9 research outputs found
Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: a multicenter, retrospective real-world experience with 200 cases outside of controlled clinical trials
In the ELOQUENT-3 trial, the combination of elotuzumab, pomalidomide and dexamethasone
(EloPd) proved a superior clinical benefit over Pd with a manageable toxicity profile, leading to its
approval in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior
therapies, including lenalidomide and a proteasome inhibitor (PI).
We report here a real-world experience of 200 RRMMs treated with EloPd in 35 Italian centers
outside of clinical trials. In our dataset, the median number of prior lines of therapy was 2, with
51% of cases undergoing autologous stem cell transplant (ASCT) and 73% exposed to
daratumumab.
After a median follow-up of 9 months, 126 patients stopped EloPd, most of them (88.9%) because
of disease progression. The overall response rate (ORR) was 55.4%, in line with the pivotal trial
results. Regarding adverse events, our cohort experienced a toxicity profile similar to the
ELOQUENT-3 trial, with no significant differences between younger (<70 years) and older
patients. The median progression-free survival (PFS) was 7 months, shorter than that observed in
the ELOQUENT-3, probably due to the different clinical characteristics of the two cohorts.
Interestingly, the ISS stage III (HR:2.55) was associated with worse PFS. Finally, our series's
median overall survival (OS) was shorter than that observed in the ELOQUENT-3 trial (17.5 versus
29.8 months). In conclusion, our real-world study confirms EloPd as a safe and possible therapeutic
choice for RRMM who received at least two prior therapies, including lenalidomide and a PI
How future surgery will benefit from SARS-COV-2-related measures: a SPIGC survey conveying the perspective of Italian surgeons
COVID-19 negatively affected surgical activity, but the potential benefits resulting from adopted measures remain unclear. The aim of this study was to evaluate the change in surgical activity and potential benefit from COVID-19 measures in perspective of Italian surgeons on behalf of SPIGC. A nationwide online survey on surgical practice before, during, and after COVID-19 pandemic was conducted in March-April 2022 (NCT:05323851). Effects of COVID-19 hospital-related measures on surgical patients' management and personal professional development across surgical specialties were explored. Data on demographics, pre-operative/peri-operative/post-operative management, and professional development were collected. Outcomes were matched with the corresponding volume. Four hundred and seventy-three respondents were included in final analysis across 14 surgical specialties. Since SARS-CoV-2 pandemic, application of telematic consultations (4.1% vs. 21.6%; p < 0.0001) and diagnostic evaluations (16.4% vs. 42.2%; p < 0.0001) increased. Elective surgical activities significantly reduced and surgeons opted more frequently for conservative management with a possible indication for elective (26.3% vs. 35.7%; p < 0.0001) or urgent (20.4% vs. 38.5%; p < 0.0001) surgery. All new COVID-related measures are perceived to be maintained in the future. Surgeons' personal education online increased from 12.6% (pre-COVID) to 86.6% (post-COVID; p < 0.0001). Online educational activities are considered a beneficial effect from COVID pandemic (56.4%). COVID-19 had a great impact on surgical specialties, with significant reduction of operation volume. However, some forced changes turned out to be benefits. Isolation measures pushed the use of telemedicine and telemetric devices for outpatient practice and favored communication for educational purposes and surgeon-patient/family communication. From the Italian surgeons' perspective, COVID-related measures will continue to influence future surgical clinical practice
Robot-assisted extravesical ureteral reimplantation (revur) for unilateral vesico-ureteral reflux in children: results of a multicentric international survey
Abstract
Purpose This multicentric international retrospective study aimed to report the outcome of robot-assisted extravesical ureteral
reimplantation (REVUR) in patients with unilateral vesico-ureteral reflux (VUR).
Methods The medical records of 55 patients (35 girls, 20 boys) underwent REVUR in four international centers of pediatric
robotic surgery for primary unilateral VUR were retrospectively reviewed. Patients’ average age was 4.9 years. The preoperative
grade of reflux was III in 12.7%, IV in 47.3% and V in 40%. Twenty-six patients (47.3%) presented a loss of renal
function preoperatively and 10 (18.1%) had a duplex system.
Results Average robot docking time was 16.2 min (range 5–30). Average total operative time was 92.2 min (range 50–170).
No conversions or intra-operative complications were recorded. All patients had a bladder Foley catheter for 24 h post-operatively.
