Development and validation of a microRNA-based signature (MiROvaR) to predict early relapse or progression of epithelial ovarian cancer: a cohort study.
The Lancet Oncology 17(8):1137 (2016)
Risk of relapse or progression remains high in the treatment of most patients with epithelial ovarian cancer, and development of a molecular predictor could be a valuable tool for stratification of patients by risk. We aimed to develop a microRNA (miRNA)-based molecular classifier that can predi...
Patient-reported outcomes in the evaluation of toxicity of anticancer treatments.
Nature Reviews Clinical Oncology 13(5):319 (2016)
Symptomatic toxicities associated with anticancer treatments, such as nausea and vomiting, are frequently underreported by clinicians, even when data are prospectively collected within clinical trials. Such underreporting can result in an underestimation of the absolute rate of toxicity, which i...
Confirmed Activity and Tolerability of Weekly Paclitaxel in the Treatment of Advanced Angiosarcoma.
Sarcoma 2016:6862090 (2016)
Background. In several prospective and retrospective studies, weekly paclitaxel showed promising activity in patients with angiosarcoma. Patients and Methods. Our study was originally designed as a prospective, phase II multicenter trial for patients younger than 75, with ECOG performance status...
Afatinib: An overview of its clinical development in non-small-cell lung cancer and other tumors.
Critical Reviews in Oncology/Hematology 97:143 (2016)
Afatinib is an oral, irreversible, tyrosine kinase inhibitor (TKI) of EGFR, HER2 and HER4. According to phase I studies, the recommended dose of afatinib was 50mg daily. Rash, acne, diarrhea and stomatitis were the most common adverse events. Afatinib failed to demonstrate an improvement in over...
The organization of clinical trials for oncology at IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale" Napoli and the impact of the OECI accreditation process.
Tumori 101 Suppl 1:33 (2015)
The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori "Fondazione G. Pascale" (INT-Pascale) is the largest Clinical Care and Research Cancer Center in Southern Italy. The mission is prevention, diagnosis, and care of cancer and innovative research in oncology....
Subgroup Analysis: Refining a Positive Result or Trying to Rescue a Negative One?
Journal of Clinical Oncology 33(36):4310 (2015)
Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research.
Journal of Medical Ethics 41(10):799 (2015)
Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA support...
Reply to P. Baldo et al.
Journal of Clinical Oncology 33(25):2826 (2015)
Treatment of Elderly Patients With Non-Small-Cell Lung Cancer: Results of an International Expert Panel Meeting of the Italian Association of Thoracic Oncology.
Clinical Lung Cancer 16(5):325 (2015)
Most patients with non-small-cell lung cancer (NSCLC) are elderly, and age has important implications for their management and treatment. In May 2014, the Italian Association of Thoracic Oncology organized an International Experts Panel Meeting with the intent to review the available evidence re...
A meta-analysis of the impact of bronchial stump coverage on the risk of bronchopleural fistula after pneumonectomy.
European Journal of Cardio-thoracic Surgery 48(2):196 (2015)
The occurrence of bronchopleural fistula (BPF) after pneumonectomy is associated with high morbidity and mortality. The incidence of BPF in historical patients not subjected to bronchial stump coverage (BSC) was between 6 and 12% after pneumonectomy for lung cancer surgery or benign disease. BSC...
Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial.
The Lancet Oncology 16(5):561 (2015)
Inhibition of angiogenesis is a valuable treatment strategy for ovarian cancer. Pazopanib is an anti-angiogenic drug active in ovarian cancer. We assessed the effect of adding pazopanib to paclitaxel for patients with platinum-resistant or platinum-refractory advanced ovarian cancer.
We did this...
Adjuvant Ovarian Suppression in Premenopausal Breast Cancer
New England Journal of Medicine 372(17):1672 (2015)
To the Editor: The results of the Suppression of Ovarian Function Trial (SOFT) by Francis et al. (Jan. 29 issue)1 are presented as practice changing. However, we are concerned about the emphasis given to the receipt of adjuvant chemotherapy — which was considered as a proxy for a disea...
Adjuvant ovarian suppression in premenopausal breast cancer.
New England Journal of Medicine 372(17):1672 (2015)
Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials.
Journal of Clinical Oncology 33(8):910 (2015)
Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients, but rather on reports by clinicians in trials. Given the potential for under-reporting, our aim was to compare reporting by patients and physicians of six toxicities (anorexia, nausea, vo...
What is the future for cancer clinical trials?
Future Oncology 11(1):5 (2015)
Prognostic Relevance of Objective Response According to EASL Criteria and mRECIST Criteria in Hepatocellular Carcinoma Patients Treated with Loco-Regional Therapies: A Literature-Based Meta-Analysis.
PLoS ONE 10(7):e0133488 (2015)
The European Association for the Study of the Liver (EASL) criteria and the modified Response Evaluation Criteria in Solid Tumors (mRECIST) are currently adopted to evaluate radiological response in patients affected by HCC and treated with loco-regional procedures. Several studies explored the ...
A randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme).
BMC Cancer 16(1):69 (2015)
Despite the improvements in diagnosis and treatment, colorectal cancer (CRC) is the second cause of cancer deaths in both sexes. Therefore, research in this field remains of great interest. The approval of bevacizumab, a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibod...
[Sustainability and new anticancer drugs].
Recenti progressi in medicina 106(1):11 (2015)
Economic problems have been reported ever more frequently to affect the chance of cancer treatment, and financial toxicity has become a relevant issue in many countries, including the United States. Data are lacking for Europe, but the impressive cost of all new anticancer drugs is challenging E...
Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial.
The Lancet Oncology 15(12):1379 (2014)
Dacomitinib is an irreversible pan-HER tyrosine-kinase inhibitor with preclinical and clinical evidence of activity in non-small-cell lung cancer. We designed BR.26 to assess whether dacomitinib improved overall survival in heavily pretreated patients with this disease.
In this double-blind, ran...
Six versus fewer planned cycles of first-line platinum-based chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data
The Lancet Oncology 15(11):1254 (2014)
Platinum-based chemotherapy is the standard first-line treatment for patients with advanced non-small-cell lung cancer. However, the optimum number of treatment cycles remains controversial. Therefore, we did a systematic review and meta-analysis of individual pati...