Interplay between HER2-Low status, hormone receptor expression, and therapeutic response to cyclin-dependent kinase 4/6 inhibitors as first-line treatment in luminal-like metastatic breast cancer: The CYCLHER study Letizia Pontolillo, Elisabetta Munzone, Paolo Vigneri, Mirco Pistelli, Antonella Palazzo, Nicla La Verde, Marco Mazzotta, Ida Paris, Daniele Alesini, Daniele Santini, Katia Cannita, Armando Orlandi, Emanuela Magnolfi, Laura Giacinti, Mimma Raffaele, Luisa Carbognin, Angela Santoro, Alessandro Rossi, Giorgia Arcuri, Claudia Sangalli, Ornella Garrone, Antonio Mulè, Carmine Valenza, Rossana Berardi, Giampaolo Tortora, Emilio Bria, Giuseppe Curigliano, Diana Giannarelli, Alessandra Fabi Breast, 2026 BACKGROUND: In hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC), the prognostic significance of estrogen receptor (ER), progesterone receptor (PgR), and HER2 immunohistochemical expression levels in patients treated with cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) remains unclear. The CYCLHER study was designed to evaluate treatment outcomes and identify biologically driven prognostic factors. METHODS: CYCLHER (NCT06243432) is a retrospective, multicenter study conducted across 16 Italian oncology centers. Patients with HR+/HER2- mBC who received first-line endocrine therapy (ET) plus CDK4/6i between November 2016 and May 2023 were included. ER, PgR and HER2 status were assessed on metastatic or primary tumor samples. The primary endpoint was real-world progression-free survival (rwPFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and attrition rate. Optimal cut-off values for ER and PgR expression were determined using Cut-off Finder v1.0. RESULTS: Among 597 eligible patients, median rwPFS was 28.1 months at a median follow-up of 41 months. HER2-low status emerged as a negative prognostic factor, being independently associated with shorter rwPFS compared to HER2-0 (p = 0.02). ER ≥ 87% and PgR ≥60% were associated with improved rwPFS, DCR, and 5-year OS rates. A prognostic score derived from the three biomarkers identified four groups with significantly different rwPFS outcomes (global log-rank p < 0.0001). The first-to-second line attrition rate was 16.2% (95% CI 12.4-20.0). The identified biomarkers did not significantly impact treatment outcomes in the second-line setting. CONCLUSIONS: CYCLHER confirms the prognostic relevance of ER, PgR, and HER2 expression in patients with HR+/HER2-mBC treated with CDK4/6i. HER2-low status was associated with poorer outcomes, supporting its potential role as a negative prognostic marker. The proposed score may facilitate personalized treatment strategies and enhance risk stratification in clinical practice.
Denosumab is associated with longer real-world progression-free survival in BRCA1/2-mutated HR+ /HER2 - breast cancer patients with bone metastases receiving CDK4/6 inhibitors: A multicenter Italian study Roberta Scafetta, Raffaella Troiano, Carla Gullotta, Alessandra Guarino, Cristina Fiore, Luisana Sisca, Elena Speziale, Marco Donato, Simone Foderaro, Fabio Venuti, Francesco Antonio Vilardi, Valentina Ricozzi, Michele Iuliani, Sonia Simonetti, Silvia Cavaliere, Alessio Cortellini, Annalisa La Cesa, Andrea Botticelli, Simone Scagnoli, Simona Pisegna, Carmen Criscitiello, Rebecca Pedersini, Caterina Sposetti, Elisa Tiberi, Giuliana D'Auria, Matteo Vergati, Marco Mazzotta, Roberta Caputo, Annarita Verrazzo, Ornella Garrone, Federica Domati, Claudia Piombino, Francesca Sofia Di Lisa, Lorena Filomeno, Teresa Arcuri, Federica Puce, Federica Riva, Michela Palleschi, Marianna Sirico, Marta Piras, Luigia Stefania Stucci, Delia De Lisi, Paolo Orsaria, Antonella Grasso, Edy Ippolito, Sara Ramella, Luca Visani, Lorenzo Livi, Stefania Gori, Luigi Rossi, Icro Meattini, Barbara Tagliaferri, Orazio Caffo, Maria Vittoria Bonomo, Ilaria Portarena, Azzurra Irelli, Elisabetta Cretella, Camillo Porta, Giampaolo Bianchini, Maria Agnese Fabbri, Ugo De Giorgi, Patrizia Vici, Angela Toss, Fiorella Ruatta, Michelino De Laurentiis, Federica Villa, Rossana Berardi, Mauro Minelli, Vittorio Altomare, Claudio Vernieri, Giuseppe Curigliano, Alessandra Chirco, Sara D'Alessandro, Bruno Vincenzi, Giuseppe Tonini, Daniele Santini, Francesco Pantano European Journal of Cancer, 2026 BACKGROUND: Preclinical evidence suggests that BRCA1/2-mutated tumors may rely on RANKL signaling for survival and proliferation. RANKL inhibition with denosumab could disrupt tumor-bone microenvironment crosstalk and potentially limit metastatic progression. We evaluated the association between denosumab and real-world progression-free survival (rwPFS) in germline BRCA1/2-mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (mBC) with bone metastases. METHODS: We performed a retrospective, multicenter study across 24 Italian hospitals including HR+/HER2- bone mBC patients treated in first- or second-line with a CDK4/6 inhibitor plus endocrine therapy. rwPFS was estimated by Kaplan-Meier and compared with log-rank tests. Center-stratified multivariable Cox models adjusted for clinically relevant covariates were used to assess the association between denosumab exposure and rwPFS. Effect modification by BRCA status was evaluated using a denosumab×BRCA1/2 mutation status. RESULTS: Among 1399 patients, 46 harbored germline BRCA1/2 mutations (13 BRCA1, 33 BRCA2), and 21 of these patients received denosumab. Among patients not receiving denosumab, BRCA1/2-wild-type/unknown patients had better rwPFS than BRCA1/2-mutated patients (median 28 vs 13 months; hazard ratio (HR) 0.48, 95% CI 0.32-0.73; p = 0.001). Among BRCA1/2-wild-type/unknown patients, denosumab use did not affect rwPFS (HR 0.98, 95% CI 0.85-1.12). Conversely, denosumab use was associated with longer rwPFS among patients with BRCA1/2 mutations (median 35 months, 95% CI 24-NR vs 13 months, 95% CI 9-27; HR 0.34, 95% CI 0.16-0.74; p = 0.006), with no significant difference between BRCA1 and BRCA2-mutated subgroups. Multivariable analysis confirmed the rwPFS benefit of denosumab in BRCA1/2-mutated patients (adjusted HR 0.45, 95% CI 0.21-0.99; p = 0.048). CONCLUSION: In this real-world cohort, denosumab use was associated with longer rwPFS in germline BRCA1/2-mutated HR+/HER2- mBC with bone metastases.
