Latest Clinical Edge

Post date: 12/17/2020 - 09:45

Key clinical point: RA patients on both oral glucocorticoids (CGs) and proton pump inhibitors (PPIs) had an increased risk of osteoporotic fractures, including to the ribs and vertebrae.

Major finding: Concomitant users of oral GCs and PPIs had a notably higher risk of fracture (adjusted hazard ratio, 1.60; 95% CI, 1.35-1.89).

Study details: A retrospective, population-based cohort study of RA patients aged 50 years or older in the United Kingdom.

Disclosures: Two of the authors reported receiving research grants and speakers’ fees from...

Post date: 12/16/2020 - 12:49

Key clinical point: Patients with suspected nonradiographic axial spondyloarthritis but without positive MRI signs of sacroiliitis and/or elevated C-reactive protein levels show no response to etanercept.

Major finding: Researchers observed similar clinical improvements at 16 weeks in the etanercept and placebo arms of the study.

Study details: A randomized, double-blind, placebo-controlled trial in 80 patients with suspected nonradiographic axial spondyloarthritis.

Disclosures: The study was supported by an unrestricted financial grant...

Post date: 12/16/2020 - 11:50

Key clinical point: The Burkitt Lymphoma International Prognostic Index may help guide treatment and clinical trials for patients with high-risk disease.

Major finding: The 3-year progression-free survival was 96% and overall survival was 99% in low-risk patients.

Study details: A retrospective data analysis of 570 U.S. and 457 non-U.S. adults with Burkitt lymphoma.

Disclosures: No study funding source was reported. Dr. Olszewski reported research funding from Spectrum Pharmaceuticals, Genentech, TG Therapeutics, and Adaptive...

Post date: 12/16/2020 - 10:59

Key clinical point: In heavily pretreated pediatric patients with relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma, venetoclax plus navitoclax with chemotherapy was well tolerated with promising responses.

Major finding: Complete responses, CRs with incomplete marrow recovery, and CRs without platelet recovery (CRp) combined occurred in 62% of B-ALL patients (8/13), 33% of T-cell acute lymphoblastic leukemia patients (1/3) and in 50% of lymphoblastic lymphoma patients (1/2).

Study details: The study included 18 pediatric patients with...

Post date: 12/16/2020 - 10:40

Key clinical point: Use of loop diuretics and nonuse of direct oral anticoagulants (DOACs) were independently associated with an increased risk of osteoporosis in patients with chronic heart failure (CHF).

Major finding: Use of loop diuretics (odds ratio [OR], 2.70; P less than .01) and nonuse of DOACs (OR for DOAC use, 0.36; P = .01) were associated with an increased risk for osteoporosis. Patients with osteoporotic BMD at 2 or 3 sites had a significantly higher rate of a composite of death...

Post date: 12/16/2020 - 10:39

Key clinical point: Switching to denosumab (Dmab) from bisphosphonates (BP) or selective estrogen receptor modulator (SERM) significantly suppressed osteoporosis progression in postmenopausal women with type 2 diabetes (T2D).

Major finding: SERM-Dmab vs. SERM-SERM group showed significantly higher percentage change (P less than .04) in lumbar spine bone mineral density. BP-Dmab and SERM-Dmab groups showed a significantly lower percentage change in serum bone-specific alkaline phosphatase and...

Post date: 12/16/2020 - 10:33

Key clinical point: The prevalence of periapical lesions is significantly higher in patients with vs. without osteoporosis. Patients treated with bisphosphonates (BPs) have a lower prevalence of periapical lesions.

Major finding: The prevalence of periapical lesions in patients with osteoporosis was significantly higher compared with the general patient population in the hospital (odds ratio, 3.36; P less than .0001). Treatment with BPs was associated with a lower prevalence of periapical lesions ...

Post date: 12/16/2020 - 10:32

Key clinical point: Psoriasis was associated with an elevated risk of osteoporosis in individuals aged 40 years or older.

Major finding: In study 1 (a follow-up study), the psoriasis group had a significantly higher risk of osteoporosis than the control group (adjusted hazard ratio, 1.09; P less than .001). In study 2 (a nested case-control study), the osteoporosis group had a significantly higher prevalence of psoriasis than the control group (adjusted odds ratio, 1.21; P less than .001).

Post date: 12/16/2020 - 10:31

Key clinical point: Roux-en-Y gastric bypass (RYGB) correlated with greater reduction in areal bone mineral density (aBMD) and greater increase in bone turnover markers vs. sleeve gastrectomy (SG).

