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Table 1 Evidence on the effectiveness of panitumumab

From: A cautionary tale: an evaluation of the performance of treatment switching adjustment methods in a real world case study

Source of evidence

Treatment effect compared to BSC

Comments

Estimand 1. All comers – OS HR (95% CI)

Estimand 2. WT KRAS – OS HR (95% CI)

Study 20020408

Panitumumab + BSC (n = 231)

KRAS assessable (n = 208)

WT KRAS (n = 124)

MT KRAS (n = 84)

BSC alone (n = 232) KRAS assessable (n = 219)

WT KRAS (n = 119)

MT KRAS (n = 100)

Study affected by treatment switching from BSC onto panitumumab. Conducted analysis of KRAS groups to ‘adjust’ for switching [15]

Compared WT and MT KRAS patients randomised to panitumumab, to MT KRAS patients randomised to BSC

HR = 0.76 (0.60–0.98)

Compared WT KRAS patients randomised to panitumumab, to MT KRAS patients randomised to BSC

HR = 0.66 (0.49–0.87)

Assumption that KRAS status is not prognostic for survival, caution required due to breaking of randomisation

Study 20100007 [25]

Panitumumab + BSC (n = 189)

BSC alone (n = 188)

Study only included patients with WT KRAS. Switching from BSC onto panitumumab not allowed

-

Intention-to-treat analysis

HR = 0.73 (0.57–0.93)

Newer study, BSC survival may have improved

CO.17 study [16]

Cetuximab + BSC (n = 287)

BSC alone (n = 285)

Switching from BSC onto cetuximab not allowed

Intention-to-treat analysis

HR = 0.77 (0.64–0.92)

Compared WT KRAS patients randomised to cetuximab, to WT patients randomised to BSC

HR = 0.55 (0.41–0.74)

[0.62 (0.44–0.87) when adjusted for potentially prognostic covariates]

Assume similar effectiveness for cetuximab and panitumumab, based on ASPECCT study [24]

  1. Notes: BSC - Best Supportive Care; CI - Confidence Interval; HR - Hazard Ratio; KRAS - Kirsten Rat Sarcoma Virus; OS - Overall Survival; WT - Wild Type. For estimand 1, the target is an estimate of the treatment effect in the complete trial population, including WT and MT KRAS patients. For estimand 2, the target is an estimate of the treatment effect in WT KRAS patients