Malignant otitis externa in Australian Aboriginal patients: A 9-year retrospective analysis from the Northern Territory.

OBJECTIVE: In the Australian Aboriginal population, type 2 diabetes occurs at a much higher prevalence, with a much younger age of onset of the disease and its complications. Despite the clear association with malignant otitis externa, no previous studies have examined malignant otitis externa in this population. This study explores the pattern of malignant otitis externa amongst Australian Aboriginal patients in the Northern Territory. DESIGN: Retrospective case series. SETTING: Otolaryngology unit in a tertiary referral hospital in Northern Territory, Australia. PARTICIPANTS: Patients admitted with malignant otitis externa between January 2007 and October 2016 were identified by reviewing case notes. Patients diagnosed with malignant otitis externa based on results from clinical, microbiological and radiological criteria were included. MAIN OUTCOME MEASURES: Complications rates, duration of hospital stay and parenteral antibiotics, age of onset and causative organisms. RESULTS: Nine patients were included. Six were Australian Aboriginal - all from regional centres. The most common causative organism was Pseudomonas aeruginosa. There was a higher-than-expected occurrence of fungal malignant otitis externa (33% of Australian Aboriginal patients), who tended to be younger at diagnosis, had longer hospital stays and had a higher disease-specific mortality. Over half of the patients did not receive follow-up gallium bone scans to monitor disease resolution, reflecting the limitations of rural health care. CONCLUSION: Malignant otitis externa in the Australian Aboriginal population is a challenging disease with high complication and mortality rates. Their rural and remote distribution is a significant barrier to specialist investigation and care. Providing effective care for this disease requires improved access to high-quality primary health care and tertiary specialist services.

Surgery, radiotherapy or a combined modality for jugulotympanic paraganglioma of Fisch class C and D.

OBJECTIVES: To identify the risks associated with surgery, radiotherapy or a combined treatment approach for Fisch class C and D jugulotympanic paraganglioma, in order to develop an individualised approach for each patient depending on Fisch class, age, mutation presence, tumour size growth rate and presenting symptoms. DESIGN: A retrospective multicenter cohort study with all patient records of patients with a head and neck paraganglioma in the Radboudumc, Nijmegen and the St. Elisabeth Hospital, Tilburg, the Netherlands. MAIN OUTCOME MEASURES: Local control, cranial nerve damage, complications, function recovery. RESULTS: We found highest local control rates after tumour debulking with postoperative radiotherapy in case of residual tumour growth, referred to as the combined treatment group, (100%; n = 19), which was significantly higher than the surgical group (82%; n = 17; P = 0.00), but did not differ from the radiotherapy group (90%; n = 29). There were significantly less complications in the radiotherapy group, when compared to surgery (63 vs 27%; P = 0.002) and the combined group (44 vs 27%; P = 0.016). Furthermore,: using a logistic regression model, we found that pretreatment tumour growth was a negative predictor for post-treatment cranial nerve function recovery (OR = 50.178, P = 0.001), reducing the chance of symptom recovery (67.3% vs 35.7%) post-treatment. CONCLUSIONS: Radiotherapy should be the treatment of choice for the elderly. For younger patients, tumour debulking should be considered, with potential radiotherapy in case of residual tumour growth.

A review of pediatric middle ear tumors and analysis of the demographics, management, and survival of pediatric rhabdomyosarcomas of the middle ear.

OBJECTIVE: To examine the types of pediatric middle ear tumors and review the demographics, management, and survival of pediatric patients with rhabdomyosarcoma (RMS) of the middle ear. METHODS: Pediatric patients in the Surveillance, Epidemiology, and End Results (SEER) database were included from 1973 to 2014 based on a diagnosis of middle ear tumors using the ICD O-3 code: C30.1: Middle ear primary site. Patients were included from ages 0-18 years. RESULTS: Forty pediatric middle ear tumor cases were identified. Twenty patients were female (50%). Twenty-seven (67.5%) cases were rhabdomyosarcomas (RMS). Pediatric RMS patients tended to be diagnosed in early childhood (mean age 5.30 years, standard deviation 2.9, range 1.00-13.00, 59.3% of patients were ages 5 or below). Most pediatric RMS patients received chemotherapy and radiation therapy as part of the treatment regimen (88.8%). Finally, the 5-year overall and disease-specific survival rates were 59% and 63% respectively. CONCLUSIONS: Pediatric middle ear tumors are rare. Females and male pediatric patients are both at risk for middle ear tumors. RMS is the most common malignant middle ear tumor affecting pediatric patients. Despite the use of multimodality therapies, survival rates for pediatric patients with RMS of the middle ear are low. Physicians may consider including middle ear tumors on the differential diagnosis for pediatric patients with symptoms presenting similarly to non-resolving otitis media.

