6-month Survival Research Articles

Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies

AbstractMosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.clinicaltrials.gov as #NCT02500407.

The role of Cabazitaxel in Patients With Castration-Resistant and Osseous Metastases Prostate Cancer. A Hellenic Cooperative Oncology Group Phase II Study: Cabazitaxel in mCRPC patients with osseous metastases

BackgroundCabazitaxel is an effective treatment in metastatic castration-resistant prostate cancer (mCRPC) patients previously exposed to docetaxel and novel hormonal treatments. Understanding the molecular biology of mCRPC disease and taking into account the several approved treatment options, biomarkers are needed to guide decision making including cabazitaxel treatment. MethodsCababone was a phase II translational study that attempted to identify predictors of cabazitaxel efficacy. mCRPC with documented bone metastases were enrolled prospectively and treated with cabazitaxel 25mg/m2 every 3 weeks. Prostate cancer biopsies, bone marrow aspirates and blood samples were collected for translational research. ResultsSixty patients were enrolled and 59 received treatment according to protocol. Six-month progression free survival (PFS) rate was 47% (95% CI: 33% - 59%) and 12-month Overall Survival (OS) rate was 70% (95% CI: 56% - 80%). Patients with reactive hematopoiesis had improved PFS and OS with cabazitaxel treatment. Mutations in HRR genes were detected in 7 patients. ConclusionsNo differences in cabazitaxel efficacy were noted according to mutational status of HRR genes analyzed. No new safety issues were detected. In conclusion, CabaBone confirmed efficacy of cabazitaxel in mCRPC patients including the subgroup of patients with HRR mutations. Reactive hematopoiesis in bone marrow biopsies was related to improved survival warranting further investigation of bone biomarkers as predictors of cabazitaxel efficacy.

Impact of Body Mass Index on Outcomes in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation Recipients: A Single-Center Retrospective Study.

Pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) face several risk factors influencing transplantation success, including nutritional status as measured by body mass index (BMI). This study analyzed BMI data collected from patients transplanted between 2003 and 2023, and aimed to evaluate whether deviations from normal BMI are associated with poorer clinical outcomes. BMI levels assessed before and after first-line treatment and pre-transplantation were analyzed retrospectively to determine a correlation with survival and post-transplant complications. Underweight patients had significantly lower 12- and 36-month overall survival rates compared to normal-weight and overweight patients (p = 1.22 × 10-8 and p = 8.88 × 10-8, respectively). Event-free survival was also lower for underweight patients at all time points. A higher pre-transplant BMI increases the risk of acute graft-versus-host disease (GVHD, p = 0.00068). Otherwise, pre-transplant BMI was not significantly correlated with early TRCs and cGVHD. As secondary objectives, this study identified differences in BMI across primary disease groups, with solid tumor patients having the highest BMI and myelodysplastic syndrome patients having the lowest. BMI cut-offs were identified to predict or protect against serious outcomes, including delayed engraftment, TRCs, and acute and chronic GVHD. This study highlights the importance of nutritional assessment and management in pediatric patients undergoing allo-HSCT to optimize post-transplant outcomes, as deviations from a normal BMI can significantly impact post-transplant health. These findings underscore the importance of integrating BMI assessment throughout the entire pre-HSCT therapeutic course to identify patients at higher risk for complications and to define more effective nutritional management strategies.

A novel scoring system proposal to guide surgical treatment indications for high grade gliomas in elderly patients: DAK-75.

High-grade gliomas are the most prevalent neurooncological desease in adults, their incidence increases with age, peaking in the seventh decade. This paper aims to address how to select patients for surgical resection by identifying pre-surgical predictors of 12-month mortality in newly diagnosed HGG patients aged ≥ 75years. A prognostic score will be proposed to guide surgical decisions based on expected survival. Retrospective observational single-center cohort study was carried out at the "Città della Salute e della Scienza-Molinette" University Hospital in Turin, Italy. All consecutive patients aged ≥ 75years newly diagnosed with HGG were included, regardless of whether they underwent surgical resection. Clinical, radiological, histological and molecular data were collected.Variables potentially available at the time of diagnosis were considered to develop a multivariable logistic regression predictive model, with 12-months overall survival as the dependent variable. 102 patients aged 75years or older received a new diagnosis of high-grade glioma, of whom 68 underwent surgical resection. Patients undergoing surgery were slightly younger (76.9 vs 79.0years, p = 0.007) and had better performance status (median KPS 80 vs 70). Most tumors undergoing surgery were localized in cortical or subcortical non-motor areas (p < 0.001) and less frequently deep-seated (p = 0.023) or multifocal (p < 0.001). A predictive model, the DAK-75 score, was developed: the AUROC of the final model was 0.822 (95% CI 0.741-0.902). The score includes clinical presentation, tumor location, and KPS, ranging from 0 to 20, categorizing risk scores into low-risk and high-risk groups (< or > 8). Higher scores corresponded to fewer surgical patients and higher one-year mortality rates (92.2% vs 47.1%, p < 0.001). DAK-75 score may represent a valuable tool in the decision-making process for neurosurgical intervention in elderly patients diagnosed with HGG. Further studies are needed to externally and prospectively validate the scoring system.

