Showing papers by "Giampaolo Tortora published in 2019"
••
Tel Aviv University1, Katholieke Universiteit Leuven2, Fox Chase Cancer Center3, Sungkyunkwan University4, University College London5, Ruhr University Bochum6, Agostino Gemelli University Polyclinic7, Integra Telecom8, Technische Universität München9, Memorial Sloan Kettering Cancer Center10, AstraZeneca11, Merck & Co.12, University of Chicago13
TL;DR: Among patients with a germline BRCA mutation and metastatic pancreatic cancer, progression-free survival was longer with maintenance olaparib than with placebo, and there was no significant between-group difference in health-related quality of life.
Abstract: Background Patients with a germline BRCA1 or BRCA2 mutation make up a small subgroup of those with metastatic pancreatic cancer. The poly(adenosine diphosphate–ribose) polymerase (PARP) in...
1,321 citations
••
University of California, San Francisco1, Vita-Salute San Raffaele University2, Charité3, Memorial Sloan Kettering Cancer Center4, Thomas Jefferson University Hospital5, Seoul National University Hospital6, Taipei Veterans General Hospital7, University of Ulsan8, Oregon Health & Science University9, Hebron University10, Katholieke Universiteit Leuven11, University of New South Wales12, Vanderbilt University13, Celgene14, University of Glasgow15
TL;DR: This data indicates that in metastatic pancreatic cancer (PC), nab-P/G demonstrated significantly longer overall survival (OS) vs G and APACT assessed efficacy & safety of nab/G vs G in surgically resected P...
Abstract: 4000Background: In metastatic pancreatic cancer (PC), nab-P/G demonstrated significantly longer overall survival (OS) vs G. APACT assessed efficacy & safety of nab-P/G vs G in surgically resected P...
124 citations
••
TL;DR: The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab, and is confirmed at the landmark analysis at 6 weeks.
Abstract: The Italian Renal Cell Cancer Early Access Program was an expanded access program that allowed access to nivolumab, for patients (pts) with metastatic renal cell carcinoma (mRCC) prior to regulatory approval. Pts with previously treated advanced or mRCC were eligible to receive nivolumab 3 mg/kg every 2 weeks. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for drug-related adverse events (drAEs) using CTCAE v.4.0. Immune-related (ir) AEs were defined as AEs displaying a certain, likely or possible correlation with immunotherapy (cutaneous, endocrine, hepatic, gastro-intestinal and pulmonary). The association between overall survival (OS) and irAEs was assessed, and associations between variables were evaluated with a logistic regression model. A total of 389 pts were enrolled between July 2015 and April 2016. Overall, the objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% CI 3.7–6.2) and the 12-month overall survival rate was 63%. Any grade and grade 3–4 drAEs were reported in 124 (32%) and 27 (7%) of pts, respectively, and there were no treatment-related deaths. Any grade irAEs occurred in 76 (20%) of patients, 8% cutaneous, 4% endocrine, 2% hepatic, 5% gastro-intestinal and 1% pulmonary. Of the 22 drAEs inducing treatment discontinuation, 10 (45%) were irAEs. Pts with drAEs had a significantly longer survival than those without drAEs (median OS 22.5 versus 16.4 months, p = 0.01). Pts with irAEs versus without irAEs had a more significant survival benefit (median OS not reached versus 16.8 months, p = 0.002), confirmed at the landmark analysis at 6 weeks. The occurrence of irAEs displayed a strong association with OS in univariable (HR 0.48, p = 0.003) and multivariable (HR 0.57, p = 0.02) analysis. The appearance of irAEs strongly correlates with survival benefit in a real-life population of mRCC pts treated with nivolumab.
107 citations
••
TL;DR: Data support a progression of malignancy that may be traced by using combined molecular and immunohistochemical analysis and comprise three different and clinically relevant molecular diseases.
71 citations
••
University of Chicago1, Vita-Salute San Raffaele University2, Katholieke Universiteit Leuven3, Hebron University4, Fox Chase Cancer Center5, Samsung Medical Center6, University College London7, Seoul National University Hospital8, Ruhr University Bochum9, Technische Universität München10, Memorial Sloan Kettering Cancer Center11, AstraZeneca12, Merck & Co.13, Sheba Medical Center14
TL;DR: HRQoL was preserved with maintenance olaparib treatment with no clinically meaningful difference compared with placebo, and these results support the observed efficacy benefit of maintenance olAParib in patients with a gBRCAm and metastatic pancreatic cancer.
35 citations
••
University of Chicago1, Vita-Salute San Raffaele University2, Katholieke Universiteit Leuven3, Hebron University4, Fox Chase Cancer Center5, Samsung Medical Center6, University College London7, Seoul National University Hospital8, Ruhr University Bochum9, Technische Universität München10, Memorial Sloan Kettering Cancer Center11, AstraZeneca12, Merck & Co.13, Sheba Medical Center14
TL;DR: PLO is the first phase III trial of the PARP inhibitor olaparib in pancreatic cancer patients with a germline BRCA1 and/or BRCa2 mutation that has shown response to the PARPs.
