Oncology最新文献

Introduction: There exist concerns regarding the use of sentinel lymph node (SLN) biopsy alone in node-positive breast cancer patients who have a clinical/radiological complete response in the axilla and are negative on histopathology after neoadjuvant chemotherapy (NACT). We hereby conducted a meta-analysis examining 5-year overall survival (OS) and disease-free survival (DFS) of such patients.

Methods: PubMed, the Cochrane CENTRAL Library, Embase, Web of Science, and Scopus were searched up to July 30, 2024, for studies reporting survival data. OS and DFS were pooled in a meta-analysis. Subgroup analysis was conducted based on the location of the study, pre-NACT node assessment, and SLN mapping technique. Random-effects meta-regression was conducted for the following moderators: age, initial T3-4, initial N2-3, breast-conserving surgery, breast pathological complete response (pCR), number of SLN removed, adjuvant radiotherapy, endocrine therapy, and follow-up.

Results: Sixteen studies with 5,249 patients were included. Meta-analysis showed that node-positive breast cancer patients showing nodal pCR after NACT and undergoing only SLN biopsy had a 5-year OS and DFS of 94% (95% CI: 92%, 96%) and 89% (95% CI: 87%, 92%), respectively. There was not much variation in the survival rate on sensitivity and subgroup analyses. Meta-regression showed that OS and DFS were higher in studies with a greater number of patients receiving endocrine therapy.

Conclusion: Breast cancer patients with cN+ who achieve a complete clinical/radiological axillary response after NACT and subsequently become SLN biopsy negative may have high rates of DFS and OS after 5 years. Given the high degree of heterogeneity, results should be interpreted with caution. We do not recommend change in treatment plans given the high risk of bias and large heterogeneity in the patient population included in the studies. Only high-quality large multicentric randomized trials can provide better evidence.

Objective: This study aims to investigate the risk signals associated with pembrolizumab and provide references for its safe and rational clinical use.

Methods: Data on adverse events (AEs) related to pembrolizumab, reported from July 2014 to September 2023, were extracted from the US FDA Adverse Event Reporting System (FAERS) database. Data mining was conducted using the Proportional Reporting Ratio (PRR) method. AEs were classified and analyzed according to the System Organ Class (SOC) and Preferred Term (PT) from the Medical Dictionary for Regulatory Activities (version 26.1).

Results: A total of 37,511 AE reports related to pembrolizumab were identified, involving 5,259 PTs and 22 SOCs. Using the PRR method, 931 positive signals were detected. The top 10 risk signals for pembrolizumab were all immune-related adverse events (irAEs) and important medical events (IMEs). The five PTs with the highest signal intensity were immune-mediated hypothyroidism, immune-mediated renal disorder, immune-mediated hepatic disorder, immune-mediated gastritis, and immune-mediated hyperthyroidism. The leading SOCs involved in AE reports were general disorders and administration site conditions (8,184; 14.11%), investigations (5,333; 9.19%), gastrointestinal disorders (4,962; 8.55%), respiratory, thoracic, and mediastinal disorders (4,937; 7.57%), and injury, poisoning, and procedural complications (3,611; 6.22%). The median time to onset of AE was 25 days (IQR 6-85 days), with the Weibull distribution test indicating an early failure-type curve. Gender and age analysis revealed that women were more likely to develop hypertension, alopecia, headache, hypothyroidism, and palmar-plantar erythrodysaesthesia syndrome, whereas men were more likely to develop interstitial lung disease, renal impairment, and death. Additionally, neutropenia was more prevalent in patients under 65 years of age, while interstitial lung disease and renal impairment were more common in patients aged 65 and above.

Conclusion: Significant age- and gender-related differences were observed in AE signals with pembrolizumab, particularly for irAEs. Clinical attention should be directed towards the potential occurrence of irAEs at the initial stages of drug administration, with appropriate measures implemented as necessary.

