Treatment switching in oncology trials and the acceptability of adjustment methods

References

• Latimer NR, Abrams KR, Lambert PC, et al. Adjusting survival time estimates to account for treatment switching in randomized controlled trials – an economic evaluation context: Methods, limitations and recommendations. Med Decis Making 2014;34(3):387-402
   Google Scholar
• Latimer N, Abrams K, Lambert PC, et al. Adjusting for treatment switching in randomized controlled trials – A simulation study and a simplified two-stage method. Stat Methods Med Res 2014. [Epub ahead of print]
   Google Scholar
• Jonsson L, Sandin R, Ekman M, et al. Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation. Value Health 2014;17(6):707-13
   PubMed Web of Science ®Google Scholar
• Ishak KJ, Proskorovsky I, Korytowsky B, et al. Methods for adjusting for bias due to crossover in oncology trials. Pharmacoeconomics 2014;32(6):533-46
   PubMed Web of Science ®Google Scholar
• Watkins C, Huang X, Latimer N, et al. Adjusting overall survival for treatment switches: commonly used methods and practical application. Pharm Stat 2013;12(6):348-57
   PubMed Web of Science ®Google Scholar
• Morden JP, Lambert PC, Latimer NR, et al. Assessing methods for dealing with treatment switching in randomized controlled trials: a simulation study. BMC Med Res Methodol 2011;11:4
   PubMed Web of Science ®Google Scholar
• Demetri GD, Garrett CR, Schoffski P, et al. Complete longitudinal analyses of the randomized, placebo-controlled, phase III trial of sunitinib in patients with gastrointestinal stromal tumor following imatinib failure. Clin Cancer Res 2012;18(11):3170-9
   PubMed Web of Science ®Google Scholar
• Korhonen P, Zuber E, Branson M, et al. Correcting overall survival for the impact of crossover via a rank-preserving structural failure time (RPSFT) model in the RECORD-1 trial of everolimus in metastatic renal-cell carcinoma. J Biopharm Stat 2012;22(6):1258-71
   PubMed Web of Science ®Google Scholar
• Colleoni M, Giobbie-Hurder A, Regan MM, et al. Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. J Clin Oncol 2011;29:1117-24
   PubMed Web of Science ®Google Scholar
• Morgan G, Palumbo A, Dhanasiri S, et al. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Brit J Haematol 2015;168(6):820-3
   PubMed Web of Science ®Google Scholar
• World Medical Association. Declaration of helsinki – ethical principles for medical research involving human subjects. JAMA 2013;310(20):2191-4
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized, placebo-controlled phase III trial. Lancet 2008;372(9637):449-56
   PubMed Web of Science ®Google Scholar
• NICE. Final appraisal determination: Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma. 2012. Available from: www.nice.org.uk/guidance/ta269/documents/melanoma-braf-v600-mutation-positive-unresectable-metastatic-vemurafenib-final-appraisal-determination-document2 [Last accessed on 23 February 2015]
   Google Scholar
• National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. NICE, London; 2013. Available from: www.nice.org.uk/article/pmg9/resources/non-guidance-guide-to-the-methods-of-technology-appraisal-2013-pdf [Last accessed on 23 February 2015]
   Google Scholar
• Latimer N, Abrams K. NICE DSU Technical Support Document 16: Adjusting survival time estimates in the presence of treatment switching, Report by the Decision Support Unit. July 2014. Available from: www.nicedsu.org.uk/TSD16_Treatment_Switching.pdf [Last accessed on 23 February 2015]
   Google Scholar
• Robins JM, Tsiatis AA. Correcting for noncompliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods 1991;20(8):2609-31
   Web of Science ®Google Scholar
• Robins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 2000;56(3):779-88
   PubMed Web of Science ®Google Scholar
