I have been active in cancer research for more than 30 years, throughout which I have established a record of accomplishments in the field of drug development and clinical trial methodology.
I have always been guided by the ambition of developing clinically relevant treatments for cancer by progressively turning the traditional empirical approach into an experimentally driven one. I have strived to connect the dots between preclinical and clinical issues since the inception of my long career at the National Cancer Institute - USA (Marsoni S et al; Cancer Treat Rep. 1984; 1985 ; Grieshaber CK and Marsoni S. Cancer Treat Rep. 1986), critically addressing the matter of finding the right treatment for the right patient well ahead of the precision medicine era (Marsoni et al. Br J Cancer. 1990; Marsoni S, Valsecchi MG. Ann Oncol. 1991; Marsoni S. Eur J Cancer. 1992; Marsoni S, Damia G. Ann Oncol. 2004).
To this end, I have designed and conducted pivotal large scale trials, mostly in colon and lung cancer, under the evidence-based medicine paradigm (Marsoni S. Lancet. 1995; Rougier et al. Lancet. 1998 Zaniboni et al Cancer. 1998, Marsoni et al; Semin Oncol. 2001; Marsoni et al. Int J Radiat Oncol Biol Phys. 2003; Labianca et al J Natl Cancer Inst. 2004; Garassino et al Lancet Oncol. 2015), turning again, from 2000 until 2010, to early drug development with the aspiration of developing more selective drugs (Olmos et al J Clin Oncol. 2012).
In the latter period, I directed the SENDO Foundation that organized many early phase trials for novel cytotoxic, targeted and epigenetic drugs (Sessa et al Eur J Cancer. 2006; Sessa et al Ann Oncol. 2007; Marsoni S, et al Epigenetics. 2008, Rojo et al Clin Cancer Res. 2010), including the trial that established trabectedin as a new drug for ovarian cancer (Sessa et al J Clin Oncol. 2005).
All along I persevered in the search for predictive biomarkers in colon and lung cancers (Sargent DJ, et al J Clin Oncol 2010; Sinicrope et al J Natl Cancer Inst. 2011 Damia G, et al. J Natl Cancer Inst Monogr. 2011 Marabese et al. Oncotarget. 2015; Rulli et al Ann Oncol. 2015; Apicella et al Oncogene. 2017).
In 2011, I found the perfect match for my skills as a trial designer in the research strategy of the Candiolo- Niguarda mCRC-committed group. Since, I have designed and led the logistic research matrix (LMR), underpinning the group’s preclinical and clinical research efforts (Leone et al J Clin Oncol 2016), thus contributing to the discovery of new targets with clinical relevance (Bertotti et al., Cancer Discov. 1, 508-523, 2011; Bertotti et al., Nature 526, 263-267, 2015; M) and the understanding of mechanism of secondary resistance to anti EGFRs (Siravegna et al Nat Med 2015).
Specifically I translated these discoveries into successful clinical applications, including establishing the efficacy of a combinatorial anti-HER2 treatment in HER2+ metastatic colorectal cancer (Valtorta et al, Modern Pathology 2015; Sartore-Bianchi et al., Lancet Oncol 2016).