Comparative real-world progression free survival of CDK4/6 inhibitors in HR+/HER2− breast cancer patients with bone metastases Roberta Scafetta, Marco Donato, Carla Gullotta, Alessandra Guarino, Cristina Fiore, Luisana Sisca, Elena Speziale, Raffaella Troiano, Simone Foderaro, Fabio Venuti, Francesco Antonio Vilardi, Valentina Ricozzi, Michele Iuliani, Sonia Simonetti, Silvia Cavaliere, Alessio Cortellini, Annalisa La Cesa, Andrea Botticelli, Simone Scagnoli, Simona Pisegna, Carmen Criscitiello, Alessandra Chirco, Sara D’Alessandro, Rebecca Pedersini, Caterina Sposetti, Elisa Tiberi, Giuliana D’Auria, Matteo Vergati, Marco Mazzotta, Roberta Caputo, Annarita Verrazzo, Maria Grazia Rossino, Federica Domati, Claudia Piombino, Francesca Sofia Di Lisa, Lorena Filomeno, Teresa Arcuri, Federica Puce, Federica Riva, Michela Palleschi, Marianna Sirico, Marta Piras, Luigia Stefania Stucci, Delia De Lisi, Paolo Orsaria, Antonella Grasso, Edy Ippolito, Sara Ramella, Luca Visani, Niccolò Bertini, Ilaria Bonaparte, Stefania Gori, Luigi Rossi, Icro Meattini, Barbara Tagliaferri, Orazio Caffo, Maria Vittoria Bonomo, Ilaria Portarena, Azzurra Irelli, Elisabetta Cretella, Camillo Porta, Giampaolo Bianchini, Maria Agnese Fabbri, Ugo De Giorgi, Patrizia Vici, Angela Toss, Ornella Garrone, Michelino De Laurentiis, Federica Villa, Rossana Berardi, Mauro Minelli, Vittorio Altomare, Claudio Vernieri, Giuseppe Curigliano, Bruno Vincenzi, Giuseppe Tonini, Daniele Santini, Francesco Pantano Oncologist, 2026 Background The introduction of CDK4/6 inhibitors (CDK4/6i) has improved outcomes in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (mBC), including in patients with bone metastases. Assessing their comparative effectiveness in real-world settings is crucial. Methods This retrospective, multicenter cohort study (January 2019–December 2023; median follow-up 39 months) evaluated the real-world progression-free survival (rwPFS) of abemaciclib, ribociclib, and palbociclib combined with endocrine therapy (ET) in HR+/HER2- mBC patients with bone metastases. Overall survival (OS) was a secondary exploratory endpoint. A total of 1399 patients with ECOG PS 0–1 and at least 12 months of follow-up were included. Analyses used propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) to adjust for confounding. Results Palbociclib showed shorter rwPFS (22 months) compared to abemaciclib (32 months; HR = 1.47, p = 0.001) and ribociclib (35 months; HR = 1.49, p &lt; 0.001). No significant difference was observed between abemaciclib and ribociclib. OS was also lower with palbociclib (47 months) versus abemaciclib (60 months; HR = 1.77, p &lt; 0.001) and ribociclib (64 months; HR = 1.69, p = 0.001). Results were consistent after PSM and IPTW adjustment. CONCLUSION Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases.
Comparative analysis of Denosumab and Zoledronic acid in advanced breast cancer patients receiving CDK4/6 inhibitors Roberta Scafetta, Marco Donato, Carla Gullotta, Alessandra Guarino, Cristina Fiore, Luisana Sisca, Elena Speziale, Raffaella Troiano, Simone Foderaro, Valentina Ricozzi, Michele Iuliani, Sonia Simonetti, Silvia Cavaliere, Alessio Cortellini, Andrea Botticelli, Simone Scagnoli, Simona Pisegna, Carmen Criscitiello, Rebecca Pedersini, Caterina Sposetti, Elisa Tiberi, Giuliana D'Auria, Matteo Vergati, Marco Mazzotta, Roberta Caputo, Annarita Verrazzo, Maria Grazia Rossino, Federica Domati, Claudia Piombino, Francesca Sofia Di Lisa, Lorena Filomeno, Teresa Arcuri, Federica Puce, Federica Riva, Michela Palleschi, Marianna Sirico, Marta Piras, Luigia Stefania Stucci, Delia De Lisi, Paolo Orsaria, Edy Ippolito, Sara Ramella, Luca Visani, Niccolò Bertini, Ilaria Bonaparte, Stefania Gori, Luigi Rossi, Icro Meattini, Barbara Tagliaferri, Orazio Caffo, Ilaria Portarena, Azzurra Irelli, Elisabetta Cretella, Camillo Porta, Giampaolo Bianchini, Agnese Fabbri, Ugo De Giorgi, Patrizia Vici, Angela Toss, Ornella Garrone, Michelino De Laurentiis, Federica Villa, Rossana Berardi, Mauro Minelli, Claudio Vernieri, Giuseppe Curigliano, Bruno Vincenzi, Giuseppe Tonini, Daniele Santini, Francesco Pantano Breast, 2025 A comparative analysis of Denosumab (DMAB) and Zoledronic Acid (ZA) was conducted in a real-world cohort of 864 patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer with bone metastases, who were undergoing CDK4/6 inhibitors plus endocrine therapy. We evaluated the time to first skeletal-related events (SREs), progression-free survival (PFS), and overall survival (OS). To adjust for confounding variables, we utilized propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) methodologies. In the unadjusted cohort, ZA was associated with a longer time to first SRE compared to DMAB (HR = 0.77, 95 % CI: 0.61-0.98, p = 0.031). Similar results were obtained in both the PSM (HR = 0.69, 95 % CI: 0.52-0.92, p = 0.011) and IPTW cohorts (HR = 0.74, 95 % CI: 0.63-0.87, p < 0.001), with ZA-treated patients showing an extended time to first SRE compared to those treated with DMAB. No differences in PFS and OS were observed between the two cohorts.
Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study Eriseld Krasniqi, Lorena Filomeno, Teresa Arcuri, Francesca Sofia Di Lisa, Antonio Astone, Claudia Cutigni, Jennifer Foglietta, Martina Nunzi, Rosalinda Rossi, Mauro Minelli, Icro Meattini, Luca Visani, Jacopo Scialino, Lorenzo Livi, Luca Moscetti, Paolo Marchetti, Andrea Botticelli, Ida Paris, Francesco Pavese, Tatiana D’Angelo, Valentina Sini, Simonetta Stani, Maria Rosaria Valerio, Antonino Grassadonia, Nicola Tinari, Marco Mazzotta, Matteo Vergati, Giuliana D’Auria, Teresa Gamucci, Loretta D’Onofrio, Simona Gasparro, Arianna Roselli, Alberto Fulvi, Gianluigi Ferretti, Andrea Torchia, Monica Giordano, Filippo Greco, Francesco Pantano, Giuseppe Tonini, Agnese Fabbri, Emilio Bria, Giovanna Garufi, Elena Fiorio, Mimma Raffaele, Mirco Pistelli, Rossana Berardi, Rosa Saltarelli, Ramy Kayal, Francesca Romana Ferranti, Katia Cannita, Azzurra Irelli, Nicola D’Ostilio, Costanza De Rossi, Raffaella Palumbo, Anna Cariello, Giuseppe Sanguineti, Fabio Calabrò, Laura Pizzuti, Maddalena Barba, Claudio Botti, Fabio Pelle, Sonia Cappelli, Flavia Cavicchi, Ilaria Puccica, Amedeo Villanucci, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici Cancers, 2024 Background/Objectives: HER2-positive breast cancer (HER2+BC) is an aggressive subtype, with neoadjuvant treatment (NAT) aiming to achieve a pathological complete response (pCR) to improve long-term outcomes. Trastuzumab emtansine (T-DM1) has been established as the standard of care in the adjuvant setting for HER2+BC patients who do not obtain pCR. The ATD study aimed to evaluate the real-world tolerability of T-DM1 in this setting. The secondary objective was to assess the effectiveness. Methods: This was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2+BC treated with adjuvant T-DM1 following a lack of pCR after NAT. Patient characteristics, NAT regimens, and surgical outcomes were recorded. Tolerability was assessed by documenting adverse events (AEs) according to the CTCAE (v5.0). Preliminary effectiveness was evaluated in terms of relapse-free survival (RFS) and overall survival (OS). Results: Overall, 228 patients (55.6%) experienced at least one AE related to T-DM1, with 4.9% experiencing grade 3 or higher AEs. The most common AEs were hepatotoxicity (18.5%) and thrombocytopenia (17.6%). T-DM1 was discontinued in 10.0% of patients due to toxicity. After a median follow-up of 25 months, 31 relapse events (7.6%) and 22 deaths (5.4%) were reported. The preliminary incidence of RFS and OS events was similar between patients who completed the T-DM1 course and those who discontinued it early. Conclusions: T-DM1 demonstrated a manageable safety profile, and the adverse events were consistent with those reported in randomized trials. The data are not yet sufficient to allow for a formal analysis of RFS and OS, and long-term follow-up is required.
