7 research outputs found
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
Effectiveness of a tailored medical support to overcome the barriers to education, treatment and good metabolic control in children with type-1 diabetes from ethnic minorities
To analyze the effectiveness of a tailored medical support to help children from ethnic minorities to achieve the same good metabolic control of autochthonous peers with type-1 diabetes (T1D)
Olaparib as maintenance treatment in relapsed platinum-sensitive BRCA mutated ovarian cancer: real world experience in two Italian cancer Centers
Background: In 2014, after FDA approval, the therapeutic armamentarium of relapsed platinum-sensitive (RPS) ovarian cancer has been enriched by the introduction of a new drug, belonging to the class of poly (ADP-ribose) polymerase inhibitors (PARPi), olaparib. This oral PARPi demonstrated to significantly prolong progression-free survival (PFS) compared to placebo as maintenance in patients with platinum-sensitive recurrent (PSR) BRCA mutated serous ovarian cancer in the pivotal phase II trial. Olaparib is actually used in daily practice, but very few data are available about its safety and activity out of clinical trials. The aim of this paper is to describe the early data on this agent according to its approval in two clinical cancer care Institutions in Italy.
Materials and Methods: This is an observational, retrospective study, carried out in two Italian Hospitals (National Cancer Institute of Naples and National Cancer Institute of Milan). Archival medical records of all the BRCA mutated relapsed ovarian cancer patients treated with olaparib in two Italian centers from September 1st, 2015 to March 14th, 2017 were analyzed. The primary endpoint is to describe the percentage of patients that received olaparib for ≥6 months and ≥12 months. Secondary endpoints include: the description of objective response rate (ORR), disease control rate (DCR), PFS and safety profile of olaparib treatment. Olaparib 400 mg twice daily capsules was given orally according to indication.
Results: From September 1st, 2015 to March 14th, 2017 twenty-two patients with RPS ovarian cancer were considered eligible for the analysis. At the time of data cut off point, about 55% of patients were receiving olaparib for at least 6 months, and 27.2% for 12 or more months. Actually, most of the patients (77.3%) is still on treatment with the PARPi. Only 3 progressions of disease (PD) were registered, therefore the median PFS has not been reached. The ORR was 33.4% and the DCR was 75%. Olaparib was globally manageable and well tolerated. Safety data were consistent with previously reported findings in literature. Most common adverse events were: fatigue (63.3%); nausea (77.3%); anemia (54.5%); thrombocytopenia (18.1%); leucopenia (36.4%). All the events were mainly of grade 1 and were transient and managed with supportive care.
Conclusions: Our preliminary analysis suggests a good benefit/toxicity ratio of olaparib also in unselected population out of clinical trials. The need to evaluate the reproducibility of literature findings in heterogeneous patients require further studies
Risonanze III. La memoria dei testi dal medioevo a oggi
Il volume raccoglie saggi di studiosi di varie discipline sul testo e la sua eco nel tempo (e nello spazio). Il Leitmotiv è il tema della memoria del testo, delle sue riscritture e delle varie forme che assume nel corso della sua storia. Si indaga sul rapporto fra il testo e il pubblico, sia in senso diacronico (tradizione testuale, ricostruzione del testo, trasformazioni del testo che si adatta a un pubblico sempre diverso a seconda delle epoche), sia in senso sincronico (intertestualità , rapporto autore-pubblico, autoriscritture, forme di comunicazione, adattamenti musicali di un testo, passaggio dal testo letterario alle arti visive e, a volte, viceversa)
Olaparib as maintenance therapy in patients with BRCA 1-2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome
Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression
The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer
BACKGROUND:
Cervical cancer cells often express Epidermal Growth Factor Receptor (EGFR). Cetuximab (CET), an anti-EGFR antibody, can be safely combined with carboplatin (C) and paclitaxel (P), a standard treatment for advanced/recurrent cervical cancer (ARCC) patients.
PATIENTS AND METHODS:
ARCC patients, ECOG PS\u202f 64\u202f1, were randomized to CP for 6\u202fcycles with or without CET (400\u202fmg/m2 one week before starting CP, then 250\u202fmg/m2 weekly) until disease progression or unacceptable toxicity. Event-free survival (EFS) was the primary endpoint. With a 4.5\u202fmonths expected median EFS and a 6.4\u202fmonths predicted EFS (HR 0.70), 0.20 one-tailed \u3b1 and 80% power, 89 events were required for the final intent-to-treat analysis.
RESULTS:
108 patients were assigned to CP (n\u202f=\u202f53) or CP-CET (n\u202f=\u202f55). Median age was 50, 69% were PS0, 76% had recurrent disease, 91% had distant metastasis and 57% had received previous chemotherapy. After a median follow-up of 23\u202fmonths, 102 patients had an event, 97 progressed and 61 died. Median EFS was 4.7 and 6.0\u202fmonths (one-tail P\u202f=\u202f0.43), median PFS was 5.2 and 7.6\u202fmonths (one-tail P\u202f=\u202f0.20) and median OS was 17.7 and 17\u202fmonths (one-tail P\u202f=\u202f0.27), with CP and CP-CET, respectively. There was no difference in the occurrence of severe adverse events, except for skin toxicity. Biomarker analysis, in a small subgroup of patients, suggests that PIK3CA mutation might be predictive of CET resistance.
CONCLUSION:
CP-CET was not more active than CP alone in unselected ARCC patien