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1. Adjuvant capecitabine in triple negative breast cancer patients with residual disease after neoadjuvant treatment: real-world evidence from CaRe, a multicentric, observational study

Author

Di Lisa, F, Krasniqi, E, Pizzuti, L, Barba, M, Cannita, K, De Giorgi, U, Borella, F, Foglietta, J, Cariello, A, Ferro, A, Picardo, E, Mitidieri, M, Sini, V, Stani, S, Tonini, G, Santini, D, La Verde, N, Gambaro, A, Grassadonia, A, Tinari, N, Garrone, O, Sarobba, G, Livi, L, Meattini, I, D'Auria, G, Vergati, M, Gamucci, T, Pistelli, M, Berardi, R, Risi, E, Giotta, F, Lorusso, V, Rinaldi, L, Artale, S, Cazzaniga, M, Zustovich, F, Cappuzzo, F, Landi, L, Torrisi, R, Scagnoli, S, Botticelli, A, Michelotti, A, Fratini, B, Saltarelli, R, Paris, I, Muratore, M, Cassano, A, Gianni, L, Gaspari, V, Veltri, E, Zoratto, F, Fiorio, E, Fabbri, M, Mazzotta, M, Ruggeri, E, Pedersini, R, Valerio, M, Filomeno, L, Minelli, M, Scavina, P, Raffaele, M, Astone, A, De Vita, R, Pozzi, M, Riccardi, F, Greco, F, Moscetti, L, Giordano, M, Maugeri-Sacca, M, Zennaro, A, Botti, C, Pelle, F, Cappelli, S, Cavicchi, F, Vizza, E, Sanguineti, G, Tomao, F, Cortesi, E, Marchetti, P, Tomao, S, Speranza, I, Sperduti, I, Ciliberto, G, Vici, P, Di Lisa F. S., Krasniqi E., Pizzuti L., Barba M., Cannita K., De Giorgi U., Borella F., Foglietta J., Cariello A., Ferro A., Picardo E., Mitidieri M., Sini V., Stani S., Tonini G., Santini D., La Verde N., Gambaro A. R., Grassadonia A., Tinari N., Garrone O., Sarobba G., Livi L., Meattini I., D'Auria G., Vergati M., Gamucci T., Pistelli M., Berardi R., Risi E., Giotta F., Lorusso V., Rinaldi L., Artale S., Cazzaniga M. E., Zustovich F., Cappuzzo F., Landi L., Torrisi R., Scagnoli S., Botticelli A., Michelotti A., Fratini B., Saltarelli R., Paris I., Muratore M., Cassano A., Gianni L., Gaspari V., Veltri E. M., Zoratto F., Fiorio E., Fabbri M. A., Mazzotta M., Ruggeri E. M., Pedersini R., Valerio M. R., Filomeno L., Minelli M., Scavina P., Raffaele M., Astone A., De Vita R., Pozzi M., Riccardi F., Greco F., Moscetti L., Giordano M., Maugeri-Sacca M., Zennaro A., Botti C., Pelle F., Cappelli S., Cavicchi F., Vizza E., Sanguineti G., Tomao F., Cortesi E., Marchetti P., Tomao S., Speranza I., Sperduti I., Ciliberto G., Vici P., Di Lisa, F, Krasniqi, E, Pizzuti, L, Barba, M, Cannita, K, De Giorgi, U, Borella, F, Foglietta, J, Cariello, A, Ferro, A, Picardo, E, Mitidieri, M, Sini, V, Stani, S, Tonini, G, Santini, D, La Verde, N, Gambaro, A, Grassadonia, A, Tinari, N, Garrone, O, Sarobba, G, Livi, L, Meattini, I, D'Auria, G, Vergati, M, Gamucci, T, Pistelli, M, Berardi, R, Risi, E, Giotta, F, Lorusso, V, Rinaldi, L, Artale, S, Cazzaniga, M, Zustovich, F, Cappuzzo, F, Landi, L, Torrisi, R, Scagnoli, S, Botticelli, A, Michelotti, A, Fratini, B, Saltarelli, R, Paris, I, Muratore, M, Cassano, A, Gianni, L, Gaspari, V, Veltri, E, Zoratto, F, Fiorio, E, Fabbri, M, Mazzotta, M, Ruggeri, E, Pedersini, R, Valerio, M, Filomeno, L, Minelli, M, Scavina, P, Raffaele, M, Astone, A, De Vita, R, Pozzi, M, Riccardi, F, Greco, F, Moscetti, L, Giordano, M, Maugeri-Sacca, M, Zennaro, A, Botti, C, Pelle, F, Cappelli, S, Cavicchi, F, Vizza, E, Sanguineti, G, Tomao, F, Cortesi, E, Marchetti, P, Tomao, S, Speranza, I, Sperduti, I, Ciliberto, G, Vici, P, Di Lisa F. S., Krasniqi E., Pizzuti L., Barba M., Cannita K., De Giorgi U., Borella F., Foglietta J., Cariello A., Ferro A., Picardo E., Mitidieri M., Sini V., Stani S., Tonini G., Santini D., La Verde N., Gambaro A. R., Grassadonia A., Tinari N., Garrone O., Sarobba G., Livi L., Meattini I., D'Auria G., Vergati M., Gamucci T., Pistelli M., Berardi R., Risi E., Giotta F., Lorusso V., Rinaldi L., Artale S., Cazzaniga M. E., Zustovich F., Cappuzzo F., Landi L., Torrisi R., Scagnoli S., Botticelli A., Michelotti A., Fratini B., Saltarelli R., Paris I., Muratore M., Cassano A., Gianni L., Gaspari V., Veltri E. M., Zoratto F., Fiorio E., Fabbri M. A., Mazzotta M., Ruggeri E. M., Pedersini R., Valerio M. R., Filomeno L., Minelli M., Scavina P., Raffaele M., Astone A., De Vita R., Pozzi M., Riccardi F., Greco F., Moscetti L., Giordano M., Maugeri-Sacca M., Zennaro A., Botti C., Pelle F., Cappelli S., Cavicchi F., Vizza E., Sanguineti G., Tomao F., Cortesi E., Marchetti P., Tomao S., Speranza I., Sperduti I., Ciliberto G., and Vici P.

