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

Objectives: A survey was conducted to evaluate perceptions, use, and information sources of medical cannabis (MC) among patients with head and neck cancer and identify opportunities for providers to clarify its use.

Methods: Two hundred eighty-nine consecutive patients with head and neck cancer seen in the radiation oncology department at a single institution in CA (October 2022 to June 2023; November 2023 to January 2024) were screened for eligibility and invited to participate. Surveys were emailed. Demographic/clinical data were collected and recorded from the electronic health record and surveys, including age, gender, race, ethnicity, metastatic status, COVID-19 vaccination status, substance use history, relationship and employment status, and education level. Associations between clinical/socioeconomic factors and perception/use of MC were analyzed using χ 2 tests.

Results: Of 258 eligible patients, 122 completed the survey. Most reported reliance on the internet for MC information (70%); only 20% reported consulting with their cancer treatment team. Most (75%) agreed MC can help reduce cancer-related symptoms. Some agreed or were neutral regarding the potential of MC to cure cancer (37%) or prolong life (61%). Overall, 61% of patients reported having used MC, primarily for recreation (72%) or symptom relief (37%). MC use was more common among white ( P =0.001), unmarried ( P =0.001), and tobacco-using individuals ( P =0.045). COVID-vaccinated individuals more often believed MC reduces symptoms ( P =0.015).

Conclusion: Many patients rely on unregulated sources regarding MC. This highlights the potential for improved provider-patient discussions to support informed decision-making regarding risks, benefits, and questions of MC in cancer care.

Objectives: Breast cancer (BC) remains a critical public health issue where early detection significantly improves outcomes. Despite advancements, disparities in screening awareness and access persist, particularly in underserved populations. This study evaluates a comprehensive, technology-driven educational campaign designed to empower individuals to advocate for their breast health, bridging gaps in knowledge and accessibility.

Methods: Between 10/1/22 and 12/2/22, a multiplatform campaign was conducted with IRB approval. The initiative utilized traditional media, including televised ads and educational videos, and digital tools such as a mobile app and website in English and Spanish. Central to this campaign was an interactive risk calculator, offering personalized BC screening recommendations. Data collection included user demographics, platform engagement metrics, and the identification of high-risk individuals. A cost-effectiveness analysis was conducted using campaign budget data.

Results: The campaign reached 673,920 individuals through televised ads and 152,672 impressions by digital ads. The website garnered 930 unique impressions, while the app recorded 2752 downloads across 131 countries. The risk calculator was completed 637 times, identifying 72 high-risk individuals. Follow-up data revealed ongoing engagement, with the calculator used an additional 1468 times. The cost per conversion was $1.62, and the cost to identify a high-risk individual was $209.27, demonstrating remarkable cost-efficiency.

Conclusions: This campaign successfully increased BC awareness and early detection efforts, leveraging a cost-effective, multiplatform approach. The integration of personalized tools like the risk calculator underscores the potential of digital interventions in health education. Future efforts should build on this model to further enhance reach and health outcomes.

Objectives: This paper examines the life and research of Otto Warburg (1883 to 1970), who identified the so-called Warburg effect. Warburg personal life and scientific career were notable.

Methods: This study summarizes the key aspects of his life, the Warburg effect, and its significance in prostate cancer.

Results: Despite being classified as non-Aryan, Warburg continued his research as the director of the Kaiser Wilhelm Institute for Cell Physiology during World War II. He also cohabited openly with a male partner. The Warburg effect is a metabolic hallmark of cancer, where cells preferentially utilize glycolysis over oxidative phosphorylation, even in the presence of oxygen. This metabolic shift confers key advantages to tumor survival, including rapid ATP production, biosynthetic support for proliferation, and resistance to apoptosis. In prostate cancer, the metabolism undergoes a unique transformation. Normal prostate cells are characterized by citrate secretion; however, as malignancy develops, the cells adapt to oxidative metabolism. At the metastatic stage, the Warburg effect becomes more pronounced and is influenced by the tumor microenvironment and interactions with cancer-associated fibroblasts and bone marrow adipocytes. These metabolic changes have significant clinical implications. While FDG-PET scans serve as a diagnostic tool in many cancers, their utility in early-stage prostate cancer is limited owing to its delayed metabolic shift. Metabolic-targeted therapies, such as dichloroacetate (DCA) and glycolysis inhibitors, are emerging as promising strategies to enhance the efficacy of chemotherapy and radiotherapy.