Transcriptional Phenocopies of Deleterious KEAP1 Mutations Correlate with Survival Outcomes in Lung Cancer Treated with Immunotherapy Stefano Scalera, Biagio Ricciuti, Daniele Marinelli, Marco Mazzotta, Laura Cipriani, Giulia Bon, Giulia Schiavoni, Irene Terrenato, Alessandro Di Federico, Joao V. Alessi, Maurizio Fanciulli, Ludovica Ciuffreda, Francesca De Nicola, Frauke Goeman, Giulio Caravagna, Daniele Santini, Ruggero De Maria, Federico Cappuzzo, Gennaro Ciliberto, Mariam Jamal-Hanjani, Mark M. Awad, Nicholas McGranahan, Marcello Maugeri-Saccà Clinical Cancer Research, 2024 Purpose: Co-occurring mutations in KEAP1 and STK11/KRAS have emerged as determinants of survival outcomes in patients with non–small cell lung cancer (NSCLC) treated with immunotherapy. However, these mutational contexts identify a fraction of nonresponders to immune checkpoint inhibitors. We hypothesized that KEAP1 wild-type tumors recapitulate the transcriptional footprint of KEAP1 mutations and that this KEAPness phenotype can determine immune responsiveness with higher precision compared to mutation-based models. Experimental Design: The Cancer Genome Atlas was used to infer the KEAPness phenotype and explore its immunological correlates at the pan-cancer level. The association between KEAPness and survival outcomes was tested in two independent cohorts of patients with advanced NSCLC treated with immunotherapy and profiled by RNA sequencing (SU2C n = 153; OAK/POPLAR n = 439). The NSCLC TRACERx421 multiregion sequencing study (tumor regions, n = 947) was used to investigate evolutionary trajectories. Results: KEAPness-dominant tumors represented 50% of all NSCLCs and were associated with shorter progression-free survival (PFS) and overall survival (OS) compared to KEAPness-free cases in independent cohorts of patients with NSCLC treated with immunotherapy (SU2C PFS P = 0.042, OS P = 0.008; OAK/POPLAR PFS P = 0.0014, OS P &lt; 0.001). Patients with KEAPness tumors had survival outcomes comparable to those with KEAP1-mutant tumors. In the TRACERx421, KEAPness exhibited limited transcriptional intratumoral heterogeneity and immune exclusion, resembling the KEAP1-mutant disease. This phenotypic state occurred across genetically divergent tumors, exhibiting shared and private cancer genes under positive selection when compared to KEAP1-mutant tumors. Conclusions: We identified a KEAPness phenotype across evolutionary divergent tumors. KEAPness outperforms mutation-based classifiers as a biomarker of inferior survival outcomes in patients with NSCLC treated with immunotherapy.
Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: the Neopearl nationwide collaborative study Agnese Fabbri, Fabrizio Nelli, Andrea Botticelli, Diana Giannarelli, Eleonora Marrucci, Cristina Fiore, Antonella Virtuoso, Simone Scagnoli, Simona Pisegna, Daniele Alesini, Valentina Sini, Armando Orlandi, Alessandra Fabi, Federico Piacentini, Luca Moscetti, Giuliana D’Auria, Teresa Gamucci, Marco Mazzotta, Laura Pizzuti, Patrizia Vici, Elisabetta Cretella, Paola Scavina, Annalisa La Cesa, Mara Persano, Francesco Atzori, Enzo Maria Ruggeri Frontiers in Oncology, 2023 PurposeClinical trials have shown a significant increase in pathologic complete response (pCR) with the addition of pertuzumab to neoadjuvant chemotherapy for patients with early-stage HER-2 positive breast cancer. To date, limited studies have examined comparative outcomes of neoadjuvant pertuzumab in real-world setting. The Neopearl study aimed to assess comparative real-life efficacy and safety of neoadjuvant pertuzumab for these patients.MethodsWe conducted a nationwide retrospective analysis involving 17 oncology facilities with a certified multidisciplinary breast cancer treatment committee. We identified patients with HER-2 positive stage II-III breast cancer treated with neoadjuvant chemotherapy based on trastuzumab and taxanes with or without pertuzumab. All patients underwent breast surgery and received a comprehensive cardiologic evaluation at baseline and after neoadjuvant treatment. Patients who received the combination of pertuzumab, trastuzumab, and chemotherapy constituted case cohort (PTCT), whereas those treated with trastuzumab and chemotherapy accounted for control cohort (TCT). The pCR rate and 5-year event free survival (EFS) were the primary outcomes. Secondary end-points were rates of conversion from planned modified radical mastectomy (MRM) to breast conservation surgery (BCS) and cardiotoxicities.ResultsFrom March 2014 to April 2021, we included 271 patients, 134 (49%) and 137 (51%) in TCT and PTCT cohort, respectively. Positive axillary lymph nodes and stage III were more frequent in PTCT cohort. The pCR rate was significantly increased in patients who received pertuzumab (49% vs 62%; OR 1.74, 95%CI 1.04-2.89) and with HER-2 enriched subtypes (16% vs 85%; OR 2.94, 95%CI 1.60-5.41). After a median follow-up of 5 years, the 5-year EFS was significantly prolonged only in patients treated with pertuzumab (81% vs 93%; HR 2.22, 95%CI 1.03-4.79). The same analysis performed on propensity score matched population showed concordant results. On univariate analysis, only patients with positive lymph nodes were found to benefit from pertuzumab for both pCR and 5-year EFS. The rates of conversion from MRM to BCS and cardiologic toxicities did not differ between the cohorts.ConclusionOur findings support previous data on improved outcomes with the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy. This benefit seems to be more significant in patients with clinically positive lymph nodes.
Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study Francesca Sofia Di Lisa, Eriseld Krasniqi, Laura Pizzuti, Maddalena Barba, Katia Cannita, Ugo De Giorgi, Fulvio Borella, Jennifer Foglietta, Anna Cariello, Antonella Ferro, Elisa Picardo, Marco Mitidieri, Valentina Sini, Simonetta Stani, Giuseppe Tonini, Daniele Santini, Nicla La Verde, Anna Rita Gambaro, Antonino Grassadonia, Nicola Tinari, Ornella Garrone, Giuseppina Sarobba, Lorenzo Livi, Icro Meattini, Giuliana D’Auria, Matteo Vergati, Teresa Gamucci, Mirco Pistelli, Rossana Berardi, Emanuela Risi, Francesco Giotta, Vito Lorusso, Lucia Rinaldi, Salvatore Artale, Marina Elena Cazzaniga, Fable Zustovich, Federico Cappuzzo, Lorenza Landi, Rosalba Torrisi, Simone Scagnoli, Andrea Botticelli, Andrea Michelotti, Beatrice Fratini, Rosa Saltarelli, Ida Paris, Margherita Muratore, Alessandra Cassano, Lorenzo Gianni, Valeria Gaspari, Enzo Maria Veltri, Federica Zoratto, Elena Fiorio, Maria Agnese Fabbri, Marco Mazzotta, Enzo Maria Ruggeri, Rebecca Pedersini, Maria Rosaria Valerio, Lorena Filomeno, Mauro Minelli, Paola Scavina, Mimma Raffaele, Antonio Astone, Roy De Vita, Marcello Pozzi, Ferdinando Riccardi, Filippo Greco, Luca Moscetti, Monica Giordano, Marcello Maugeri-Saccà, Alessandro Zennaro, Claudio Botti, Fabio Pelle, Sonia Cappelli, Flavia Cavicchi, Enrico Vizza, Giuseppe Sanguineti, Federica Tomao, Enrico Cortesi, Paolo Marchetti, Silverio Tomao, Iolanda Speranza, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici Frontiers in Oncology, 2023 BackgroundIn triple negative breast cancer patients treated with neoadjuvant chemotherapy, residual disease at surgery is the most relevant unfavorable prognostic factor. Current guidelines consider the use of adjuvant capecitabine, based on the results of the randomized CREATE-X study, carried out in Asian patients and including a small subset of triple negative tumors. Thus far, evidence on Caucasian patients is limited, and no real-world data are available.MethodsWe carried out a multicenter, observational study, involving 44 oncologic centres. Triple negative breast cancer patients with residual disease, treated with adjuvant capecitabine from January 2017 through June 2021, were recruited. We primarily focused on treatment tolerability, with toxicity being reported as potential cause of treatment discontinuation. Secondarily, we assessed effectiveness in the overall study population and in a subset having a minimum follow-up of 2 years.ResultsOverall, 270 patients were retrospectively identified. The 50.4% of the patients had residual node positive disease, 7.8% and 81.9% had large or G3 residual tumor, respectively, and 80.4% a Ki-67 &gt;20%. Toxicity-related treatment discontinuation was observed only in 10.4% of the patients. In the whole population, at a median follow-up of 15 months, 2-year disease-free survival was 62%, 2 and 3-year overall survival 84.0% and 76.2%, respectively. In 129 patients with a median follow-up of 25 months, 2-year disease-free survival was 43.4%, 2 and 3-year overall survival 78.0% and 70.8%, respectively. Six or more cycles of capecitabine were associated with more favourable outcomes compared with less than six cycles.ConclusionThe CaRe study shows an unexpectedly good tolerance of adjuvant capecitabine in a real-world setting, although effectiveness appears to be lower than that observed in the CREATE-X study. Methodological differences between the two studies impose significant limits to comparability concerning effectiveness, and strongly invite further research.
