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ones; nonetheless, we know that many targeted drugs work regardless of a biomarker (e.g., anti-VEGF
[47]
drugs ) and some biomarkers used for the treatment choice are far from being precise (e.g., PD-L1 for
[48]
immunotherapy ). It’s therefore dangerous to exclude wide populations of biomarker-negative patients
from the trials without solid data regarding biomarker predictivity. Such matter should be addressed before
the initiation of clinical trials, and preclinical studies should strongly link the biomarker status to safety and
activity, together with deeply elucidating the biology of the marker.

CONCLUSION
The way we conduct clinical trials in oncology has been designed in an era where cytotoxic compounds
were the only systemic agents available to treat cancer. The evolution of anticancer therapies, with the
development of targeted drugs and more recently immunotherapies, has progressively changed the way we
conduct clinical trials, leading to innovative trial designs, such as Basket and Umbrella trials. In this context,
PGx offer a powerful tool to implement PM, thus enhancing safety and activity of study compounds by
selecting the right drug for the right patient. Moreover, the implementation of PGx into enrichment study
designs promises to accelerate drug development, leading to faster drug availability for patients and cost
savings for the pharmaceutical companies. The trend toward enriching trials coincides with a progressive
[49]
trend in genotyping patients in clinical practice : diseases such as non-small cell lung cancer proved to
benefit from wide NGS sequencing , and with the recent advances of PM in other big killers (e.g., metastatic
[50]
[51]
breast cancer ) the implementation of sequencing techniques in the clinical setting could expand. In this
scenario, we expect that early PGx findings from clinical trials will become easier to translate into clinical
practice benefits, and that, in the next future, medical oncologists will have the possibility to disclose the
complex genomic landscape of patients before prescribing each anticancer drug.

DECLARATIONS
Authors’ contributions
Conception or design of the work: Tarantino P, Curigliano G
Review of literature: Tarantino P, Trapani D, Morganti S, Ferraro E, Viale G, D’Amico P, Duso BA
Drafting the article: Tarantino P, Trapani D, Morganti S, Ferraro E, Viale G, D’Amico P, Duso BA
Critical revision of the article: Tarantino P, Trapani D, Curigliano G
Final approval of the version to be published: Tarantino P, Trapani D, Morganti S, Ferraro E, Viale G, D’Amico
P, Duso BA, Curigliano G

Data source and availability
Not applicable.

Financial support and sponsorship
None.

Conflicts of interest
All authors declared that there are no conflicts of interest.

Ethical approval and consent to participate
Not applicable.

Consent for publication
Not applicable.

Copyright
© The Author(s) 2019.