Conclusions: Elucidating the role of metabolic reprogramming in prostate cancer could reveal new avenues for treatment, particularly for castration-resistant and metastatic diseases.

Objectives: Academic promotion in radiation oncology is influenced by multiple factors, including scholarly productivity and demographic characteristics. While citation-based metrics such as the h-index are increasingly used as objective measures of academic output, the impact of demographic factors such as sex and underrepresented minority (URM) status remains inadequately defined. This study represents the first evaluation of the predictive value of h-index, sex, and URM status on academic promotion.

Methods: A retrospective cohort of 554 radiation oncologists from 51 NCI-designated Comprehensive Cancer Centers, initially identified in 2019 (T1) and re-evaluated in 2023 (T2), was assessed. Academic promotion status, h-index (2019), sex, URM status, and institutional affiliation were recorded. A generalized linear mixed model assessed associations between these variables and promotion status, with significance defined as P<0.05.

Results: The cohort included 203 women (36.7%) and 21 URMs (3.8%); overall, 338 (61%) received promotions between T1 and T2. The mean h-index was 12.3 (median=9), with promoted individuals averaging 15.3 versus 10 for those not promoted. A statistically significant association was found between a higher h-index and promotion (P<0.0001). Further analysis revealed that neither female sex (odds ratio: 1.02, 95% CI: 0.68-1.52; P=0.94) nor URM status (odds ratio: 0.57, 95% CI: 0.19-1.71; P=0.32) was significantly associated with promotion.

Conclusions: In the first examination of the impact of h-index on radiation oncology promotion, a higher h-index is a statistically significant predictor of academic promotion among radiation oncologists. Given limited statistical power to detect differences by demographic characteristics and ongoing underrepresentation of certain groups compared with the population, ongoing work to ensure fair access to opportunities for all remains important.

Objectives: This trial served as a proof-of-concept for whether inhibition of protein kinase C iota (PKCι) with auranofin and sirolimus provide antineoplastic effects in patients with recurrent high-grade serous ovarian cancer.

Methods: This drug combination was administered to patients with recurrent high-grade serous ovarian cancer. Dosing was based on unpublished phase 1 data and consisted of auranofin 6 mg and sirolimus 5 mg both orally per day of a 28-day cycle. The primary endpoint was tumor response. Available tumor tissue was assessed for PKCι protein expression by immunohistochemistry (IHC) and PRKCI copy number by fluorescence in-situ hybridization (FISH) after the start of cancer therapy.

Results: Twenty-two patients were enrolled, and 21 were evaluable for all clinical trial endpoints. One patient was unevaluable because she did not receive a full chemotherapy cycle. No tumor responses were seen in the first 21 patients, resulting in early trial termination per a priori trial design. The median progression-free survival was 2.1 months (95% CI: 1.8-3.7). The median overall survival was 4.4 months (95% CI: 2.6-12.5). Fourteen (67%) patients had at least one grade 3 or worse adverse event. Nineteen of 21 evaluable patients had available tumor tissue, which showed the median PKCι copy number averaged per cell of 3 (range: 2 to 7), and PKCι expression (at least 1+) in all.

Conclusions: As prescribed here, auranofin and sirolimus manifested no antineoplastic activity in patients with recurrent high-grade serous ovarian cancer that expressed PKCι.

Objectives: Cholangiocarcinoma is the second most common primary liver tumor with a highly aggressive course and poor prognosis (5-year survival ≤15%). Here, we assessed trends in regional and demographic differences in cholangiocarcinoma-related mortality in the United States from 1999 to 2020.

