Eastern Cooperative Oncology Group Score Research Articles

Real-World Comparison of Cabazitaxel Versus 177Lu-PSMA Radiopharmaceutical Therapy in Metastatic Castration-Resistant Prostate Cancer.

177Lu-vipivotide tetraxetan prostate-specific membrane antigen (177Lu-PSMA) therapy is under current scientific investigation and aims to become established in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, real-world evidence in treatment comparison is scant. Methods: We relied on the FRAMCAP database and compared cabazitaxel versus 177Lu-PSMA therapy in mCRPC patients regarding progression-free survival (PFS) and overall survival (OS). Sensitivity analyses addressed second- to fourth-line mCRPC treatment to approximate current phase III patient selection criteria. Results: Of 373 patients, 14% received cabazitaxel, 65% received 177Lu-PSMA, and 21% received both. Patients undergoing 177Lu-PSMA therapy were significantly older than cabazitaxel patients (median, 72 y vs. 66 y; P < 0.01), and a higher proportion had an Eastern Cooperative Oncology Group score of 2 or more (12% vs. 5.0%, P = 0.1). Rates of a prostate-specific antigen decline of at least 50% were 32% versus 0% for 177Lu-PSMA versus cabazitaxel. In outcome analyses, significant superior median PFS was observed for 177Lu-PSMA versus cabazitaxel (13.4 mo vs. 7.1 mo, P < 0.001), even after multivariable adjustment (hazard ratio, 0.38; P < 0.001). Regarding OS, rates also significantly differed, with median OS of 14.7 mo versus 16.5 mo versus 29.6 mo for cabazitaxel versus 177Lu-PSMA versus both treatments (P < 0.01). In sensitivity analyses of second- to fourth-line mCRPC treatment, PFS rates and median OS rates for cabazitaxel versus 177Lu-PSMA versus both therapies qualitatively remained the same as for the entire cohort. Conclusion: In a real-world setting, 177Lu-PSMA provides significantly better PFS and qualitatively better OS rates than does cabazitaxel chemotherapy and should therefore be considered a valuable treatment option for advanced mCRPC patients according to the European Medicines Agency approval.

Comparison of Peripheral Neurotoxicity of Weekly Paclitaxel Versus Thrice Weekly Paclitaxel Chemotherapy Among Cancer Patients

Objective: To compare peripheral neurotoxicity of weekly Paclitaxel vs thrice weekly Paclitaxel chemotherapy among cancer patients. Study Design: Quasi-experimental study. Place and Duration of study: Oncology Department, Combined Military Hospital, Rawalpindi, Pakistan from Feb to Nov 2021. Methodology: We enrolled 200 patients with diagnosed malignancies taking Paclitaxel chemotherapy for more than three months and less than one year. They were divided into two groups: Group-A received Paclitaxel weekly while Group-B received this medication thrice weekly. Peripheral neurotoxicity was assessed by consultant oncologist on the basis of Eastern Cooperative Oncology Group score and patients in both groups were categorised into four grades from 0 to 3, on the basis of clinical symptoms described in ECOG score. Results: Out of 200 cancer patients prescribed Paclitaxel, 67(33.5%) were male while 133(66.5%) were female, 107(53.5%) received Paclitaxel weekly while 93(46.5%) received thrice weekly, 65(32.5%) had Grade 0 neuropathy, 90(45%) had Grade-I, 42(21%) had Grade-II while 03(1.5%) had Grade-III neuropathy. Dosage schedule was not associated with presence and severity of neurotoxicity. Conclusion: A significant number of cancer patients using Paclitaxel had presence of neuropathy in our study, regardless of weekly or thrice weekly dosing of Paclitaxel.

Factors Associated With Death at 30 Days and Evaluation of Clinical Risk Scores Among Patients With Cancer Admitted With Postchemotherapy Infection in Uganda: A Prospective Cohort Study

Abstract Background Little is known about outcomes from cancer chemotherapy–-associated infections in sub-Saharan Africa. Accordingly, among patients with cancer admitted with postchemotherapy infection in Mbarara, Uganda, we aimed to determine (1) the 30-day case fatality rate, (2) factors associated with mortality rate, and (3) clinical risk score performance. Methods We enrolled participants aged ≥18 years if they (1) received cancer chemotherapy within the past 30 days, (2) were admitted to the oncology ward, and (3) were prescribed intravenous antibiotics. We used Cox proportional hazards regression to determine predictors of death at 30 days and calculated the area under the receiver operating characteristic curve (AUC) for each clinical risk score. Results Among 150 participants, 67 (45%) were female, and the median (interquartile range) age was 56 (43–66) years. Esophageal cancer (18%) and pneumonia (42%) were the most common cancer and infection, respectively. Death occurred within 30 days in 63 participants (42%). Quick Sequential Organ Failure Assessment (qSOFA) score ≥2 (adjusted hazard ratio, 2.51 [95% confidence interval, 1.42–4.44]; P = .001), and Universal Vital Assessment (UVA) score &amp;gt;4 (2.13 [.08–4.18, P = .03) were independently associated with death at 30 days. An Eastern Cooperative Oncology Group (ECOG) score ≥3 was similarly independently associated with death at 30 days in the qSOFA and UVA models. The AUCs for qSOFA and UVA scores were 0.70 (95% confidence interval, .63–.79) and 0.72 (.64–.80), respectively. Conclusions In participants with postchemotherapy infection in Mbarara, Uganda, the case fatality rate was high. ECOG, qSOFA, and UVA scores were associated with death at 30 days.