• White IR, Babiker AG, Walker S, Darbyshire JH. Randomization-based methods for correcting for treatment changes: Examples from the Concorde trial. Stat Med 1999;18(19):2617-34
   Google Scholar
• NICE. Final appraisal determination: Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer. 2012. Available from: www.nice.org.uk/guidance/ta263/documents/breast-cancer-metastatic-bevacizumab-1st-line-with-capecitabine-final-appraisal-determination-guidance2 [Last accessed on 23 February 2015]
   Google Scholar
• NICE. Final appraisal determination: Imatinib for the adjuvant treatment of gastrointestinal stromal tumors (review of NICE technology appraisal guidance 196). 2014. Available from: www.nice.org.uk/guidance/ta326/documents/gastrointestinal-stromal-tumours-imatinib-adjuvant-rev-ta196-id696-final-appraisal-determination-document2 [Last accessed on 23 February 2015]
   Google Scholar
• NICE. Final appraisal determination: Crizotinib for previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene. Available from: www.nice.org.uk/guidance/ta296/documents/lung-cancer-nonsmallcell-anaplastic-lymphoma-kinase-fusion-gene-previously-treated-crizotinib-final-appraisal-determination3 [Last accessed on 23 February 2015]
   Google Scholar
• The Pharmaceutical Benefits Scheme, Australian Government, Department of Health, Crizotinib, 200mg and 250mg, capsule, Xalkori®. November 2013. Available from: www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2013-11/crizotinib [Last accessed on 23 February 2015]
   Google Scholar
• PBAC. Public summary document – July 2014 PBAC Meeting: 7.8 Ruxolitinib, 5mg, 15mg, 20mg tablets, Jakavi®, Novartis Pharmaceuticals Australia Pty Ltd. Available from: www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2014-07/ruxolitinib-psd-07-2014.pdf [Last accessed on 23 February 2015]
   Google Scholar
• SMC. Resubmission: vemurafenib 240mg film-coated tablet (Zelboraf®), SMC No. (792/12). 2013. Available from: www.scottishmedicines.org.uk/files/advice/vemurafenib__Zelboraf__RESUBMISSION_FINAL_Nov_2013_for_Website.pdf [Last accessed on 23 February 2015]
   Google Scholar
• SMC. Resubmission: crizotinib, 200mg and 250mg, hard capsule (Xalkori®), SMC No. (865/13). 2013. Available from: www.scottishmedicines.org.uk/files/advice/crizotinib_Xalkori_Resubmission_FINAL_September_2013_website.pdf [Last accessed on 23 February 2015]
   Google Scholar
• pCODR. Expert review committee (pERC) final recommendation – Everolimus. 2012. Available from: www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-afinitor-fn-rec.pdf [Last accessed on 23 Febeuary 2015]
   Google Scholar
• pCODR. Final economic guidance report: Everolimus (Afinitor) for pancreatic neuroendocrine tumors. 2012. Available from: www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-afinitor-pnets-fn-egr.pdf [Last accessed on 23 February 2015]
   Google Scholar
• pCODR. Expert review committee (pERC) final recommendation – Pazopanib. 2012. Available from: www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-votrientmrcc-fn-rec.pdf [Last accessed on 23 February 2015]
   Google Scholar
• pCODR. Final clinical guidance report: Pazopanib hydrochloride (Votrient) for metastatic renal cell carcinoma. 2012. Available from: www.pcodr.ca/idc/groups/pcodr/documents/pcodrdocument/pcodr-votrientmrcc-fn-cgr.pdf [Last accessed on 23 February 2015]
   Google Scholar
• IQWiG. IQWiG Reports – Commission No. A13-35. Dabrafenib – benefit assessment according to § 35a social code book v. extract. 2013. Available from: www.iqwig.de/download/A13-35_Dabrafenib_Extract-of-dossier-assessment.pdf [Last accessed on 23 February 2015]
   Google Scholar
• IQWiG. IQWiG in dialogue 2014. ‘Benefit assessment in studies with allowed treatment switching’. Abstracts of presentations. 2014. Available from: www.iqwig.de/download/Abstracts_Programme_en.pdf [Last accessed on 23 February 2015]
   Google Scholar