American Journal of Clinical Oncology-Cancer Clinical Trials最新文献

For patients with locoregionally confined pancreatic ductal adenocarcinoma (PDAC), margin-negative surgical resection is the only known curative treatment; however, the majority of patients are not operable candidates at initial diagnosis. Among patients with resectable disease who undergo surgery alone, the 5-year survival remains poor. Adjuvant therapies, including systemic therapy or chemoradiation, are utilized as they improve locoregional control and overall survival. There has been increasing interest in the use of neoadjuvant therapy to obtain early control of occult metastatic disease, allow local tumor response to facilitate margin-negative resection, and provide a test of time and biology to assist with the selection of candidates most likely to benefit from radical surgical resection. However, limited guidance exists regarding the relative effectiveness of treatment options. In this systematic review, the American Radium Society multidisciplinary gastrointestinal expert panel convened to develop Appropriate Use Criteria evaluating the evidence regarding neoadjuvant treatment for patients with PDAC, including surgery, systemic therapy, and radiotherapy, in terms of oncologic outcomes and quality of life. The evidence was assessed using the Population, Intervention, Comparator, Outcome, and Study (PICOS) design framework and "Preferred Reporting Items for Systematic Reviews and Meta-analyses" 2020 methodology. Eligible studies included phases 2 to 3 trials, meta-analyses, and retrospective analyses published between January 1, 2012 and December 30, 2022 in the Ovid Medline database. A summary of recommendations based on the available literature is outlined to guide practitioners in the management of patients with PDAC.

Background: Creatine supplementation is an effective ergogenic nutrient for athletes, as well as for people starting a health or fitness program. Resistance training has previously been identified as an important method of increasing muscle mass and strength, especially in people with cancer to avoid sarcopenia. The potential of creatine supplementation for adaptations produced by resistance training in patients with cancer is still unknown. The primary aim of this study is to evaluate the effectiveness of a supervised resistance training program intervention with and without creatine supplementation in patients with breast cancer.

Methods: Is a multicentre, randomized, blind, placebo-controlled study. Patients will be randomly assigned to a control group and 2 experimental groups. The first training resistance group (RG) will perform resistance training, while the second experimental resistance-creatine group will perform the same resistance training as the RG and will also receive a 5 g/d creatine supplementation during the intervention. RG participants will follow the same daily dosing protocol, but in their case, with dextrose/maltodextrin. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involve the largest muscle groups, performed 3 times a week on nonconsecutive days. Both the RG and the resistance-creatine group will receive a supplement of soluble protein powder (20 to 30 g) daily.

Conclusion: This intervention will help to better understand the potential of nonpharmacological treatment for improving strength and well-being values in patients with breast cancer with and without creatine supplementation.

Objectives: This practice parameter was revised collaboratively by the American College of Radiology (ACR), the American College of Nuclear Medicine, the American Radium Society, the American Society for Radiation Oncology, and the Society of Nuclear Medicine and Molecular Imaging. The document is intended to serve as a resource for appropriately trained and licensed physicians who perform therapeutic procedures with unsealed sources, referred to in the document using the more inclusive terminology of radiopharmaceuticals, for which a written directive is required for authorized users under NRC 10 CFR 35.300.

Methods: This practice parameter was developed according to the process described under the heading The Process for Developing ACR Practice Parameters and Technical Standards on the ACR website ( https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards ) by the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the American Radium Society.

Results: This practice parameter addresses the overall role of the applicable physician-authorized user, Qualified Medical Physicist, and other specialized personnel involved in the delivery of radiopharmaceutical therapy. Therapeutic radiopharmaceuticals include those administered as elemental radioactive isotopes (radionuclides) or the radioactive element incorporated into a targeting molecule (ligand) by one or more chemical bonds. This document provides guidance regarding general principles of radionuclide therapies and indications of various alpha, beta, gamma, and mixed emission agents with references to several recent practice parameters on new and commonly performed radiopharmaceutical therapies.

Conclusion: This document addresses clinical circumstances, elements of available agents, and the qualifications and responsibilities of various members of the radiation care team, specifications of consultation and other clinical documentation, post-therapy follow-up, radiation safety precautions, elements of quality control and improvement programs, infection control, and patient education to ensure optimal patient care and safety when utilizing radiopharmaceuticals.

Objectives: This study evaluated real-world treatment patterns of approved bone-targeting agents (BTAs) with various mechanisms of action-pamidronate, zoledronic acid, and denosumab-for the prevention of skeletal-related events in patients with bone metastases (BM) from solid tumors.

Methods: Adult patients with BM secondary to solid tumors between January 1, 2014, and December 31, 2018, were identified from the Flatiron Health Oncology Services Comprehensive Electronic Records database and categorized by BTA use and therapy type. Time from diagnosis to initiation, persistence (mean time on treatment), and compliance (≥12 administrations/year) with BTA with up to 4 years of follow-up were examined.

