99 research outputs found
LEZIONI SUI TITOLI DI CREDITO
No full textAggiornamento di contributo originariamente scritto dal Prof. Giulio Partesotti
Condizioni per il rilascio dell'autorizzazione. Stretti legami. Misura del capitale, del fondo di garanzia e del fondo di organizzazione (Commento agli artt. 9-9bis-10 d. lgs. 17 marzo 1995, n. 174)
No full textQuote ed azioni delle società cooperative di assicurazione (commento all'art. 11 d. lgs. 17 marzo 1995, n. 174)
No full textForme pensionistiche complementari (commento all'art. 120 d. lgs. 17 marzo 1995, n. 174)
No full textAutorizzazione all'esercizio dei rami infortuni e malattia (commento all'art. 16 d. lgs. 17 marzo 1995, n. 174)
No full textEstensione dell'autorizzazione ad altri rami (commento all'art. 15 d. lgs. 17 marzo 1995, n. 174)
No full texta cura di Partesotti e Ricolf
Abstract OT1-03-03: Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)
No full textAbstract
Background: Tumor-infiltrating lymphocytes (TILs) have been reported to be associated with increased therapeutic efficacy of trastuzumab in the (neo)adjuvant setting for HER2-positive breast cancer (BC). Subcutaneous (SC) trastuzumab has been observed to act at different immunologic levels than IV trastuzumab. Therefore, by modifying the modality of administration of trastuzumab, it could be possible to interfere with different pathways of the immune system and exert a favorable immunomodulation in HER2-positive BC.
Trial design: In this non-comparative, phase II, neoadjuvant, randomized study, patients will be treated with FEC chemotherapy (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) q21 for 3 cycles. Then, they will be randomly assigned in a 1:1 ratio to receive: docetaxel (75 mg/m2) plus pertuzumab (840 mg loading dose, then 420 mg) plus IV trastuzumab (8 mg/kg loading dose, then 6 mg/kg) q21 for 4 cycles (Group A) or, docetaxel plus pertuzumab plus SC trastuzumab (fixed dose of 600 mg) q21 for 4 cycles (Group B). After surgery, study patients will receive trastuzumab q21 x 14 cycles using the same formulation (SC or IV) of the preoperative phase.
Eligibility criteria: Patients must have previously untreated, T2-4d primary HER2-positive BC with no metastatic disease. Other inclusion criteria are: age 18 or older; ECOG performance status 0-1; availability of tumor tissue from diagnostic biopsy; normal left ventricular ejection fraction; normal organ and marrow function.
Specific aims: The main objective of this trial is to evaluate variations of host immune response parameters to either trastuzumab SC or trastuzumab IV given in combination with pertuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive BC. Tumor samples obtained at diagnosis and at definitive surgery will be centrally analyzed for TILs. Blood samples will be also collected during study treatment for tumor-specific lymphocyte cell activity (TLA) analysis. Feasibility, efficacy, safety and health-related quality of life will be also evaluated.
Statistical methods: The primary endpoint is post-surgery pathologic TIL rate on residual disease. The threshold for classifying subjects with high TILs, or not, is defined as equal to 15%, according to the median TIL rate observed in primary HER2-positive tumors. Because this is a phase II study with 2 non-comparative arms, Simon's optimal 2-stage design will be used for each of the 2 study groups. For each arm we assume: p1 = 0.4, expected rate of subjects with high TILs on residual disease, p0 = 0.1, lowest limit of the subject rate (alpha= 0.05; beta= 0.20).
Present accrual and target accrual: A total of 60 patients (first stage: 16 patients) will be enrolled from multiple institutions. From November 29, 2016 to June 11, 2017, 34 patients have been recruited.
Contact information:Dr. Antonino Musolino, MD, MSc, PhD; Medical Oncology Unit, University Hospital of Parma; Tel: +390521702316; Fax: +390521995448; e-mail: [email protected]. Clinical Trials.gov: NCT03144947.
Citation Format: Musolino A, Gori S, Cavanna L, Graiff C, Frassoldati A, Bria E, Bisagni G, Zambelli A, Partesotti G, Brandes A, Bonetti A, Moscetti L, Zamagni C, Rocca A, Generali D, Montemurro F, Gianni L, Tognetto M, Maglietta G, Todeschini R. Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-03-03.</jats:p
Aggressive non-Hodgkin's lymphoma in the elderly: A validated prognostic evaluation performed by the Gruppo Italiano per lo Studio dei Linfomi (GISL)
No full textMOPP/EBV/CAD hybrid chemotherapy with or without limited radiotherapy in advanced or unfavourably presenting Hodgkin's disease. A report from the Italian Lymphoma Study Group
No full textPURPOSE: We explored the feasibility, toxicity, and preliminary results of a chemotherapy (CT) regimen, mechlorethamine, vincristine, procarbazine, and prednisone (MOPP)/epidoxirubicin, bleomycin, and vinblastine (EBV)/lomustine (CCNU), doxorubicin, and vindesine (CAD), derived through hybridization, shortening, and intensification of a corresponding 10-drug alternating combination CAD/MOPP/doxorubicin, bleomycin, and vinblastine (ABV), effective in treatment of advanced Hodgkin's disease (HD). PATIENTS AND METHODS: Hybridization involved all drugs except CCNU and mechlorethamine, which were administered in alternating cycles; the length of therapy was reduced from nine to six cycles. The average projected drug doses during the six cycles were increased by 42%, with an overall 1.54 dose-intensification; epidoxorubicin was substituted for doxorubicin at equivalent tumoricidal doses. Radiotherapy (RT) was optional and its indications were limited. RESULTS: Eighty assessable patients with previously untreated, advanced or unfavorably presenting HD were treated in nine cooperating institutions between 1988 and 1991. RT was delivered to 22 patients. Remissions were complete (CR) in 75 patients (93%), partial in three (4%), and null in two (3%). The median relative dose-intensity was 0.71 for the overall regimen. Three of five patients who failed to achieve CR, and two of the four who relapsed, received lower relative dose-intensive cycles. Nonhematologic toxicity was acceptable, but there was considerable hematologic toxicity. Fatal gastrointestinal bleeding was seen in one patient. CONCLUSION: Caution is advised due to the short median follow-up period. Nevertheless, in addition to the excellent response rate, (1) the results were reached through abbreviation, intensification, and hybridization of an existing alternating regimen; (2) RT had limited use in this program, which may have contributed to lowering the risk of second tumors; and (3) the results were obtained in a multicenter study (a condition that often impairs results from clinical trials)
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