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2016 ; 13
(3
): 352-7
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Assessing survival benefit when treatment delays disease progression
#MMPMID26908538
Schoenfeld DA
; Finkelstein DM
Clin Trials
2016[Jun]; 13
(3
): 352-7
PMID26908538
show ga
BACKGROUND: For a potentially lethal chronic disease like cancer, it is often
infeasible to compare treatments on the basis of overall survival, so a combined
outcome such as progression-free survival (which is the time from randomization
to progression or death) has become an acceptable primary endpoint. The rationale
of using an efficacy measure that is dominated by the time to progression is that
an effective treatment will delay progression and when treatment is stopped at
progression, the effect of treatment after this time is small. However, often
trials that show a significant benefit for delaying progression but not on
overall survival are not universally viewed as providing convincing evidence that
the drug should become the standard of care. METHODS: We propose that when there
is a significant treatment effect of delaying progression, a Bayesian analysis of
overall survival should be undertaken. We suggest using a joint piecewise
exponential model, where the treatment effect on the hazard for progression and
for death after progression is captured through two distinct parameters. We
develop a plot of the overall survival advantage of the new therapy versus the
prior distribution of the relative hazard for death after progression. This plot
can augment the discussion about whether the new treatment is beneficial on
survival. RESULTS: In the example of an early breast cancer trial for which a new
treatment significantly delayed disease recurrence, our Bayesian analysis showed
that with very reasonable assumptions on the effects of treatment after
recurrence, there is a high probability that the new treatment improves overall
survival. CONCLUSION: For a clinical trial for which treatment delays
progression, the proposed method can improve the interpretability of the survival
comparison using data from the study.
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