A Case of CUP with Malignant Pleural Effusion: Overcoming Diagnostic and Therapeutic Hurdles with Chemotherapy

Introduction: Cancers of unknown primary (CUPs) present a diagnostic challenge as their origin is unidentified at diagnosis. Massive pleural effusion (MPE), indicative of lung metastasis in CUP, categorizes the condition into an unfavorable subset with a poor prognosis. Patients in this subset may exhibit a lower response to specific therapies. Case Presentation: A 62-year-old woman presented with cough, severe dyspnea, and MPE in the left lung. Thoracocentesis was performed, extracting 1,200 mL of hemorrhagic fluid, followed by the placement of an indwelling pleural catheter. The cytological examination of the pleural effusion indicated an adenocarcinoma, with immunohistochemistry revealing positive CK7 and negative CK20, Napsin A, and TTF-1. Additionally, elevated levels of Ca-125 (1,605 U/mL) and Ca 15-3 (242 U/mL) raised suspicion of gynecological malignancy. Thorax and abdominal CT scans, breast and thyroid ultrasounds showed no signs of malignancy, leading to the diagnosis of CUP. The patient’s performance status according to the Eastern Cooperative Oncology Group (ECOG) score was 4. Initial carboplatin 5 AUC and paclitaxel 175 mg/m2 administration resulted in improvement in performance status with ECOG score of 1, alleviation of dyspnea, reduction in pleural effusion 1 week after chemotherapy, with minimal effusion observed at 3 weeks, and Ca-125 levels decreased to 33.6 U/mL thereafter. Discussion: Empiric chemotherapy using carboplatin and paclitaxel is a feasible option for managing CUP with MPE mimicking gynecological malignancies with elevated Ca-125 and Ca 15-3 markers; initiating chemotherapy in poor performance status patients is beneficial with proper clinical judgment.

Predictors of symptom recurrence and survival in patients with malignant gastric outlet obstruction treated with self-expanding metal stents.

Malignant gastric outlet obstruction (GOO) poses a substantial symptomatic burden. While various therapeutic options exist, self-expanding metal stents (SEMS) are a common palliative choice for patients who are ineligible for surgery. We studied SEMS outcomes to identify factors influencing stent dysfunction and patient survival. A multi-centre, retrospective review of 190 patients with GOO undergoing SEMS at three tertiary hospitals was performed over 2016-2022. Technical success, clinical success and adverse outcomes were recorded. Predictors of stent dysfunction and survival were evaluated using multivariate regression. Technical success was achieved in 186/190 (97.9%) and clinical success in 156/186 (83.9%), defined as post-procedural gastric outlet obstruction symptom score (GOOSS) ≥2. Eighty-two (44.1%) patients experienced an adverse event with stent occlusion the most common (23.1%). Approximately one-third (32.3%) underwent a repeat intervention. Mean stent patency time was 67 days (standard deviation=76), and median post-stent survival was 95 days (37-197). Covered and partially covered SEMS carried three times the risk of stent dysfunction compared to uncovered SEMS (odds ratio 3.06, p=0.008). Mortality predictors were Eastern Cooperative Oncology Group score ≥2 (p=0.03), extrinsic outlet obstruction (p=0.05) and presence of ascites (p=<0.001). SEMS demonstrated technical and clinical success but posed a high risk of recurrence, with stent patency time falling short of survival in our cohort. With an evolving landscape of therapeutics for GOO, appropriate patient selection is paramount. Individuals with reduced performance status, extrinsic obstruction and/or ascites may be better candidates for SEMS due to more limited life expectancy. In this setting, uncovered SEMS carry the lowest risk of reintervention.

Efficacy of Atezolizumab Plus Bevacizumab Combined with Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Real-World Study.

