Journal of the National Comprehensive Cancer Network最新文献

Background: Interventions to address sexual health in hematopoietic stem cell transplant (HSCT) survivors are limited.

Methods: We conducted a pilot randomized trial of a digital app, SHIFT (Sexual Health and Intimacy Following Transplant), to address sexual dysfunction in HSCT survivors who were ≥3 months post autologous or allogeneic HSCT. Patients were randomly assigned to SHIFT or enhanced usual care. All participants first underwent a brief physical examination by a trained HSCT clinician. Participants assigned to the intervention received access to SHIFT for 8 weeks. SHIFT consists of 5 modules addressing the biological, interpersonal, social, and psychological causes of sexual dysfunction. The primary endpoint was feasibility, defined a priori as ≥60% enrollment of eligible patients, and 60% of those assigned to SHIFT completing ≥70% of the modules. We assessed patient satisfaction with sex, interest in sex, orgasm pleasure (using the Patient-Reported Outcomes Measurement Information System [PROMIS]), quality of life (QoL; using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant [FACT-BMT]), and anxiety and depression symptoms (using the Hospital Anxiety and Depression Scale [HADS]) at baseline, 8 weeks, and 12 weeks. The preliminary effects of SHIFT on study outcomes were explored using analysis of covariance (ANCOVA) and estimates of effect size at 8 weeks (Cohen's d).

Results: We enrolled 64.2% (61/95) of eligible patients. Of those assigned to the intervention, 70.0% completed 4 of the 5 SHIFT modules and 66.7% completed all SHIFT modules. At 8 weeks, SHIFT participants reported improved satisfaction with sex (14.6 vs 12.3; d=0.46), interest in sex (6.7 vs 5.7; d=0.59), orgasm pleasure (9.7 vs 8.3; d=0.37), QoL (115.6 vs 108.3; d=0.45), and symptoms of anxiety (4.5 vs 6.4; d=0.47) and depression (3.6 vs 5.4; d=0.62) compared with the control group.

Conclusions: The SHIFT digital app to address sexual dysfunction demonstrated feasibility and promising preliminary efficacy in improving sexual health outcomes, QoL, and psychological distress for HSCT survivors.

Background: Immune checkpoint inhibitors (ICIs) are widely used cancer drugs. We developed "UPLIFT," a video and question prompt list (QPL) intervention to educate patients about ICI risks and benefits.

Patients and methods: We conducted a randomized controlled trial of UPLIFT versus usual care among 130 adults initiating ICIs and caregivers. Dyads were randomized 1:1 to receive UPLIFT or usual care prior to ICI initiation. Participants completed surveys at enrollment, 72 hours, and 6 weeks post-ICI initiation. The primary outcomes were feasibility (≥70% enrollment of eligible patients and ≥80% of UPLIFT patients reviewing the video and QPL) and ICI knowledge (8 items, scored as % correct). We also assessed acceptability of UPLIFT (3 items), anxiety (6-item State-Trait Anxiety Inventory), and patient activation (number of questions asked in oncology visit). We used descriptive statistics, analysis of covariance (ANCOVA), and negative binomial models.

Results: We enrolled 130 of 178 eligible patients (73%) and 56 caregivers. Patients (mean age, 67 years [range, 31-92]) had diagnoses of melanoma (41%), lung cancer (26%), or other cancers. All UPLIFT patients (100%) watched the video; 47% used the QPL. Nearly all patients (61/65; 94%) felt "somewhat" or "very comfortable" with UPLIFT. ICI knowledge improved among UPLIFT patients versus controls at 72 hours (difference in adjusted mean % correct at 72 hours, 9% [95% CI, 3%-16%]). The change in anxiety at 72 hours did not significantly differ and there was no difference in knowledge or anxiety change at 6 weeks across groups. UPLIFT patients asked more questions (ratio, 1.27 [95% CI, 0.97-1.66]).

Conclusions: A novel educational intervention about ICI risks and benefits was feasible to deliver, deemed acceptable, and shows promise in improving knowledge and activation to ask questions without increasing anxiety. A future study evaluating UPLIFT's efficacy in these and other outcomes, including severe ICI toxicity, is warranted.

Background: The association between the use of antihistamines targeting histamine receptor H1 (AH1) and breast cancer risk in individuals with type 2 diabetes mellitus (T2DM) remains understudied, warranting further investigation.

Methods: Using the Taiwan National Health Insurance Research Database from 2008 to 2018, we conducted a cohort study on women aged ≥18 years with T2DM, employing propensity score matching (PSM) to compare breast cancer risk between AH1 users (defined as at least 28 cumulative defined daily doses annually) and nonusers. Cox regression models were used to estimate adjusted hazard ratios (aHRs).

Results: The baseline characteristics of the study population were assessed, with 142,642 women enrolled between 2008 and 2018. After PSM, the AH1 use and nonuse groups showed comparable variables. The aHR for breast cancer was significantly lower in the AH1 use group compared with the nonuse group (aHR, 0.54; 95% CI, 0.44-0.66; P<.0001). Dose-dependent analysis revealed a significant trend (Ptrend=.0002), indicating a lower breast cancer risk with increasing AH1 use. The incidence rate of breast cancer was lower in AH1 users compared with nonusers, with an incidence rate ratio of 0.78 (95% CI, 0.65-0.93).

Conclusions: AH1 use shows promise in reducing breast cancer risk in individuals with T2DM, particularly with higher dosages, warranting further research and consideration by health care practitioners.

