephens, S. Edkins, S. Clegg, et al. 2002. Mutations of the BRAF gene in human cancer. Nature 417:949-954. [OpenAIRE]

5. Jakob, J. A., R. L. Jr Bassett, C. S. Ng, J. L. Curry, R. W. Joseph, G. C. Alvarado, et al. 2012. NRAS mutation status is an independent prognostic factor in metastatic melanoma. Cancer 118:4014-4023.

6. Latimer, N. R., K. R. Abrams, P. C. Lambert, M. J. Crowther, A. J. Wailoo, J. P. Morden et al. 2014. Adjusting survival time estimates to account for treatment switching in randomized controlled trials-an economic evaluation context: methods, limitations and recommendations. Med. Decis. Making 34:387-402.

7. Finkelstein, D. M., and D. A. Schoenfeld. 2011. Correcting for discretionary treatment crossover in an analysis of survival in the Breast International Group BIG 1-98 trial by using the inverse probability of censoring weighted method. J. Clin. Oncol. 29:1093-1095.

8. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal 2013. Available at: URL: http://www.nice.org.uk/article/pmg9/ resources/non-guidance-guide-to-the-methods-oftechnology-appraisal-2013-pdf [accessed 1 July 2015].

9. Briggs, A., K. Claxton, and M. Sculpher. 2006. Decision Modelling for Health Economic Evaluation. Oxford University Press Inc, New York.

10. Gold, M. R., J. E. Siegel, L. B. Russell, and M. C. Weinstein. 1996. Cost-effectiveness in health and medicine. Oxford University Press Inc, New York.

11. Canadian Agency for Drugs and Technologies in Health. 2006. Guidelines for the economic evaluation of health technologies: Canada. 3rd ed. Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada.

12. Tappenden, P., J. Chilcott, S. Ward, S. Eggington, D. Hind, and S. Hummel. 2006. Methodological issues in the economic analysis of cancer treatments. Eur. J. Cancer 42:2867-2875. [OpenAIRE]

13. Morden, J. P., P. C. Lambert, N. R. Latimer, K. R. Abrams, and A. J. Wailoo. 2011. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med. Res. Methodol. 11:4. [OpenAIRE]

14. Robins, J. M., and A. A. Tsiatis. 1991. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun. Stat. Theory Methods 20:2609-2631.

15. Robins, J. M., and D. M. Finkelstein. 2000. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 56:779-788.

30 references, page 1 of 2
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