Transarterial chemoembolization (TACE), when used in combination with immunotherapy and antiangiogenic therapy, has been shown to have synergistic anticancer effects. The aim of this study was to further assess the efficacy and safety of TACE combined with atezolizumab and bevacizumab in the treatment of unresectable hepatocellular carcinoma (HCC) in the real world. Between August 2021 and September 2023, clinical information was collected from consecutive HCC patients who received treatment via TACE-Atezo/Bev at four tertiary institutions. This study evaluated the objective response rate (ORR), overall survival (OS), and progression-free survival (PFS) as outcomes. Predictors for OS and PFS were also analyzed. Treatment-related adverse events (TRAEs) were recorded and assessed. Ninety-two patients were enrolled in this study, with a median follow-up duration of 14.1 months. The ORRs based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) and RECIST 1.1 criteria were 54.3% and 41.3%, respectively. The median OS and PFS of the patients were 15.9 months [95% confidence interval (CI), 14.5-17.2 months] and 9.1 months (95% CI, 7.4-10.8 months), respectively. Multivariate analyses revealed that the Eastern Cooperative Oncology Group score and neutrophil‒lymphocyte ratio were independent risk factors for OS, whereas tumor size and extrahepatic metastasis were independent risk factors for PFS. Grade 3/4 TRAEs occurred in 16.3% (15/92) of the patients and were controlled conservatively. The combination of Atezo/Bev with TACE demonstrated acceptable synergistic therapeutic effects and manageable safety profiles in patients with unresectable HCC.

Can some inflammatory parameters predict the survival of patients with malignant pleural effusion?

Background: This study aimed to investigate whether there is a correlation between some serum inflammatory markers and the survival of patients with malignant pleural effusions (MPEs). Methods: The prospective study included 125 patients (67 males, 58 females; median age: 62 years; range, 40 to 92 years) who underwent thoracentesis for pleural effusion between January 2020 and December 2021. An overall survival analysis was performed, and survival differences between the groups were investigated. The cutoff value of the inflammatory parameters associated with mortality was determined by receiver operating characteristic analysis. Results: Median survival after detection of MPE was six months, and three- and five-year overall survivals were 16% and 4%, respectively. There was a significant correlation between the ECOG (Eastern Cooperative Oncology Group) score of the patients and the median survival. Serum C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), fluid albumin, and serum lactate dehydrogenase (LDH)-to-pleural LDH ratio and survival had a statistically significant relationship in receiver operating characteristic analysis. Threshold values were determined accordingly. Poor prognostic factors that were found to be statistically significant were high CRP (p=0.001), high NLR (p=0.001), high PLR (p=0.02), and high serum LDH-to-pleural LDH ratio (p=0.04). Conclusion: Some serum inflammatory markers, including high CRP, high NLR, high PLR, and high serum LDH-to-pleural LDH ratio, can be a simple and inexpensive method in predicting prognosis in patients with MPE.

Efficacy and Toxicity of [177Lu]Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer: Results from the U.S. Expanded-Access Program and Comparisons with Phase 3 VISION Data.

The phase 3 VISION trial demonstrated that [177Lu]Lu-PSMA-617 prolonged progression-free survival and overall survival (OS) in prostate-specific membrane antigen [PSMA]-positive metastatic castration-resistant prostate cancer (mCRPC) patients who progressed on taxane-based chemotherapy and androgen receptor-signaling inhibitors (ARSIs). The U.S. expanded-access program (EAP; NCT04825652) was opened to provide access to [177Lu]Lu-PSMA-617 for eligible patients until regulatory approval was obtained. This study aimed to evaluate the efficacy and safety profile of [177Lu]Lu-PSMA-617 within the EAP and compare the results with those from the VISION trial. Methods: Patients enrolled in the EAP at 4 institutions in the United States with available toxicity and outcome data were included. Outcome measures included OS, a prostate-specific antigen (PSA) response rate (RR) of at least 50%, and incidences of toxicity according to Common Terminology Criteria for Adverse Events version 5.0. Differences in baseline characteristics, outcome data, and toxicity between the EAP and VISION were evaluated using t testing of proportions and survival analyses. Results: In total, 117 patients with mCRPC who received [177Lu]Lu-PSMA-617 within the EAP between May 2021 and March 2022 were eligible and included in this analysis. Patients enrolled in the EAP were more heavily pretreated with ARSI (≥2 ARSI regimens: 70% vs. 46%; P < 0.001) and had worse performance status at baseline (Eastern Cooperative Oncology Group score ≥ 2: 19% vs. 7%; P < 0.001) than VISION patients. EAP and VISION patients had similar levels of grade 3 or higher anemia (18% vs. 13%; P = 0.15), thrombocytopenia (13% vs. 8%; P = 0.13), and neutropenia (3% vs. 3%; P = 0.85) and similar PSA RRs (42% vs. 46%; P = 0.50) and OS (median: 15.1 vs. 15.3 mo; P > 0.05). Conclusion: Patients with PSMA-positive mCRPC who received [177Lu]Lu-PSMA-617 within the EAP were later in their disease trajectory than VISION patients. Patients enrolled in the EAP achieved similar PSA RRs and OS and had a safety profile similar to that of the VISION trial patients.