Results: This study included 27,268 patients with BM (breast cancer, 32.7%; lung cancer, 16.5%; prostate cancer, 17.2%; and other solid tumors, 33.6%); of these, 41.4% initiated denosumab after BM diagnosis; 21.3%, zoledronic acid; 0.6%, pamidronate; and 36.7% had no treatment record. Mean (SD) time to initiation for denosumab or zoledronic acid was 68.6 (157.0) days (denosumab, 70.3 (160.4) days; zoledronic acid, 65.2 [150.2] days). Mean persistence and compliance (first year of treatment) were significantly higher for denosumab than for zoledronic acid (22.0 vs. 14.9 mo [ P <0.0001] and 42.3% vs. 34.8% [ P <0.0001], respectively). Treatment compliance was the highest in patients with breast cancer (denosumab, 48.2%; zoledronic acid, 39.1%).

Conclusion: Real-world BTA treatment patterns in the United States suggest that over one-third of patients with BM secondary to solid tumors remain untreated and less than 50% of the patients received ≥12 administrations/year of BTA therapy.

Background: Diagnosis of malignant pulmonary nodules can greatly reduce the occurrence of lung cancer death, and computed tomography (CT) is commonly used in diagnosis. In addition, tumor-associated autoantibodies (TAAbs) show high specificity and stability. We aim to establish a computable risk model of pulmonary nodules by combining CT with TAAb detection.

Methods: The concentrations of 7 TAAbs (p53, PGP9.5, SOX2, GAGE7, GBU4-5, CAGE, MAGEA1, and CAGE) were assayed using the enzyme-linked immunosorbent assay in 136 patients with pulmonary nodules (84 with newly diagnosed lung adenocarcinoma, 21 with squamous cell carcinoma, and 31 with benign nodules) and 42 control subjects without pulmonary nodules. We then drew receiver operating characteristic curves and conducted logistic regression to analyze the diagnostic efficiency of our method in the detection of lung cancer.

Results: The positivity rate of the 7 TAAbs was 49.5%, and the specificity was 83.6%. Our regression results indicated 65% overall accuracy, 44.76% sensitivity, and 76.71% specificity. Notably, when combined with CT imaging and the demographic characteristics, diagnostic accuracy increased to 73.4%, sensitivity to 61.5%, and specificity to 87.1%. The positive predictive value and negative predictive value were 93% and 41%, respectively.

Conclusion: Our study provides a method that combines 7 serum TAAbs with imaging and demographic characteristics to diagnose malignant pulmonary nodules more accurately than existing methods.

Objectives: Stereotactic Body Radiotherapy (SBRT) and Yttrium-90 (Y90) are among the ablative therapies used as treatment options for localized hepatocellular carcinoma (HCC). To date, direct comparisons of the 2 modalities' outcomes and costs are lacking. This study aimed to analyze demographic, treatment, and cost information for patients with HCC treated with SBRT and Y90.

Methods: Patients with HCC treated with SBRT or Y90 radioembolization between January 2018 and January 2020 at one institution were retrospectively reviewed. Demographic and treatment data were compared utilizing χ 2 tests. Kaplan-Meier curves and log-rank tests were applied to compare overall survival and progression-free survival in different treatment groups. Cox proportional hazard models were applied to analyze the unadjusted and adjusted survival differences. Ten SBRT and 10 Y90 patients were randomly selected for Medicare cost analysis.

Results: Sixty-three patients received Y90, and 21 received SBRT. On univariable and multivariable analysis, there was no significant difference in overall survival or progression-free survival between the Y90 and SBRT cohorts. SBRT patients had higher American Joint Committee on Cancer staging ( P =0.039), greater tumor size (4.07 vs. 2.96 cm, P =0.013), and greater rates of prior liver-directed therapy (71.4% SBRT vs. 12.7% Y90, P <0.001). The average cost for SBRT was $15,148, and Y90 was $41,360.

Conclusions: SBRT and Y90 are effective therapies in the treatment of HCC, specifically having similar overall survival and progression-free survival. Y90 was found to have a significantly higher cost than SBRT. This study demonstrates the need for prospective studies to assess these modalities in treating HCC.

Objective: The safety of single-treatment stereotactic radiosurgery (SRS) for vestibular schwannoma (VS) with radiographic evidence of brainstem compression but without motor deficit is controversial. Data on linear accelerator (linac)-based SRS in this setting are scarce. We address this with an outcomes report from an unselected series of patients with VS with radiographic brainstem compression treated with linac SRS.

Methods: We included 139 patients with unilateral VS (any size) with radiographic brainstem compression (all without serious brainstem neurological deficits). The SRS prescription dose was 12.5 Gy (single fraction) using 6MV linac-produced photon beams, delivered with a multiple arc technique. Inclusion criteria required at least 1 year of radiographic follow-up with magnetic resonance imaging. The primary endpoint was freedom from serious brainstem toxicity (≥grade 3 Common Terminology Criteria for Adverse Events v5); the secondary was freedom from enlargement (tumor progression or any requiring intervention). We assessed serious cranial nerve complications, excluding hearing loss, defined as Common Terminology Criteria for Adverse Events v5 grade 3 toxicity.