Major finding: From baseline to 1 year, aBMD in femoral neck, total hip, and lumbar spine decreased significantly more after RYGB than after SG (mean [95% confidence interval] between group differences: −2.8% [−0.8% to −4.7%], −3.0% [−0.9% to −5.0%], and −4.2% [−2.1% to −6.4%], respectively). The increase in procollagen type 1 N-terminal...

Post date: 12/15/2020 - 10:27

Key clinical point: A dual-targeted CAR T cell therapy may extend responses and prevent relapse.

Major finding: The overall response rate was 93.8%.

Study details: Early phase 1 study of GC012F in 16 patients with relapsed/refractory multiple myeloma.

Disclosures: The study was supported by participating medical centers and Gracell Biotechnologies. Dr. Fu and Dr. Wong reported no relevant conflicts of interest to disclose.

Post date: 12/14/2020 - 15:12

Key clinical point: A phase 1 first-in-human study demonstrated synthetic T-cell receptor and antigen receptor technical feasibility, clinical safety and efficacy in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia.

Major finding: On day 14 following transplant, 100% had achieved a minimal residual disease–negative complete response/CR with incomplete hematologic recovery.

Study details: The first-in-human study included 18 CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia patients, with a median bone marrow blast level pre–CAR T...

Post date: 12/14/2020 - 14:56

Key clinical point: Sacubitril/valsartan resulted in reverse cardiac remodeling in patients with type 2 diabetes.

Major finding: Left-ventricle ejection fraction improved 8.7 percentage points in patients with T2DM.

Study details: Post hoc analysis of 361 patients with T2DM enrolled in the PROVE-HF trial investigating sac/val therapy for heart failure.

Disclosures: Lead author Muhammad Shahzeb Khan, MD, MSc, has no relevant financial relationships to disclose. Corresponding author Javed Butler, MD, MPH, MBA disclosed financial relationships...

Post date: 12/14/2020 - 09:33

Key clinical point: This meta-analysis suggests that the use of androgen receptor inhibitors (ARIs; enzalutamide, apalutamide, or darolutamide) is associated with an increased risk of fall and fracture in patients with prostate cancer.

Major finding: In the pooled analysis, use of ARI was associated with a higher risk of all-grade falls (relative risk [RR], 1.80; P less than .001), grade 3 or greater fall (RR, 1.60; P less than .001), all-grade fractures (RR, 1.59; P less than .001),...

Post date: 12/14/2020 - 09:32

Key clinical point: Men with metastatic castration-resistant prostate cancer (mCRPC) who receive sipuleucel-T at any time have significantly prolonged overall survival compared with those who receive androgen-receptor signaling pathway inhibitors (ASPIs) alone.

Major finding: In a retrospective cohort analysis of treatment-naive men with mCRPC, first-line sipuleucel-T vs first-line ASPIs (first-line cohort) and any-line sipuleucel-T vs any-line ASPIs (any-line cohort) were compared.

Study details:...

Post date: 12/14/2020 - 09:31

Key clinical point: In patients with localized prostate cancer undergoing radiotherapy, adjuvant androgen deprivation therapy (ADT) improves oncologic outcomes without increasing late toxicities compared with neoadjuvant ADT.

Major finding: At 15 years, adjuvant vs neoadjuvant ADT significantly improved biochemical failure: (33% vs 43%; P = .002), distant metastasis (12% vs 18%; P = .04) and progression-free survival (36% vs 29%; P = .01). There was no significant increase in either late grade 3...

Post date: 12/14/2020 - 09:30

Key clinical point: External beam radiation therapy (EBRT) plus a high-dose rate brachytherapy boost (BB) for the treatment of prostate cancer was not associated with worse functional outcomes or health-related quality of life compared with EBRT alone.

Major finding: EBRT-BB was found to be non-inferior to EBRT alone for the urinary incontinence, sexual, bowel and hormonal domains of Expanded Prostate Cancer Index Composite-26.

Study details: The study included patients diagnosed with intermediate...

Post date: 12/14/2020 - 09:29

Key clinical point: Combination treatment with androgen deprivation therapy (ADT) shows survival benefit in patients with metastatic hormone-sensitive prostate cancer (mHSPC) vs. ADT alone. ADT in combination with radiotherapy (RT) or enzalutamide extends overall survival (OS) in low-volume disease.

