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Gridelli C.,S.G. Moscati Hospital | Rossi A.,S.G. Moscati Hospital | de Marinis F.,Thoracic Oncology Unit 1st
Lung Cancer | Year: 2010

Purpose and methods: To evaluate how the new strategic approaches impact on clinical practice for the treatment of advanced non-small cell lung cancer (NSCLC) in Italy, an Italian survey was launched through the Italian Association of Thoracic Oncology (AIOT) website. The survey included 16 items with multiple answers: 4 regarding the professional characteristics of each member, 9 the first-line treatment, and 3 the second-line therapy. Results: From June 30 to July 30, 2008, 320 oncologists, AIOT members, were invited to fulfil the survey. A total of 176 (55%) out of 320 invited members completed the questionnaire. The data evidenced a high adherence to the International guidelines. In fact, the standard of care are platinum-based regimens for first-line therapy, single-agent chemotherapy for "special patients populations" including elderly and PS 2 patients, and licensed agents, i.e. docetaxel, pemetrexed and erlotinib, for second-line therapy. Moreover, great importance is given to the need of a specific histology diagnosis for an appropriate "histology-based treatment". Conclusions: The present survey highlights a high adherence to the International guidelines and the importance of choosing an appropriate "histology-based treatment" by the Italian oncologists. © 2009 Elsevier Ireland Ltd. All rights reserved. Source

Gridelli C.,S.G. Moscati Hospital | Morgillo F.,The Second University of Naples | Favaretto A.,Istituto Oncologico Veneto | de Marinis F.,Thoracic Oncology Unit 1st | And 11 more authors.
Annals of Oncology | Year: 2011

Background: Sorafenib is a small-molecule multitargeted kinase inhibitor that blocks the activation of C-RAF, B-RAF, c-KIT, FLT-3, RET, vascular endothelial growth factor receptor 2 (VEGFR-2), VEGFR-3 and platelet-derived growth factor receptor β. The aim of this multicenter, randomized phase II study was to evaluate clinical activity and safety of sorafenib in combination with erlotinib or gemcitabine in unselected untreated elderly patients with non-small-cell lung cancer (NSCLC). Methods: The trial was designed to select the most promising sorafenib-containing combination in previously untreated elderly (≥70 years) stage IIIB or IV NSCLC patients, with performance status of zero to two. Patients were randomly assigned to one of the following combinations: gemcitabine, 1200 mg/m2 days 1 and 8, every 21 days, for a maximum of six cycles, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 1); or erlotinib, 150 mg/day, plus sorafenib, 800 mg/day, until disease progression or unacceptable toxicity (arm 2). A selection design was applied with 1-year survival rate as the primary end point of the study, requiring 58 patients. Results: Sixty patients were randomly allocated to the study (31 patients in arm 1 and 29 patients in arm 2). After a median follow-up of 15 months, 10 patients [32%, 95% confidence interval (CI) 16% to 49%] in arm 1 and 13 patients (45%, 95% CI 27% to 63%) in arm 2 were alive at 1 year. Median overall survival was 6.6 and 12.6 months in arm 1 and arm 2, respectively. Observed toxic effects were consistent with the expected drug profiles. Conclusions: The combination of erlotinib and sorafenib was feasible in elderly patients with advanced NSCLC and was associated with a higher 1-year survival rate than the other arm. According to the selection design, this combination warrants further investigation in phase III trials. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Ricciardi S.,Thoracic Oncology Unit 1st | De Marinis F.,Thoracic Oncology Unit 1st
Current Opinion in Oncology | Year: 2010

Purpose of Review: Brain metastases are an important cause of morbidity and mortality, and are the most common intracranial tumors in adults. The prognosis of patients with brain metastases is very poor. The increasing incidence of brain metastases is directly related to the improvements in the treatment of systemic disease. Commonly, brain metastases are discovered after the diagnosis of cancer, often after other systemic metastases have developed.In this review article, we present the standard treatment approach and discuss new directions. Recent Findings: The most widely used treatment for patients with brain metastases is whole-brain radiotherapy. Actually, surgery and radiotherapy remain the principal therapeutic interventions. In contrast, the benefit of chemotherapy has long been viewed with skepticism.In an effort to improve the therapeutic ratio, radiosensitizers are often used concurrently with external-beam radiation: motexafin gadolinium and efaproxaril.Novel anticancer agents are under clinical investigation. Summary: The management of patients with brain metastases with non-small cell lung cancer has improved over time, due to the development of new treatment options and a better knowledge of prognostic factors.In the next 5 years, the results of several ongoing multicenter randomized trials will become available to further define the role of various radiation sensitizers and chemotherapeutic agents in combination with stereotactic radiosurgery, whole-brain radiation therapy, or both. Copyright © 2010 Lippincott Williams & Wilkins. Source

Ricciardi S.,Thoracic Oncology Unit 1st | De Marinis F.,Thoracic Oncology Unit 1st
Oncology | Year: 2010

Lung cancer is the leading cause of cancer deaths worldwide. Novel targeted therapies based on specific molecular and biological characteristics of lung cancer have emerged as a new treatment paradigm. The current globally accepted standard of treatment for advanced non-small-cell lung cancer (NSCLC) is platinum-based combination therapy. Recently, several ongoing phase I and II trials with new drugs in NSCLC have been registered, such as sorafenib, sunitinib, mTOR inhibitors and ASA404. The optimal use of new agents is more likely in combination with standard cytotoxic or other targeted agents. Further investigations into adverse events with targeted therapy are urgently needed as these impact an increasing number of patients. Copyright © 2010 S. Karger AG. Source

Ricciardi S.,Thoracic Oncology Unit 1st | Tomao S.,University of Rome La Sapienza | de Marinis F.,Thoracic Oncology Unit 1st
Lung Cancer: Targets and Therapy | Year: 2011

Lung cancer is the leading cause of cancer deaths worldwide. Targeting the epidermal growth factor receptor (EGFR) has played a central role in advancing non-small-cell lung cancer (NSCLC) research, treatment, and patient outcome over the last few years. Erlotinib is a human epidermal growth factor receptor Type 1/EGFR tyrosine kinase inhibitor. Erlotinib monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen. We present the results of phase I, II, III, and IV trials. Erlotinib monotherapy has shown a significant improvement in median survival, quality of life, and related symptoms in an unselected population of patients in second- and third-line therapy as a single agent. Most commonly reported erlotinib-related adverse effects were rash and diarrhea. In general, patients with adenocarcinoma histology, female gender, Asian ethnicity, and nonsmokers have a better response when treated with erlotinib. Ongoing trials seek to improve therapy with this agent in monotherapy or in combination regimens and better understanding of predictors of benefit with therapy © 2011 Ricciardi et al, publisher and licensee Dove Medical Press Ltd. Source

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