Overall survival (OS) of metastatic renal cell carcinoma (mRCC) patients corrected for crossover using inverse probability of censoring weights (IPCW) and rank preserving structural failure time (RPSFT) models: Two analyses from the RECORD-1 trial.

Cabozantinib versus everolimus, nivolumab, axitinib, sorafenib and best supportive care: A network meta-analysis of progression-free survival and overall survival in second line treatment of advanced renal cell carcinoma

“…However, comparison to nivolumab is not impacted by the cross-over issue. In the RECORD-1 trial the estimate for OS HR for everolimus vs placebo (BSC) is 0.87 [0.65, 1.17] in ITT population and 0.60 [0.22, 1.65] once adjusted to cross-over by using rank-preserving structural failure time (RPSFT) model published by Korhonen et al [ 43 ]. The RPSFT model relies on assumption of constant effect of active treatment (in this case everolimus) in terms of relative survival time.…”

“…Since the method requires additional censoring of patient data, the precision of the HR estimate is lower than for the ITT estimate. However, the method was shown to be preferable to simple adjustments, such as censoring of patients at time of crossover [ 43 ]. It should be noted that one other possible approach has been considered by Hollaender, using inverse probability of censoring weights and multivariate Cox models [ 44 ].…”

Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma

“…The search identified 235 potential studies. From these, as well as hand searches of reference lists of retrieved studies, ASCO and ECCO web sites, and prior systematic reviews, a total of 31 studies were identified, representing 10 943 patients, 75 treatment groups, and 41 potential treatment comparisons that reported sufficient information for either the analysis of correlation between differences in median PFS/TTP and differences in median OS or between -ln HR PFS/TTP and −ln HR OS ( Table 1 ) ( Kruit et al , 1997 ; Negrier et al , 1998 , 2000 , 2007 , 2008 ; Medical Research Council Renal Centre Collaborators, 1999 ; Pyrhonen et al , 1999 ; Motzer et al , 2000 , 2007 , 2008 , 2009 , 2010 ; Atzpodien et al , 2001 , 2002 , 2004 , 2006 ; Dutcher et al , 2003 ; Yang et al , 2003 ; Atkins et al , 2004 ; Aass et al , 2005 ; Donskov et al , 2005 ; McDermott et al , 2005 ; Tannir et al , 2006 ; Bukowski et al , 2007 ; Escudier et al , 2007a , 2007b ; Hudes et al , 2007 ; Amato et al , 2008 ; Figlin et al , 2008 ; Sternberg et al , 2009 , 2010a ; Gore et al , 2010 ; Korhonen and Malangone, 2010 ; Rini et al , 2010 ; Korhonen et al , 2011 ; Wiederkehr et al , 2011 ). The great majority of the studies that were excluded for lack of information on both PFS or TTP and OS.…”

“…For the phase III trial of everolimus, placebo patients were allowed to crossover to everolimus after documented progression ( McDermott et al , 2005 ; Korhonen and Malangone, 2010 ; Motzer et al , 2010 ; Korhonen et al , 2011 ; Wiederkehr et al , 2011 ). For this study we used median OS based on analysis using the RPSFT model to control for crossover ( Korhonen and Malangone, 2010 ; Korhonen et al , 2011 ); the HR for OS was based on analysis using IPCW analysis ( Wiederkehr et al , 2011 ). For phase III trial of pazopanib, the HR for OS was based on the analysis using RPSFT to control for crossover ( Sternberg et al , 2010b ).…”

“…To include results of studies with extensive crossover without controlling for crossover would add no useful information to the analyses. The RPSFT and IPCW methods used in the analyses of everolimus ( Korhonen and Malangone, 2010 ; Korhonen et al , 2011 ; Wiederkehr et al , 2011 ) and pazopanib ( Sternberg et al , 2010b ) are useful methods for analysing OS in the context of selective crossover ( Finkelstein and Schoenfeld, 2011 ; Morden et al , 2011 ; Rimawi and Hilsenbeck, 2012 ).…”