Introduction: Religiosity and spirituality (SpR) can be vital in helping people face life's challenges. While Spiritual Care (SpC) is used in palliative care, this study explores effects for cancer patient's self-care (SC) in earlier stages .

Methods: Using validated instruments we surveyed patients about SpR (SpNQ-20, GrAw-7, SpREUK), and factors of SC: well-being (WHO-5, L-1), self-efficacy (ASKU), ability to change (PIAC), as well as lay etiology and the use of Complementary and alternative Medicine (CAM). Data were analyzed using SPSS according a three-step plan with descriptive methods, Spearman correlations and mediation analysis.

Results: We included 108 patients (41 female, 63 males, four no data) with a median age of 66 years (range 30-89). Welch tests show a less well-being, self-efficacy and ability to change in our study population (p < 0.05) compared to non-cancer controls. Whitney-U-test has documented increased well-being, CAM use if the patients were S/R+ (p < 0.05). S/R self-categorization had no impact on PIAC and ASKU. Perceptual spirituality (GrAw-7) correlates with all factors of SC (p < 0.05): WHO-5 (rs = 0.25), PIAC (rs = 0.25), ASKU (rs = 0.296), L-1 (rs = 0.35) and CAM use (rs = 0.39, p < 0.001). Mediation analysis demonstrates that the impact of Spirituality on self-care (CAM use) is mediated by religiosity, GrAw-7 and spiritual needs.

Conclusion: Spirituality and hidden spiritual needs are a valuable resource. By integrating SpC early in the treatment, we can create support ways and improve SC, well-being and coping.

Introduction: Non-small cell lung cancer (NSCLC) lung cancer continues to be a substantial issue in public health, and cardiovascular disease (CVD) is also an important cause of death in NSCLC patients. There is a lack of studies comparing the effects of surgery and radiation therapy on the risk of CVD mortality in patients with early stage NSCLC. This study planned to compare the effects of surgery alone and radiation therapy alone on the risk of CVD mortality in patients with early stage NSCLC.

Methods: In this cohort study, the data of 32,896 participants with NSCLC at stage I or stage II in 2010-2015 were retrieved from the surveillance, epidemiology, and end results (SEER) database. The primary endpoint of this study was CVD mortality, indicating patients died of CVDs and the follow-up was ended in 2020. Univariable Cox regression model was applied to identify covariates. The associations of surgery or radiation therapy with CVD mortality in in patients with early stage NSCLC were evaluated via univariable and multivariable Cox regression models and Fine-Gray competitive risk model. Hazards ratio (HR) and confidence interval (CI) were computed.

Results: The median follow-up time was 48.00 (17.00, 60.00) months. There were 854 (6.45%) participants died of CVD in the radiation therapy group and 729 (5.35%) participants died of CVD in the surgery group. After adjusting for confounding factors, the elevated risk of CVD mortality in patients with early stage NSCLC was observed in patients receiving radiation therapy compared to those receiving surgery (HR = 2.33, 95% CI: 2.02-2.69). In the competing risk model, the risk of CVD mortality in patients with early stage NSCLC was also increased in patients receiving radiation therapy (HR = 1.37, 95% CI: 1.2.6-1.55). In the PSM group, the risk of CVD mortality in patients with early stage NSCLC was also increased in patients who underwent radiation therapy (HR = 2.62, 95% CI: 2.12-3.24). Subgroup analysis also revealed that radiation therapy was correlated with increased risk of CVD mortality in NSCLC patients with tumor size ≥50 mm or <50 mm, the original primary site in the left or right, histologic types of squamous cell NSCLC or adenocarcinoma NSCLC, stage I and II, and patients ≥65 years or <65 years.

Conclusions: Radiation therapy was associated with elevated risk of CVD mortality compared to surgery in patients with early stage NSCLC.