Association of time to start of enteral nutrition and outcome in cats with hepatic lipidosis.

Enteral nutrition (EN) is essential for management of hepatic lipidosis (HL) in cats. To determine if time to start of EN and other clinicopathologic variables are associated with outcome in cats with HL. Forty-eight cats with HL. Retrospective study. Information retrieved from medical records and client communications included clinicopathologic findings, time to start of EN, initial % of resting energy requirements provided, type of feeding tube, duration of hospitalization, and 3-month survival. Variables were compared between surviving and nonsurviving cats and between cats fed ≤12 hours and >12 hours after hospital admission. Multivariable statistical testing was performed to further investigate variables of interest. Seventeen of 25 (68%) cats fed ≤12 hours and 13 of 23 (57%) of cats fed >12 hours after hospital admission survived (P = .55). Only increasing age (odds ratio [OR], 1.313; 95% confidence interval [CI], 1.032-1.671; P = .03) and the presence of ascites (OR, 6.415; 95% CI, 1.354-30.395; P = .02) were associated with death in multivariable analysis. Hospitalization duration (median, interquartile range [IQR]) was shorter in cats fed >12 hours (2.8 days; IQR, 2.1-3.8 days) as compared with cats fed ≤12 hours (4.8 days; IQR, 3.6-6.2 days) after hospital admission (P < .001). An initial stabilization period before EN introduction does not decrease survival or increase duration of hospitalization in cats with HL.

Assessment of traumatic brain injury treatment guided by continuous monitoring of intracranial pressure and brain tissue oxygen partial pressure: A single-center pilot study

Severe traumatic brain injury (TBI) is a leading cause of death and disability. Monitoring intracranial pressure (ICP) is recommended, but the data on the outcomes are conflicting. Adding continuous brain tissue oxygen partial pressure (PbtO2) monitoring may have some benefit but the OXY-TC suggested it did not improve 6-month neurological outcomes. This single-center pilot randomized controlled study aimed to evaluate whether adding PbtO2 monitoring was feasible and could improve the prognosis of severe TBI. The participants were randomized into either an ICP alone or an ICP + PbtO2 group for 7 days, with treatment protocols based on existing guidelines. Clinical parameters were collected hourly. The primary outcome was the feasibility of using PbtO2 monitoring. The secondary outcomes were 6-month survival, analyzed by the log-rank test, the 3- and 6-month Glasgow Outcome Scale (GOS) scores, compared between groups by chi-squared test. Seventy patients were included (36 ICP, 34 ICP + PbtO2). The ICP + PbtO2 group had lower mean daily ICP (13.4 vs. 18.2 mmHg, P = 0.0024) and higher mean daily cerebral perfusion pressure (82.1 vs. 74.5 mmHg, P = 0.0055). The ICP + PbtO2 group had higher 6-month survival (79.4 % vs. 55.6 %, P = 0.0337) and more favorable outcomes at 3 months (67.6 % vs. 38.9 %, P = 0.0160) and 6 months (70.6 % vs. 41.7 %, P = 0.0149). Adding PbtO2 monitoring to ICP monitoring is feasible in patients with severe TBI and could maybe improve the intermediate-term outcomes. The results will serve to design larger trials.

Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial

Newly diagnosed patients with high-risk acute graft-versus-host disease (aGVHD) often experience poor clinical outcomes and low complete remission rates. Ruxolitinib with corticosteroids showed promising efficacy in improving response and failure free survival in our phase I study. This study (ClinicalTrials.gov: NCT04061876) sought to evaluate the safety and effectiveness of combining ruxolitinib (RUX, 5 mg/day) with corticosteroids (1 mg/kg/day methylprednisolone, RUX/steroids combined group) versus using methylprednisolone alone (2 mg/kg/day, steroids-only group). Newly diagnosed patients with intermediate- or high-risk aGVHD were included, with risk levels classified by either the Minnesota aGVHD Risk Score or biomarker assessment. Patients were randomized in a ratio of 1:1 into 2 groups: 99 patients received RUX combined with methylprednisolone, while the other 99 received methylprednisolone alone as the initial treatment. The RUX/steroids group showed a significantly higher overall response rate (ORR) on day 28 (92.9%) compared to the steroids-only group (70.7%, Odds Ratio [OR] = 5.8; 95% Confidence Interval [CI], 2.4–14.0; P < 0.001). Similarly, the ORR on day 56 was higher in the RUX/steroids group (85.9% vs. 46.5%; OR = 7.07; 95% CI, 3.36–15.75; P < 0.001). Additionally, the 18-month failure-free survival was significantly better in the RUX/steroids group (57.2%) compared to the steroids-only group (33.3%; Hazard Ratio = 0.46; 95% CI, 0.31–0.68; P < 0.001). Adverse events (AEs) frequencies were comparable between both groups, with the exception of fewer grade 4 AEs in the RUX/steroids group (26.3% vs. 50.5% P = 0.005). To our knowledge, this study is the first prospective, randomized controlled trial to demonstrate that adding ruxolitinib to the standard methylprednisolone regimen provides an effective and safe first-line treatment for newly diagnosed high-risk acute GVHD.

Comparison of CHOP-19 and CHOP-25 for treatment of peripheral nodal B-cell lymphoma in dogs: A European multicenter retrospective cohort study.

Peripheral nodal B-cell lymphomas (PNBCL) represent the most common presentation of lymphomas in dogs. Multiagent CHOP (C = cyclophosphamide, H = hydroxydaunorubicin [Doxorubicin], O = Oncovin, P = prednisolone)-based chemotherapy protocols have been widely accepted as gold standard 1st-line treatment. CHOP-25 and CHOP-19 are most commonly prescribed but have never been directly compared. Our primary aim was to compare outcomes of dogs diagnosed with PNBCL, treated using a 1st-line CHOP-19 or CHOP-25 protocol. A secondary objective was to determine the impact of protocol-related variables on outcomes. Five hundred two dogs from 16 European oncology referral centers. One hundred fifty-five dogs were treated with CHOP-19 and 347 dogs with CHOP-25. Retrospective, multicentric cohort study of dogs diagnosed with PNBCL between 2014 and 2021. The 6-month, 1-year, and median progression-free survival (PFS) were 56.5% (95% confidence interval [CI], 49.2-65.0), 14.1% (95% CI, 9.4-21.0), and 196 days (95% CI, 176-233) with CHOP-19; and 56.4% (95% CI, 51.4-61.9), 17% (95% CI, 13.4-21.6), and 209 days (95% CI, 187-224) with CHOP-25. The 1-year, 2-year and median overall survival (OS) were 36.9% (95% CI, 29.7-46.0), 13.5% (95% CI, 8.6-21.1), and 302 days (95% CI, 249-338) with CHOP-19; and 42.8% (95% CI, 37.7-48.7), 15.4% (95% CI, 11.7-20.4), and 321 days (95% CI, 293-357) with CHOP-25. No significant difference in PFS and OS was found between the 2 protocols. Our study confirmed similar outcomes for dogs with PNBCL treated with 1st-line CHOP-19 or CHOP-25. Both protocols therefore could be used as a standard of care in future trials.

The Outcomes of Adult Acquired Buried Penis Surgical Reconstruction.

Adult Acquired Buried Penis (AABP) is a morbid condition that often requires surgical intervention. This retrospective study of 46 patients who underwent AABP surgery from November 2017 to July 2023 evaluates surgical outcomes, functional outcomes, and patient-reported outcomes. The median follow-up (FU) was 46 months. Patients were categorized by surgical complexity using the Pariser classification, with 76.1% undergoing high-complexity procedures (Pariser ≥ III). Common comorbidities included obesity (58.7%), prior circumcision (52.2%), and hypertension (52.2%). The low-complexity group had a shorter hospital stay (p = 0.02). No other significant differences were noted between groups in terms of Body Mass Index, operative time, or FU. Sexual dysfunction (45.7%) and urinary issues (38.1%) were the main reasons for surgical consultation. Skin grafting was required in 63.0% of patients; partial graft loss was more common in full thicknes skin graft group (p = 0.04). Postoperative complications occurred in 32.6% of patients, 13.3% of which were classified severe (Clavien ≥ III). The median increase in stretched penile length was 2 cm. The recurrence rate was 21.7%. The 12-month recurrence-free survival rate was 89.1%. All groups saw significant improvements in urinary and sexual function post-surgery (p < 0.05), and high patient satisfaction was reported (90.3%). Despite the complication rate, AABP surgery significantly improves quality of life, with ongoing advancements in technique anticipated to enhance outcomes further.