Dynamic changes in peripheral lymphocytes and antibody response following a third dose of SARS-CoV-2 mRNA-BNT162b2 vaccine in cancer patients Enzo Maria Ruggeri, Fabrizio Nelli, Diana Giannarelli, Agnese Fabbri, Julio Rodrigo Giron Berrios, Antonella Virtuoso, Eleonora Marrucci, Marco Mazzotta, Marta Schirripa, Carlo Signorelli, Mario Giovanni Chilelli, Francesca Primi, Cristina Fiore, Valentina Panichi, Giuseppe Topini, Maria Assunta Silvestri Scientific Reports, 2022 The aim of this study was to evaluate the association of circulating lymphocytes profiling with antibody response in cancer patients receiving the third dose of COVID-19 mRNA-BNT162b2 vaccine. Immunophenotyping of peripheral blood was used to determine absolute counts of lymphocyte subsets, alongside detection of IgG antibodies against receptor-binding-domain (RBD) of the SARS-CoV-2 Spike protein (S1) before booster dosing (timepoint-1) and four weeks afterward (timepoint-2). An IgG titer ≥ 50 AU/mL defined a positive seroconversion response. An IgG titer ≥ 4446 AU/mL was assumed as a correlate of 50% vaccine efficacy against symptomatic infections. A total of 258 patients on active treatment within the previous six months were enrolled between September 23 and October 7, 2021. The third dose resulted in an exponential increase in median anti-RBD-S1 IgG titer (P < 0.001), seroconversion rates (P < 0.001), and 50% vaccine efficacy rates (P < 0.001). According to ROC curve analysis, T helper and B cells were significantly associated with seroconversion responses at timepoint-1, whereas only B cells were relevant to 50% vaccine efficacy rates at timepoint-2. A positive linear correlation was shown between anti-RBD-S1 IgG titers and these lymphocyte subset counts. Multivariate analysis ruled out a potential role of T helper cells but confirmed a significant interaction between higher B cell levels and improved antibody response. These findings suggest that peripheral counts of B cells correlate with humoral response to the third dose of mRNA-BNT162b2 vaccine in actively treated cancer patients and could provide insights into a more comprehensive assessment of vaccination efficacy.
The Impact of the Hippo Pathway and Cell Metabolism on Pathological Complete Response in Locally Advanced Her2+ Breast Cancer: The TRISKELE Multicenter Prospective Study Eriseld Krasniqi, Francesca Sofia Di Lisa, Anna Di Benedetto, Maddalena Barba, Laura Pizzuti, Lorena Filomeno, Cristiana Ercolani, Nicola Tinari, Antonino Grassadonia, Daniele Santini, Mauro Minelli, Filippo Montemurro, Maria Agnese Fabbri, Marco Mazzotta, Teresa Gamucci, Giuliana D’Auria, Claudio Botti, Fabio Pelle, Flavia Cavicchi, Sonia Cappelli, Federico Cappuzzo, Giuseppe Sanguineti, Silverio Tomao, Andrea Botticelli, Paolo Marchetti, Marcello Maugeri-Saccà, Ruggero De Maria, Gennaro Ciliberto, Francesca Sperati, Patrizia Vici Cancers, 2022
MicroRNA-based signatures impacting clinical course and biology of ovarian cancer: a miRNOmics study E. Krasniqi, A. Sacconi, D. Marinelli, L. Pizzuti, M. Mazzotta, D. Sergi, E. Capomolla, S. Donzelli, M. Carosi, A. Bagnato, T. Gamucci, S. Tomao, C. Natoli, P. Marchetti, A. Grassadonia, N. Tinari, M. De Tursi, E. Vizza, G. Ciliberto, L. Landi, F. Cappuzzo, M. Barba, G. Blandino, P. Vici Biomarker Research, 2021
KEAP1 and TP53 Frame Genomic, Evolutionary, and Immunologic Subtypes of Lung Adenocarcinoma With Different Sensitivity to Immunotherapy Stefano Scalera, Marco Mazzotta, Giacomo Corleone, Francesca Sperati, Irene Terrenato, Eriseld Krasniqi, Laura Pizzuti, Maddalena Barba, Patrizia Vici, Enzo Gallo, Simonetta Buglioni, Paolo Visca, Edoardo Pescarmona, Daniele Marinelli, Francesca De Nicola, Ludovica Ciuffreda, Frauke Goeman, Maurizio Fanciulli, Raffaele Giusti, Andrea Vecchione, Ruggero De Maria, Federico Cappuzzo, Paolo Marchetti, Gennaro Ciliberto, Marcello Maugeri-Saccà Journal of Thoracic Oncology, 2021
The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial Laura Pizzuti, Maddalena Barba, Marco Mazzotta, Eriseld Krasniqi, Marcello Maugeri-Saccà, Teresa Gamucci, Rossana Berardi, Lorenzo Livi, Corrado Ficorella, Clara Natoli, Enrico Cortesi, Daniele Generali, Nicla La Verde, Alessandra Cassano, Emilio Bria, Luca Moscetti, Andrea Michelotti, Vincenzo Adamo, Claudio Zamagni, Giuseppe Tonini, Domenico Sergi, Daniele Marinelli, Giancarlo Paoletti, Silverio Tomao, Andrea Botticelli, Paolo Marchetti, Nicola Tinari, Antonino Grassadonia, Maria Rosaria Valerio, Rosanna Mirabelli, Maria Agnese Fabbri, Nicola D’Ostilio, Enzo Veltri, Domenico Corsi, Ornella Garrone, Ida Paris, Giuseppina Sarobba, Icro Meattini, Mirco Pistelli, Francesco Giotta, Vito Lorusso, Carlo Garufi, Antonio Russo, Marina Cazzaniga, Pietro Del Medico, Mario Roselli, Angela Vaccaro, Letizia Perracchio, Anna di Benedetto, Theodora Daralioti, Isabella Sperduti, Ruggero De Maria, Angelo Di Leo, Giuseppe Sanguineti, Gennaro Ciliberto, Patrizia Vici Scientific Reports, 2021
PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting Laura Pizzuti, Eriseld Krasniqi, Isabella Sperduti, Maddalena Barba, Teresa Gamucci, Maria Mauri, Enzo Maria Veltri, Icro Meattini, Rossana Berardi, Francesca Sofia Di Lisa, Clara Natoli, Mirco Pistelli, Laura Iezzi, Emanuela Risi, Nicola D’Ostilio, Silverio Tomao, Corrado Ficorella, Katia Cannita, Ferdinando Riccardi, Alessandra Cassano, Emilio Bria, Maria Agnese Fabbri, Marco Mazzotta, Giacomo Barchiesi, Andrea Botticelli, Giuliana D’Auria, Anna Ceribelli, Andrea Michelotti, Antonio Russo, Beatrice Taurelli Salimbeni, Giuseppina Sarobba, Francesco Giotta, Ida Paris, Rosa Saltarelli, Daniele Marinelli, Domenico Corsi, Elisabetta Maria Capomolla, Valentina Sini, Luca Moscetti, Lucia Mentuccia, Giuseppe Tonini, Mimma Raffaele, Luca Marchetti, Mauro Minelli, Enzo Maria Ruggeri, Paola Scavina, Olivia Bacciu, Nello Salesi, Lorenzo Livi, Nicola Tinari, Antonino Grassadonia, Angelo Fedele Scinto, Rosalinda Rossi, Maria Rosaria Valerio, Elisabetta Landucci, Simonetta Stani, Beatrice Fratini, Marcello Maugeri-Saccà, Michele De Tursi, Angela Maione, Daniele Santini, Armando Orlandi, Vito Lorusso, Enrico Cortesi, Giuseppe Sanguineti, Paola Pinnarò, Federico Cappuzzo, Lorenza Landi, Claudio Botti, Federica Tomao, Sonia Cappelli, Giulia Bon, Fabio Pelle, Flavia Cavicchi, Elena Fiorio, Jennifer Foglietta, Simone Scagnoli, Paolo Marchetti, Gennaro Ciliberto, Patrizia Vici Therapeutic Advances in Medical Oncology, 2021
