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Petrelli F.,Azienda Ospedaliera Treviglio Caravaggio | Barni S.,Azienda Ospedaliera Treviglio Caravaggio
Medical Oncology | Year: 2012

Adjuvant trastuzumab (T) significantly reduces the risk of progression and death in HER-2 positive highrisk early breast cancer. The differential benefit of T, administered either sequential or concomitant, has been calculated with 2 comparative meta-analyses of randomized trials. We have meta-analyzed sequential and concomitant arms of 6 T adjuvant trials separately and then calculated the pooled hazard ratios (HRs) for disease-free survival (DFS) and overall survival (OS) in both metaanalyses. Primary cardiac event rates have also been metaanalyzed. In the concomitant T meta-analysis, HRs for DFS and OS were 0.62 and 0.68, respectively (P < 0.0001 and <0.00001 for both endpoints). Conversely, in the sequential T meta-analysis, HRs for DFS and OS were, respectively, 0.74 and 0.87, where P is, however, significant only in the first comparison (P < 0.00001 and P = 0.09). Relative risks (RRs) for major cardiac events (severe cardiac hearth failure or death) are 2.44 (P = 0.07) in the concomitant T meta-analysis and 8.35 (P < 0.0001) in the sequential T meta-analysis. Concomitant adjuvant T therapy seems to give a significant and greater benefit than sequential administration in both DFS and OS, and the number of cases of severe cardiotoxicity does not seem to be higher in concomitant administration than in the sequential one. © Springer Science+Business Media, LLC 2011. Source


Petrelli F.,Azienda Ospedaliera Treviglio Caravaggio | Barni S.,Azienda Ospedaliera Treviglio Caravaggio
Medical Oncology | Year: 2012

Bevacizumab is approved for use as first-line therapy in advanced breast cancer according to pivotal ECOG 2,100 trial. Recently, Food and Drug Administration (FDA) voted unanimously against this licensed indication from the product's labeling. This is because 2 other trials have been conducted (AVADO and RIBBON-1) and both have shown a statistically significant improvement in progression-free survival, although of a much smaller magnitude than was seen in E2100 study. After metaanalysing 2-s-line randomized bevacizumab trials that addressed a little bit different populations (a pure secondline population in RIBBON2 and an heavily pretreated [1-2 previous lines] population in Miller trial), we have discovered that overall response rate (relative risk 1.63; 95% CI 1.02-2.62; P = 0.04) and progression-free survival (hazard ratio 0.85; 95% CI 0.73-0.98; P = 0.03) were significantly increased with the addition of bevacizumab to chemotherapy. Despite both trials, the results are not significant in terms of duration of responses; however, bevacizumab appears not to increase the toxicity of chemotherapy (in particular febrile neutropenia). In conclusion, bevacizumab label in breast cancer could be reconsidered at least for second-line setting where a standard option does not exist, and a real difference in OS is unproven and unnecessary with any regimen in randomized trials. © 2011 Springer Science+Business Media, LLC. Source


Petrelli F.,Azienda Ospedaliera Treviglio Caravaggio | Cabiddu M.,Azienda Ospedaliera Treviglio Caravaggio | Barni S.,Azienda Ospedaliera Treviglio Caravaggio
Medical Oncology | Year: 2012

The aim of this pooled-analysis is to evaluate the benefit of capecitabine (C) versus standard intravenous 5-Fluorouracil (5-FU) as monochemotherapy or combination therapy in advanced colorectal cancer (CRC) in terms of safety and efficacy. Eligible patients have been randomized to receive either C-based or 5-FU-based chemotherapy for the treatment of advanced CRC. Relative risks (RRs) with 95% confidence intervals (CIs) of selected side effects (diarrhea, nausea, vomiting, stomatitis, hand and foot syndrome, neutropoenia, febrile neutropoenia, and cardio toxicity) and overall response rate (ORR) were calculated and hazard ratios (HRs) of progression-free survival (PFS) and overall survival were obtained, respectively, from published data. The RRs of stomatitis and neutropoenia are 0.39 and 0.40, respectively with C (P<0.00001). In particular high-grade mucositis and neutropoenia, they are reduced by 69 and 74%, respectively (RR: 0.31 and 0.26). Diarrhea, nausea, vomiting, febrile neutropoenia, and cardio toxicity with C are not worse than with 5-FU. The RR of hand and foot syndrome with C compared to 5-FU is 3.45, (P<0.00001). Response rate, PFS, and OS are equivalent in both C- and 5-FUbased regimens. The use of C instead of 5-FU in advanced colorectal cancer regimens results in significantly less toxicity in terms of stomatitis and neutroponenia. Only hand and foot syndrome is worse with C than with 5-FU. Activity and efficacy are similar. Capecitabine could be therefore considered standard of care in advanced CRC. © Springer Science+Business Media, LLC 2011. Source


