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Stacchiotti S.,Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori | Palassini E.,Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori | Sanfilippo R.,Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori | Vincenzi B.,Biomedical University of Rome | And 9 more authors.
Annals of Oncology | Year: 2012

Background: Angiosarcoma is a highly aggressive soft tissue sarcoma. Responses to anthracyclines plus/minus ifosfamide, and taxanes alone or in combination with gemcitabine are well documented. Very few data are available on gemcitabine as a single agent. Patients and methods: We retrospectively reviewed all cases of advanced progressive angiosarcoma treated with gemcitabine as a single agent (1000 mg/m. 2 i.v. every week for 3 weeks every 4 weeks), at Istituto Nazionale Tumori and within the Italian Rare Cancers Network from January 2008 to November 2010. Results: Twenty-five patients [mean age: 52 years; radiation therapy (RT)-related: 8] received gemcitabine. Best tumor response by RECIST was as follows: complete response = 2, partial response = 14, stable disease = 2, progressive disease = 7 cases, for an overall response rate (PR + CR) of 68%. Six of eight post-RT angiosarcomas responded to treatment. Median overall survival (OS) was 17 months. Median progression-free survival (PFS) was 7 months (range 1-40 months). One patient with a locally advanced thyroid angiosarcoma became resectable after 5 months of gemcitabine, with <10% residual viable tumor cells seen on surgical specimen. Overall, gemcitabine was well tolerated. Conclusions: Gemcitabine is active in both RT- and non-RT-related angiosarcoma, with dimensional and possibly long-lasting responses. A formal phase II study on gemcitabine as a single agent is warranted. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Lebbe C.,University Paris Diderot | Lorigan P.,Christie NHS Foundation Trust | Ascierto P.,Unit of Medical Oncology and Innovative Therapy | Testori A.,Italian National Cancer Institute | And 5 more authors.
European Journal of Cancer | Year: 2012

Background: MELanoma treatment patterns and Outcomes among patients with unresectable stage III or stage IV Disease: a retrospective longitudinal surveY (MELODY), the first multicountry, observational survey in patients with advanced melanoma, aimed to quantify the impact of existing treatment strategies by capturing information on treatment patterns and clinical outcomes. Patients and methods: Patients attending a participating site between 1st July 2005 and 30th June 2006 with ≥2 months follow-up were eligible. Data were retrieved retrospectively from advanced melanoma diagnosis until 1st May 2008. Treatment data were collected by line of therapy and response and progression-free survival data by line of systemic treatment. Overall survival (OS) was evaluated for all treated patients. Results: Among all patients screened, 776 were eligible for this analysis. Median OS from the date of advanced disease diagnosis was 16.4 months. After excluding patients diagnosed prior to 1st July 2005 to account for any bias resulting from patient selection, the 12-month survival rate and median OS from the start date of second-line treatment was 28.8% and 6.8 months, respectively. Survival was lower in patients with brain metastases, elevated lactate dehydrogenase levels and more advanced disease. Rates of complete/partial tumour response were 15% and 7% in patients treated with first- and second-line systemic therapy, respectively. Conclusions: Despite receiving first- and second-line treatment, most patients with advanced melanoma have short survival times and poor prognoses, reinforcing the need for new treatments. © 2012 Elsevier Ltd. All rights reserved. Source

Ascierto M.L.,U.S. National Institutes of Health | Ascierto M.L.,University of Genoa | Idowu M.O.,Virginia Commonwealth University | Zhao Y.,U.S. National Institutes of Health | And 14 more authors.
Journal of Translational Medicine | Year: 2013

Background: Recent observations suggest that immune-mediated tissue destruction is dependent upon coordinate activation of immune genes expressed by cells of the innate and adaptive immune systems.Methods: Here, we performed a retrospective pilot study to investigate whether the coordinate expression of molecular signature mostly associated with NK cells could be used to segregate breast cancer patients into relapse and relapse-free outcomes.Results: By analyzing primary breast cancer specimens derived from patients who experienced either 58-116 months (~5-9 years) relapse-free survival or developed tumor relapse within 9-76 months (~1-6 years) we found that the expression of molecules involved in activating signaling of NK cells and in NK cells: target interaction is increased in patients with favorable prognosis.Conclusions: The parameters identified in this study, together with the prognostic signature previously reported by our group, highlight the cooperation between the innate and adaptive immune components within the tumor microenvironment. © 2013 Ascierto et al.; licensee BioMed Central Ltd. Source

Ascierto P.A.,Unit of Medical Oncology and Innovative Therapy | Simeone E.,Unit of Medical Oncology and Innovative Therapy | Sznol M.,Yale Cancer Center | Fu Y.-X.,University of Chicago | Melero I.,University of Navarra
Seminars in Oncology | Year: 2010

Monoclonal antibodies (mAbs) provide a pharmacological platform to block or activate the function of surface receptors. The immune system has evolved receptorligand pairs that repress or empower the cellular immune response, which, if tampered with, unleash more potent cellular immunity against tumor antigens. Agonist antibodies directed against CD137 (4-1BB) on the surface of antigen-primed T lymphocytes increase tumor immunity that is curative against some transplantable murine tumors. A fully human IgG4 anti-CD137 antibody is under development with signs of clinical activity and cases of severe liver toxicity that seem to be on-target and dose-dependent effects. Programmed death-1 (PD1) is a surface molecule delivering inhibitory signals important to maintain T-cell functional silence against their cognate antigens. Interference with PD1 or its ligand PD-L1 (B7-H1) increases antitumor immunity. As a result anti-PD1 and antiPD-L1 human mAbs are under clinical development. Phase I trials with anti-PD1 mAb have yielded encouraging results with durable objective responses and a reasonable safety profile. As new class of drugs in cancer therapy, immunostimulatory mAbs have resulted in redefinition of tumor response criteria and rethinking of the rationale for combining these among each other and with other strategies. © 2010 Elsevier Inc. All rights reserved. Source

Gogas H.,National and Kapodistrian University of Athens | Abali H.,Baskent University | Ascierto P.A.,Unit of Medical Oncology and Innovative Therapy | Demidov L.,Blokhin Cancer Center | And 6 more authors.
American Journal of Therapeutics | Year: 2015

Metastatic melanoma has a poor prognosis; the median survival for patients with stage IV melanoma ranges from 8 to 18 months after diagnosis. Interferon-α provides significant improvement in disease-free survival at the cost of poor tolerability. Identifying patients who benefit the most may improve the cost:benefit ratio. In addition, no data exist for the role of adjuvant therapy in noncutaneous melanoma. Molecular profiles may help to identify patients who benefit the most from adjuvant interferon therapy. In this review, the American Joint Commission on Cancer 2009 staging criteria and emerging biomarker data to guide adjuvant treatment decisions will be discussed. Several criteria to guide selection of patients are discussed in detail. These include Breslow thickness, number of positive lymph nodes, whether or not the primary lesion has ulcerated, immunologic markers, and cytokine profiles. Substantial progress has been made in deciding which patients benefit from interferon-α adjuvant therapy. Interferon-α is the only agent currently approved for the adjuvant treatment of this deadly disease, despite its side effect profile. More effective drugs with better tolerability are needed. © 2013 Wolters Kluwer Health, Inc. Source

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