Nivolumab + Tacrolimus + Prednisone ± Ipilimumab for Kidney Transplant Recipients With Advanced Cutaneous Cancers.

PURPOSE: Cancer-related mortality rates among kidney transplant recipients (KTR) are high, but these patients have largely been excluded from trials of immune checkpoint inhibitors because of immunosuppression and risk of treatment-related allograft loss (TRAL). We conducted a prospective clinical trial testing nivolumab (NIVO) + tacrolimus (TACRO) + prednisone (PRED) ± ipilimumab (IPI) in KTR with advanced cutaneous cancers. METHODS: Adult KTR with advanced melanoma or basal, cutaneous squamous, or Merkel cell carcinomas were eligible. Immunosuppression was standardized to TACRO (serum trough 2-5 ng/mL) + PRED 5 mg once daily. Patients then received NIVO 480 mg IV once every 4 weeks. The primary composite end point was partial or complete (tumor) response (CR) or stable disease per RECIST v1.1 without allograft loss at 16W. Patients with progressive disease (PD) could receive IPI 1 mg/kg IV + NIVO 3 mg/kg once every 3 weeks × 4 followed by NIVO. Donor-derived cell-free DNA (dd-cfDNA) levels were measured approximately once every 2 weeks as a potential predictor of allograft rejection. RESULTS: Among eight evaluable patients, none met the trial's primary end point. All eight patients experienced PD on NIVO + TACRO + PRED; TRAL occurred in one patient. Six patients then received IPI + NIVO + TACRO + PRED. Best overall responses: two CR (one with TRAL) and four PD (one with TRAL). In total, 7 of 8 pre-NIVO tumor biopsies contained a paucity of infiltrating immune cells. In total, 2 of 5 on-NIVO biopsies demonstrated moderate immune infiltrates; both patients later experienced a CR to IPI + NIVO. In 2 of 3 patients with TRAL, dd-cfDNA elevations occurred 10 and 15 days before increases in serum creatinine. CONCLUSION: In most KTR with advanced skin cancer, TACRO + PRED provides insufficient allograft protection and compromises immune-mediated tumor regression after administration of NIVO ± IPI. Elevated dd-cfDNA levels can signal treatment-related allograft rejection earlier than rises in serum creatinine.

Identifying critical quality metrics in Mohs Surgery: A national expert consensus process.

BACKGROUND: Amid a movement toward value-based healthcare, increasing emphasis has been placed on outcomes and cost of medical services. To define and demonstrate the quality of services provided by Mohs surgeons, it is important to identify and understand the key aspects of Mohs micrographic surgery (MMS) that contribute to excellence in patient care. OBJECTIVE: The purpose of this study is to develop and identify a comprehensive list of metrics in an initial effort to define excellence in MMS. METHODS: Mohs surgeons participated in a modified Delphi process to reach a consensus on a list of metrics. Patients were administered surveys to gather patient perspectives. RESULTS: Twenty-four of the original 66 metrics met final inclusion criteria. Broad support for the initiative was obtained through physician feedback. LIMITATIONS: Limitations of this study include attrition bias across survey rounds and participation at the consensus meeting. Furthermore, the list of metrics is based on expert consensus instead of quality evidence-based outcomes. CONCLUSION: With the goal of identifying metrics that demonstrate excellence in performance of MMS, this initial effort has shown that Mohs surgeons and patients have unique perspectives and can be engaged in a data-driven approach to help define excellence in the field of MMS.

Mohs surgeon workforce survey: a spectrum of clinical, academic, and leadership activities.

Workforce adequacy for Mohs micrographic surgery (MMS) is not fully understood. The purpose of this study was to describe the current spectrum of clinical, academic, advocacy and leadership activities through a survey of members of the American College of Mohs Surgery (ACMS). The ACMS membership was electronically sent a 43-question anonymous survey between January and May 2023 and there was a 10.7% response rate representing 184 members across 37 states. Nearly 90% are board certified in micrographic dermatologic surgery and 10.3% indicate that they practice in a rural setting (57.1% suburban and 32.6% urban). The median number of half-day surgeons performed Mohs surgery is 6 and nearly half of Mohs surgeons work in a dermatology-only medical group (48.4%), do no use immunohistochemical stains (60.3%), and do not participate in a multidisciplinary tumor board (58.7%). Many respondents indicate they have capacity in their clinical schedules to accommodate more cases and the reasons are multifactorial.

An organizational framework for patient-reported outcome instruments in dermatologic surgery: a systematic review and qualitative analysis.

