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3 results on '"Dotti, K. F."'

2. Khorana score and thromboembolic risk in stage II–III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial

Author

Barni, S, Rosati, G, Lonardi, S, Pella, N, Banzi, M, Zampino, M, Dotti, K, Rimassa, L, Marchetti, P, Maiello, E, Artioli, F, Ferrari, D, Labianca, R, Bidoli, P, Zaniboni, A, Sobrero, A, Iaffaioli, V, De Placido, S, Frassineti, G, Ciarlo, A, Buonadonna, A, Silvestris, N, Piazza, E, Pavesi, L, Moroni, M, Clerico, M, Aglietta, M, Giordani, P, Galli, F, Petrelli, F, Barni S., Rosati G., Lonardi S., Pella N., Banzi M., Zampino M. G., Dotti K. F., Rimassa L., Marchetti P., Maiello E., Artioli F., Ferrari D., Labianca R., Bidoli P., Zaniboni A., Sobrero A., Iaffaioli V., De Placido S., Frassineti G. L., Ciarlo A., Buonadonna A., Silvestris N., Piazza E., Pavesi L., Moroni M., Clerico M., Aglietta M., Giordani P., Galli F., Petrelli F., Barni, S, Rosati, G, Lonardi, S, Pella, N, Banzi, M, Zampino, M, Dotti, K, Rimassa, L, Marchetti, P, Maiello, E, Artioli, F, Ferrari, D, Labianca, R, Bidoli, P, Zaniboni, A, Sobrero, A, Iaffaioli, V, De Placido, S, Frassineti, G, Ciarlo, A, Buonadonna, A, Silvestris, N, Piazza, E, Pavesi, L, Moroni, M, Clerico, M, Aglietta, M, Giordani, P, Galli, F, Petrelli, F, Barni S., Rosati G., Lonardi S., Pella N., Banzi M., Zampino M. G., Dotti K. F., Rimassa L., Marchetti P., Maiello E., Artioli F., Ferrari D., Labianca R., Bidoli P., Zaniboni A., Sobrero A., Iaffaioli V., De Placido S., Frassineti G. L., Ciarlo A., Buonadonna A., Silvestris N., Piazza E., Pavesi L., Moroni M., Clerico M., Aglietta M., Giordani P., Galli F., and Petrelli F.

Abstract

Background: The risk of venous thromboembolic events (VTE) during adjuvant chemotherapy for colorectal cancer (CRC) is unknown. We aim to evaluate if the Khorana score (KS) can predict this risk, and if it represents a prognostic factor for overall survival (OS) through a post hoc analysis of the phase III TOSCA trial of different durations (3- versus 6-months) of adjuvant chemotherapy. Methods: A logistic regression model was used to test the associations between the risk of VTE and the KS. The results are expressed as odds ratios (OR) with 95% confidence intervals (95% CI). To assess the effect of the KS on OS, multivariable analyses using Cox regression models were performed. The results are expressed as hazard ratios (HR) with 95% CI. Results: Among 1380 CRC patients with available data, the VTE risk (n = 72 events: 5.2%) was similar in the two duration arms (5.5% versus 4.9%), with 0.2% of patients belonging to the high-risk KS group. Rates of VTE were similar in the low- and intermediate-risk groups (4.8% versus 6.4%). KS did not represent an independent predictive factor for VTE occurrence. Chemotherapy duration was not associated with VTE risk. In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63–1.36; p = 0.6835). Conclusions: The use of the KS did not predict VTEs in a low–moderate thromboembolic risk population as CRC. These data did not support the use of KS to predict VTE during adjuvant chemotherapy, and suggest that other risk assessment models should be researched.

Published
2020

3. Impact of Metformin Use and Diabetic Status During Adjuvant Fluoropyrimidine-Oxaliplatin Chemotherapy on the Outcome of Patients with Resected Colon Cancer: A TOSCA Study Subanalysis