Triple combination of vemurafenib, cobimetinib, and atezolizumab in real clinical practice in the Russian Federation: results of the A1 cohort of the ISABELLA study.

Among several treatment options for BRAF-mutant metastatic melanoma, a combination of BRAF inhibitor, MEK inhibitor, and anti-PDL1 antibody seems to be a new emergent approach recently registered in the Russian Federation. It is still not clear which patient population benefits more from this simultaneous use of three drugs instead of its sequencing. This study aimed to evaluate patients' characteristics treated in real practice in 14 Russian regions by triple combination and to analyze their outcomes depending on biomarkers (PD-L1 expression). This was a part (cohort A1) of a prospective non-interventional study of clinical outcomes and biomarkers in patients with skin melanoma. Patients were included in cohort A1 if combination treatment with vemurafenib (vem) + cobimetinib (cobi) + atezolizumab (atezo) was initiated no earlier than 12 weeks (84 days) prior to written informed consent to participate in this study. The index event was the initiation of therapy with all three drugs vem + cobi + atezo (i.e., triple combination). The primary efficacy endpoint of the study was the 24-month overall survival (OS), defined as the time from the index date to the date of death from any cause. If the patient did not experience an event, the OS will be censored at the date of the last contact. Objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) in the Intention to treat (ITT) population, in biomarker positive population, and in population with brain metastases were also evaluated. Quality of life questionnaires were pre-planned by protocol if it was a part of routine practice. Adverse events were also collected. Between March 2021 and May 2023, 59 patients were enrolled in 19 centers from 14 regions of Russia. Thirty-one of 59 (52.4%) patients had central nervous system metastases, and 18 of 31 (58.4%) were symptomatic. Forty of 59 patients (68%) received the triple combination as the first-line treatment. The median follow-up period was 16.83 [95% confidence interval (CI) 13.8-19.8] months. The mean duration of therapy with this regimen was 9.95 months (95% CI 7.48-13.8). ORR was 55.1%; progression as the best outcome was seen in 16.3%. The median DoR was 12.95 months (95% CI 11.0-14.8 months), with a median of 20.3 months (95% CI 9.1-31.5 months) when triple therapy was administered in the first-line treatment. In patients with brain metastases (N = 31), ORR was 45.1%; the median DoR was 12.95 (95% CI 11.0-14.8 months). The median PFS in the entire population was 13.6 months (95% CI 8.6-18.6); the 24-month PFS was 22%. The estimated median OS in the entire population was 15.8 months (95% CI NA); 24-month OS was 45% (95% CI 0.32-0.64). In multivariate Cox regression model, biomarkers of interest [lactate dehydrogenase, Programmed cell death ligand-1 (PD-L1)] did not have statistically significant impact on PFS, OS, or DoR probably due to high data missing rate. No unexpected adverse events were reported. Grades 3-4 AEs were seen in 23 of 59 patients (38%) with most common were skin and liver toxicity. Triple combination of atezolizumab, vemurafenib, and cobimetinib had proven its efficacy and tolerability in real settings. No impact of potential predictive biomarkers was seen (NCT05402059).

Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial

Perioperative immunotherapy improves short-term outcomes in resectable non-small-cell lung cancer (NSCLC). We now report 5-year survival from the NADIM trial to assess its long-term benefit. NADIM was a multicentre, single-arm, phase 2 trial conducted across 18 hospitals in Spain. Patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had histologically or cytologically confirmed, treatment-naive, resectable stage IIIA NSCLC (American Joint Committee on Cancer, 7th edition criteria). The neoadjuvant treatment consisted of three cycles of intravenous paclitaxel (200 mg/m2) and carboplatin (area under the curve 6 mg/mL per min) with nivolumab (360 mg). After surgery, 1 year of adjuvant treatment with intravenous nivolumab monotherapy was administered (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months). The primary endpoint was 24-month progression-free survival, with 5-year progression-free survival and overall survival as secondary endpoints, assessed in the intention-to-treat population (ie, all patients who received neoadjuvant treatment). Toxicity profile was also assessed as a secondary endpoint. This trial is registered at ClinicalTrials.gov (NCT03081689) and is complete; this is the final report of the trial. Between April 26, 2017, and Aug 25, 2018, 51 patients were assessed for eligibility, of whom 46 comprised the intention-to-treat population (34 [74%] male and 12 [26%] female, median age 63 years [IQR 58-70]). Follow-up was concluded at 60 months (data cutoff July 11, 2023; median follow-up 60·0 months [IQR 60·0-60·0]). 5-year progression-free survival in the intention-to-treat population was 65·0% (95% CI 49·4-76·9), and overall survival was 69·3% (53·7-80·6). Disease progression occurred in 11 (24%) patients; 14 (30%) patients died, including nine (20%) from disease relapse and five (11%) from non-tumour-related causes. Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in 14 (30%) of 46 patients during neoadjuvant treatment and in seven (19%) of 37 during adjuvant treatment. The most common grade 3 or worse TRAEs were increased lipase and febrile neutropenia (three [7%] each) during neoadjuvant treatment, and elevated serum lipase (four [7%]) and elevated serum amylase (three [8%]) during adjuvant treatment. Serious TRAEs included elevated serum lipase and neutropenia (one [2%] each) during neoadjuvant treatment, and elevated serum lipase (one [3%]) during adjuvant treatment. No treatment-related surgery delays, deaths, or unexpected long-term toxicities were reported. Perioperative chemoimmunotherapy showed a promising long-term benefit with no concerning safety data, reinforcing its use in resectable stage IIIA NSCLC. Bristol-Myers Squibb, Spanish Ministry of Science, Instituto de Salud Carlos III, European Union.

Comparison of programmed sedation care with conventional care in patients receiving mechanical ventilation for acute respiratory failure.

The aim of this study is to evaluate the effectiveness of planned sedation therapy in comparison to standard care for patients receiving mechanical ventilation for acute respiratory failure (ARF). The research included a total of sixty individuals who underwent mechanical ventilation for acute respiratory failure (ARF). Utilizing the random number table method, these patients were randomized at random to either the planned sedation care group (Group PSC) or the conventional care group (Group C). The objective was to assess and contrast the impact of treatment on the two groups. Significantly shorter durations of mechanical ventilation, sedative use, ICU therapy, length of stay, incidence of delirium, and adverse events were observed in Group PSC compared with Group C (P < 0.05). A higher 1-month survival rate following mechanical ventilation, a higher post-intervention forced expiratory volume in one second (FEV1) as a percentage of the expected value, a higher post-intervention forced vital capacity (FVC), and a higher patient family care satisfaction rate were observed in Group PSC compared to Group C (P < 0.05). The scheduled administration of sedative therapy in patients receiving mechanical ventilation for acute respiratory failure (ARF) offers significant, reliable, and effective therapeutic benefits.

Apatinib plus hepatic arterial infusion of oxaliplatin and raltitrexed for hepatocellular carcinoma with extrahepatic metastasis: phase II trial

Most patients with advanced hepatocellular carcinoma (HCC) ultimately experience tumor progression after first-line systemic therapies. Systemic therapy is generally recommended as second-line treatment for advanced HCC in the major guidelines. Combining apatinib with hepatic arterial infusion chemotherapy (HAIC) likely drives synergistic activity on advanced HCC with extrahepatic metastasis. This phase II trial (ChiCTR2000029082) aimed to assess efficacy and safety of this combination in patients with HCC with extrahepatic metastasis who have progressed after first-line systemic therapies. The primary end point was the objective response rate (ORR). The secondary endpoints were progress-free survival (PFS), disease control rate (DCR), 6- and 12-month survival rates, overall survival (OS), and adverse events (AEs). Thirty-nine patients received oral treatment with apatinib, and hepatic artery infusion oxaliplatinplus raltitrexed. Per RECIST v1.1, the ORR and DCR was 53.8% and 89.7% in the patients population, respectively. The median PFS and OS was 6.2 months and 11.3 months, respectively. The 6- and 12-month survival rates were 81.7% and 44.1%, respectively. All AEs were manageable by medication or dose modifications. Apatinib plus HAIC for second-line therapy in advanced HCC with extrahepatic metastasis shows promising efficacy and manageable toxicities.