The NCCN Guidelines for Head and Neck Cancers address tumors arising in the oral cavity (including mucosal lip), pharynx, larynx, and paranasal sinuses, as well as occult primary cancer, salivary gland cancer, and mucosal melanoma (MM). The specific site of disease, stage, and pathologic findings guide treatment (eg, the appropriate surgical procedure, radiation targets, dose and fractionation of radiation, indications for systemic therapy). The NCCN Head and Neck Cancers Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize the panel's most recent recommendations regarding management of nasopharynx cancer and ongoing research in this area.

Background: Physical activity (PA) and dexamethasone (Dex) when used independently have modest benefits for cancer-related fatigue (CRF) in patients with advanced cancer. In this study we aimed to determine the feasibility (adherence, safety, and satisfaction) of combining PA with Dex versus PA with placebo (PBO) for CRF, and to explore the effects of PA+Dex and PA+PBO on CRF.

Patients and methods: In this phase II, randomized, double-blind controlled trial, eligible patients had advanced cancer and a CRF score of ≥4 on the Edmonton Symptom Assessment Scale (ESAS) for fatigue (0-10 scale). Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (PA+Dex arm) or PBO (PA+PBO arm) twice daily for the first 7 days. Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores from baseline to days 8 and 29 were assessed. Other outcomes included change in quality-of-life scores.

Results: A total of 64 (89%) patients were evaluable. Adherence rates for study medication, resistance exercise, and aerobic exercise were 91% and 92% (P=.15), 83% and 70.6% (P=.35), and 82.9% and 78.3% (P=.73), respectively, in the PA+Dex and PA+PBO arms. The satisfaction rates for the PA+Dex and PA+PBO arms were 98% and 79%, respectively. Median (IQR) changes in FACIT-F scores at days 8 and 29 from baseline were 9 (2 to 16; P<.001) and 5.75 (0 to 12.5; P=.015) for the PA+Dex arm, respectively, and 3.5 (-2.1 to 10; P=.054) and 6.5 (2.5 to 15.5; P=.006) for the PA+PBO arm, respectively. We found a significant treatment effect in the PA+Dex arm using exploratory linear mixed model analysis, with treatment showing an improvement of 5.63 units for FACIT-F scores (95% CI, 1.74-9.52; P=.005). We found significant improvement in Functional Assessment of Cancer Therapy-General (FACT-G), Patient-Reported Outcomes Measurement Information System-Fatigue Short Form 7a (PROMIS-Fatigue SF-7a), and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) totals on days 8 and 29 in the PA+Dex arm. There was no significant difference in grade ≥3 adverse events between the arms (P=.36).

Conclusions: Our study found that the use of combination PA+Dex and PA+PBO for CRF was feasible and associated with high rates of satisfaction, adherence to medication and PA intervention, and tolerability. CRF improvement with PA+Dex was clinically significant at days 8 and 29. Further larger studies are justified.

Clinicaltrials: gov identifier: NCT03583255.

Background: HPV infection is implicated in approximately half of global penile squamous cell carcinoma (PSCC) cases. Previous studies on HPV DNA and p16INK4a status in PSCC have yielded inconclusive prognostic findings. This meta-analysis aims to elucidate the prognostic role of HPV in PSCC by pooling data on disease-free survival (DFS), disease-specific survival (DSS), and overall survival (OS).

Methods: We systematically searched Medline and Embase up to January 2023 for relevant human studies. Data from eligible publications reporting HPV DNA or p16INK4a status, along with and DFS, DSS, or OS outcomes, were extracted. A random-effects meta-analysis model was used to synthesize data, with study weights based on size and significance. The study protocol was registered with PROSPERO (CRD42019131355).

Results: Out of 544 studies screened, 34 publications were included, comprising a pooled sample size of 3,944 patients. p16INK4a-positive status was associated with improved OS (hazard ratio [HR], 0.54; 95% CI, 0.39-0.75; I2=31%), DFS (HR, 0.52; 95% CI, 0.29-0.94; I2=20%), and DSS (HR, 0.34; 95% CI, 0.23-0.50; I2=18%). HPV DNA positivity was significantly associated with improved DFS (HR, 0.63; 95% CI, 0.46-0.87; I2=13%) and DSS (HR, 0.46; 95% CI, 0.29-0.75; I2=47%) but not OS (HR, 0.92; 95% CI, 0.74-1.11; I2=0%).

Conclusions: This meta-analysis, comprising the largest number of patients with PSCC to date, shows a notable correlation between p16INK4a immunohistochemistry positivity and survival outcomes. These findings support the understanding that penile cancer cases not associated with HPV tend to behave more aggressively. We support p16INK4a immunohistochemistry testing as part of the initial diagnostic evaluation of patients with PSCC.

Colorectal cancer (CRC) is a heterogeneous group of diseases comprising several molecular subtypes. Comprehensive DNA sequencing is now standard practice to identify these subtype. Until recently, KRAS mutation status in metastatic CRC was primarily used as a biomarker to predict resistance to EGFR inhibition. However, with up to 40% of CRC cases harboring KRAS mutations, therapeutic targeting of RAS has been an area of great need. The development of KRASG12C inhibitors has led to the FDA approval of drugs for treating non-small cell lung cancer. Recently, these and other newly developed inhibitors have been investigated as monotherapies and in combination for metastatic KRASG12C-mutant CRC. This review examines the development of these inhibitors and highlights data supporting the inclusion of sotorasib and adagrasib, in combination with either panitumumab or cetuximab, in the NCCN Guidelines for CRC for the treatment of refractory metastatic disease.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Lung Cancer Screening provide criteria for selecting individuals for screening and offer recommendations for evaluating and managing lung nodules detected during initial and subsequent annual screening. These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Lung Cancer Screening.