Fifteen-Year Experience of a Single Institution: Outcomes for Early-Stage Hodgkins Lymphoma Comparing Chemotherapy Alone Versus Combined Modality Therapy

Doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy is the current standard treatment for early-stage Hodgkins lymphoma (HL). The use of consolidative radiation therapy (RT) in addition to chemotherapy may lead to better survival rates but is controversial because of concerns about long-term toxicity. The aim of this study is to compare outcomes of patients receiving ABVD chemotherapy alone (CTX alone) versus ABVD with consolidative RT (CMT). A single-institution, retrospective review of patients with HL diagnosed from 2000 to 2014 was conducted. Patients were identified from the National Cancer Database. Inclusion criteria included patients aged ≥18 years, with stage I or II HL, who received ABVD with a complete response with/without CMT. Consolidative RT must have been started within 90 days of completing chemotherapy. Institutional review board approval was obtained. Follow-up details and treatment responses were collected from medical record reviews. Standard statistical analysis and Kaplan-Meier curves were used to estimate relapse-free survival (RFS). One hundred and 8 patients with early-stage HL were identified. The median age at diagnosis was 31 years (range, 19-72). Most patients were female (63%) and Caucasian (65%). stage II HL was present in 89%of patients, 89% had an Eastern Cooperative Oncology Group score of 0 or 1, 35% had B symptoms, and 9% had extranodal involvement. A total of 52.8% received CMT (n = 57) and 47.2% received CTX alone (n = 51). The CMT group had fewer cycles of chemotherapy compared to the CTX-alone group (mean cycles, 5.2 vs 5.7, P = 0.045). Twenty-four relapse events occurred in the CTX-alone group, while no relapse events occurred in the CMT group. RFS at 10 years was significantly improved in the CMT group (100%) compared to CTX alone (47.4%, P < .0001; HR = .03, P < .001). ABVD with consolidative RT was associated with improved RFS. Further studies of toxicity comparisons, advanced stages, and nonfavorable HL are warranted.

Identification of primary mediastinal B-cell lymphomas with higher clonal dominance and poorer outcome using 5′RACE

AbstractThere is a scarcity of data on the tumor B-cell receptor (BCR) repertoire and lymphoid microenvironment in primary mediastinal B-cell lymphoma (PMBL). We applied 5ʹ rapid amplification of complimentary DNA ends (5′RACE) to tumor RNA samples from 137 patients with PMBL with available gene expression profiling and next-generation sequencing data. We obtained 5′RACE results for 75 of the 137 (54.7%) patients with the following clinical characteristics: median age (range), 33 years (18-64); female, 53.3%; performance status score 0 to 1, 86.7%; stage I to II, 57.3%; first-line treatment with anti-CD20 plus doxorubicin-based chemotherapy, 100%. Among the 60 biopsies that expressed a productive BCR, we highlighted a strong somatic hypermutation profile, defined as <98% identity to the germ line sequence, with 58 (96.7%) patients carrying mutated IgVH. We then identified a subgroup of 12 of the 75 patients (16%) with a worse prognosis (progression-free survival [PFS]: hazard ratio [HR], 17; overall survival [OS]: HR, 21) that was associated with the highest clonal dominance (HCD) status, defined as the dominant clonotype representing >81.1% and >78.6% of all complementarity-determining region 3 sequences for IgVH and IgVL, respectively. When compared with other patients, this subgroup had similar clinical characteristics but a greater median allele frequency for all somatic variants, a decreased BCR diversity, and greater expression of PDL1/PDL2 and MS4A1 genes, suggesting greater tumoral infiltration. We confirmed this poorer prognosis in a multivariate model and in an independent validation cohort in which 6 of 37 (16%) PMBL patients exhibited HCD (PFS: HR, 12; OS: HR, 17).

Can Cytoreductive Nephrectomy Improve Outcomes of Nivolumab Treatment in Patients with Metastatic Clear-Cell Renal Carcinoma?

Background: This study aimed to investigate the effect of cytoreductive nephrectomy (CN) on the survival outcomes of nivolumab used as a subsequent therapy after the failure of at least one anti-vascular endothelial growth factor (VEGF) agent in patients with metastatic clear-cell renal-cell carcinoma (ccRCC). Methods: We included 106 de novo metastatic ccRCC patients who received nivolumab after progression on at least one anti-VEGF agent. Multivariate Cox regression analysis was performed to investigate the factors affecting survival in patients receiving nivolumab. Results: Of the 106 de novo metastatic ccRCC patients, 83 (78.3%) underwent CN. There were no statistical differences between the two groups in terms of age, gender, Eastern Cooperative Oncology Group (ECOG) score, tumor size, International Metastatic RCC Database Consortium (IMDC) risk group, number of previous treatment lines, first-line anti-VEGF therapy, or metastasis sites (p = 0.137, p = 0.608, p = 0.100, p = 0.376, p = 0.185, p = 0.776, p = 0.350, and p = 0.608, respectively). The patients who received nivolumab with CN had a longer time to treatment discontinuation (TTD) [14.5 months, 95% confidence interval (CI): 8.6-20.3] than did those without CN 6.7 months (95% CI: 3.9-9.5) (p = 0.001). The median overall survival (OS) was 22.7 months (95% CI: 16.1-29.4). The patients with CN had a median OS of 22.9 months (95% CI: 16.3-29.4), while those without CN had a median OS of 8.1 months (95% CI: 5.6-10.5) (p = 0.104). In the multivariate analysis, CN [hazard ratio (HR): 0.521; 95% CI: 0.297-0.916; p = 0.024] and the IMDC risk score (p = 0.011) were statistically significant factors affecting TTD; however, the IMDC risk score (p = 0.006) was the only significant factor for overall survival. Conclusions: Our study showed that the TTD of nivolumab was longer in metastatic ccRCC patients who underwent cytoreductive nephrectomy.

