Incidence of anxiety disorder among adults with hidradenitis suppurativa.

BACKGROUND: There is limited data on risk of new-onset anxiety disorders in hidradenitis suppurativa (HS) patients. OBJECTIVES: To compare the risk of new-onset anxiety disorder in patients with HS and controls, and to describe risk factors for development of anxiety among HS patients. METHODS: Retrospective cohort analysis of a US electronic health records database between 2011-2020. Adults newly diagnosed with HS at a dermatology or primary care visit and controls were included. The primary outcome was new diagnosis of generalized anxiety disorder, phobic disorders, panic disorder, or unspecified anxiety. Cox proportional hazards regression was used to compare the crude risk of any anxiety disorder between groups and assess independent association with HS while controlling for potential demographic, clinical, and healthcare-related confounders. RESULTS: Among 9,597 HS patients and 959,493 controls, the incidence rate of anxiety was 5.74 and 3.86 per 100 person-years, respectively. Crude risk among all patients was 48% higher for those with HS compared to controls (HR 1.48, 95%CI 1.40-1.55). When stratifying by index encounter type, HS patients had 2.43 (95%CI 2.13-2.77) times the risk of anxiety disorder compared to dermatology controls and 1.46 (95%CI 1.38-1.55) times the risk compared to primary care controls. Adjusted hazard ratio for HS vs. control was 1.11 (95%CI 1.05-1.17) overall, 1.26 (95%CI 1.07-1.48) in the dermatology subgroup, and 1.07 (95%CI 1.01-1.13) in the primary care subgroup. Risk factors for incident anxiety diagnosis among HS patients included depression (HR 1.69, 95%CI 1.48-1.93), female sex (HR 1.41, 95% CI 1.23-1.60), younger age (HR 0.87 per 10-year increase, 95%CI 0.84-0.90), White race, Medicaid insurance (HR 1.22, 95%CI 1.07-1.40), tobacco smoking (HR 1.16, 95%CI 1.03-1.31), and having one or more emergency department visits in the year before HS diagnosis. Absolute incidence rates of anxiety disorders were highest among HS patients who were aged 18-29 years (7.10 per 100 person-years), female (6.34 per 100 person-years), and White (6.79 per 100 person-years). CONCLUSIONS: HS is independently associated with increased risk of anxiety disorders. An increased risk remains, but is attenuated, when controlling for confounders. The relative risk may be particularly high among patients managed by dermatologists.

Evaluating Immune-Related Adverse Events Using PRO-CTCAE in a Phase II Study of Ipilimumab for Hormone-Sensitive Prostate Cancer.

Introduction: Use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) during chemotherapy is associated with decreased hospitalization rates, improved quality of life, and longer survival. Limited data exist on the benefit of this symptom assessment tool for monitoring immune-related adverse events (irAEs). Methods: We incorporated irAE-related items from the National Cancer Institute's (NCI) PRO-CTCAE in a trial evaluating ipilimumab in combination with androgen deprivation therapy in 16 patients with hormone-sensitive prostate cancer. For comparison, NCI's CTCAE version 4.0 was used by clinicians. Results: IrAE-related PRO-CTCAE surveys and matched CTCAEs (184 pairs) reporting abdominal pain, diarrhea, fatigue, anorexia, nausea, vomiting, rash, and pruritus were collected at each treatment administration and during follow-up. Fatigue, diarrhea, rash, and pruritus were the symptoms most frequently reported by both patients and clinicians. Agreement was lowest for pruritus (κ = 0.10) and highest for rash (κ = 0.64). IrAEs were more commonly reported and of higher grade with PRO-CTCAE scores compared with CTCAE grades. Conclusion: PRO-CTCAEs focused on irAEs capture the patient's immunotherapy experience while complementing the clinician's toxicity assessment measures. Further study is needed to assess PRO-CTCAE's utility in identifying and managing irAEs.

Spine Pain and Metastatic Prostate Cancer: Defining the Contribution of Nonmalignant Etiologies.

PURPOSE: In patients with metastatic prostate cancer (MPC), the contribution of nonmalignant etiologies to morbidity is often overlooked. METHODS: We retrospectively reviewed the documented specialist assessments of back pain in men with MPC in a joint medical oncology and physiatry clinic at our tertiary cancer care center. Data on cancer disease extent, hormonal status, sites of spread, pain characteristics, physiatric examination findings, imaging, and recommended management were reviewed, extracted, and codified. For those with back pain at a site of known disease, pain etiology was classified as malignant, nonmalignant, or mixed. RESULTS: Ninety-three men were collaboratively assessed for back pain, 24 (26%) with a biochemical recurrence and 69 (74%) with MPC of whom 53 (77%) reported pain in an area of known spinal metastases including 35 (66%) metastatic castration-resistant disease and 34 (64%) a precancer history of back pain. The presenting pain symptoms of the 53 patients were activity-related in 22 (42%), radicular in eight (15%), transitional movement-related in seven (13%), biologic in five (9%), and multifactorial in 11 (21%). Overall, pain was deemed malignant in 20 (38%; five castration-sensitive, 15 metastatic castration resistant prostate cancer), nonmalignant in 12 (23%; four castration-sensitive, eight CRPC), and of mixed etiology in 21 (40%; nine castration-sensitive, 12 CRPC). CONCLUSION: Nonmalignant etiologies contributed significantly to back pain at sites of metastatic spread for 33/53 (62%) patients with MPC assessed by medical oncology and physiatry. We recommend multidisciplinary care for patients with MPC and back pain to address nonmalignant etiologies that contribute to functional compromise.

Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy.

BACKGROUND: Phase 2 trial endpoints that can be utilized in high-risk biochemical recurrence (BCR) after prostatectomy as a way of more rapidly identifying treatments for phase 3 trials are urgently needed. The efficacy of abiraterone acetate plus prednisone (AAP) in BCR is unknown. OBJECTIVE: To compare the rates of complete biochemical responses after testosterone recovery after 8 mo of AAP and degarelix, a gonadotropin-releasing hormone antagonist, alone or in combination. DESIGN SETTING AND PARTICIPANTS: Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study. INTERVENTION: Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo. Secondary endpoints were undetectable PSA at 8 mo and time to testosterone recovery. RESULTS AND LIMITATIONS: For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1-17%], arm 2: 17.1% [95% CI: 7-32%], arm 3: 11.9% [95% CI: 4-26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36). AAP therapy showed the shortest median time to testosterone recovery (36.0 wk [95% CI: 35.9-36.1]) relative to degarelix (52.9 wk [95% CI: 49.0-56.0], p < 0.001). Rates of undetectable PSA at 8 mo differed between AAP with degarelix and degarelix alone (p = 0.04), but not between AAP alone and degarelix alone (p = 0.12). Limitations of this study include a lack of long-term follow-up. CONCLUSIONS: Rates of undetectable PSA levels with testosterone recovery were similar between arms, suggesting that increased androgen suppression with AAP and androgen deprivation therapy (ADT) is unlikely to eradicate recurrent disease compared with ADT alone. PATIENT SUMMARY: We evaluated the use of abiraterone acetate plus prednisone (AAP) and androgen deprivation therapy (ADT), AAP alone, or ADT alone in men with biochemically recurrent, nonmetastatic prostate cancer. While more men who received the combination had an undetectable prostate-specific antigen (PSA) level at 8 mo on treatment, once men came off treatment and testosterone level rose, there was no difference in the rates of undetectable PSA levels. This suggests that the combination is not able to eradicate disease any better than ADT alone.

Phase 3 Randomized Controlled Trial of Androgen Deprivation Therapy with or Without Docetaxel in High-risk Biochemically Recurrent Prostate Cancer After Surgery (TAX3503).

BACKGROUND: No standard of care exists for patients with high-risk biochemical recurrence (BCR) after prostatectomy. OBJECTIVE: To evaluate whether addition of docetaxel to androgen deprivation therapy (ADT) improved progression-free survival (PFS) in high-risk BCR patients. DESIGN, SETTING, AND PARTICIPANTS: TAX3503 was a multicenter phase 3 trial that randomized patients with high-risk BCR to ADT for 18 mo ± docetaxel (75 mg/m2 q3w for ten cycles). Eligibility included prostate-specific antigen (PSA) ≥1.0 ng/ml after prostatectomy alone or after postoperative radiation therapy, PSA doubling time ≤9 mo, and absence of metastases on computed tomography and bone scintigraphy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was PFS following testosterone recovery to noncastrate levels (testosterone >50 ng/dl). Secondary endpoints included time to testosterone recovery, overall survival (OS), quality of life, and safety. RESULTS AND LIMITATIONS: Between September 2007 and May 2011, 413 patients were assigned to ADT ± docetaxel. In 2012, following completion of accrual and treatment, the sponsor withdrew support of the study, and in 2013, a registry was created to secure the primary endpoint. The final analysis included data from the original trial and registry. At a median follow-up of 33.6 mo, 260 patients demonstrated testosterone recovery, which occurred similarly between groups. ADT plus docetaxel trended toward a nonclinically meaningful improvement in PFS (median 26.2 vs 24.7 mo) for the testosterone-recovered population (218 events, hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.61-1.04) and in OS for the intention-to-treat population (medians not reached, HR 0.51, 95% CI 0.23-1.10). Grade ≥3 adverse events occurred more frequently in the ADT plus docetaxel group (48.0% vs 10.8%). CONCLUSIONS: TAX3503 did not demonstrate a meaningful benefit of adding docetaxel to ADT in patients with high-risk BCR. Testosterone recovery was unaffected by addition of docetaxel to ADT. PATIENT SUMMARY: Addition of docetaxel to androgen deprivation therapy did not meaningfully improve outcomes for men with high-risk biochemically recurrent prostate cancer.