Results: Median magnetic resonance imaging follow-up time was 5 years, and median tumor size was 2.5 cm in greatest axial dimension and 5 ml in volume. The median brainstem D0.03 ml=12.6 Gy and median brainstem V10 Gy=0.4 ml. At 5 years, the actuarial freedom from serious brainstem toxicity was 100%, and freedom from tumor enlargement (requiring surgery and/or due to progression) was 90%. Severe facial nerve damage in patients without tumor enlargement was 0.9%.

Conclusion: Linac-based SRS, as delivered in our series for VS with radiographic brainstem compression, is safe and effective.

Objectives: In randomized clinical trials in patients with hepatocellular cancer (HCC), combination therapy with atezolizumab and bevacizumab (Atezo-Bev) prolonged survival, and these treatments have become the standard first-line therapy for advanced HCC. However, clinical trials may not reflect real-life clinical practice due to treatment selection criteria. Thus, our aim was to understand predictors of HCC outcomes with these treatments in a real-world, multicenter setting.

Methods: A retrospective review of all patients 18 years of age or older treated for advanced primary liver cancer between February 2020 and August 2022 was conducted to assess the relationship between overall survival and clinical and biochemical variables before or during treatment. Univariate and multivariate Cox regression survival analyses were performed to identify predictors of survival following treatment.

Results: One hundred and eleven eligible patients with unresectable HCC received Atezo-Bev over a consecutive 30-month period. Cox regression identified several significant ( P <0.05) predictors of survival, including pretreatment albumin (hazard ratios [HR]: 0.2; CI: 0.1-0.4), total bilirubin (HR: 1.3; CI: 1.2-1.5), and international normalized ratio (HR: 5.6; CI: 2.5-12.5). In multivariate analyses, these were significantly associated as predictors of mortality, and patients with pretreatment albumin <3.5 mg/dL had significantly lower survival than those ≥3.5 (153 vs. 522 d, P <0.0001).

Conclusions: Pretreatment hypoalbuminemia, high bilirubin, and biochemical tests indicative of hepatic or renal dysfunction can independently predict short-term mortality in advanced HCC patients receiving Atezo-Bev.

Background: Concurrent chemoradiotherapy based on hyperfractionated accelerated radiotherapy (HART) is the first-line recommended regimen for the treatment of small-cell lung cancer (SCLC). However, Stereotactic Body Radiotherapy (SBRT) is also regarded as an effective treatment for limited-stage (LS) SCLC, and the efficacy and safety of HART versus SBRT stay controversial.

Methods: In this study, 188 LS-SCLC patients were retrospectively divided into two groups receiving chemotherapy combined with either HART or SBRT. In HART group, patients received 4500 cGy in 30 fractions, administered twice daily for 3 weeks. Whereas in the SBRT group, a total radiation dose of 4000-4500 cGy was delivered in 10 fractions over 2 weeks. Thirty-three pairs of patients were finally included for next analysis.

Results: The estimated objective response rates were 63.6 % (21/33) and 78.8 % (26/33) in HART group and SBRT group, respectively (P = 0.269). Furthermore, there was no significant difference between HART and SBRT groups in overall survival (26 months vs. 29 months, P = 0.362) and progression free survival (11 months vs. 15 months, P = 0.223). As for the adverse events, toxicity of both groups is similar and slight that no grade 4 event was observed. Grade 3 pneumonitis cases were all occurred in the HART group (9.1%, 3/33, P = 0.238), and grade 3 esophagitis cases were all occurred in the SBRT group (6.1%, 2/33, P = 0.492).

Conclusion: Compared with HART, SBRT could be another effective treatment with satisfactory safety for the concurrent chemoradiotherapy in patients with LS-SCLC.

Objectives: Although metastatic breast cancer (MBC) is considered incurable, human epidermal growth receptor 2 (HER2)-directed therapy has improved outcomes significantly, with some patients experiencing durable responses to treatment. The aim of this study was to identify potential predictors of long-term survival (LTS) among patients with de novo HER2-positive MBC who received HER2-directed treatment.

Methods: Eligible patients from 2008 to 2018 were identified using the Manitoba Cancer Registry. LTS was defined as survival ≥5 years from the time of diagnosis. Univariate logistic regression models were performed to assess variables of clinical interest and the odds of LTS. Overall survival (OS) was defined as the time from diagnosis of MBC to death of any cause. OS was estimated using the Kaplan-Meier method with log-rank comparative analyses as a univariate analysis. A Cox proportional hazards model was used for OS estimates in a univariate analysis.

Results: A total of 62 patients were diagnosed with de novo HER2-positive MBC and received HER2-directed therapy. Eighteen (29%) achieved LTS. The median OS of the whole cohort was 50.2 months (95% CI: 28.6-not reached). Radiographic response to first-line treatment was associated with LTS; complete and partial responses were both associated with higher odds of LTS (odds ratio: 28.33 [95% CI: 2.47-4006.71, P = 0.0043] and odds ratio: 7.80 [95% CI: 0.7317-1072.00, P = 0.0972], respectively). The best radiographic response was associated with improved OS.

Conclusions: Radiographic response to first-line HER2-directed therapy is a predictor for LTS in patients with de novo HER2-positive MBC. Larger studies are needed to identify patients who can safely discontinue HER2-targeted therapy.