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

Objective: To identify prognostic factors predicting recurrence in vulvar cancer patients undergoing surgery.

Methods: We retrospectively evaluated data from consecutive patients with vulvar cancer treated between 2002 and 2024 in 2 Italian centers. Basic descriptive statistics and multivariable analysis were used to create predictive models for patient outcomes. Five-year disease-free survival (DFS) and overall survival (OS) were analyzed using a Cox proportional hazards model.

Results: The study included 283 patients diagnosed with vulvar cancer (239 with squamous cell carcinoma). The most frequent stages were stage I (50.9%) and stage III (30.4%). After a median follow-up of 27 months, 91 (32.2%) recurrences were observed, of which 20% were local, 6% were regional, and 6% were distant. The five-year DFS and OS were 46% and 60%, respectively. Multivariate analysis identified the presence of positive lymph nodes (hazard ratio [HR]: 3.54, 95% confidence interval [CI]: 1.04-12.08), age (HR: 1.02, 95% CI: 1-1.04), FIGO stage II (HR: 3.12, 95% CI: 1.24-7.87), and FIGO stage IV (HR: 3.85, 95% CI: 1.19-12.43) as factors associated with worse DFS. Positive nodes (HR: 2.64, 95% CI: 1.2-5.8) and tumor diameter >4 cm (HR: 1.89, 95% CI: 1.05-3.42) were associated with OS. FIGO stage >I was predictive of regional and distant recurrences, but no factor was found to correlate with local recurrence.

Conclusions: FIGO stage >I was predictive of regional and distant recurrences, while no factors influencing local recurrence were identified. Positive nodes, age, and FIGO stage >I correlated with DFS, whereas tumor diameter >4 cm and positive nodes influenced OS.

Objectives: Among patients that underwent palliative RT (pRT) at a single institution, we evaluated whether differences exist across race and ethnicity in location of pRT consultation and delivery of pRT.

Methods: This retrospective study included cancer patients aged 18 years or older who received pRT between 10/2021 and 10/2022. Logistic regression models were used to examine univariable (UVA) and multivariable (MVA) associations between race and pRT consult in the inpatient (vs. outpatient) setting. A subset analysis of quality metrics for pRT delivery was limited to patients who had outpatient consults for pain.

Results: Four hundred forty patients underwent 548 pRT consults (104 inpatient and 444 outpatient) followed by a course of pRT. Most patients were male (58.2%), White non-Hispanic (WNH) (72.6%), and English-speaking (92.9%). On MVA adjusting for histology, language, and insurance type, consults for Black/African American (BAA) patients had 2.92 higher odds of being performed in the inpatient setting compared with consults for WNH patients (95% CI: 1.28-6.70, P =0.011), although the global P -value was P =0.217. Among 290 outpatient consults for painful lesions, no differences in time to pRT start (global P =0.84), number of prescribed fractions of RT (global P =0.94), or new prescriptions for opioids (global P =0.69) were noted by race and ethnicity.

Conclusions: In this study, BAA race was associated with the location of pRT consultation, but no discernible differences were noted regarding the outpatient delivery of pRT for pain. These findings support the importance of inpatient pRT programs to ensure equitable access. More research is needed to understand barriers to outpatient consult.

Objectives: Breast cancer accounted for over 1/3 of new US cancer diagnoses in 2024, remains the most commonly diagnosed cancer globally, and is the leading cause of cancer-related mortality among women. We evaluated breast cancer patient experience at a National Cancer Institute-designated cancer center to assess potential barriers to optimal care.

Methods: Over a 10-month period (4/1/24 to 1/31/25), eligible breast cancer patients identified in clinic visits and who self-reported diagnoses were surveyed about their experience. Each survey included a "Likelihood to Recommend" (LTR) question, scored on a 5-point Likert scale, as a proxy for satisfaction. We examined surveys from 2 service lines: medical practice (clinic visits) and outpatient oncology (radiation/infusion). We extracted demographic data from the electronic medical record. Underrepresented minorities (URMs) were defined as African American, Native American, and/or Hispanic patients. Fisher's exact test assessed differences by race and ethnicity ( P <0.05).

Results: Of 15,153 patients (76.5% White, 9.9% Black, 7.6% Native American, and 94.3% non-Hispanic), 2,066 patients (13.6% response rate) completed the surveys. Response rates were significantly higher among White/non-Hispanic patients compared with URMs ( P =0.0001). For outpatient oncology, patient experiences did not significantly differ by race or ethnicity. For medical practice, a trend toward significance was observed by ethnicity ( P =0.07), but not by race.

Conclusions: Our retrospective cohort study found significantly lower survey response rates among URMs, which could indicate barriers to sharing patient experiences. These findings establish a baseline for comparison and support future implementation of targeted navigation programs to improve patient experience and care delivery.

Objectives: In patients with surgically unresectable disease who undergo neoadjuvant chemoradiation (CRT) or neoadjuvant radiation therapy (RT) before surgical staging, little is known about whether adjuvant chemotherapy confers a survival benefit. We aim to explore the survival impact of adjuvant chemotherapy in patients with locally advanced endometrial cancer who undergo neoadjuvant CRT or RT.