Abstract

Background: In 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. Methods: We 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. Results: Overall, 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 >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. Conclusion: The 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 ef

Published
2023

2. Copy number alterations in stage I epithelial ovarian cancer highlight three genomic patterns associated with prognosis

Author

Pesenti, C, Beltrame, L, Velle, A, Fruscio, R, Jaconi, M, Borella, F, Cribiu, F, Calura, E, Venturini, L, Lenoci, D, Agostinis, F, Katsaros, D, Panini, N, Bianchi, T, Landoni, F, Miozzo, M, D'Incalci, M, Brenton, J, Romualdi, C, Marchini, S, Pesenti C., Beltrame L., Velle A., Fruscio R., Jaconi M., Borella F., Cribiu F. M., Calura E., Venturini L. V., Lenoci D., Agostinis F., Katsaros D., Panini N., Bianchi T., Landoni F., Miozzo M., D'Incalci M., Brenton J. D., Romualdi C., Marchini S., Pesenti, C, Beltrame, L, Velle, A, Fruscio, R, Jaconi, M, Borella, F, Cribiu, F, Calura, E, Venturini, L, Lenoci, D, Agostinis, F, Katsaros, D, Panini, N, Bianchi, T, Landoni, F, Miozzo, M, D'Incalci, M, Brenton, J, Romualdi, C, Marchini, S, Pesenti C., Beltrame L., Velle A., Fruscio R., Jaconi M., Borella F., Cribiu F. M., Calura E., Venturini L. V., Lenoci D., Agostinis F., Katsaros D., Panini N., Bianchi T., Landoni F., Miozzo M., D'Incalci M., Brenton J. D., Romualdi C., and Marchini S.

Abstract

Background: Stage I epithelial ovarian cancer (EOC) encompasses five histologically different subtypes of tumors confined to the ovaries with a generally favorable prognosis. Despite the intrinsic heterogeneity, all stage I EOCs are treated with complete resection and adjuvant therapy in most of the cases. Owing to the lack of robust prognostic markers, this often leads to overtreatment. Therefore, a better molecular characterization of stage I EOCs could improve the assessment of the risk of relapse and the refinement of optimal treatment options. Materials and methods: 205 stage I EOCs tumor biopsies with a median follow-up of eight years were gathered from two independent Italian tumor tissue collections, and the genome distribution of somatic copy number alterations (SCNAs) was investigated by shallow whole genome sequencing (sWGS) approach. Results: Despite the variability in SCNAs distribution both across and within the histotypes, we were able to define three common genomic instability patterns, namely stable, unstable, and highly unstable. These patterns were based on the percentage of the genome affected by SCNAs and on their length. The genomic instability pattern was strongly predictive of patients’ prognosis also with multivariate models including currently used clinico-pathological variables. Conclusions: The results obtained in this study support the idea that novel molecular markers, in this case genomic instability patterns, can anticipate the behavior of stage I EOC regardless of tumor subtype and provide valuable prognostic information. Thus, it might be propitious to extend the study of these genomic instability patterns to improve rational management of this disease.