Role of chemotherapy in vulvar cancers: Time to rethink standard of care? Marco Mazzotta, Laura Pizzuti, Eriseld Krasniqi, Francesca Sofia Di Lisa, Federico Cappuzzo, Lorenza Landi, Domenico Sergi, Fabio Pelle, Sonia Cappelli, Claudio Botti, Enrico Vizza, Silverio Tomao, Luca Marchetti, Giuseppe Sanguineti, Andrea Botticelli, Paolo Marchetti, Valentina Magri, Simona Pisegna, Aldo Venuti, Federica Tomao, Federica Buzzacchino, Gennaro Ciliberto, Maddalena Barba, Patrizia Vici Cancers, 2021
Exploring the role of respiratory microbiome in lung cancer: A systematic review Fabiana Perrone, Lorenzo Belluomini, Marco Mazzotta, Maristella Bianconi, Vincenzo Di Noia, Fiammetta Meacci, Michele Montrone, Daniele Pignataro, Arsela Prelaj, Silvia Rinaldi, Marco Russano, Giulia Sartori, Paolo Bironzo, Francesco Facchinetti, Jessica Menis, Marcello Tiseo, Domenico Galetta, Silvia Novello, Sara Pilotto Critical Reviews in Oncology Hematology, 2021
Circulating hpv dna in the management of oropharyngeal and cervical cancers: Current knowledge and future perspectives Eriseld Krasniqi, Maddalena Barba, Aldo Venuti, Laura Pizzuti, Federico Cappuzzo, Lorenza Landi, Silvia Carpano, Paolo Marchetti, Alice Villa, Enrico Vizza, Greta Giuliano, Marco Mazzotta, Daniele Marinelli, Sandra Gnignera, Cristina Vincenzoni, Vincenzo Stranges, Domenico Sergi, Antonio Giordano, Federica Tomao, Marcello Maugeri-Saccà, Giuseppe Sanguineti, Francesca Sofia Di Lisa, Silverio Tomao, Gennaro Ciliberto, Patrizia Vici Journal of Clinical Medicine, 2021
Second-line eribulin in triple negative metastatic breast cancer patients. Multicentre retrospective study: The tetris trial Eriseld Krasniqi, Laura Pizzuti, Maria Rosaria Valerio, Elisabetta Capomolla, Claudio Botti, Giuseppe Sanguineti, Paolo Marchetti, Elisabetta Anselmi, Silverio Tomao, Antonio Giordano, Corrado Ficorella, Katia Cannita, Lorenzo Livi, Icro Meattini, Maria Mauri, Filippo Greco, Enzo Maria Veltri, Andrea Michelotti, Luca Moscetti, Francesco Giotta, Vito Lorusso, Ida Paris, Federica Tomao, Daniele Santini, Giuseppe Tonini, Alice Villa, Vittorio Gebbia, Teresa Gamucci, Gennaro Ciliberto, Isabella Sperduti, Marco Mazzotta, Maddalena Barba, Patrizia Vici International Journal of Medical Sciences, 2021
KEAP1-driven co-mutations in lung adenocarcinoma unresponsive to immunotherapy despite high tumor mutational burden D. Marinelli, M. Mazzotta, S. Scalera, I. Terrenato, F. Sperati, L. D'Ambrosio, M. Pallocca, G. Corleone, E. Krasniqi, L. Pizzuti, M. Barba, S. Carpano, P. Vici, M. Filetti, R. Giusti, A. Vecchione, M. Occhipinti, A. Gelibter, A. Botticelli, F. De Nicola, L. Ciuffreda, F. Goeman, E. Gallo, P. Visca, E. Pescarmona, M. Fanciulli, R. De Maria, P. Marchetti, G. Ciliberto, M. Maugeri-Saccà Annals of Oncology, 2020
Loss of HER2 and decreased T-DM1 efficacy in HER2 positive advanced breast cancer treated with dual HER2 blockade: the SePHER Study Giulia Bon, Laura Pizzuti, Valentina Laquintana, Rossella Loria, Manuela Porru, Caterina Marchiò, Eriseld Krasniqi, Maddalena Barba, Marcello Maugeri-Saccà, Teresa Gamucci, Rossana Berardi, Lorenzo Livi, Corrado Ficorella, Clara Natoli, Enrico Cortesi, Daniele Generali, Nicla La Verde, Alessandra Cassano, Emilio Bria, Luca Moscetti, Andrea Michelotti, Vincenzo Adamo, Claudio Zamagni, Giuseppe Tonini, Giacomo Barchiesi, Marco Mazzotta, Daniele Marinelli, Silverio Tomao, Paolo Marchetti, Maria Rosaria Valerio, Rosanna Mirabelli, Antonio Russo, Maria Agnese Fabbri, Nicola D’Ostilio, Enzo Veltri, Domenico Corsi, Ornella Garrone, Ida Paris, Giuseppina Sarobba, Francesco Giotta, Carlo Garufi, Marina Cazzaniga, Pietro Del Medico, Mario Roselli, Giuseppe Sanguineti, Isabella Sperduti, Anna Sapino, Ruggero De Maria, Carlo Leonetti, Angelo Di Leo, Gennaro Ciliberto, Rita Falcioni, Patrizia Vici Journal of Experimental and Clinical Cancer Research, 2020
Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence Eriseld Krasniqi, Laura Pizzuti, Giacomo Barchiesi, Domenico Sergi, Silvia Carpano, Claudio Botti, Ramy Kayal, Giuseppe Sanguineti, Paolo Marchetti, Andrea Botticelli, Daniele Marinelli, Teresa Gamucci, Clara Natoli, Antonino Grassadonia, Nicola Tinari, Silverio Tomao, Giuseppe Tonini, Daniele Santini, Aandrea Michelotti, Lucia Mentuccia, Aangela Vaccaro, Emanuela Magnolfi, Alain Gelibter, Valentina Magri, Enrico Cortesi, Loretta D’Onofrio, Alessandra Cassano, Marina Cazzaniga, Luca Moscetti, Agnese Fabbri, Angelo Fedele Scinto, Domenico Corsi, Luisa Carbognin, Emilio Bria, Nicla La Verde, Carlo Garufi, Pia Di Stefano, Rossana Mirabelli, Enzo Veltri, Ida Paris, Francesco Giotta, Vito Lorusso, Elisa Landucci, Corrado Ficorella, Mario Roselli, Vincenzo Adamo, Giuseppina Ricciardi, Antonio Russo, Maria Rosaria Valerio, Rossana Berardi, Mirco Pistelli, Katia Cannita, Claudio Zamagni, Ornella Garrone, Editta Baldini, Lorenzo Livi, Icro Meattini, Pietro Del Medico, Daniele Generali, Ruggero De Maria, Emanuela Risi, Gennaro Ciliberto, Alice Villa, Isabella Sperduti, Marco Mazzotta, Maddalena Barba, Antonio Giordano, Patrizia Vici Journal of Cellular Physiology, 2020