Introduction: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent adverse event without an established, standard treatment. As mirogabalin is a gabapentinoid confirmed useful for diabetic, peripheral neuropathic pain, we examined the efficacy of mirogabalin for CIPN using quantitative sensory and pain analytical devices.

Methods: This was a single-arm, open-label, prospective study conducted at the University of Tsukuba Hospital between April 2022 to April 2024. Patients with grade 2 or higher CIPN during weekly paclitaxel treatment for primary breast cancer were enrolled and received mirogabalin orally for 4 weeks. The primary endpoint was the Visual Analogue Scale (VAS) for peripheral neuropathy. Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) scores were obtained, and PainVision was used as an objective CIPN evaluation.

Results: A total of 20 patients were enrolled. The median VAS score before starting mirogabalin was 13.50 for the hands and 25.00 for the feet. After 4 weeks of treatment, there was significant worsening in the hands (VAS score of 37.00) but no significant difference was observed for the feet. There were no significant differences in PNQ of the limbs between before and 4 weeks after the mirogabalin treatment, although the mean of the Neurotoxicity Subscale of FACT/GOG-NTX significantly worsened. Median PainVision scores for feet also significantly worsened from 50.30 to 89.40, but no significant change was observed for hands. PainVision feet score changes negatively correlated with FACT/GOG-NTX total scores. In the patient satisfaction survey, 14 patients (70%) were satisfied with mirogabalin and 15 patients (75%) wanted to continue.

Conclusions: Although mirogabalin was not wholly effective for CIPN caused by paclitaxel treatment in breast cancer patients, the satisfaction survey suggests some patient-perceived benefits which cannot be detected by conventional evaluation methods.

Background/aim: Rapid development of systemic treatments has resulted in improved prognosis for unresectable hepatocellular carcinoma (uHCC) patients. Since immune therapy shows a favorable therapeutic efficacy, use of tumor markers as biomarkers for monitoring treatment response is necessary. This study aimed to elucidate changes in positive rates of 3 available tumor markers in Japan, including alpha-fetoprotein (AFP), des-gamma-carboxy prothrombin (DCP), and lens culinaris agglutinin-reactive AFP (AFP-L3) in uHCC patients treated with systemic therapies over time.

Material/methods: From 2009 to 2023, 1470 uHCC patients with data of tumor markers before starting treatment were enrolled. The positivity cut-off value for AFP was 20 ng/mL, for AFP-L3 was 10%, and for DCP was 40 mAU/mL. After dividing the 15 years examined into three periods of five years each (period I, II, III), clinical features of the enrolled patients were evaluated, retrospectively.

Results: The percentage of Barcelona Clinic Liver Cancer stage B patients who received systemic therapy increased from period I to III (27.7%, 38.5%, 46.6%, respectively, P<0.001), which was also seen for HCC patients with a non-viral etiology (alcohol and others) (29.9%, 39.7%, 49.6%, respectively P<0.001). Positive rates for AFP (67.8%, 62.1%, 50.8%, respectively) and DCP (84.1%, 80.5%, 72.7%, respectively) were decreased (each P<0.001), while the AFP-L3 rate did not show a significant change (54.4%, 57.7%, 51.9%, respectively P=0.390). Among the AFP-negative patients, the rate of positive for DCP or AFP-L3 was increased (24.4%, 28.1%, 35.4%, respectively, P=0.002).

Conclusion: Based on introduction of systemic treatment in an early stage and increasing numbers of HCC cases with a non-viral etiology, the positive rate of AFP level has been declining. Thus, determination of DCP and AFP-L3 in addition to AFP as markers should be more actively utilized in clinical practice, as well as clinical trials for monitoring and evaluating treatment response in this era of combination immunotherapy as a powerful treatment.

Introduction: Chemotherapy can cause sleep disorders, anxiety, depression, and decreased quality of life (QoL). This study aimed to compare sleep, anxiety, depression, and QoL during chemotherapy in patients with breast cancer to provide appropriate treatment at the appropriate time.