Methods: The CDC WONDER (Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research) database was utilized to examine death certificates (1999-2020) for cholangiocarcinoma-related mortality. Age-adjusted mortality rates were extracted per 100,000 individuals, and their associated annual percent changes with 95% CIs were calculated. To identify overall trends for demographic (sex, race, ethnicity, and age) and regional groups, Joinpoint regression (NCI, version 5.0.2) was utilized.

Results: One lakh forty-eight thousand eight hundred fifty-one cholangiocarcinoma-related deaths occurred between 1999 and 2020. The overall age-adjusted mortality rate has increased from 1.9 in 1999 to 3.2 in 2020. Higher mortality rates were observed for males (males: 2.9 vs. females: 2.3), non-Hispanic Asian or Pacific Islander patients (3.3), and metropolitan area residents (2.6). African Americans exhibited the highest annual percent increase since 1999 (3.47; 95% CI: 3.01-4.12). Rhode Island, Connecticut, Massachusetts, Minnesota, Wisconsin, Illinois, Washington, Alaska, and Hawaii ranked in the top 90th percentile, and the northeast region had the highest overall age-adjusted mortality rates.

Conclusions: In the last 2 decades, Cholangiocarcinoma-related mortality has increased overall in the United States. Demographic and geographic disparities persist, with higher age-adjusted mortality rates observed in males, Asians, and individuals residing in the northeast region and metropolitan areas. Further research and targeted strategies for different demographics are needed to curb increasing levels of Cholangiocarcinoma-related mortality in the United States.

Objectives: Black breast cancer patients have substantially decreased access to optimal breast-conserving cancer care than white patients. Patient navigation has never been formally implemented into the receipt of radiation therapy (RT) for black patients. We present initial results from an ongoing phase I trial assessing the impact of patient navigation on RT completion in this patient population.

Methods: The Navigator-Assisted Hypofractionation (NAVAH) program is a phase I trial (clinicaltrials.gov, NCT05978232) involving black breast cancer patients consented for postlumpectomy RT. Participants were assigned a patient navigator throughout the course of RT and post-RT care, and provided travel vouchers to offset RT transportation cost. Patients refusing trial participation were assessed to determine RT completion rate. The primary trial endpoint is RT completion rate following initiation of patient navigation.

Results: Of 54 trial-eligible patients, 36 accepted and 18 declined; no patient had received navigation before being offered trial enrollment. Of those declining enrollment 12/18 (66.7%) completed RT; of these 12, 9 (75%) completed RT without delay. 34/36 patients (94.4%) who enrolled completed RT, of whom 19 (55.9%) completed RT without delay. The differences in RT completion between patients having accepted versus declined trial enrollment were statistically significant ( P = 0.0124).

Conclusions: Early results of an ongoing phase I trial reveal that incorporation of patient navigation following initial radiation oncology consultation significantly improves adjuvant RT completion rates in early-stage black breast cancer patients. Further work examining patient navigation is ongoing.

Objectives: Antibody-drug conjugates (ADCs) have improved outcomes for metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative or low breast cancer; however, direct efficacy comparisons are limited. We compared trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG), and datopotamab deruxtecan (Dato-DXd) in chemotherapy-pretreated HR+/HER2-negative or low metastatic breast cancers.

Methods: This meta-analysis conducted a comprehensive search of the Embase and Ovid Medline databases up to July 2025. Efficacy endpoints were progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Hazard and odds ratios were calculated for the relevant outcomes. Safety was assessed using grade ≥3 treatment-related adverse events (TRAEs).

Results: Four randomized controlled trials were included. All 3 ADCs significantly improved PFS (P<0.00001) and ORR (P=0.008) compared with chemotherapy. Both T-DXd and SG demonstrated significant OS benefits (P=0.002), whereas Dato-DXd did not (P=0.94). For SG, OS benefit was observed primarily in later (≥3) lines (P=0.03). Among them, T-DXd demonstrated the most favorable outcomes across PFS, OS, and ORR, particularly in earlier lines. Grade ≥3 treatment-related adverse events (TRAEs) were most frequent with SG (60.2%), followed by T-DXd (52.6%) and Dato-DXd (20.8%). Neutropenia was the most common grade ≥3 TRAE with SG and T-DXd, while stomatitis was most common with Dato-DXd.