Major finding: Compared with ADT monotherapy, significant OS improvement (hazard ratio; 95% confidence interval) was seen with ADT+abiraterone+prednisolone (0.64; 0.56-0.73), ADT+apalutamide (0.67; 0.51-0.89), ADT+docetaxel (0.78; 0.69-0.88), and ADT+...

Post date: 12/14/2020 - 09:23

Key clinical point: Adding immunotherapy to chemotherapy for early triple-negative breast cancer did not increase symptom burden.

Major finding: Health-related quality-of-life measures were similar whether patients received chemotherapy with atezolizumab or with placebo. For example, mean physical function scores were about 90% in both treatment arms at baseline, dropped to about 65% in each arm by cycle 5, and rebounded to about 80% by cycle 7.

Study details: Exploratory patient-reported outcomes from 328 patients in the phase 3 IMpassion031 trial.


Post date: 12/14/2020 - 09:15

Key clinical point: A real-world study has revealed factors associated with longer overall survival in patients who receive cabozantinib to treat heavily pretreated, metastatic renal cell carcinoma.

Major finding: Receiving cabozantinib at a starting dose of 60 mg/day (P = .0486), prior nephrectomy (P = .0109), favorable or intermediate risk according to the International Metastatic RCC Database Consortium (P < .0001), and body mass index of 25 kg/m2 or higher (P = .0021) were all significantly associated with better overall survival.


Post date: 12/11/2020 - 17:21

Key clinical point: Breast cancer survivors are less likely to conceive and have more complications when they do, but pregnancy does not increase the risk of cancer recurrence, a review suggests.

Major finding: Relative to the general population, breast cancer survivors were 60% less likely to become pregnant, and they had higher odds of complications such as preterm birth (45% higher) and low birth weight (50% higher), but their risk of cancer recurrence was not increased.

Study details: A systematic review and meta-analysis using data from 39 studies that...

Post date: 12/11/2020 - 14:43

Key clinical point: Different gene expression in synovial tissue, compared with skin, may explain differing treatment responses for skin and joints in psoriatic arthritis treated with anti-TNF agents and the anti–IL-23/IL-12 inhibitor ustekinumab.

Major finding: Some patients with psoriatic arthritis have lower levels of gene expression for key drug targets in their synovial tissues.

Study details: Observational, open-label study in 27 patients with active psoriatic arthritis.

Disclosures: The study was supported by the Queen Mary...

Post date: 12/11/2020 - 14:35

Key clinical point: For B-cell malignancies, synthetic lethality is a viable treatment approach, according to preliminary clinical trial data with once-daily oral DTRM-555, a triple combination therapy.

Major finding: In efficacy analysis for 22 evaluable patients, there were overall response rates of 46% in the RT group and 45% in the diffuse large B-cell lymphoma group.

Study details: The phase 1 trial in chronic lymphocytic leukemia, B-cell non-Hodgkin lymphoma, or Hodgkin lymphoma included 24 adults with life expectancy >12 weeks, good performance status...

Post date: 12/11/2020 - 13:03

Key clinical point: Prescription opioid use was associated with an increased risk for major depressive disorder (MDD) and anxiety and stress-related disorders (ASRD).

Major finding: Multivariable mendelian randomization (MR) analysis showed that genetic liability for increased prescription opioid use was associated with an increased risk for MDD (odds ratio [OR], 1.14; P = .005) and ASRD (OR, 1.30; P = .006). Bidirectional analyses showed that genetic liability for MDD, but not ASRD, increased the risk for...

Post date: 12/11/2020 - 13:02

Key clinical point: Pain and functionality should be assessed and treated in patients with partially remitted major depressive disorder (MDD).

Major finding: Pain (visual analogue scale) correlated significantly and negatively with functional impairment (Social and Occupational Functioning Assessment Scale; r = −0.21; P less than .001). Pain correlated positively with age (r = 0.33; P = .007) and depression (r = 0.28; P = .006). In the Remission from Depression Questionnaire, the pain group showed higher...

Post date: 12/11/2020 - 13:00

Key clinical point: Psilocybin-assisted therapy showed large, rapid, and sustained antidepressant effects in major depression disorder (MDD).

Major finding: 67% and 71% of MDD patients who received psilocybin showed a clinically significant response (50% or more reduction in GRID-Hamilton Depression Rating scores [HAMD] score) at week 1 and week 4 of follow-up, respectively. 58% and 54% were in remission (7 or lower GRID-HAMD score) at week 1 and week 4, respectively.