Methods: This prospective study included patients with breast cancer who received chemotherapy at Pusan National University Yangsan Hospital. We used three self-reporting questionnaires regarding quality of sleep (QoS), anxiety, depression, and QoL. QoL was measured using the Pittsburgh Sleep Quality Index, anxiety using the Beck Anxiety Inventory, depression using the Beck Depression Inventory, and QoL using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. Patients were assessed before, after, and during chemotherapy.

Results: In total, 55 patients were enrolled in this study, of whom 49 completed three self-reporting questionnaires. Anxiety, depression, QoS, and QoL varied during the study. Anxiety, depression, and QoL scores were lowest at the end of chemotherapy (p < 0.005). However, QoS scores were lowest at the beginning of chemotherapy (p < 0.005). Cancer subtype (triple-negative vs. luminal type), T stage, type of breast surgery (breast-conserving surgery vs. mastectomy), and chemotherapy type (adjuvant vs. neoadjuvant) did not show a relationship with QoL, anxiety, depression, or QoS; however, age exhibited differences in all four areas. Patients aged >50 years experienced more sleep disturbances, anxiety, depression, and a decreased QoL. In addition, anxiety was increased during chemotherapy in patients with lymph node metastasis.

Conclusions: Patients with breast cancer experience sleep disturbances, anxiety, depression, and low QoL during chemotherapy. During chemotherapy, these symptoms are often overlooked owing to the side effects of chemotherapy. Proper treatment and emotional support will help patients improve their QoL, anxiety, depression, and QoL.

Introduction: The real-world safety profiles of the demethylating agents Azacitidine and Decitabine remain inadequately characterized despite their widespread clinical use. Both drugs are extensively employed for the treatment of hematologic malignancies such as myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). This study aims to evaluate their adverse event (AE) profiles by leveraging data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Methods: All adverse drug event (ADE) data related to Azacitidine and Decitabine were collected from the FAERS database from its inception through the second quarter of 2024 (Q2). After standardizing the data, four disproportionality methods were applied to evaluate the association between Azacitidine, Decitabine, and ADEs. The Weibull shape parameter (WSP) was used to analyze the time-to-onset curves.

Results: Among the 15,538 ADEs where Azacitidine was the primary suspect drug, a total of 439 preferred terms (PTs) and two system organ classes (SOCs) showed significant disproportionality across all four algorithms. These SOCs included INFECTIONS AND INFESTATIONS (n=7328, ROR 3.78) and BLOOD AND LYMPHATIC SYSTEM DISORDERS (n=5613, ROR 8.92). Compared with the Azacitidine label, 52 previously unreported ADEs were identified at the PT level. Among the 3,064 ADEs where Decitabine was the primary suspect drug, a total of 200 PTs and two SOCs exhibited significant disproportionality across all four algorithms. These SOCs included BLOOD AND LYMPHATIC SYSTEM DISORDERS (n=1284, ROR 6.53) and SURGICAL AND MEDICAL PROCEDURES (n=571, ROR 3.41). Compared with the Decitabine label, 29 previously unreported ADEs were identified at the PT level. Furthermore, the Bayesian Confidence Propagation Neural Network (BCPNN) algorithm revealed that the highest IC025 values for both Azacitidine and Decitabine were concentrated in SOCs related to benign, malignant, and unspecified tumors.

Conclusion: In summary, using the FAERS database, we compared the real-world safety profiles of two demethylating agents, Azacitidine and Decitabine. The results indicate that adverse drug reactions (ADRs) related to these two agents are concentrated in the hematologic, respiratory, circulatory, and digestive systems, as well as in neoplasms of unspecified nature, warranting close clinical attention.

Introduction: Multiple primary malignancies (MPMs) are a rare scenario, particularly in patients with hepatocellular carcinoma (HCC). Research addressing MPM patients with HCC is limited. Therefore, we conducted a retrospective study to explore the clinical features and outcomes of MPM patients involving HCC.