Anxiety and depression are common in surgical oncology patients: Results of a prospective cohort study

BackgroundThe oncology patient population is vulnerable to elevated levels of anxiety and depression. These states of psychological distress have been associated with negative effects on treatment course and outcomes, but reported prevalence rates are varied. The General Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) questionnaires are screening tools that can be utilized to assess the levels of anxiety and depression, respectively. MethodsThis prospective, surgeon-blinded study assessed the preoperative prevalence of anxiety and depression in patients with abdominal malignancies who underwent curative-intent resection. Postoperative outcomes and survival were assessed. ResultsOverall, 218 patients were enrolled and included in the final analysis. Patients were stratified into groups by severity of anxiety and depression. 67 (31 %) patients reported at least mild anxiety as defined by GAD-7 score of 5 +, and 74 (34 %) patients reported at least mild depression, as defined by PHQ-9 score of 5 +. Functional status as defined by Eastern Cooperative Oncology Group scores was associated with anxiety (P = 0.003) and depression (P = 0.024). Depression was associated with race and ethnicity (P = 0.014) and marital status (P = 0.021), with Hispanic/Latino and unpartnered patients reporting higher rates of depression. ConclusionAnxiety and depression are common in the surgical oncology population, affecting a third of the patient population in this prospective study. In addition to a thorough social assessment, the GAD-7 and PHQ-9 questionnaires can be utilized preoperatively to identify patients with psychological distress. SynopsisAnxiety and depression were assessed preoperatively in patients with abdominal malignancies who underwent curative-intent resection. These states of psychological distress were highly prevalent, affecting a third of the population, and significantly associated with certain vulnerable groups.

Survival among patients with lung cancer managed at a tertiary care center in North India.

Though there has been advancement in the management of lung cancer, it is not well utilized due to its limited availability and high cost. This is a prospective observational study done at a tertiary care center from January 2014 to December 2022, involving patients with primary lung cancer. After tumor-node-metastasis staging and molecular testing, the patients received chemotherapy, radiotherapy, surgery, targeted therapy, and immunotherapy in various combinations as per the prevailing National Comprehensive Cancer Network Guidelines. 92 patients were enrolled in the study, with the mean age being 58.94±10.33 and 72 (78.26%) being males. 69 (75%) patients were either current or former smokers. 78 (84.78%) patients had an Eastern Cooperative Oncology Group (ECOG) score of 0-2 while the remaining had an ECOG of 3-4. 80 (86.95%) patients had non-small cell lung cancer (NSCLC) [44 (47.83%) adenocarcinoma, 25 (27.17%) squamous cell carcinoma, and 11 (11.95%) NSCLC: not otherwise specified], while 12 (13.04%) patients had small cell lung cancer. One (1.08%) patient each presented in stage I and stage II, 31 (33.69%) patients presented in stage III, and 59 (64.13%) patients presented in stage IV. 44 patients with adenocarcinoma were subjected to mutational analysis, and an epidermal growth factor receptor mutation was found in 13 (29.5%) patients. None of the patients had ALK mutation, ROS-1 rearrangement, or BRAF mutation. PD-L1 expression was evaluated in 9 patients with NSCLC, and it was found in 6 (66.66%) patients. The overall mean survival was 12.7 months. The mean survival for patients with stages I, II, III, and IV was 70, 96, 8.1, and 12.7 months, respectively. Survival in stage IV was better than in stage III, as the eligible patients received targeted therapy and immunotherapy. Targeted therapy and immunotherapy have improved survival. Molecular analysis should be done whenever indicated, and eligible patients must be administered targeted therapy and immunotherapy.

