Surrogate markers for targeted therapy-based treatment activity and efficacy
Open accessAbstract
Predictive biomarkers capable of discriminating individuals who will benefit from a given therapy from those who will not are key to personalized medicine. New drugs are developed in patients with advanced disease, when ethical and practical shortcomings limit the collection of tumor specimens. The neoadjuvant setting offers a unique opportunity for overcoming these limitations. Tumor samples are collected at diagnosis and posttreatment surgery as part of a routine therapeutic approach. Pathological complete response has been consistently associated with long-term survival and may be useful as an intermediate endpoint in developing and evaluating predictive, as well as surrogate, biomarkers. In window-of-opportunity studies, new drugs are administered shortly before planned surgery, and the effect of the intervention can be assessed by comparing diagnostic biopsy with the surgical specimen. Until now, clinically useful and validated predictive markers for targeted therapy are rare, but appropriate investigations in neoadjuvant studies will likely change this.
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Pathological complete remission from neoadjuvant therapies is not included as a criterion for clinical benefit because of lack of consistent evidence that it is a valid surrogate for survival.
“Pathological complete remission from neoadjuvant therapies is not included as a criteria for clinical benefit because of lack of consistent evidence that it is a valid surrogate for survival in clinical studies [39][40][41][42].”
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- Authors
- Bianchini, G., & Gianni, L.
- Affiliations
- IRCCS Ospedale San Raffaele (IT)
- Venue
- JNCI Monographs
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-10-01
- Volume
- 2011
- Issue
- 43
- Pages
- 91-94
- ISSN
- 1052-6773 (ISSN-L)
- 1745-6614
- OpenAlex
- W2098842062
- Cited by
- 2
- References
- 28
- Citations by year
- 2015: 1 · 2014: 1
- FWCI
- 0.11
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JNCI Monographs (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Gastric Cancer Management and Outcomes
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- predictive biomarkers, surrogate endpoints, targeted therapy, neoadjuvant therapy, pathological complete response, personalized medicine, treatment response, tumor specimens, advanced disease
- MeSH terms
- Poly(ADP-ribose) Polymerase Inhibitors, Trastuzumab, Lapatinib, Phosphoinositide-3 Kinase Inhibitors, Antineoplastic Agents, Breast Neoplasms, Enzyme Inhibitors, Female, Humans, Predictive Value of Tests, Quinazolines, Biomarkers, Tumor, Randomized Controlled Trials as Topic, Treatment Outcome, Ki-67 Antigen, Neoadjuvant Therapy, Validation Studies as Topic, Precision Medicine, Molecular Targeted Therapy, Antibodies, Monoclonal, Humanized
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