Pancoast Tumors: 11-Year Single-Centre Experience.

Pancoast tumors encompass any tumor located on the lung apex, extending into structures in the thoracic inlet and, often, leading to the characteristic clinical syndrome. The main goal of this study is to analyze the response to multimodal treatment and outcome of patients with Pancoast tumors. We performed a retrospective cohort single center study of patients with superior sulcus nonsmall cell lung carcinomas who underwent surgery between January of 2011 and February of 2022. A total of ten patients were considered, 80,0% were male with a mean age of 53,6 (±6,6) years. At diagnosis, two tumors were stage II and eight were stage III. Histopathology revealed eight were adenocarcinomas and two were sarcomatoid carcinomas. All patients underwent neoadjuvant treatment before surgery. Nine patients received lung lobectomy, with en bloc resection comprising, predominantly, the chest wall (80,0%) and brachial plexus (30,0%). In one patient, surgery was aborted. Surgical histopathology showed free surgical margins were achieved in eight patients (80,0%). Two patients achieved full tumoral remission (ypT0N0, 22,2%), two tumors were stage I (22,2%), two were stage II (22,2%), two were stage III (22,2%) and one tumor was stage IV (11,1%). Mean disease-free survival was 83,9 (CI95% 42,1-125,8) months. 3-month disease-free survival rate was 88,9% and 1-year and 5-year disease-free survival rates were 63,5%. After the first-year follow-up, there was no evidence of disease progression. Mean overall survival was 115,7 (CI95% 89,3-142,1) months. At 3-month, 1-year and 5-years, overall survival was 88,9%. Although considering the small sample of patients, the survival of Pancoast tumors in our institution exhibits a positive outcome, when compared to current literature, Significant improvements have been reported recently, in understanding the nature of Pancoast tumors, emphasizing the importance of a multidisciplinary approach but still, further research is required.

Nutritional screening on hospital admission and one-year clinical outcomes in a prospective cohort of older patients

Background & AimsMalnutrition negatively affects the prognosis and quality of life of hospitalized patients. However, there are several gaps between evidence-based knowledge and current clinical practice. Our primary aim was to describe the prevalence of malnutrition risk in a cohort of in a cohort of older inpatients; secondly, we explored its predictors and its independent impact on 12-month survival. MethodsProspective study focused on patients aged 65 years and older consecutively admitted for any reason to the acute geriatric and general medical units of an Italian university hospital. Comprehensive geriatric assessment data, including the short form of the Mini Nutritional Assessment (MNA-SF), were collected within 48 hours of admission. The prevalence of malnutrition and risk of malnutrition according to the MNA-SF represented the main outcome. Correlations among clinical variables, nutritional status, and one-year survival were analyzed using multivariable and Cox models. ResultsAmong 594 patients (median age: 84 years, 49.5% female), mostly living at home with moderate functional autonomy, 82.3% were identified as probably malnourished or at risk of malnutrition according to MNA-SF (39.9% and 42.4%, respectively). Malnutrition and the risk of malnutrition were positively associated with living alone at home (OR 2.803, 95%CI 1.567-5.177, p<0.001), and negatively associated with autonomy in IADL (OR 0.765, 95%CI 0.688-0.846, p<0.001) and the best performance at HST (OR 0.901, 95%CI 0.865-0.936; p<0.001). After 12 months, 31.8% of patients was dead and mortality was positively correlated with malnutrition according to MNA-SF (OR 2.493, 95%CI 1.345-4.751, p=0.004), institutionalization (OR 2.815, 95%CI 1.423-5.693, p=0.003) and severe cognitive impairment (OR 1.701, 95%CI 1.031-2.803, p=0.036). ConclusionMalnutrition is common among older inpatients upon admission, primarily influenced by their functional and cognitive status, and it is linked to a worse prognosis. Early incorporation of thorough nutritional and functional assessments into clinical practice is crucial to improve prognosis prediction and enable timely, focused interventions targeting modifiable causal factors in a patient-centered approach.