Brentuximab vedotin plus cyclophosphamide, doxorubicin, etoposide, and prednisone followed by brentuximab vedotin consolidation in CD30-positive peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 study

CD30 expression is universal in anaplastic large-cell lymphoma and is expressed in some other peripheral T-cell lymphoma subtypes. Incorporation of brentuximab vedotin into initial therapy for people with CD30-positive peripheral T-cell lymphomas prolonged progression-free survival, but there is room for improvement, especially for people with non-anaplastic large-cell lymphoma subtypes. We conducted a multicentre, international, single-arm, phase 2 trial to evaluate the safety and activity of CHEP-BV (cyclophosphamide, doxorubicin, prednisone, brentuximab vedotin, and etoposide) followed by brentuximab vedotin consolidation in patients with CD30-expressing peripheral T-cell lymphomas across five academic centres in the USA and Canada. Adults aged 18 years or older with newly diagnosed, untreated CD30-positive peripheral T-cell lymphomas, Eastern Cooperative Oncology Group score of 0-2, and adequate organ function were eligible to receive six planned cycles of CHEP-BV (ie, 1·8 mg/kg brentuximab vedotin intravenously on day 1, cyclophosphamide 750 mg/m2 intravenously on day 1, doxorubicin 50 mg/m2 intravenously on day 1, etoposide 100 mg/m2 daily intravenously on days 1-3, and prednisone 100 mg daily orally on days 1-5) with prophylactic G-CSF. Patients who responded to the treatment could receive brentuximab vedotin consolidation for up to ten additional cycles either after autologous haematopoietic stem-cell transplantation (HSCT) or directly after CHEP-BV. The primary endpoints were unacceptable toxicity during a 3-plus-3 safety lead-in in participants who received study treatment and completed the safety evaluation period (to confirm the recommended phase 2 dose of brentuximab vedotin in CHEP-BV) and the complete response rate after CHEP-BV induction therapy in participants who received study treatment and had response evaluation. The study was registered at ClinicalTrials.gov (NCT03113500), and this cohort completed the trial. The trial is ongoing with the enrolment of a new cohort. 54 patients were screened for eligibility and 48 were eligible for the study. The participants (18 [38%] women and 30 [63%] men; 34 [71%] White, four [8%] Black, five [10%] Asian, ten [21%] Hispanic, and 37 [77%] non-Hispanic people) were recruited and enrolled between Dec 4, 2017, and June 14, 2021, and followed up until Aug 25, 2023, when the database was locked for analysis. 48 participants were evaluable for toxicity, and 47 were evaluable for response (one participant died from COVID-19 before response assessment). During the safety lead-in, one of six participants had an unacceptable toxicity (ie, platelet count <10 000 per mm3 in a participant with extensive bone marrow involvement), and the proposed phase 2 dose of 1·8 mg/kg brentuximab vedotin in CHEP-BV was confirmed. At completion of CHEP-BV, 37 of 47 participants had complete response, yielding a complete response rate of 79% (95% CI 64-89). The most common CHEP-BV-related toxicities of grade 3 or higher were neutropenia (14 [29%] of 48), leukopenia (11 [23%]), anaemia (ten [21%]), febrile neutropenia (ten [21%]), lymphopenia (nine [19%]), and thrombocytopenia (nine [19%]). There were no treatment-related deaths. In patients with mostly CD30-expressing peripheral T-cell lymphomas other than non-anaplastic large-cell lymphoma, CHEP-BV (with or without autologous HSCT) followed by brentuximab vedotin consolidation was safe and active. SeaGen, Leukemia and Lymphoma Society, Lymphoma Research Foundation, and the National Cancer Institute of the National Institutes of Health.

Risk Without Reward: Differing Patterns of Chemotherapy Use Do Not Improve Outcomes in Stage II Early-Onset Colon Cancer.

Rising rates of early-onset colon cancer (EOCC) present challenges in deciding how to optimally treat patients. Although standard of care for stage II CC is surgical resection, adding chemotherapy for high-risk disease, evidence suggests treatment selection may differ by age. We investigated whether adjuvant chemotherapy (AC) administration rates differ between patients with early- and later-onset stage II CC. Data originated from the nationwide Flatiron Health electronic health record (EHR)-derived deidentified database spanning January 1, 2003, to August 1, 2021. Adults with stage II CC were grouped as age 18-49 years (EOCC) and those age 50 years or older (later-onset colon cancer [LOCC]). Demographics, Eastern Cooperative Oncology Group score, tumor stage and site, and chemotherapy were included. Primary outcomes included rates of AC administration by age and ethnicity; secondary outcomes included overall survival (OS) and time to metastatic disease (TTMD). Univariate and multivariable logistic regression models evaluated relationships between chemotherapy administration, age, and ethnicity, adjusting for significant covariates. One thousand sixty-five patients were included. Median age of patients with EOCC was 45.0 years versus 69.0 years for patients with LOCC. Adjusted multivariate analysis showed patients with EOCC received AC significantly more often than patients with LOCC. Non-Hispanic patients received AC at significantly lower rates than Hispanic patients in both cohorts. Subanalysis of stage IIA patients showed that patients with EOCC were more likely to receive AC than patients with LOCC. No significant differences in OS or TTMD were observed by age regardless of AC administration in stage II overall; however, patients with stage IIA EOCC receiving AC had significantly longer TTMD than those not receiving AC. AC was given preferentially in stage II EOCC, even in stage IIA, despite deviation from guidelines. This may expose low-risk patients to unnecessary toxicities and suggests bias toward treating younger patients more aggressively, despite unclear evidence for better outcomes.