Efficacy of immunotherapy in lung cancer with co-occurring mutations in NOTCH and homologous repair genes Marco Mazzotta, Marco Filetti, Mario Occhipinti, Daniele Marinelli, Stefano Scalera, Irene Terrenato, Francesca Sperati, Matteo Pallocca, Francesco Rizzo, Alain Gelibter, Andrea Botticelli, Giorgia Scafetta, Arianna Di Napoli, Eriseld Krasniqi, Laura Pizzuti, Maddalena Barba, Silvia Carpano, Patrizia Vici, Maurizio Fanciulli, Francesca De Nicola, Ludovica Ciuffreda, Frauke Goeman, Ruggero De Maria, Andrea Vecchione, Raffaele Giusti, Gennaro Ciliberto, Paolo Marchetti, Marcello Maugeri-Saccà Journal for Immunotherapy of Cancer, 2020
Neoadjuvant endocrine therapy in breast cancer: Current knowledge and future perspectives Giacomo Barchiesi, Marco Mazzotta, Eriseld Krasniqi, Laura Pizzuti, Daniele Marinelli, Elisabetta Capomolla, Domenico Sergi, Antonella Amodio, Clara Natoli, Teresa Gamucci, Enrico Vizza, Paolo Marchetti, Claudio Botti, Giuseppe Sanguineti, Gennaro Ciliberto, Maddalena Barba, Patrizia Vici International Journal of Molecular Sciences, 2020
Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting Laura Pizzuti, Eriseld Krasniqi, Giacomo Barchiesi, Marina Della Giulia, Fiorentino Izzo, Giuseppe Sanguineti, Paolo Marchetti, Marco Mazzotta, Raffaele Giusti, Andrea Botticelli, Teresa Gamucci, Clara Natoli, Antonino Grassadonia, Nicola Tinari, Laura Iezzi, Silverio Tomao, Federica Tomao, Giuseppe Tonini, Daniele Santini, Antonio Astone, Andrea Michelotti, Claudia De Angelis, Lucia Mentuccia, Angela Vaccaro, Emanuela Magnolfi, Alain Gelibter, Valentina Magri, Enrico Cortesi, Loretta D'Onofrio, Alessandra Cassano, Ernesto Rossi, Marina Cazzaniga, Luca Moscetti, Claudia Omarini, Federico Piacentini, Maria A. Fabbri, Angelo F. Scinto, Domenico Corsi, Luisa Carbognin, Emilio Bria, Nicla La Verde, Riccardo Samaritani, Carlo Garufi, Sandro Barni, Rosanna Mirabelli, Roberta Sarmiento, Enzo M. Veltri, Giuliana D'Auria, Ida Paris, Francesco Giotta, Vito Lorusso, Franca Cardillo, Elisabetta Landucci, Maria Mauri, Corrado Ficorella, Mario Roselli, Vincenzo Adamo, Giuseppina R.R. Ricciardi, Antonio Russo, Rossana Berardi, Mirco Pistelli, Elena Fiorio, Katia Cannita, Valentina Sini, Nicola D'Ostilio, Jennifer Foglietta, Filippo Greco, Claudio Zamagni, Ornella Garrone, Barbara Di Cocco, Editta Baldini, Lorenzo Livi, Isacco Desideri, Icro Meattini, Giuseppina Sarobba, Pietro Del Medico, Michele De Tursi, Daniele Generali, Ruggero De Maria, Emanuela Risi, Gennaro Ciliberto, Isabella Sperduti, Alice Villa, Maddalena Barba, Angelo Di Leo, Patrizia Vici International Journal of Cancer, 2020
Mutations in the KEAP1-NFE2L2 Pathway Define a Molecular Subset of Rapidly Progressing Lung Adenocarcinoma Frauke Goeman, Francesca De Nicola, Stefano Scalera, Francesca Sperati, Enzo Gallo, Ludovica Ciuffreda, Matteo Pallocca, Laura Pizzuti, Eriseld Krasniqi, Giacomo Barchiesi, Patrizia Vici, Maddalena Barba, Simonetta Buglioni, Beatrice Casini, Paolo Visca, Edoardo Pescarmona, Marco Mazzotta, Ruggero De Maria, Maurizio Fanciulli, Gennaro Ciliberto, Marcello Maugeri-Saccà Journal of Thoracic Oncology, 2019
Immunotherapy in HER2-positive breast cancer: State of the art and future perspectives E. Krasniqi, G. Barchiesi, L. Pizzuti, M. Mazzotta, A. Venuti, M. Maugeri-Saccà, G. Sanguineti, G. Massimiani, D. Sergi, S. Carpano, P. Marchetti, S. Tomao, T. Gamucci, R. De Maria, F. Tomao, C. Natoli, N. Tinari, G. Ciliberto, M. Barba, P. Vici Journal of Hematology and Oncology, 2019
Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience Laura Pizzuti, Antonio Giordano, Andrea Michelotti, Marco Mazzotta, Clara Natoli, Teresa Gamucci, Claudia De Angelis, Elisabetta Landucci, Lucrezia Diodati, Laura Iezzi, Lucia Mentuccia, Agnese Fabbri, Maddalena Barba, Giuseppe Sanguineti, Paolo Marchetti, Silverio Tomao, Luciano Mariani, Ida Paris, Vito Lorusso, Simona Vallarelli, Alessandra Cassano, Francesca Aroldi, Armando Orlandi, Luca Moscetti, Domenico Sergi, Maria Giuseppina Sarobba, Giuseppe Tonini, Daniele Santini, Valentina Sini, Enzo Veltri, Angela Vaccaro, Laura Ferrari, Michele De Tursi, Nicola Tinari, Antonino Grassadonia, Filippo Greco, Andrea Botticelli, Nicla La Verde, Claudio Zamagni, Daniela Rubino, Enrico Cortesi, Valentina Magri, Giulia Pomati, Simone Scagnoli, Elisabetta Capomolla, Ramy Kayal, Angelo Fedele Scinto, Domenico Corsi, Marina Cazzaniga, Lucio Laudadio, Samantha Forciniti, Maria Mancini, Luisa Carbognin, Patrizia Seminara, Sandro Barni, Riccardo Samaritani, Mario Roselli, Ilaria Portarena, Antonio Russo, Corrado Ficorella, Katia Cannita, Silvia Carpano, Mirco Pistelli, Rossana Berardi, Ruggero De Maria, Isabella Sperduti, Gennaro Ciliberto, Patrizia Vici Journal of Cellular Physiology, 2019
A nomogram to predict survival in non-small cell lung cancer patients treated with nivolumab Andrea Botticelli, Massimiliano Salati, Francesca Romana Di Pietro, Lidia Strigari, Bruna Cerbelli, Ilaria Grazia Zizzari, Raffaele Giusti, Marco Mazzotta, Federica Mazzuca, Michela Roberto, Patrizia Vici, Laura Pizzuti, Marianna Nuti, Paolo Marchetti Journal of Translational Medicine, 2019
A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study Teresa Gamucci, Laura Pizzuti, Clara Natoli, Lucia Mentuccia, Isabella Sperduti, Maddalena Barba, Domenico Sergi, Laura Iezzi, Marcello Maugeri-Saccà, Angela Vaccaro, Emanuela Magnolfi, Alain Gelibter, Giacomo Barchiesi, Valentina Magri, Loretta D’Onofrio, Alessandra Cassano, Ernesto Rossi, Andrea Botticelli, Luca Moscetti, Claudia Omarini, Maria Agnese Fabbri, Angelo Fedele Scinto, Domenico Corsi, Luisa Carbognin, Marco Mazzotta, Emilio Bria, Jennifer Foglietta, Riccardo Samaritani, Carlo Garufi, Luciano Mariani, Sandro Barni, Rosanna Mirabelli, Roberta Sarmiento, Vincenzo Graziano, Daniele Santini, Paolo Marchetti, Giuseppe Tonini, Luigi Di Lauro, Giuseppe Sanguineti, Giancarlo Paoletti, Silverio Tomao, Ruggero De Maria, Enzo Veltri, Ida Paris, Francesco Giotta, Agnese Latorre, Antonio Giordano, Gennaro Ciliberto, Patrizia Vici Cancer Biology and Therapy, 2019