Patient-reported outcomes (PROs) describe measures of a patient's experience throughout medical care as reported by the patient (Mercieca-Bebber et al. in Patient Relat Outcome Meas, 2018). Various PRO instruments exist. It is challenging to select appropriate instruments given the absence of an organizational framework which describes all measurable PROs in dermatologic surgery and represents which instruments measure which outcomes. Our objective was to systematically review all validated PRO instruments in dermatologic surgery and use qualitative analysis to develop an organizational framework representing PRO measures and instruments. PubMed/MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane databases were searched to retrieve validated PRO instruments in the dermatologic surgery population. The constant comparative method of qualitative analysis was used to develop an organizational framework representing all PROs in dermatologic surgery. All instruments were sorted into this framework. The search identified 3195 articles; 35 validated instruments were extracted and qualitatively analyzed. The organizational framework sorted all instruments into 36 PRO measures aligned with the National Institutes of Health Patient-Reported Outcomes Measurement Information System (Gershon RC, Rothrock N, Hanrahan R, et al (2010) The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research). Measures were grouped into four categories (expectations, satisfaction, quality of life, needs) describing how patients experience these outcomes and lenses through which researchers can evaluate them. In conclusion, we have proposed an organizational framework for use in choosing validated instruments to develop and answer PRO research questions.

Predictors of patient satisfaction with Mohs micrographic surgery at time of surgery and 3 months postsurgery: A prospective cohort study.

BACKGROUND: Despite the importance of patient satisfaction in ensuring high-quality care, studies investigating patient satisfaction in Mohs micrographic surgery (MMS) are limited. OBJECTIVE: We investigated the factors associated with patient satisfaction in MMS for nonmelanoma skin cancer and how patient satisfaction changes in the postoperative period. METHODS: In this prospective cohort study including 100 patients, patient satisfaction surveys were administered at the time of surgery and at 3 months postsurgery. Sociodemographic characteristics, medical history, and surgical parameters were collected by chart review. Univariate linear and logistic regression models were created to examine these relationships. RESULTS: Decreased satisfaction was observed in patients requiring 3 or more MMS stages both at the time of surgery (P = .047) and at 3 months post-surgery (P = .0244). Patients with morning procedures ending after 1:00 pm had decreased satisfaction at the time of surgery (P = .019). A decrease in patient satisfaction between the time of surgery and 3 months postsurgery was observed in patients with surgical sites on the extremities (P = .036), larger preoperative lesion sizes (P = .012), and larger defect sizes (P = .033). LIMITATIONS: Single-institution data, self-selection bias, and recall bias. CONCLUSION: Patient satisfaction with MMS is impacted by numerous factors and remains dynamic over time.

Association of sociodemographic characteristics with utilization of sentinel lymph node biopsy for American Joint Committee on Cancer 8th edition T1b cutaneous melanoma.

Sentinel lymph node biopsy (SLNB) is an important staging and prognostic tool for cutaneous melanoma (CM). However, there exists a knowledge gap regarding whether sociodemographic characteristics are associated with receipt of SLNB for T1b CMs, for which there are no definitive recommendations for SLNB per current National Comprehensive Cancer Network guidelines. We performed a retrospective analysis of the 2012-2018 National Cancer Database, identifying patients with American Joint Committee on Cancer staging manual 8th edition stage T1b CM, and used multivariable logistic regression to analyze associations between sociodemographic characteristics and receipt of SLNB. Among 40,458 patients with T1b CM, 23,813 (58.9%) received SLNB. Median age was 62 years, and most patients were male (57%) and non-Hispanic White (95%). In multivariable analyses, patients of Hispanic (aOR 0.67, 95%CI 0.48-0.94) and other (aOR 0.78, 95%CI 0.63-0.97) race/ethnicity, and patients aged > 75 (aOR 0.33, 95%CI 0.29-0.38), were less likely to receive SLNB. Conversely, patients in the highest of seven socioeconomic status levels (aOR 1.37, 95%CI 1.13-1.65) and those treated at higher-volume facilities (aOR 1.29, 95%CI 1.14-1.46) were more likely to receive SLNB. Understanding the underlying drivers of these associations may yield important insights for the management of patients with melanoma.

Epidemiology, management, and treatment outcomes of metastatic spinal melanoma.

Metastatic spinal melanoma is a rare and aggressive disease process with poor prognosis. We review the literature on metastatic spinal melanoma, focusing on its epidemiology, management, and treatment outcomes. Demographics of metastatic spinal melanoma are similar to those for cutaneous melanoma, and cutaneous primary tumors tend to be most common. Decompressive surgical intervention and radiotherapy have traditionally been considered mainstays of treatment, and stereotactic radiosurgery has emerged as a promising approach in the operative management of metastatic spinal melanoma. While survival outcomes for metastatic spinal melanoma remain poor, they have improved in recent years with the advent of immune checkpoint inhibition, used in conjunction with surgery and radiotherapy. New treatment options remain under investigation, especially for patients with disease refractory to immunotherapy. We additionally explore several of these promising future directions. Nevertheless, further investigation of treatment outcomes, ideally incorporating high-quality prospective data from randomized controlled trials, is needed to identify optimal management of metastatic spinal melanoma.

Patient Anxiety Related to Patient-Perceived Delays in Surgical Treatment of Skin Cancer.

