Lung cancer patients without chief complaints have been increasingly identified by physical examination. This study aimed to profile and compare chief complaints with patient-reported symptoms of lung cancer patients before surgery.Data were extracted from a multicenter, prospective longitudinal study (CN-PRO-Lung 1) in China from November 2017 to January 2020. A comparison between chief complaints and patient-reported symptoms was analyzed using the Chi-squared test.A total of 201 (50.8%) lung cancer patients without chief complaints were found by physical examination at admission, and 195 (49.2%) patients had chief complaints. The top 5 chief complaints were coughing (38.1%), expectoration (25.5%), chest pain (13.6%), hemoptysis (10.6%), and shortness of breath (5.3%). There were significantly more patients with chief complaints of coughing (38.1% vs 15.0%, P <0.001) and pain (20.5% vs 6.9%, P<0.001) than those with the same symptoms rated ≥4 via MD Anderson Symptom Inventory‒Lung Cancer (MDASI-LC). There were less patients with chief complaints of fatigue (1.8% vs 10.9%, P<0.001), nausea (0.3% vs 2.5%, P=0.006), and vomiting (0.3% vs 1.8%, p=0.032) than those with the same symptoms rated ≥4 via MDASI-LC. In patients without chief complaints, the five most common moderate to severe patient-reported symptoms were disturbed sleep (19.5%), distress (13.5%), dry mouth (13%), sadness (12%), and difficulty remembering (11.1%).Symptoms of lung cancer patients not included in the chief complaint could be identified via a patient-reported outcome instrument, suggesting the necessity of implementing the patient-reported outcome assessment before lung cancer surgery for better patient care.
Supplementary Data from <i>RAB37</i> Hypermethylation Regulates Metastasis and Resistance to Docetaxel-Based Induction Chemotherapy in Nasopharyngeal Carcinoma
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We previously reported superior symptom control of electronic patient-reported outcome (ePRO)–based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, –0.86 [95% CI, –1.32 to –0.39]) and affective interference (estimate, –0.70 [95% CI, –1.14 to –0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.
The American Joint Committee on Cancer (AJCC) staging system is inadequate for an accurate prognosis in nasopharyngeal carcinoma (NPC). Thus, new biomarkers are under intense investigation. Here, we investigated whether the density of TILs could predict prognosis in NPC. First, we used 1490 cases of nasopharyngeal carcinoma samples from two independent cohorts to evaluate the density and distribution of tumor‐infiltrating lymphocytes (TILs). Second, in one cohort, we assessed associations between TILs and clinical outcomes in 593 randomly selected samples (defined as the training set) and validated findings in the remaining 593 samples (defined as the validation set). Furthermore, we confirmed the prognostic value of TILs in a second independent cohort of 304 cases (defined as the independent set). Based on multivariable Cox regression analysis, we also established an effective prognostic nomogram including TILs to improve accuracy in predicting disease‐free survival (DFS) for patients with nondisseminated NPC. We found that high TILs in the training set were significantly associated with favorable DFS [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.28–0.58, p < 0.001], overall survival (OS, HR 0.42, 95% CI 0.27–0.64, p < 0.001), distant metastasis‐free survival (DMFS, HR 0.37, 95% CI 0.23–0.58, p < 0.001) and local‐regional recurrent free survival (LRRFS, HR 0.43, 95% CI 0.25–0.73, p = 0.002). Multivariate analysis showed that TILs are an independent prognostic indicator for DFS in all cohorts. In summary, this study indicated that TILs may reflect the immunological heterogeneity of NPC and could represent a new prognostic biomarker.
Youkenafil is a novel oral selective PDE5 inhibitor for treating Erectile Dysfunction. This investigation assessed pharmacokinetics (PK), safety, and tolerability of youkenafil and its main metabolite (M459) after taking 100 mg youkenafil hydrochloride tablets in elderly and young subjects. This Phase I, single-center, open-label, parallel-group, single-dose study was conducted on 24 individuals (12 elders and 12 youngsters). Each subject received a single oral 100 mg youkenafil hydrochloride tablets. Blood samples were collected before medication and up to 48 hours after medication for PK analysis. Safety and tolerability were also assessed, including treatment-emergent adverse events (TEAEs), laboratory tests, 12-lead ECG, vital sign inspections, color vision examinations, and physical examinations. Plasma concentrations of youkenafil and M459 were quantified. PK parameters were determined by non-compartmental analysis. Median Tmax of elderly and young groups were both 0.733 h. However, Cmax, AUC0-t, and AUC0-∞ of youkenafil were separately 16.8%, 37.2%, and 37.5% higher in elders and t1/2 of youkenafil was 2.1 h longer in elders. More great differences were observed for M459. T1/2 values were 4.05 h longer in elders, with Cmax, AUC0-t and AUC0-∞ 73.7%, 81.1%, and 81.4% higher in elders. Two (8.3%) elderly subjects reported TEAEs (all grade Ⅰ in severity) and both recovered without any treatment. No serious adverse reactions (SAEs) or serious unexpected suspected adverse reactions (SUSARs) occurred in this study. This was the first PK research of youkenafil and M459 in elderly men. PK parameters differences between youkenafil and M459 were comparable between elderly and young groups. Moreover, safety and tolerability of youkenafil were favorable in both groups.
