Head: Federico Cappuzzo
STAFF

In 2020, our research pipeline focused mainly on genomic and clinical biomarkers of effectiveness and toxicity of anticancer treatments, with the aim of integrating clinical decisions for patients with solid tumors. All scientific activities are based on the active collaboration with other units (clinical, preclinical, diagnostic) and with other national and international cancer centers.

Although our unit for years was involved almost exclusively in breast cancer research, since September 2020 the interest is focused on thoracic malignancies and in phase I trials.

In lung cancer the Unit is now coordinating several national and international studies with immunotherapy or target therapies, in patients with non-small-cell lung cancer (NSCLC) or in small-cell lung cancer (SCLC).

In all studies there is a relevant translational activity aiming at identifying molecular mechanisms involved in drug sensitivity or resistance. In December 2020 we started an international phase II trial comparing the best Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor sequencing in EGFR mutant NSCLC (CAPLAND trial). Several other trials will start in 2021 both industry sponsored or Investigator Initiated Trials. In breast cancer our Unit continued its research activity by coordinating the following multicentric studies:

1. In the neo/adjuvant setting: Hippo SAB, TRISKELE, NeoTAZ, NeoCarbo, PHOBOS and a study of prognostic relevance of DNA Damage biomarkers in elderly patients undergoing neoadjuvant hormone therapy.
2. In the advanced setting: the STEPP trial, focused on the therapeutic algorithm of HER2+ Bca, was awarded by the Ministry of Health; moreover, INDACO, PALBOSS , REPER, the TETRIS trial (under review), a retrospective study on the prognostic role of hormone receptor expression in HER2+ Bca and the SePher study, coordinated together with a preclinical department (under review); we also set up the PANHER, a multicenter retrospective study to investigate the performance of available treatments for metastatic HER2+ Bca patients in recent years.

Furthermore, we actively adhered with a non-coordinating role to the following trials: NATALEE, HERMIONE 8, HERMIONE 9, DEDiCa, Neogene, VIP, a retrospective study on Trastuzumab-related cardiotoxicity, SEQUERPLUS, VasMUoss, MARIO, POSITIVE, BioItaLEE, VICTOR3, VICTOR6 COMPLEEMENT-1, IMPASSION 131, EVA, ECHO, BRIDE, TiLT, GIM16-FEVEX, HERBA, ESEMPiO, eve-exe study.

Concerning solid tumors other than Bca, we also adhered to a phase I dose escalation and cohort expansion trial of an anti-PD-1 agent in advanced solid tumors. We also focused on the HIPPO pathway within the HIERARCHY study, a spontaneous multicentric multi-tumor study coordinated by the OM2.

For gynecological tumors, we join several MITO projects, the in-ACTO study and participate to multicenter TRAMANT-01 trial; furthermore, our researches on gynecologic cancer yielded further publications. The study of miR signature in relapsed, high-grade serous ovarian cancer is nearing completion and the final manuscript will be produced shortly.

Our trial on DNA damage and HIPPO biomarkers in locally advanced/metastatic gastric cancer, awarded by the Ministry of Health, is ongoing.

In 2020 a total of 37 papers have been published.