The clinical significance of PD-L1 in advanced gastric cancer is dependent on ARID1A mutations and ATM expression Simonetta Buglioni, Elisa Melucci, Francesca Sperati, Matteo Pallocca, Irene Terrenato, Francesca De Nicola, Frauke Goeman, Beatrice Casini, Carla Azzurra Amoreo, Enzo Gallo, Maria Grazia Diodoro, Edoardo Pescarmona, Patrizia Vici, Domenico Sergi, Laura Pizzuti, Luigi Di Lauro, Marco Mazzotta, Maddalena Barba, Maurizio Fanciulli, Ilio Vitale, Ruggero De Maria, Gennaro Ciliberto, Marcello Maugeri-Saccà Oncoimmunology, 2018
Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab Laura Pizzuti, Domenico Sergi, Isabella Sperduti, Luigi Di Lauro, Marco Mazzotta, Claudio Botti, Fiorentino Izzo, Luca Marchetti, Silverio Tomao, Paolo Marchetti, Clara Natoli, Antonino Grassadonia, Teresa Gamucci, Lucia Mentuccia, Emanuela Magnolfi, Angela Vaccaro, Alessandra Cassano, Ernesto Rossi, Andrea Botticelli, Valentina Sini, Maria G Sarobba, Maria Agnese Fabbri, Luca Moscetti, Antonio Astone, Andrea Michelotti, Claudia De Angelis, Ilaria Bertolini, Francesco Angelini, Gennaro Ciliberto, Marcello Maugeri-Saccà, Antonio Giordano, Maddalena Barba, Patrizia Vici Cancer Biology and Therapy, 2018
Comparative real-world progression free survival of CDK4/6 inhibitors in HR+/HER2− breast cancer patients with bone metastases R Scafetta, M Donato, C Gullotta, A Guarino, C Fiore, L Sisca, E Speziale, ... The Oncologist 31 (5), oyag146 , 2026 2026
Denosumab is associated with longer Real-World Progression-Free Survival in BRCA1/2-Mutated HR+/HER2− breast cancer patients with bone metastases receiving CDK4/6 inhibitors: a … R Scafetta, R Troiano, C Gullotta, A Guarino, C Fiore, L Sisca, E Speziale, ... European Journal of Cancer, 116703 , 2026 2026
Comparative analysis of Denosumab and Zoledronic acid in advanced breast cancer patients receiving CDK4/6 inhibitors R Scafetta, M Donato, C Gullotta, A Guarino, C Fiore, L Sisca, E Speziale, ... The Breast 82, 104502 , 2025 2025 Citations: 7
3313 Impact of radiotherapy heart dose in HER 2+ breast cancer patients undergoing chemotherapy with trastuzumab pertuzumab: a real life multicentre study E Ippolito, V Masiello, S De Matteis, P Anselmo, F Marazzi, S Minuti, ... Radiotherapy and Oncology 206, S568-S569 , 2025 2025
Prognostic value of lymph node ratio (LNR) and log odds of positive lymph nodes (LODDS) in patients with locally advanced triple-negative breast cancer: An oncological-high … I Puccica, S Cappelli, M Clementi, M Mazzotta, D Corallino, P Vici, ... Il Giornale di Chirurgia-Journal of the Italian Surgical Association 45 (2), e65 , 2025 2025
Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study E Krasniqi, L Filomeno, T Arcuri, FS Di Lisa, A Astone, C Cutigni, ... Cancers 16 (23), 4104 , 2024 2024 Citations: 1
Transcriptional Phenocopies of Deleterious KEAP1 Mutations Correlate with Survival Outcomes in Lung Cancer Treated with Immunotherapy S Scalera, B Ricciuti, D Marinelli, M Mazzotta, L Cipriani, G Bon, ... Clinical Cancer Research 30 (19), 4397-4411 , 2024 2024 Citations: 3
Abstract PO4-04-10: Selection criteria for second-line treatments after Cyclin-dependent kinase 4/6 inhibitors failure in Hormone Receptor positive metastatic breast cancer … ME Cazzaniga, E Rossi, A Turla, M Ambroggi, A Baggi, R Berardi, ... Cancer Research 84 (9_Supplement), PO4-04-10-PO4-04-10 , 2024 2024
Selection criteria for second-line treatments after Cyclin-dependent kinase 4/6 inhibitors failure in Hormone Receptor positive metastatic breast cancer patients: the … ME Cazzaniga, E Rossi, A Turla, M Ambroggi, A Baggi, R Berardi, ... CANCER RESEARCH 84 (9) , 2024 2024
Transcriptional phenocopies of deleterious KEAP1 mutations dictate survival outcomes in lung cancer treated with immunotherapy S Scalera, B Ricciuti, D Marinelli, M Mazzotta, L Cipriani, G Bon, ... medRxiv, 2023.10. 30.23297743 , 2023 2023
NRF2-driven transcription and KEAPness predict survival outcomes in lung cancer treated with immunotherapy S Scalera, B Ricciuti, D Marinelli, M Mazzotta, L Cipriani, G Bon, ... 2023
417P New insights into second-line (2L) choices after CDK4/6 inhibitors (CDK4/6i) in hormone receptor-positive (HR+)/human epidermal growth factor 2-negative (HER2-) metastatic … V Cogliati, E Rossi, A Turla, M Ambroggi, R Berardi, F Borella, L Coltelli, ... Annals of Oncology 34, S358 , 2023 2023
Pathologic response and survival after neoadjuvant chemotherapy with or without pertuzumab in patients with HER2-positive breast cancer: the Neopearl nationwide collaborative study A Fabbri, F Nelli, A Botticelli, D Giannarelli, E Marrucci, C Fiore, A Virtuoso, ... Frontiers in oncology 13, 1177681 , 2023 2023 Citations: 4
Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe , a multicentric … FS Di Lisa, E Krasniqi, L Pizzuti, M Barba, K Cannita, U De Giorgi, ... Frontiers in oncology 13, 1152123 , 2023 2023 Citations: 9
Clonal KEAP1 mutations with loss of heterozygosity share reduced immunotherapy efficacy and low immune cell infiltration in lung adenocarcinoma S Scalera, B Ricciuti, M Mazzotta, N Calonaci, JV Alessi, L Cipriani, G Bon, ... Annals of Oncology 34 (3), 275-288 , 2023 2023 Citations: 33
Dynamic changes in peripheral lymphocytes and antibody response following a third dose of SARS-CoV-2 mRNA-BNT162b2 vaccine in cancer patients EM Ruggeri, F Nelli, D Giannarelli, A Fabbri, JR Giron Berrios, A Virtuoso, ... Scientific Reports 12 (1), 21908 , 2022 2022 Citations: 12
Real-Life Experience of the Prognostic Significance of the Primary Tumor Location on the Timing of Colorectal Liver Metastases: A Retrospective Analysis C Signorelli, PM Amodio, MG Chilelli, R Santoro, M Schirripa, TV Ranalli, ... Cureus 14 (10) , 2022 2022 Citations: 1