Abstract: LBA4Background: Pancreatic cancer (PC) pts with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) have shown response to the PARP inhibitor olaparib (Kaufman 2015). POLO is the first phase III trial ...
17 citations
••
TL;DR: The hypothesis is that the early administration of an active, non-cross resistant second-line regimen such as ramucirumab plus paclitaxel may prolong the time in which patients are progression-free, and consequently have a better quality of life.
Abstract: Platinum/fluoropyrimidine regimens are the backbone of first-line chemotherapy for advanced gastric cancer (AGC). However response rates to first line chemotherapy range from 30 to 50% and disease progression occurs after 4–6 cycles. The optimal duration of first-line therapy is still unknown and its continuation until disease progression represents the standard. However this strategy is often associated with cumulative toxicity and rapid development of drug resistance. Moreover, only about 40% of AGC pts. are eligible for second-line treatment. This is a randomized, open-label, multicenter phase III trial. It aims at assessing whether switch maintenance to ramucirumab plus paclitaxel will extend the progression-free survival (PFS) of subjects with HER-2 negative AGC who have not progressed after 3 months of a first-line with a platinum/fluoropyrimidine regimen (either FOLFOX4, mFOLFOX6 or XELOX). The primary endpoint is to compare Progression-Free Survival (PFS) of patients in ARM A (switch maintenance to ramucirumab and placlitaxel) versus ARM B (continuation of the same first-line therapy with oxaliplatin/fluoropyrimidine). Secondary endpoints are: overall survival, time-to-treatment failure, overall response rate, duration of response, percentage of patients that will receive a second line therapy according to arm treatment, safety, quality of life. Exploratory studies including Next-Generation Sequencing (NGS) in archival tumor tissues are planned in order to identify potential biomarkers of primary resistance and prognosis. The ARMANI study estimates if patients treated with early swich with ramucirumab plus paclitaxel received benefit when compared to those treated with continuation of first line therapy. The hypothesis is that the early administration of an active, non-cross resistant second-line regimen such as ramucirumab plus paclitaxel may prolong the time in which patients are progression-free, and consequently have a better quality of life. Moreover, this strategy may rescue all those subjects that become ineligible for second-line therapy due to the rapid deterioration of health status after the first disease progression. ARMANI is registered at ClinicalTrials.gov (
NCT02934464
, October 17, 2016) and EudraCT(2016–001783-12, April 202,016).
11 citations
••
Seoul National University Hospital1, Sheba Medical Center2, Vita-Salute San Raffaele University3, Katholieke Universiteit Leuven4, Hebron University5, Fox Chase Cancer Center6, Samsung Medical Center7, University College London8, Ruhr University Bochum9, Technische Universität München10, Memorial Sloan Kettering Cancer Center11, AstraZeneca12, Merck & Co.13, University of Chicago14
4 citations
••
Vita-Salute San Raffaele University1, University Hospitals of Cleveland2, Charité3, University of Ulsan4, Memorial Sloan Kettering Cancer Center5, Seoul National University Hospital6, University of Verona7, Sarah Cannon Research Institute8, University of California, San Francisco9, Katholieke Universiteit Leuven10, Vanderbilt University11, Celgene12
3 citations
••
Katholieke Universiteit Leuven1, Sheba Medical Center2, Vita-Salute San Raffaele University3, Hebron University4, Fox Chase Cancer Center5, Samsung Medical Center6, University College London7, Seoul National University Hospital8, Ruhr University Bochum9, Technische Universität München10, Memorial Sloan Kettering Cancer Center11, AstraZeneca12, Merck & Co.13, University of Chicago14
1 citations
••
TL;DR: This data indicates that BV + fluoropyrimidine as a M regimen after induction CT + BV plus SAKK 41/... may be a viable treatment for central giant cell granuloma.
Abstract: 3550Background: Although CAIRO3 and AIO KRK 0207 trials demonstrated the benefit of BV + fluoropyrimidine as a M regimen after induction CT + BV, the role of BV alone is not clear. Indeed, SAKK 41/...
••
University of Chicago1, Vita-Salute San Raffaele University2, Katholieke Universiteit Leuven3, Hebron University4, Fox Chase Cancer Center5, Samsung Medical Center6, Seoul National University Hospital7, Ruhr University Bochum8, Technische Universität München9, Memorial Sloan Kettering Cancer Center10, AstraZeneca11, Merck & Co.12, Sheba Medical Center13
••
TL;DR: Weight gain and overweight have been related to an increased risk of recurrence and mortality in patients affected by EBC, but the adherence to nutritional intervention is not consistent.
Abstract: 11575Background: Weight gain and overweight have been related to an increased risk of recurrence and mortality in patients affected by EBC. However, the adherence to nutritional intervention is not...