Author

Vincenzo Adamo, Sabino De Placido, Luigi Cavanna, Evaristo Maiello, Sandro Barni, Francesca Galli, Claudio Vernieri, M. Nicolini, Massimo Aglietta, Sara Lonardi, Maria Di Bartolomeo, Laura Ferrari, Emiliano Tamburini, Azzurra Damiani, Maria Giulia Zampino, Rosario Vincenzo Iaffaioli, Francesco Leonardi, Gerardo Rosati, Katia Fiorella Dotti, F. Galli, Paolo Marchetti, Paolo Giordani, Giovanni Lo Re, Alberto Zaniboni, Roberto Labianca, Maria Antista, Tosca Investigators, A. Ciarlo, Maria Banzi, Lorenzo Pavesi, Paolo Bidoli, Giovanni Luca Frassineti, Maria Chiara Tronconi, S. Ferrario, Stefania Gori, Daris Ferrari, Marina Faedi, Mario Clerico, Angela Buonadonna, Saverio Cinieri, Vernieri, C., Galli, F., Ferrari, L., Marchetti, P., Lonardi, S., Maiello, E., Iaffaioli, R. V., Zampino, M. G., Zaniboni, A., De Placido, S., Banzi, M., Damiani, A., Ferrari, D., Rosati, G., Labianca, R. F., Bidoli, P., Frassineti, G. L., Nicolini, M., Pavesi, L., Tronconi, M. C., Buonadonna, A., Ferrario, S., Re, G. L., Adamo, V., Tamburini, E., Clerico, M., Giordani, P., Leonardi, F., Barni, S., Ciarlo, A., Cavanna, L., Gori, S., Cinieri, S., Faedi, M., Aglietta, M., Antista, M., Dotti, K. F., Di Bartolomeo, M., Vernieri, C, Galli, F, Ferrari, L, Marchetti, P, Lonardi, S, Maiello, E, Iaffaioli, R, Zampino, M, Zaniboni, A, De Placido, S, Banzi, M, Damiani, A, Ferrari, D, Rosati, G, Labianca, R, Bidoli, P, Frassineti, G, Nicolini, M, Pavesi, L, Tronconi, M, Buonadonna, A, Ferrario, S, Re, G, Adamo, V, Tamburini, E, Clerico, M, Giordani, P, Leonardi, F, Barni, S, Ciarlo, A, Cavanna, L, Gori, S, Cinieri, S, Faedi, M, Aglietta, M, Antista, M, Dotti, K, and Di Bartolomeo, M

Subjects
Aged, Antineoplastic Agents, Chemotherapy, Adjuvant, Colonic Neoplasms, Diabetes Mellitus, Type 2, Female, Fluorouracil, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Oxaliplatin, Risk Factors, 0301 basic medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, endocrine system diseases, Colorectal cancer, colon cancer (CC), radical surgery, Antineoplastic Agents, 03 medical and health sciences, 0302 clinical medicine, Type 2 diabetes mellitus (T2DM), colon cancer (CC), metformin, radical surgery, TOSCA study, Risk Factors, Diabetes mellitus, Internal medicine, Gastrointestinal Cancer, medicine, Adjuvant therapy, Humans, Hypoglycemic Agents, Prospective cohort study, Cancer staging, business.industry, Hazard ratio, nutritional and metabolic diseases, Middle Aged, medicine.disease, Metformin, Oxaliplatin, Type 2 diabetes mellitus (T2DM), 030104 developmental biology, TOSCA study, colon cancer, Diabetes Mellitus, Type 2, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Colonic Neoplasms, Female, Fluorouracil, business, medicine.drug
Abstract

Background Type 2 diabetes mellitus (T2DM) is associated with increased risk of colon cancer (CC), whereas metformin use seems to be protective. However, the impact of metformin use on the risk of death or disease recurrence after radical surgery for CC remains uncertain. Materials and Methods This is a substudy conducted in patients with high-risk stage II or stage III CC randomized in the TOSCA trial, which compared 3 versus 6 months of fluoropyrimidine-oxaliplatin adjuvant chemotherapy. Objective of the study was to investigate the impact of metformin exposure during adjuvant chemotherapy on overall survival (OS) and relapse-free survival (RFS). We also evaluated the impact of T2DM or metformin dosage on clinical outcomes. Results Out of 3,759 patients enrolled in the TOSCA trial, 133 patients with diabetes (9.2%) and 1,319 without diabetes (90.8%) were recruited in this study. After excluding 13 patients with diabetes without information on metformin exposure, 76 patients with T2DM (63.3%) were defined as metformin users and 44 (36.7%) as metformin nonusers. After a median follow-up of 60.4 months, 26 (21.7%) patients relapsed and 16 (13.3%) died. Metformin use was neither associated with OS (adjusted hazard ratio [HR], 1.51; 95% confidence interval [CI], 0.48–4.77; p = .4781) nor with RFS (HR, 1.56; 95% CI, 0.69–3.54; p = .2881). Similarly, we found no association between T2DM or metformin dosage and OS or RFS. Conclusions Metformin use and T2DM did not impact on OS or RFS in patients with resected CC treated with adjuvant fluoropyrimidine-oxaliplatin chemotherapy. Larger studies and longer follow-up are required to clarify the potential efficacy of metformin in improving the prognosis of patients with CC. Implications for Practice The role of the antidiabetic drug metformin in colon cancer prevention and treatment is highly debated. While low-dose metformin reduced the incidence of colorectal adenomas in two prospective studies, its effect in patients with already established colon cancer remains unclear. In this study, the potential impact of metformin on the survival of resected colon cancer patients who received adjuvant chemotherapy was investigated in the context of the TOSCA study. We did not find any association between metformin use or dosages and patient survival. Prospective studies are required to draw definitive conclusions about metformin impact on colon cancer recurrence and survival.

Published
2018

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