The Impact of the Hippo Pathway and Cell Metabolism on Pathological Complete Response in Locally Advanced Her2+ Breast Cancer: The TRISKELE Multicenter Prospective Study E Krasniqi, FS Di Lisa, A Di Benedetto, M Barba, L Pizzuti, L Filomeno, ... Cancers 14 (19), 4835 , 2022 2022 Citations: 3
Peripheral lymphocyte subset counts predict antibody response after SARS-CoV-2 mRNA-BNT162b2 vaccine in cancer patients: Results from the Vax-On-Profile study F Nelli, A Fabbri, V Panichi, D Giannarelli, G Topini, JRG Berrios, ... International Immunopharmacology 108, 108774 , 2022 2022 Citations: 10
Immunogenicity and early clinical outcome after two or three doses of SARS-CoV-2 mRNA-BNT162b2 vaccine in actively treated cancer patients: results from the prospective … F Nelli, D Giannarelli, A Fabbri, MA Silvestri, JRG Berrios, A Virtuoso, ... Annals of Oncology 33 (7), 740-742 , 2022 2022 Citations: 9
MOST CITED SCHOLAR PUBLICATIONS
KEAP1-driven co-mutations in lung adenocarcinoma unresponsive to immunotherapy despite high tumor mutational burden D Marinelli, M Mazzotta, S Scalera, I Terrenato, F Sperati, L D'Ambrosio, ... Annals of Oncology 31 (12), 1746-1754 , 2020 2020 Citations: 231
Immunotherapy in HER2-positive breast cancer: state of the art and future perspectives E Krasniqi, G Barchiesi, L Pizzuti, M Mazzotta, A Venuti, M Maugeri-Saccà, ... Journal of hematology & oncology 12 (1), 111 , 2019 2019 Citations: 147
Neoadjuvant endocrine therapy in breast cancer: current knowledge and future perspectives G Barchiesi, M Mazzotta, E Krasniqi, L Pizzuti, D Marinelli, E Capomolla, ... International journal of molecular sciences 21 (10), 3528 , 2020 2020 Citations: 102
Mutations in the KEAP1-NFE2L2 pathway define a molecular subset of rapidly progressing lung adenocarcinoma F Goeman, F De Nicola, S Scalera, F Sperati, E Gallo, L Ciuffreda, ... Journal of Thoracic Oncology 14 (11), 1924-1934 , 2019 2019 Citations: 87
KEAP1-mutant NSCLC: the catastrophic failure of a cell-protecting hub S Scalera, M Mazzotta, C Cortile, E Krasniqi, R De Maria, F Cappuzzo, ... Journal of thoracic oncology 17 (6), 751-757 , 2022 2022 Citations: 82
Loss of HER2 and decreased T-DM1 efficacy in HER2 positive advanced breast cancer treated with dual HER2 blockade: the SePHER Study G Bon, L Pizzuti, V Laquintana, R Loria, M Porru, C Marchiò, E Krasniqi, ... Journal of Experimental & Clinical Cancer Research 39 (1), 279 , 2020 2020 Citations: 75
A nomogram to predict survival in non-small cell lung cancer patients treated with nivolumab A Botticelli, M Salati, FR Di Pietro, L Strigari, B Cerbelli, IG Zizzari, R Giusti, ... Journal of Translational Medicine 17 (1), 99 , 2019 2019 Citations: 63
KEAP1 and TP53 frame genomic, evolutionary, and immunologic subtypes of lung adenocarcinoma with different sensitivity to immunotherapy S Scalera, M Mazzotta, G Corleone, F Sperati, I Terrenato, E Krasniqi, ... Journal of Thoracic Oncology 16 (12), 2065-2077 , 2021 2021 Citations: 60
A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study T Gamucci, L Pizzuti, C Natoli, L Mentuccia, I Sperduti, M Barba, D Sergi, ... Cancer Biology & Therapy 20 (2), 192-200 , 2019 2019 Citations: 51
Prognostic relevance of neutrophil to lymphocyte ratio (NLR) in luminal breast cancer: a retrospective analysis in the neoadjuvant setting A Grassadonia, V Graziano, L Iezzi, P Vici, M Barba, L Pizzuti, G Cicero, ... Cells 10 (7), 1685 , 2021 2021 Citations: 50
Long-term safety and real-world effectiveness of trastuzumab in breast cancer M Mazzotta, E Krasniqi, G Barchiesi, L Pizzuti, F Tomao, M Barba, P Vici Journal of clinical medicine 8 (2), 254 , 2019 2019 Citations: 43
Circulating HPV DNA in the management of oropharyngeal and cervical cancers: current knowledge and future perspectives E Krasniqi, M Barba, A Venuti, L Pizzuti, F Cappuzzo, L Landi, S Carpano, ... Journal of Clinical Medicine 10 (7), 1525 , 2021 2021 Citations: 39
Exploring the role of respiratory microbiome in lung cancer: A systematic review F Perrone, L Belluomini, M Mazzotta, M Bianconi, V Di Noia, F Meacci, ... Critical reviews in oncology/hematology 164, 103404 , 2021 2021 Citations: 37
Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real‐world evidence E Krasniqi, L Pizzuti, G Barchiesi, D Sergi, S Carpano, C Botti, R Kayal, ... Journal of cellular physiology 235 (11), 7900-7910 , 2020 2020 Citations: 35
Observational study of coagulation activation in early breast cancer: development of a prognostic model based on data from the real world setting C Mandoj, L Pizzuti, D Sergi, I Sperduti, M Mazzotta, L Di Lauro, A Amodio, ... Journal of translational medicine 16 (1), 129 , 2018 2018 Citations: 34
Clonal KEAP1 mutations with loss of heterozygosity share reduced immunotherapy efficacy and low immune cell infiltration in lung adenocarcinoma S Scalera, B Ricciuti, M Mazzotta, N Calonaci, JV Alessi, L Cipriani, G Bon, ... Annals of Oncology 34 (3), 275-288 , 2023 2023 Citations: 33
Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor‐positive, advanced breast cancer: a real‐world experience L Pizzuti, A Giordano, A Michelotti, M Mazzotta, C Natoli, T Gamucci, ... Journal of Cellular Physiology 234 (6), 7708-7717 , 2019 2019 Citations: 30
Eribulin in triple negative metastatic breast cancer: critic interpretation of current evidence and projection for future scenarios L Pizzuti, E Krasniqi, G Barchiesi, M Mazzotta, M Barba, A Amodio, ... Journal of Cancer 10 (24), 5903 , 2019 2019 Citations: 28
Efficacy of immunotherapy in lung cancer with co-occurring mutations in NOTCH and homologous repair genes M Mazzotta, M Filetti, M Occhipinti, D Marinelli, S Scalera, I Terrenato, ... Journal for Immunotherapy of Cancer 8 (2), e000946 , 2020 2020 Citations: 24
The clinical significance of PD-L1 in advanced gastric cancer is dependent on ARID1A mutations and ATM expression S Buglioni, E Melucci, F Sperati, M Pallocca, I Terrenato, F De Nicola, ... Oncoimmunology 7 (8), e1457602 , 2018 2018 Citations: 22