Real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and laboratory parameters in patients across metastatic tumor sites

Objectives: PacliALLTM is the first and only indigenously developed brand of nab-paclitaxel in India that has shown bioequivalence to the global reference (Abraxane®). However, real-world Evidence is scarce about the use of it in different tumor sites beyond approved indications. This study assessed the effects of nab-paclitaxel (PacliALLTM) on clinical outcomes in patients diagnosed with different metastatic cancers in a tertiary care hospital in India. Material and Methods: In this retrospective study, data on demographics, medical history, and laboratory investigations were collected from medical records of patients with metastatic cancer. Patients on nab-paclitaxel were included, and data on laboratory findings, including hematological, liver, and kidney function tests and prognostic outcomes, were evaluated. Results: The study population consisted of 73 patients with metastatic cancer (mean age- 54.6 years). Primary sites of cancer in most patients were the oral cavity (40.8%), followed by breast and ovary (15.3%, each). The Eastern Cooperative Oncology Group score was 0 in 84.3% and 1 in 14.3% of patients. Weekly analyses showed no significant differences in hemoglobin, neutrophil, creatinine, random blood glucose (RBG), and serum glutamic-oxaloacetic transaminase levels. A significant proportion of patients reported anemia and RBG &gt;125 mg/dL at baseline (97.1% and 63.4%, respectively) and week 17 (85.1% and 88.1%, respectively). Most patients had a partial response at week 17 (76.8%), respectively. No serious adverse reactions were reported, requiring a change in treatment. Conclusion: Nab-paclitaxel showed manageable tolerability and favorable response rates in metastatic cancer patients. It is widely used beyond approved indications in a significant proportion of patients across various tumor sites.

Evidence of being cured for nasopharyngeal carcinoma: results of a multicenter patient-based study in China

The survival rates of patients with nasopharyngeal carcinoma (NPC) have improved significantly, but there is no consensus on whether they can be considered cured. We aimed to determine whether a statistical cure could be achieved for patients with NPC in the contemporary therapeutic landscape. This retrospective multicenter study enrolled 6315 patients with nonmetastatic NPC from nonendemic and endemic regions of China from 2007 to 2020. We applied mixture and nonmixture cure models to estimate the cure probabilities and cure times by incorporating background mortality for the general population, matching by gender, age, and diagnosed year. With death as the uncured event, the probability of patients with NPC achieving a life expectancy at par with the general population was 78.1%. Considering progression as the uncured event, the likelihood of patients attaining a life expectancy without progression equivalent to that of the general population was 72.4%. For individuals, the probabilities of achieving cure were conditional and time-dependent, requiring approximately 7.1 and 4.7 years with 95% certainty, respectively. The corresponding cure times for uncured patients were 8.9 and 6.8 years, respectively. The cure probability was correlated with age, Eastern Cooperative Oncology Group score, TNM staging, Epstein-Barr virus DNA copies, and lactate dehydrogenase. The correlation was excellent between 5-year overall survival/progression-free survival and cure fractions. Statistical cure is potentially achievable among patients with NPC undergoing contemporary treatment modalities. The results hold significant potential implications for both clinical practice and patient perspectives. National High Level Hospital Clinical Research Funding; Beijing Xisike Clinical Oncology Research Foundation; Beijing hope run fund.

Comparison of Characteristics and Survival of New-Onset Hepatocellular Carcinomas With or Without Cirrhosis in a Tertiary Center.