BACKGROUND: Patients undergoing dermatologic surgery report higher anxiety levels than those undergoing nonsurgical treatments. However, little is known about the association between patient-perceived delays in skin cancer surgery and patient-reported anxiety. OBJECTIVE: To examine the relationship between patient-perceived delays in surgery and patient-reported anxiety. METHODS MATERIALS: Patients undergoing wide local excision or Mohs micrographic surgery were recruited to complete a survey to assess perception of surgical delay and anxiety related to skin cancer surgery using the validated Psychosocial Screen for Cancer-Revised. Demographic and surgical characteristics were collected through chart review. Chi-square and Student t -tests were used to compare demographic and surgical information between patients who did and did not perceive a surgical delay. Differences in anxiety and depression scores for patients who did and did not report a delay were assessed using univariate and multivariate regressions. RESULTS: Twenty-seven percent ( N = 33) of patients perceived a surgical delay. Perception of surgical delay was associated with increased time between biopsy and surgery ( p = .0001) and increased self-reported anxiety scores after controlling for various demographic and surgical factors ( p = .038). CONCLUSION: Patient-perceived delays in dermatologic surgery are associated with increased time to surgery and patient-reported anxiety.

Time to treatment and complexity of Mohs micrographic surgery.

The impact of time to treatment (TTT) on the surgical management of keratinocyte carcinoma, specifically the complexity of Mohs micrographic surgery (MMS), is incompletely understood. We performed a retrospective chart review of patients undergoing MMS for keratinocyte carcinoma between July 1, 2019 and February 28, 2021 to examine associations between TTT and surgical characteristics. The median TTT for the 1571 patients treated with MMS during the study period was 42 days (interquartile range 28-61 days). In adjusted analyses, increasing TTT was not associated with increasing utilization of flap or graft repairs. Although a 42-day increase in TTT was associated with a 17.6 mm2 increase in the post-operative surgical defect size after MMS, TTT was not associated with linear repair length or flap/graft repair area. In conclusion, TTT was not independently associated with the type of repair or repair length after MMS, suggesting that the complexity of Mohs reconstruction is not influenced by TTT within the time range studied in this cohort.

Perception of culturally competent care among a national sample of skin cancer patients.

Given limited information about patient experiences with cultural competency within dermatology, we sought to characterize the perception of culturally competent care among skin cancer patients in the United States. We used the 2017 National Health Interview Survey (NHIS) to identify a sample of patients with skin cancer and analyzed responses to the following questions: "How important is it for providers to understand or share your culture?" and "How often are you able to see health care providers that understand or share your culture?" For each question, we calculated the overall prevalence along with adjusted odds ratios for each sociodemographic group. Overall, 31% (95% CI 27-35%) of skin cancer patients responded that it was very or somewhat important for providers to share/understand culture. Patients with income below 200% of the federal poverty level (aOR 1.52; 95% CI 1.02-2.25), foreign-born patients (aOR 3.33; 95% CI 1.25-8.88), and patients with the highest educational attainment of a high school diploma (aOR 1.50; 95% CI 1.08-2.09) all had increased odds of placing importance on sharing/understanding culture. Furthermore, 80% (95% CI 75-85%) of skin cancer patients responded that they were able to see providers that shared/understood their culture all or most of the time, and therefore 20% of patients had access to culturally competent care only some or none of the time. Our study revealed that many (31%) skin cancer patients highly value culturally competent care, with lower-income, foreign-born patients, and patients with the highest educational attainment of a high school diploma, placing greater importance on culturally competent care. However, as many (20%) skin cancer patients have limited access to culturally competent care, future research should focus on analyzing and improving care for patient groups affected by cultural barriers.

Evaluating publication bias for clinical trials supporting new dermatologic drug approvals from 2003 to 2018.

The degree of publication bias and impact of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which aimed to improve clinical trial transparency, has yet to be examined for recent dermatologic drugs. The objective of our study was to estimate the degree of publication bias for clinical trials supporting FDA approval of new dermatologic drugs. This retrospective cohort study examined all phase II and III efficacy trials supporting approval of new dermatologic drugs from 2003 to 2018. FDA drug approval documents were reviewed for supportive clinical trial information, and publications were matched using PubMed and Google Scholar searches. Ratios of relative risks (RRR) comparing positive versus non-positive trials before and after FDAAA enactment served to estimate publication bias. We found that the likelihood of publishing positive versus non-positive drug trials in dermatology was unchanged before and after FDAAA enactment (RRR 0.87, 95% CI 0.37-2.08), as was the likelihood of publishing without misleading interpretation (RRR 1.51, 95% CI 0.22-10.50). There was no measurable publication bias for efficacy trials supporting new drug approvals in dermatology over the past 15 years. Fewer pre-FDAAA trials (n = 21) compared to post-FDAAA trials (n = 106) met inclusion criteria. Though not analyzed in this study, safety and secondary efficacy results are other potential sources for publication bias.