Real World Outcomes in Patients With Recurrent, Advanced, or Metastatic Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab

AimsPatients with endometrial cancer who progress following first line therapy have improved survival outcomes with pembrolizumab and lenvatinib (pem/len) compared with standard of care chemotherapy, as demonstrated in KEYNOTE-775. This was in a group of trial patients with good performance status and excluded those with carcinosarcoma histology. In KEYNOTE-775 pem/len was associated with significant toxicity, leading to dose reductions, treatment cessation, and patient morbidity. We set out to assess the tolerability, toxicity and outcomes following pem/len for patients with recurrent, advanced or metastatic endometrial cancer in a real-world setting. Materials and methodsUK centres treating patients with pem/len for advanced endometrial cancer within the compassionate access programme were approached. Retrospective data were analysed for those treated between May 2022 and June 2023. Data on patient demographics, treatment, toxicity and outcomes were extracted from medical records. Toxicity and tolerability were compared in those over and under the age of 70. ResultsSeven centres returned data for 70 patients. Median age of patients was 68.5 years (range 45–85) with a performance status of 0–1 in 77.1% and of 2 in 22.9%. Histological subtypes included serous (34.3%), endometrioid (32.9%), carcinosarcoma (14.3%), clear cell (7.1%), mixed (2.9%) and other (8.6%). Grade ≥3 toxicity was reported in 55.7% with any-grade toxicity observed in 85.7%. In those aged ≥70 years (n = 30) the rate of grade ≥3 toxicity was 60.0%. Rates of dose reduction of lenvatinib were 64.3%, and toxicity-related treatment interruption was 45.7%. The 6-month progression-free and overall survival rates were 54.0% (95%CI: 39.0–66.8) and 70.1% (95%CI:56.5–80.1) respectively. ConclusionThis real-world, observational study of pem/len showed comparable tolerability, toxicity, and outcomes to previously reported clinical trial data. Our cohort included patients with a poorer PS and a broader range of histological subtypes including carcinosarcoma.

MetaWise: Combined Feature Selection and Weighting Method to Link the Serum Metabolome to Treatment Response and Survival in Glioblastoma.

Glioblastoma (GBM) is a highly malignant and devastating brain cancer characterized by its ability to rapidly and aggressively grow, infiltrating brain tissue, with nearly universal recurrence after the standard of care (SOC), which comprises maximal safe resection followed by chemoirradiation (CRT). The metabolic triggers leading to the reprogramming of tumor behavior and resistance are an area increasingly studied in relation to the tumor molecular features associated with outcome. There are currently no metabolomic biomarkers for GBM. Studying the metabolomic alterations in GBM patients undergoing CRT could uncover the biochemical pathways involved in tumor response and resistance, leading to the identification of novel biomarkers and the optimization of the treatment response. The feature selection process identifies key factors to improve the model's accuracy and interpretability. This study utilizes a combined feature selection approach, incorporating both Least Absolute Shrinkage and Selection Operator (LASSO) and Minimum Redundancy-Maximum Relevance (mRMR), alongside a rank-based weighting method (i.e., MetaWise) to link metabolomic biomarkers to CRT and the 12-month and 20-month overall survival (OS) status in patients with GBM. Our method shows promising results, reducing feature dimensionality when employed on serum-based large-scale metabolomic datasets (University of Florida) for all our analyses. The proposed method successfully identified a set of eleven serum biomarkers shared among three datasets. The computational results show that the utilized method achieves 96.711%, 92.093%, and 86.910% accuracy rates with 48, 46, and 33 selected features for the CRT, 12-month, and 20-month OS-based metabolomic datasets, respectively. This discovery has implications for developing personalized treatment plans and improving patient outcomes.

Is surgery without curettage effective for periacetabular Metastasis? Insights from a survival study of 93 patients

BackgroundThe main aim of this study was to analyse the 6-month survival rates in peri-acetabular metastasis patients undergoing total hip arthroplasty (THA) with an acetabular cage and without curettage. The secondary objectives were to analyse the global survival rates, the factors influencing patient survival and to evaluate mechanical complication rates after THA. MethodsThis study was carried out on a cohort of 93 consecutive patients who underwent THA with an acetabular cage without curettage for acetabular metastasis or multiple myeloma lesions between 2010 and 2020. The National Death Registry was consulted to obtain the exact date of death of the patients; the minimum follow-up time was 2 years. ResultsThe 6-month survival rate for all types of cancer was 78 % [68 – 85], the 1-year survival rate was 66 % [55 – 74], and the 5-year survival rate was 26 % [17 – 36]. The median overall survival for the cohort was 24.37 months [16.10 – 32.63]. The mean overall survival was 46.02 months [32.89 – 59.16]. At last contact, 86 % of the operated patients were walking again.No patient died from surgery. The ECOG performance status score, the number of bone metastatic sites, the presence of visceral metastases and the number of lines of systemic therapy undertaken prior to surgery were negative survival factors. Three patients (3.2 %) had early prosthetic dislocation, 2 patients (2.2 %) showed aseptic loosening of her partial hip implant after 10 and 11 years respectively and 4 patients (4.3 %) had an early infection treated by debridement, antibiotics and implant retention to control the infection. During the follow-up period, no new femoral metastases were detected in any patient. ConclusionSurgery without curettage is an effective treatment for periacetabular metastasis. It gives reliable results, regardless of the type of acetabular lesion, allowing most patients to walk again and does not modify the patient’s survival.

