OBJECTIVES: Licensing and reimbursement of anticancer drugs should rely on evidence from patient-relevant endpoints such as overall survival (OS). Nevertheless, evidence from surrogate endpoints may also be useful, as it may expedite the regulatory approval and coverage decisions of new therapies. It is therefore essential that candidate surrogate endpoints be properly validated. However, there is no consensus on statistical methods for such validation and on how the evidence thus derived should be applied by policy-makers. METHODS: We review meta-analyses of therapeutic interventions against advanced solid tumours published until December 2012 that quantified the statistical association between progression-free survival (PFS) or time-to-progression (TTP) and OS. We assessed the suitability of the two surrogates using three current surrogate validation frameworks: Bucher’s framework, the German Institute of Quality and Efficiency in Health Care’s (IQWiG) framework and the Biomarker-Surrogacy Evaluation Schema (BSES3). RESULTS: Thirty-one meta-analyses were included which employed a variety of statistical methods to assess surrogate validity. The strength of the association between PFS or TTP and OS was generally low. The level of evidence (observation-level vs. treatment-level) available supporting an association between PFS or TTP and OS varied considerably by cancer type, by evaluation tools and was not always consistent even within one specific cancer type. CONCLUSIONS: Not in all solid tumours the treatment-level association between PFS or TTP and OS has been investigated. According to the IQWiG’s framework, only PFS achieved acceptable evidence of surrogacy in metastatic colorectal and ovarian cancer treated with cytotoxic agents, whereas in no indication did the two candidate endpoints achieve good evidence of surrogacy according to BSES3. Our study emphasises the challenges of surrogate-endpoint validation and the importance of building consensus on appropriate statistical techniques to examine surrogacy and on the development of evaluation frameworks for policy-makers.