Conclusions: T-DXd demonstrated better efficacy in pretreated HR+/HER2-low metastatic breast cancer (MBC), especially in earlier lines. SG showed significant OS benefit primarily in later lines. Dato-DXd showed no OS benefit but had the most favorable safety profile.

Objectives: We evaluated the cost-effectiveness of adjuvant alectinib versus adjuvant platinum-based chemotherapy for patients with resectable (stage IB to IIIA) ALK+ non-small cell lung cancer using a US societal perspective.

Methods: We developed a cohort-level Markov model to compare adjuvant alectinib versus platinum-based chemotherapy using a lifetime time horizon (40 y) with a monthly cycle length and 3% discounting of health state utilities and costs. Patients started in a disease-free health state; downstream health states included treated (first- or second-line) or untreated metastatic or nonmetastatic recurrence, or death. Patient characteristics, adjuvant treatment patterns, and health utilities were based on the ALINA trial.

Results: When measured across a lifetime time horizon, adjuvant alectinib was estimated to lead to 3.1 additional quality-adjusted life-years (QALYs) with $429,925 lower total costs per patient, demonstrating a dominant cost-effectiveness ratio compared with adjuvant platinum-based chemotherapy (more effective and less costly). The net monetary benefit in favor of adjuvant alectinib was $895,766 at a willingness-to-pay (WTP) threshold of $150,000/QALY gained. In probabilistic sensitivity analysis, adjuvant alectinib has a 99.6% probability of being more effective and less costly than adjuvant chemotherapy. The incremental cost-effectiveness ratio for adjuvant alectinib remained dominant when all model inputs were varied in the one-way sensitivity analysis.

Conclusions: In comparison with platinum-based chemotherapy, adjuvant alectinib offers substantial additional clinical and economic value to society.

Objectives: Breast cancer remains the most prevalent cancer among women in the United States, with hormone receptor-positive (HR+) and HER2-negative subtypes comprising a significant proportion of cases. Despite advancements in treatment, resistance to endocrine therapies remains a substantial clinical challenge, especially in patients with mutations in the PIK3CA gene.

Methods: A literature review was conducted to evaluate the safety and efficacy of inavolisib in breast cancer. Studies published through November 2024 were identified using PubMed, Google Scholar, and ClinicalTrials.gov. Phases I to III clinical trials in English were included. The review focused on safety outcomes (eg, serious adverse events) and efficacy outcomes (eg, progression-free survival), which were summarized narratively.

Results: Inavolisib, a selective PI3Kα inhibitor, presents a promising option for patients with PIK3CA-mutated HR+HER2-negative advanced or metastatic breast cancer. In the INAVO120 trial, inavolisib combined with palbociclib and fulvestrant significantly extended progression-free survival (PFS) in patients with PIK3CA mutations. The median PFS was 15.0 months for the treatment arm compared with 7.3 months in the placebo group (hazard ratio: 0.43, P <0.001). The objective response rate (ORR) was 58.4% in the treatment arm, underscoring the drug's antitumor efficacy. Safety profiles revealed manageable adverse events, primarily hyperglycemia, neutropenia, and stomatitis. The incidence of these side effects was notable but manageable with appropriate supportive care. Inavolisib offers a new treatment for HR+HER2-negative advanced breast cancer, showing promising efficacy and safety. However, implementation challenges include high costs, insurance coverage issues, and limited access to required genetic testing through FoundationOne Liquid CDx assay, potentially creating barriers to equitable patient access.

Conclusions: Inavolisib represents a significant advancement in the treatment of advanced HR+HER2-negative breast cancer, offering an effective option for patients with PIK3CA mutations. However, to fully realize its potential, health care systems must address challenges related to patient access, insurance coverage, and the availability of companion diagnostics. Further long-term studies will be essential to assess the enduring impact of this treatment on patient outcomes.