Survival analysis of primary molars following pulpectomy performed under dental general anesthesia: a five-year retrospective study

BackgroundCurrently, the indications for pulpectomy of primary molars performed under dental general anesthesia vary across countries. Therefore, we retrospectively investigated the five-year survival rate of primary molars following pulpectomy performed under dental general anesthesia and the impact of this treatment on permanent successors, assessed the risk factors related to overall survival and clarified the indications for pulpectomy.MethodsThe medical records of children receiving pulpectomy of primary molars under dental general anesthesia from August 1, 2013, to November 30, 2023, were reviewed. Potential risk factors, including gender, age, general health, tooth type, tooth location, endodontic diagnosis and quality of root filling, were assessed via univariate and multivariate Cox proportional hazards regression models, and the survival rate was examined via the Kaplan‒Meier technique. Moreover, the rate of resorption of the root canal filling materials, degree of resorption of the overfilled/over-extended root canal filling materials and development of permanent successors were assessed by clinical and radiographic examination.ResultsThe study included 320 teeth from 161 children (86 boys and 75 girls). The overall five-year survival rate was 38.2%, and the mean overall survival time was 54.2 months. Endodontic diagnosis was considered a significant risk factor (P < 0.05). In the first, second and third years, 57.4%, 81.8%, and 94.8%, respectively, of obturation materials in the root canals were resorbed at a faster rate than the roots. There was an altered eruption direction in 7 permanent teeth, and 4 permanent teeth were diagnosed with enamel hypoplasia.ConclusionsIn this study, the 60-month survival rate of primary molars treated by pulpectomy under dental general anesthesia was 38.32%. Operators should have an accurate assessment of the status of the pulp, have a strict grasp of the preoperative indications and select the appropriate treatment method according to the guidelines. Individual cases suggest overfilling, overextension and periapical periodontitis in primary molars have an impact on enamel hypoplasia and altered eruption direction in permanent teeth.

Short-term efficiency of plasma exchange in combination with immunosuppressants and/or biologics in the treatment of idiopathic inflammatory myopathy with rapidly progressive interstitial lung disease: a systematic review and meta-analysis

Objective Rapidly progressive interstitial lung disease (RP-ILD) is a frequent and serious manifestation of idiopathic inflammatory myopathy (IIM) associated with poor outcomes. Plasma exchange (PE) can quickly remove pathogenic substances from the blood. Therefore, PE may be efficacious in IIM patients who have elevated levels of autoantibodies, cytokines and chemokines, fighting for time for immunosuppressive therapy. However, the value of adding PE to immunosuppressants remains unclear. The purpose of this study was to determine the short-term outcomes, including the survival rate at 6 months and change of the laboratory data, of PE in combination with immunosuppressants and/or biologics in the treatment of IIM-RP-ILD. Methods We searched PubMed, Embase and Cochrane Library to find reports of interest published from inception to March 4, 2024. STATA 15.1 was used for data analysis. A fixed or random-effects model with inverse-variance weighting was used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI). Results Two hundred and thirty studies were identified. Eleven studies, including five retrospective cohort studies, four case-control studies and two case series, were included. PE was performed on 114 patients. The survival rate at 6 months was 80% (95%CI = 64%–92%), with moderate heterogeneity (I 2=63.45%, p < 0.05). Moreover, the 6-month survival rate was significantly better in the PE group than in the non-PE group (RR, 1.34; 95% CI = 1.05–1.71, I 2=30.7%; p = 0.194). ILD-related serum markers, including ferritin, KL-6 and anti-MDA-5 antibody titres, were significantly suppressed by a series of PE treatments (p < 0.05). Conclusion The application of PE therapy plus treatment with corticosteroids, immunosuppressants and/or biologics was effective for patients with IIM-RP-ILD. PE may have additional supportive effect in intractable disease.