Methods: A retrospective, single-institution review of all patients from April 2008 to October 2021 who underwent neoadjuvant RT or CRT before surgical resection of endometrial cancer was performed. Kaplan-Meier method with log-rank test was used to determine differences in overall survival (OS) and disease-free survival (DFS) between the group that received adjuvant chemotherapy and the group that did not. Subgroup analysis was performed to assess whether specific subgroups benefited from adjuvant chemotherapy.

Results: Eighty-nine patients, 48 (54%) of whom received adjuvant chemotherapy, were identified. There was no statistically significant difference in OS ( P =0.062) between those who received adjuvant chemotherapy and those who did not. Adjuvant chemotherapy had a significant association with worse DFS ( P =0.037). On subgroup analysis, there were no statistically significant differences in OS or DFS in any subgroups when examining the impact of adjuvant chemotherapy.

Conclusions: After receiving neoadjuvant CRT or RT for advanced and high-grade endometrial cancers, adjuvant chemotherapy was not predictive of improved OS, but was predictive of worse DFS. A larger cohort and longer follow-up are needed to ascertain whether certain high-risk subgroups of patients benefit from adjuvant chemotherapy.

Objectives: Randomized trials showed that the third-generation antibody-drug conjugate, sacituzumab govitecan (SG), is active against metastatic triple-negative breast cancer (mTNBC). Real-world data are relatively limited. This retrospective study reports the efficacy and safety of SG in a series of women with mTNBC in clinical practice.

Methods: Eighty-four patients with widely pretreated, de novo, or metachronous mTNBC were treated with SG at the recommended dose of 10 mg/kg on days 1 and 8 every 3 weeks over a 3-hour intravenous infusion at 6 medical oncology units.

Results: No complete response was observed. Overall, 29 patients (34%; 95% CI: 24.4%-44.7%) achieved a partial response with a median duration of 6 months (range: 5 to 14 mo). Twenty patients 24 (29%; 95% CI: 18.9%-38.2%) had stabilization of disease with a median duration of 7 months (4 to 13 mo), while 31 (37%; 95% CI: 26.6%-47.2%) progressed. The median progression-free survival was 5 months (range: 1 to 14 mo) and the median overall survival as 10 months (range: 1 to 18 mo). Twelve patients (22%) had metastatic deposits in CNS and had received radiotherapy.

Conclusions: The real-life data reported in this paper confirm the randomized trial results regarding efficacy and tolerability. The authors stressed the importance of the early identification of severe side effects in managing these patients.

Objective: Cachexia is commonly defined based on weight loss at the time of cancer diagnosis. However, regular weight measurements before cancer diagnosis are often lacking and may be subject to recall bias if retrospectively self-reported by patients. To analyze the development and progression of cachexia, we employ body weight trajectories from 1 year before and after diagnosis of non-small cell lung cancer (NSCLC). We hypothesized that cachexia could be detected as early as 1 year before NSCLC diagnosis and that cachexia prevalence would increase in the year following diagnosis.

Methods: This retrospective study included consecutive patients with NSCLC treated at UTSW between 2005 and 2019 who had body weight measurements before and after NSCLC diagnosis recorded in their electronic health records. Weights were binned in 3-month intervals. Cachexia was defined per the International Consensus Definition of cachexia, that is, loss of >5% body weight 12 months preceding cancer diagnosis for patients with BMI ≥20 kg/m 2 or weight loss of >2% for patients with a BMI <20 kg/m 2 . The association of disease stage and primary treatment with weight changes was investigated.

Results: Among 4294 patients screened, 661 patients were included in the final analysis. Patients had a mean age of 69.3 (SD: 10.6) years, and a majority were current/former smokers (83%), identified as white (76%), and were diagnosed with either stage I (47%) or stage IV (28%) nonsquamous NSCLC (78%). At cancer diagnosis, 28% (n=183) presented with cachexia, having incurred a mean loss of 8.6 (SEM: 0.4%) ( P <0.0001) of body weight within the year before cancer diagnosis. Weight loss after cancer diagnosis was comparable in patients with and without cachexia at cancer diagnosis ( P =0.05). By 12 months postcancer diagnosis, 58% of patients (n=383) met the criteria for cachexia based on weight loss. Weight loss consistent with cachexia occurred over a median period of 220 (IQR: 265) days.

Conclusion: Weight loss in patients with cachexia at NSCLC diagnosis may commence as early as 12 months before cancer diagnosis. Within a year after a cancer diagnosis, more than half of patients develop cachexia, particularly those with advanced disease. These findings support the integration of early nutritional and pharmacological interventions in patients with NSCLC.

Objectives: While genomic profiling has identified prognostic markers in sarcoma, clinical risk stratification remains largely histology-based. The combined impact of multiple genomic instability features on survival remains poorly understood. This study evaluated the prognostic utility of a novel Measure Of Sarcoma Aggregate Instability Complex (MOSAIC) Score.