Published
2022

3. A comprehensive investigation of histotype-specific microRNA and their variants in stage I epithelial ovarian cancers

Author

Velle, A, Pesenti, C, Grassi, T, Beltrame, L, Martini, P, Jaconi, M, Agostinis, F, Calura, E, Katsaros, D, Borella, F, Fruscio, R, D'Incalci, M, Marchini, S, Romualdi, C, Velle, Angelo, Pesenti, Chiara, Grassi, Tommaso, Beltrame, Luca, Martini, Paolo, Jaconi, Marta, Agostinis, Federico, Calura, Enrica, Katsaros, Dionyssios, Borella, Fulvio, Fruscio, Robert, D'Incalci, Maurizio, Marchini, Sergio, Romualdi, Chiara, Velle, A, Pesenti, C, Grassi, T, Beltrame, L, Martini, P, Jaconi, M, Agostinis, F, Calura, E, Katsaros, D, Borella, F, Fruscio, R, D'Incalci, M, Marchini, S, Romualdi, C, Velle, Angelo, Pesenti, Chiara, Grassi, Tommaso, Beltrame, Luca, Martini, Paolo, Jaconi, Marta, Agostinis, Federico, Calura, Enrica, Katsaros, Dionyssios, Borella, Fulvio, Fruscio, Robert, D'Incalci, Maurizio, Marchini, Sergio, and Romualdi, Chiara

Abstract

isomiRs, the sequence-variants of microRNA, are known to be tissue and cell type specific but their physiological role is largely unknown. In this study we explored for the first time the expression of isomiRs across different stage I epithelial ovarian cancer (EOC) histological subtypes, in order to shed new light on their biological role in tumor growth and progression. In a multi-centric retrospective cohort of tumor biopsies (n=215) we sequenced small RNAs finding 971 expressed miRNAs, 64% of which are isomiRs. Among them, 42 isomiRs showed a clear histotype specific pattern, confirming our previously identified miRNA markers (miR192/194 and miR30a-3p/5p for mucinous and clear cell subtypes respectively) and uncovering new biomarkers for all the five subtypes. Using integrative models, we found that the 38% of these miRNA expression alterations is the result of copy number variations while the 17% of differential transcriptional activities. Our work represents the first attempt to characterize isomiRs expression in stage I EOC within and across subtypes and to contextualize their alterations in the framework of the large genomic heterogeneity of this tumor.

Published
2023

4. Transcriptional Characterization of Stage I Epithelial Ovarian Cancer: A Multicentric Study

Author

Calura, E, Ciciani, M, Sambugaro, A, Paracchini, L, Benvenuto, G, Milite, S, Martini, P, Beltrame, L, Zane, F, Fruscio, R, Marchette, M, Borella, F, Tognon, G, Ravaggi, A, Katsaros, D, Bignotti, E, Odicino, F, D'Incalci, M, Marchini, S, Romualdi, C, Calura, Enrica, Ciciani, Matteo, Sambugaro, Andrea, Paracchini, Lara, Benvenuto, Giuseppe, Milite, Salvatore, Martini, Paolo, Beltrame, Luca, Zane, Flaminia, Fruscio, Robert, Marchette, Martina Delle, Borella, Fulvio, Tognon, Germana, Ravaggi, Antonella, Katsaros, Dionyssios, Bignotti, Eliana, Odicino, Franco, D'Incalci, Maurizio, Marchini, Sergio, Romualdi, Chiara, Calura, E, Ciciani, M, Sambugaro, A, Paracchini, L, Benvenuto, G, Milite, S, Martini, P, Beltrame, L, Zane, F, Fruscio, R, Marchette, M, Borella, F, Tognon, G, Ravaggi, A, Katsaros, D, Bignotti, E, Odicino, F, D'Incalci, M, Marchini, S, Romualdi, C, Calura, Enrica, Ciciani, Matteo, Sambugaro, Andrea, Paracchini, Lara, Benvenuto, Giuseppe, Milite, Salvatore, Martini, Paolo, Beltrame, Luca, Zane, Flaminia, Fruscio, Robert, Marchette, Martina Delle, Borella, Fulvio, Tognon, Germana, Ravaggi, Antonella, Katsaros, Dionyssios, Bignotti, Eliana, Odicino, Franco, D'Incalci, Maurizio, Marchini, Sergio, and Romualdi, Chiara