In this study, we aimed to assess the effects of enhanced external counterpulsation (EECP) and individual shear rate therapy (ISRT) on peripheral artery function in patients with lower extremity atherosclerotic disease (LEAD). We randomly assigned 45 LEAD patients to receive 35 sessions of 45 min of EECP (n = 15), ISRT (n = 15), or sham-control (n = 15). Flow-mediated dilation in the brachial artery (brachial-FMD); 6-min walk distance; blood flow in the popliteal, posterior tibial, anterior tibial, and dorsalis pedis arteries; and plasma levels were measured before and after the 7 weeks treatment. 36-item Short Form Health Survey [SF-36] was analyzed before, after 7 weeks, and 3-month follow-ups. EECP treatment significantly improved brachial-FMD and quality of life, increased walking distance, and increased blood flow and the diameters of the popliteal artery and posterior tibial artery (all P < 0.01). Conversely, ISRT markedly increased blood flow in the anterior tibial artery (P < 0.05). EECP and ISRT decreased the endothelin-1 and asymmetrical dimethylarginine levels in patients with LEAD (both P < 0.01). Additionally, sVCAM-1 was significantly reduced after EECP intervention (P = 0.004). Our findings demonstrate that EECP and ISRT have beneficial effects on walking distance, quality of life, flow-mediated dilation, endothelial-derived vasoactive agents, and inflammatory and oxidative stress in LEAD patients. Date of registration: 2021-06-21. Trial registration: ChiCTR2100048086.
Abstract Context: Patients undergoing surgery for lung cancer experience a variety of symptoms such as pain and coughing, which interfere patients’ daily function after surgery. However, there may be some differences between the perception of symptoms by medical staff and the actual situation of patients. Objectives This study aimed to investigate patient’s experiences after lung cancer surgery and analyze whether the perception of postoperative symptoms by the medical staff differed from that reported by patients. Methods Semi-structured qualitative interviews concerning in-hospital experiences were conducted from June 2018 to October 2019 in 39 patients undergoing lung cancer surgery at the Sichuan Cancer Hospital. Moreover, 22 thoracic medical staff were instructed to answer open questions about their perception of symptoms related to the lung cancer surgery. Types and frequencies of symptoms from patients and medical staff were compared. Results Thirty-nine patients were interviewed, and 22 medical staff from the Department of Thoracic Surgery were investigated. The most frequent patient-reported symptoms were pain (967 times, 39 patients, 100%), coughing (904 times, 37 patients, 94.87%), shortness of breath (491 times, 35 patients, 89.74%), disturbed sleep (412 times, 34 patients, 87.18%), and interference with walking (347 times, 36 patients, 92.31%). Of the above symptoms, four were perceived by medical staff, whereas interference with walking was replaced by fatigue. Conclusion Although the medical staff and patients had a certain consensus on main symptoms, differences in perception still exist. Medical staff need to pay more attention to postoperative interference with walking.
The present study aimed to assess the efficacy and safety of immune checkpoint inhibitor (ICI)-based therapy in patients with metastatic breast cancer (MBC). Therefore, eligible patients with histologically confirmed MBC, treated with ICI-based therapy, were enrolled. The primary endpoint was progression-free survival (PFS) and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. A total of 90 patients with MBC, treated with ICI-based therapy, with different treatment lines, were included in the present study. The median age was 50 years (range, 27-76). The predominant tumor subtypes were triple negative (53.3%) and luminal (31.1%) breast cancer. The majority of patients (61.1%) were heavily pretreated (lines of treatment, ≥3). Approximately half of the patients (46.7%) had ≥3 metastatic sites. The overall ORR was 36.7% (33/90 patients), while a DCR of 78.9% (71/90 patients) was also recorded. With a median follow-up of 16.0 months, the median PFS and OS were 4.9 months [95% confidence interval (CI), 3.8-6.1] and 13.9 months (95% CI, 9.5-18.2), respectively. Patients treated with ICIs as first-line therapy exhibited notable improvement, with a median PFS of 11.0 months (95% CI, 6.0-16.0) and a median OS of 24.3 months (95% CI, 11.4-37.2). In addition, the pretreatment blood platelet-to-lymphocyte ratio was an independent risk factor for PFS [hazard ratio (HR)=2.406; 95% CI, 1.325-4.370; P=0.004] and OS (HR=2.376; 95% CI, 1.059-5.328; P=0.036). The most common adverse events were nausea (44.4%), neutropenia (42.0%) and alanine aminotransferase/aspartate aminotransferase elevation (22.2%). Furthermore, three (3.3%) patients developed grade 1/2 immuno-related toxicity and recovered after supportive care. Overall, the present study suggested that the ICI-based therapy exhibited encouraging clinical outcomes with manageable toxicity in patients with MBC in real-world settings, with the most favorable efficacy in first-line treatment.
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