Methods: We conducted a secondary analysis of 2138 sarcoma patients from the Sarcoma (MSK, Nat Commun. 2022) data set in cBioPortal. The MOSAIC score integrated 6 genomic instability markers: mutation burden, whole-genome doubling, copy number alterations, ploidy, microsatellite instability, and a fraction of genome altered. Cox proportional hazards models adjusted for clinical covariates assessed survival associations.

Results: Higher MOSAIC scores correlated with worse survival (HR=1.11 per unit, 95% CI: 1.07-1.15, P =4.67 × 10 -8 ). The first principal component explained 47.6% of the total variance. A threshold effect emerged between quartiles, with higher quartiles showing nearly doubled mortality risk (adjusted HRs: Q2=1.89, Q3=1.88, Q4=1.96; all P <0.001). Chromosomal instability markers (copy number alterations: 0.51, whole-genome doubling: 0.49) contributed more than point mutations (mutation burden: 0.15). MOSAIC's prognostic impact varied by anatomic site, with strong effects in thoracic (HR=1.66, P =4.74 × 10 -4 ) and trunk (HR=1.50, P =0.018) sarcomas.

Conclusions: MOSAIC provides independent prognostic value across sarcoma subtypes, surpassing conventional clinical factors. Its integration of routine genomic features broadens applicability and may inform immunotherapy response prediction. The observed threshold effect and dominance of chromosomal instability markers offer novel insights into sarcoma biology and therapeutic targeting. Prospective validation is warranted for clinical implementation.

Objectives: Active cigarette smoking leads to increased CXCL5 production. CXCL5 mediates the immune response by attracting immune cells to areas of inflammation. Elevated CXCL5 levels are associated with various inflammatory diseases and tumorigenesis. In addition, smoking is linked to an increase in the level of the cytokine CEACAM6 in the bloodstream of smokers. CEACAM6 is increased in pancreatic adenocarcinoma, breast cancer, non-small-cell lung cancer, gastric cancer, colon cancer, and other cancers and promotes tumor progression, invasion, and metastasis. Although cytokine secretion in the innate immune response returns to nonsmoker levels after quitting smoking, the effects on the adaptive response appear to persist for years or decades due to epigenetic memory. As a result, epigenetic changes induced by smoking may contribute to long-lasting alterations in immune function, including elevated CXCL5 and CEACAM6. The effects of cannabis smoking might be similar.

Methods: In the current study we used UK Biobank (UKB) data to assess the relationship of CXCL5, CEACAM6, and pulmonary function to cigarette and cannabis smoking. Our UK Biobank application was approved as UKB project 57245 (S.L. and P.H.R.). Our analysis included all subjects with smoking and/or marijuana use data in the UK Biobank database. Circulating levels of CXCL5 and CEACAM6 were from UKB Olink data. Individual CXCL5 and CEACAM6 levels are NPX, Normalized Protein expression, Olink arbitrary unit in Log2 scale (Olink Proteomics AB, Uppsala, Sweden; http://www.olink.com ).

Results: Current smokers and past smokers had elevated circulating levels of CXCL5 and CECAM6. In multivariate analysis, current, past, or no smoking history was significantly related to CXCL5 level and CECAM6 levels, independent of the effects of age, sex. Frequency of cannabis use had a similar effect. In multivariate analysis, frequency of cannabis use was significantly related to CXCL5 level and CECAM6 levels, independent of the effects of age, sex, and years between last cannabis use and enrollment in study.

Conclusions: We can confirm a previous report of epigenetic changes induced by cigarette smoking that may contribute to long-lasting alterations in immune function related to CXCL5 and CEACAM6. In addition, we have found that these same long-lasting smoking alterations in immune function related to CXCL5 and CEACAM6 occur in cannabis smokers, possibly rendering them vulnerable to smoking-related tumors in later life.

Objectives: This practice parameter was revised collaboratively by the American College of Radiology (ACR), the American College of Nuclear Medicine (ACNM), the American Radium Society (ARS), and the Society of Nuclear Medicine and Molecular Imaging (SNMMI). The document represents an update of the radium-223 therapy practice parameter developed by the societies in 2019.

Methods: This practice parameter was revised 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-Nuclear Medicine and Molecular Imaging of the ACR Commissions on Nuclear Medicine and Molecular Imaging and the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology, in collaboration with the ACNM, the ARS, and the SNMMI. Reports available since the publication of the initial document in 2019 were collected and reviewed.

Results: Since the publication of the initial radium-223 practice parameter in 2019, there has been significant investigation of the agent in the management of numerous metastatic cancer sites, in addition to additional studies of its use in metastatic hormone-resistant prostate cancer. This updated document considers physical properties of the agent, current and investigative indications, qualifications and responsibilities of personnel, specifications of the evaluation exam and treatment, the therapeutic use of unsealed radiopharmaceutical sources, radiation safety, and quality control.

Conclusions: This updated practice parameter is intended to guide appropriately trained and credentialed physicians performing therapy with radium-223 dichloride. All aspects of patient and radioisotope management are considered, as are current indications and ongoing investigations.