Average hospital stay was 2 days (range 1–3). Average follow-up length was 28 months (range 9–60). We recorded
three (5.4%) postoperative complications: 1 small urinoma resolved spontaneously (II Clavien) and 2 persistent reflux, only
one requiring redo-surgery using endoscopic injection (IIIb Clavien).
Conclusion REVUR is a safe and effective technique for treatment of primary unilateral VUR. The procedure is easy and
fast to perform thanks to the 6° of freedom of robotic arms. The learning curve is short and it is useful to begin the robotics
experience with a surgeon expert in robotic surgery as proctor on the 2nd robot console. The high cost and the diameter of
instruments remain the main challenges of robotics applications in pediatric urology.
Keywords Vesico-ureteral reflux · Robot · Lich-Gregoire procedure · Children · Procto
Current strategies for detection and approach to measurable residual disease in Acute Myeloid Leukemia
Baseline cytogenetic/genetic features have been widely recognized to play a critical prognostic role in acute myeloid leukemia (AML) and have proven useful in designing riskadapted treatment strategies. Nevertheless, to improve further the outcome of AML patients we are still in need of accurate methods to explore the quality of response and to adequately discriminate patients who are likely to relapse over time from those who are in deep and stable remission. In this view, is it well established that measurement of leukemic cells surviving chemotherapy (called measurable residual disease, MRD) during the course of treatment may be a reliable biomarker in predicting relapse. Detection of MRD relies on highly sensitive techniques, such as quantitative polymerase chain reaction and multiparametric flow cytometry, which, due to their levels of specificity and sensitivity, are increasingly included in the decision-making process of AML treatment. In the present manuscript, we will review the current techniques of MRD investigation and their clinical contribution to AML management
Correlation Between Type of Retrieval Incision and Postoperative Outcomes in Laparoscopic Liver Surgery: A Critical Assessment
Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: a multicenter, retrospective real-world experience with 200 cases outside of controlled clinical trials
: In the ELOQUENT-3 trial, the combination of elotuzumab, pomalidomide and dexamethasone (EloPd) proved a superior clinical benefit over Pd with a manageable toxicity profile, leading to its approval in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI). We report here a real-world experience of 200 RRMMs treated with EloPd in 35 Italian centers outside of clinical trials. In our dataset, the median number of prior lines of therapy was 2, with 51% of cases undergoing autologous stem cell transplant (ASCT) and 73% exposed to daratumumab. After a median follow-up of 9 months, 126 patients stopped EloPd, most of them (88.9%) because of disease progression. The overall response rate (ORR) was 55.4%, in line with the pivotal trial results. Regarding adverse events, our cohort experienced a toxicity profile similar to the ELOQUENT-3 trial, with no significant differences between younger (<70 years) and older patients. The median progression-free survival (PFS) was 7 months, shorter than that observed in the ELOQUENT-3, probably due to the different clinical characteristics of the two cohorts. Interestingly, the ISS stage III (HR:2.55) was associated with worse PFS. Finally, our series's median overall survival (OS) was shorter than that observed in the ELOQUENT-3 trial (17.5 versus 29.8 months). In conclusion, our real-world study confirms EloPd as a safe and possible therapeutic choice for RRMM who received at least two prior therapies, including lenalidomide and a PI
Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended follow‐up of a multicenter, retrospective real‐world experience with 321 cases outside of controlled clinical trials
The ELOQUENT-3 trial demonstrated the superiority of the combination of elotuzumab, pomalidomide, and dexamethasone (EloPd) in terms of efficacy and safety, compared to Pd in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The present study is an 18-month follow-up update of a previously published Italian real-life RRMM cohort of patients treated with EloPd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. After a median follow-up of 17.7 months, 213 patients (66.4%) experienced disease progression or died. Median progression-free survival (PFS) and overall survival (OS) were 7.5 and 19.2 months, respectively. The updated multivariate analysis showed a significant reduction of PFS benefit magnitude both in advanced International Staging System (ISS) (II and III) stages and previous exposure to daratumumab cases. Instead, advanced ISS (II and III) stages and more than 2 previous lines of therapy maintained an independent prognostic impact on OS. Major adverse events included grade three-fourths neutropenia (24.9%), anemia (13.4%), lymphocytopenia (15.5%), and thrombocytopenia (10.7%), while infection rates and pneumonia were 19.3% and 8.7%, respectively. A slight increase in the incidence of neutropenia and lymphocytopenia was registered with longer follow-up. In conclusion, our real-world study still confirms that EloPd is a safe and possible therapeutic choice for RRMM. Nevertheless, novel strategies are desirable for those patients exposed to daratumumab