Although hepatocellular carcinoma (HCC) usually develops in cirrhotic livers, HCCs could also arise in non-cirrhotic livers. We aimed to compare the characteristics and survival of cirrhotic- and non-cirrhotic HCCs. Data of HCC patients between 2011 and 2021 in a single tertiary center was evaluated retrospectively. Demographic, clinical, laboratory, tumoral and pathological features, and survival outcomes of cirrhotic and non-cirrhotic HCCs were compared. The study included 188 HCC patients. Median age was 64 (26-92) years and similar for study groups (P = .208). Both groups had similar male/female ratio. Forty-two patients (22.3%) had HCC in non-cirrhotic liver. Non-cirrhotic HCCs had similar tumor differentiation type, radiological characteristics, Milan, University of California San Francisco, and the Barcelona Clinic Liver Cancer stages, but more unifocal lesion (78.6% vs. 59.6%) and larger tumor size (89.5 (16-240) mm vs. 59.0 (12-290) mm) at presentation compared to non-cirrhotic HCCs. Despite larger tumor size, non-cirrhotic HCC patients had better overall, disease-free and progression-free survival rates than cirrhotic HCCs. Overall survivals for 1 and 3 years were 71.4% and 49.7% for non-cirrhotic and 54% and 28.3% for cirrhotic HCCs, respectively (P = .035). According to Cox analyses, Eastern Cooperative Oncology Group score (P <.001, hazards ratio (HR): 4.05) and curative treatments (P < .001, HR: 0.21) were predictive for overall survival in cirrhotic HCCs. Curative treatment (P = .027, HR: 0.31) was found to be a significant predictor for overall survival in non-cirrhotic HCCs. Vascular invasion was the only independent predictor for disease-free survival (HR: 2.62, 95% CI 1.01-6.93, P = .049) for non-cirrhotic HCCs. Despite larger tumor size and similar tumor stages, compared to cirrhotic HCCs, non-cirrhotic HCCs were associated with better survival outcomes.

Internal urethral sphincter reconstruction with anterior bladder neck tube for robotic and laparoscopic radical prostatectomy: improving early return of continence.

In recent years, despite several surgical techniques having been applied, the early incontinence rate after radical prostatectomy (RP) remains high. In this study, we reconstructed an internal urethral sphincter (IUS) with anterior bladder neck tube (ABNT) to improve early return of continence and find a more effective technique for early urinary incontinence after RP. In this study, 96 previous patients who did not receive an ABNT between October 2018 and May 2020 were compared as historical controls (the control group). A total of 210 consecutive patients underwent robotic or laparoscopic RP with ABNT between May 2020 and February 2023 (the ABNT group). The inclusion criteria included Eastern Cooperative Oncology Group (ECOG) score 0-1 and localized prostate cancer (clinical stages cT1-3, cN0, cM0). The exclusion criteria included patients with diabetes, neurologic diseases, previous pelvic operations, symptoms of urinary incontinence, prior radiation, focal therapy, or androgen deprivation therapy for prostate cancer. ABNT was reconducted with a U-shaped flap from the anterior wall of the bladder neck, and was then anastomosed with the urethra. In the control group, the bladder outlet was directly anastomosed with the urethra. Continence, as defined if 0 pads were used per day and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score ≤6, was assessed at 1, 4, 8, 12, and 24 weeks after catheter removal. At 2 weeks after catheter removal, urethral pressure profilometry (UPP) and upright urethrography were performed to evaluate the function of ABNT in the ABNT group. More patients in the ABNT group were continent than those in the control group at 1 week (85.2% vs. 22.9%, P<0.001), 4 weeks (91.4% vs. 27.1%, P<0.001), 8 weeks (95.2% vs. 40.6%, P<0.001), 12 weeks (100% vs. 71.9%, P<0.001), and at 24 weeks (100% vs. 87.5%, P<0.001) after catheter removal. Stricture was presented in 5.2% and 2.1% (P=0.34) in the ABNT group and control group, respectively. UPP showed that a functional IUS was reconstructed with ABNT. Upright urethrography showed that the ABNT was filled with contrast medium in the urination period and with no contrast medium during the storage period and interruption of urination. The ABNT technique significantly improved early return of continence in comparison with the no ABNT technique, especially the immediate continence. The ABNT technique reconstructed the functional IUS with acceptable urethral stricture. The limitations of the present study include that the comparison was conducted retrospectively with a historical cohort and lack of randomization, and the single center setting. A prospective, randomized, and multicenter evaluation is expected.

Risk factorsfor preoperative frailty in older patients withgastric cancer: a systematic review and meta-analysis.

To summarize the available evidence on risk factors for preoperative frailty in older gastric cancer patients. We comprehensively searched the CNKI, Wanfang, VIP, CBM, PubMed, Embase, The Cochrane Library, Web of Science, and CINAHL databases for preoperative articles on risk factors for frailty in older gastric cancer patients. The search was conducted from the time of construction of the library to January 27, 2024, with no language restrictions. The quality of the included studies was rated by the Newcastle-Ottawa Scale and the Agency for Healthcare Research and Qualitytool. A total of 20 studies were included, including 16 cohort studies and 4 cross-sectional studies, with a total sample size of 51,717 individuals. The results of the meta-analysis showed that age, albumin, hemoglobin, cancer stage III-IV, Charlson Comorbidity Index score ≥ 3, Eastern Cooperative Oncology Group score > 2, American Society of Anesthesiologists score > 2, smoking, nutritional risk, high school degree or above, and sleep disorders are the main influencing factors for the occurrence of preoperative frailty in older gastric cancer patients. Among them, high school degree or above was aprotective factor. Our study provides valid evidence of risk factors for preoperative frailty in older patients with gastric cancer and informs clinical healthcare professionals to make targeted interventions.