Methods: We retrospectively analyzed records of patients diagnosed with HCC from January 2013 to October 2023 in the First Affiliated Hospital of Xiamen University. HCC patients with extrahepatic tumors were identified. Their clinical characteristics and survival data were further analyzed.

Results: Among the 1,556 patients with HCC, 106 (6.8%) were identified with EHPM, of which 29 were synchronous and 77 were metachronous. A total of 96 patients had double primary cancers, and 10 patients had triple primary cancers. The most common EHPMs were lung cancer (15%), followed by colorectal tumors and stomach cancer. Compared with the synchronous group, the curative treatment rate of HCC and EHPM in the metachronous group is higher. During follow-up period, 29 patients died, of which 20 (69%) died from HCC-related causes. The median overall survival (OS) time was 88 months, with 1-, 3-, 5-, and 10-year cumulative survival rates of 92.4%, 88%, 82.5%, and 69.6%, respectively. The 1-, 3-, and 5-year HCC-specific OS (HOS) rates were 81.8%, 75.8%, and 71.9%, respectively. Univariate analysis revealed that Child-Pugh class (B-C), HCC tumor size >5 cm, non-radical treatment for HCC or EHPM, HCC recurrence, BCLC staging (C-D), and synchronous appearance were significantly associated with shorter OS and HOS. Factors such as Childs class, tumor size, treatment modality, and synchronous presentation were identified as independent predictors of OS through Cox analysis. Childs class, tumor size, non-radical treatment, BCLC staging, and HCC recurrence were found to be independent factors affecting HOS.

Conclusion: The occurrence of extrahepatic primary tumors is not rare, underscoring the importance for oncologists being alert to the development of secondary tumor development in HCC patients. However, the co-occurrence of other primary tumors alongside HCC does not appear to worsen patient prognosis. Notably, curative resection, where feasible, emerges as a vital factor in extending patient survival.

Introduction: With high incidence and mortality rates, lung cancer is now one of the most common cancers in the world. The 5-year survival rate of lung cancer patients is very low, and predicting the prognosis of lung cancer patients and using it to develop treatment strategies and interventions is important for prolonging the survival time of patients. Folate metabolism involves various aspects such as methylation of DNA, RNA, proteins, lipids, etc. Disorders of folate metabolism are closely related to cardiovascular diseases, immunodeficiencies, tumors, etc., and TYMS is a key enzyme in the folate metabolic pathway. We investigated and analyzed the relationship between single nucleotide polymorphism rs3819102 synergistic clinical features in the TYMS and prognosis in lung cancer.

Methods: A total of 888 Han Chinese patients with primary lung cancer were recruited between January and November 2009 (10 months), including Changhai Hospital Affiliated to the Naval Military Medical university (Second Military Medical University) and Taizhou Institute of Health Sciences of Fudan University. Of these, 49 were excluded due to incomplete data collected for various reasons. The study was approved by the Ethics Committee of the School of Life Sciences, Fudan University, and written informed consent was obtained from all participating subjects. This study does not include minors. Genomic DNA was extracted from patient blood samples using the Qiagen Blood Kit (Qiagen, Chatsworth, California) and genotyped using SNPscan technology. The association between TYMS polymorphism rs3819102 and prognostic was analyzed by the Kaplan-Meier (KM) analysis, log-rank test, and Cox proportional-hazards model.

Results: In the Han nationality nonsmoking patients in China, compared with AA + AG genotype, the GG genotype (GG vs. AA + AG: adjusted hazard ratio = 1.69, 95% confidence interval: 1.00-2.83, p = 0.048401) of rs3819102 conferred a worse prognosis. TYMS rs3819102 A > G mutation shortened lung cancer patients' survival and worse prognosis.

Conclusion: TYMS rs3819102 may be a prognostic factor for deterioration in lung cancer patients.