Abstract | BACKGROUND: Progression-free survival (PFS) and time to progression ( TTP) are frequently used to establish the clinical efficacy of anti- cancer drugs. However, the surrogacy of PFS/ TTP for overall survival (OS) remains a matter of uncertainty in metastatic breast cancer (mBC). This study assessed the relationship between PFS/ TTP and OS in mBC using a trial-based approach. METHODS: WE CONDUCTED A SYSTEMATIC LITERATURE REVIEW ACCORDING TO THE PICO METHOD: 'Population' consisted of women with mBC; 'Interventions' and 'Comparators' were standard treatments for mBC or best supportive care; 'Outcomes' of interest were median PFS/ TTP and OS. We first performed a correlation analysis between median PFS/ TTP and OS, and then conducted subgroup analyses to explore possible reasons for heterogeneity. Then, we assessed the relationship between the treatment effect on PFS/ TTP and OS. The treatment effect on PFS/ TTP and OS was quantified by the absolute difference of median values. We also conducted linear regression analysis to predict the effects of a new anti- cancer drug on OS on the basis of its effects on PFS/ TTP. RESULTS: A total of 5,041 studies were identified, and 144 fulfilled the eligibility criteria. There was a statistically significant relationship between median PFS/ TTP and OS across included trials (r=0.428; P<0.01). Correlation coefficient for the treatment effect on PFS/ TTP and OS was estimated at 0.427 (P<0.01). The obtained linear regression equation was ΔOS =-0.088 (95% confidence interval [CI] -1.347-1.172) + 1.753 (95% CI 1.307-2.198) × ΔPFS (R(2)=0.86). CONCLUSION: Results of this study indicate a significant association between PFS/ TTP and OS in mBC, which may justify the use of PFS/ TTP in the approval for commercialization and reimbursement of new anti- cancer drugs in this cancer setting.
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Authors | Catherine Beauchemin, Dan Cooper, Marie-Ève Lapierre, Louise Yelle, Jean Lachaine |
Journal | OncoTargets and therapy
(Onco Targets Ther)
Vol. 7
Pg. 1101-10
( 2014)
ISSN: 1178-6930 [Print] New Zealand |
PMID | 24971020
(Publication Type: Journal Article)
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