Barni S.,Azienda Ospedaliera Treviglio Caravaggio | Cabiddu M.,Azienda Ospedaliera Treviglio Caravaggio | Ghilardi M.,Azienda Ospedaliera Treviglio Caravaggio | Petrelli F.,Azienda Ospedaliera Treviglio Caravaggio
Critical Reviews in Oncology/Hematology | Year: 2011

Malignant ascites is defined as a condition in which fluid containing cancer cells accumulates in the abdomen. The cancers most commonly associated to ascites are ovarian (37%), pancreato-biliary (21%), gastric (18%), oesophageal (4%), colorectal (4%), and breast (3%). Treatment of malignant ascites remains a challenge. In the majority of patients systemic chemotherapy is ineffective and diuretics and paracentesis are still the only approaches, but new promising option are appearing, as cytoreductive debulking surgery and intraperitoneal (IP) or intravenous biological (target) therapies. More promising, after the recognition of potential epithelial targets as Epithelial Cell Adhesion Molecule (EpCAM), are the trifunctional antibodies able to bind these cell adhesion molecules and, at the same, time the immune system cells. These agents have been developed for malignant ascites with the aim also to prolong the need for subsequent paracentesis. So patients with malignant ascites may look at the future with hope and growing optimism. © 2010 Elsevier Ireland Ltd. Source


Petrelli F.,Azienda Ospedaliera Treviglio Caravaggio | Borgonovo K.,Azienda Ospedaliera Treviglio Caravaggio | Cabiddu M.,Azienda Ospedaliera Treviglio Caravaggio | Barni S.,Azienda Ospedaliera Treviglio Caravaggio
Clinical Lung Cancer | Year: 2012

Advanced nonsmall-cell lung cancer (NSCLC) harboring activating mutations of epidermal growth factor receptor (EGFR) are particularly sensitive to tyrosine kinase inhibitors (TKIs), namely erlotinib and gefitinib. The purpose of this meta-analysis was to evaluate the benefit of EGFR TKIs in EGFR-mutated NSCLCs. Eligible studies included published randomized controlled trials in which erlotinib or gefitinib (alone or with chemotherapy) were compared with standard therapy in 1260 patients with EGFR-mutated NSCLCs who were included in 13 trials. The mutational status was obtained through a retrospective or prospective analysis. Relative risk (RR) was calculated for response rate, and hazard ratios (HRs) were calculated for progression-free and overall survival. EGFR TKIs increase the chance of obtaining an objective response almost 2-fold when compared with chemotherapy (RR, 2.06; 2p <.00001). The response rate was 70% vs. 33.2% in first-line trials. In 3 second-line trials, response rates were 47.4% vs. 28.5%, with a benefit similar to first-line trials (RR, 1.79; 2p =.04). EGFR TKIs reduced the hazard of progression by 70% in all trials (HR, 0.30; 2p <.00001) and by 65% in first-line trials only (HR, 0.35; 2p <.00001). Overall, however, they do not improve survival (HR, 0.96; 2p =.71). NSCLCs harboring EGFR mutations derive greater benefit from erlotinib or gefitinib than from chemotherapy. All patients affected by NSCLC with an EGFR-positive mutation test result must be offered the opportunity to be treated with an EGFR TKI upfront or during the natural course of the disease if not previously exposed. © 2012 Elsevier Inc. All rights reserved. Source

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