Abstract

Stage I epithelial ovarian cancer (EOC) represents about 10% of all EOCs. It is characterized by a complex histopathological and molecular heterogeneity, and it is composed of five main histological subtypes (mucinous, endometrioid, clear cell and high, and low grade serous), which have peculiar genetic, molecular, and clinical characteristics. As it occurs less frequently than advanced-stage EOC, its molecular features have not been thoroughly investigated. In this study, using in silico approaches and gene expression data, on a multicentric cohort composed of 208 snap-frozen tumor biopsies, we explored the subtype-specific molecular alterations that regulate tumor aggressiveness in stage I EOC. We found that single genes rather than pathways are responsible for histotype specificities and that a cAMP-PKA-CREB1 signaling axis seems to play a central role in histotype differentiation. Moreover, our results indicate that immune response seems to be, at least in part, involved in histotype differences, as a higher immune-reactive behavior of serous and mucinous samples was observed with respect to other histotypes.

Published
2019

5. Transcriptional Characterization of Stage I Epithelial Ovarian Cancer: A Multicentric Study

Author

Calura, E, Ciciani, M, Sambugaro, A, Paracchini, L, Benvenuto, G, Milite, S, Martini, P, Beltrame, L, Zane, F, Fruscio, R, Marchette, M, Borella, F, Tognon, G, Ravaggi, A, Katsaros, D, Bignotti, E, Odicino, F, D'Incalci, M, Marchini, S, Romualdi, C, Calura, Enrica, Ciciani, Matteo, Sambugaro, Andrea, Paracchini, Lara, Benvenuto, Giuseppe, Milite, Salvatore, Martini, Paolo, Beltrame, Luca, Zane, Flaminia, Fruscio, Robert, Marchette, Martina Delle, Borella, Fulvio, Tognon, Germana, Ravaggi, Antonella, Katsaros, Dionyssios, Bignotti, Eliana, Odicino, Franco, D'Incalci, Maurizio, Marchini, Sergio, Romualdi, Chiara, Calura, E, Ciciani, M, Sambugaro, A, Paracchini, L, Benvenuto, G, Milite, S, Martini, P, Beltrame, L, Zane, F, Fruscio, R, Marchette, M, Borella, F, Tognon, G, Ravaggi, A, Katsaros, D, Bignotti, E, Odicino, F, D'Incalci, M, Marchini, S, Romualdi, C, Calura, Enrica, Ciciani, Matteo, Sambugaro, Andrea, Paracchini, Lara, Benvenuto, Giuseppe, Milite, Salvatore, Martini, Paolo, Beltrame, Luca, Zane, Flaminia, Fruscio, Robert, Marchette, Martina Delle, Borella, Fulvio, Tognon, Germana, Ravaggi, Antonella, Katsaros, Dionyssios, Bignotti, Eliana, Odicino, Franco, D'Incalci, Maurizio, Marchini, Sergio, and Romualdi, Chiara

Abstract

Stage I epithelial ovarian cancer (EOC) represents about 10% of all EOCs. It is characterized by a complex histopathological and molecular heterogeneity, and it is composed of five main histological subtypes (mucinous, endometrioid, clear cell and high, and low grade serous), which have peculiar genetic, molecular, and clinical characteristics. As it occurs less frequently than advanced-stage EOC, its molecular features have not been thoroughly investigated. In this study, using in silico approaches and gene expression data, on a multicentric cohort composed of 208 snap-frozen tumor biopsies, we explored the subtype-specific molecular alterations that regulate tumor aggressiveness in stage I EOC. We found that single genes rather than pathways are responsible for histotype specificities and that a cAMP-PKA-CREB1 signaling axis seems to play a central role in histotype differentiation. Moreover, our results indicate that immune response seems to be, at least in part, involved in histotype differences, as a higher immune-reactive behavior of serous and mucinous samples was observed with respect to other histotypes.

Published
2019

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