Incidence of Intralabyrinthine Schwannoma: A Population-based Study Within the United States.

OBJECTIVE: To describe the incidence of intralabyrinthine schwannoma (ILS) utilizing the Rochester Epidemiology Project (REP), a unique medical consortium in the United States that covers a complete population of all ages in a well-defined geographic area over the past half-century. PATIENTS: All patients with ILS diagnosed between January 1, 1966 and December 31, 2016 in Olmsted County, Minnesota, identified using the REP medical records-linkage system. MAIN OUTCOME MEASURES: Incidence of ILS. RESULTS: Fourteen incident cases of ILS were identified in Olmsted County since 1966-a period spanning 5.9 million person-years. Over the past decade, the incidence rate of ILS was 0.81 per 100,000 person-years and 1.1 over the last 5 years. Since 1966, the cumulative incidence rate of ILS over the past 50 years was 0.26 per 100,000 person-years. The median age at diagnosis was 60 years (interquartile ranges, 39-70). Incidence increased with age: over the last 5 years, those aged 60 to 69 exhibited an incidence rate of 2.7 per 100,000 person-years and those 70+ displayed a rate of 4.1. All patients had varying levels of asymmetrical sensorineural hearing loss with 64% of patients presenting with class D hearing. Four (29%) patients had a history of sudden sensorineural hearing loss, five (36%) reported imbalance and/or vertigo, and four (29%) reported aural fullness. Three of the 14 (21%) patients had neurofibromatosis type 2. CONCLUSION: The incidence of ILS exceeds 1 per 100,000 person-years with modern diagnostic imaging. The rising incidence of ILS in recent years most likely reflects improved capacity for disease detection rather than a true increase in tumor development. Given the reputability of the REP consortium, these data suggest that ILS comprises a more common entity than previously considered.

Carcinoma of the Middle Ear: A Review of the National Cancer Database.

INTRODUCTION: Malignancy of the middle ear is a rare condition with limited data available for clinical guidance. STUDY DESIGN: Retrospective evaluation of a large national database. SETTING: Deidentified national cancer database. PATIENTS: Subjects with diagnosis of malignancy of the middle ear in the National Cancer Database between 2004 and 2012. MAIN OUTCOME MEASURES: Demographic information and tumor characteristics were evaluated. The primary endpoint of interest is overall survival. RESULTS: The most common histology was squamous cell carcinoma (SCC) (50%). Multivariable Cox proportional hazard analysis found the following variables had a significant negative impact on overall survival: age (HR 1.04 95% CI [1.02-1.05]), squamous cell carcinoma, not otherwise specified (NOS) (HR 2.08 95% CI [1.30-3.32]), squamous cell carcinoma, keratinizing, NOS (HR 4.20 95% CI [2.14-8.24]), embroynal rhabdomyosarcoma, NOS (HR 4.96 95% CI [1.17-21.11]), and unknown extension (HR 2.87 95% CI [1.22-6.74]). For patients of SCC who underwent surgery, 30 had positive margins and 29 underwent adjuvant radiation. For these, no survival advantage was found with the addition of chemotherapy, regardless of node status. CONCLUSION: Malignancy of the middle ear is a rare condition with prognosis that depends on histology. The most common histology, SCC, is associated with the poorest overall survival. Evaluation of large national datasets can add significantly to the understanding of such uncommon tumors.

Adenoid cystic carcinoma of the external ear: a population based study.

PURPOSE: To determine the incidence of adenoid cystic carcinoma of the external ear in the United States, and to evaluate the clinical characteristics and survival outcomes associated with the disease. MATERIALS AND METHODS: Data were extracted from the Surveillance, Epidemiology, and End Results (SEER) 18 Database of the National Cancer Institute. The study cohort included patients diagnosed with adenoid cystic carcinoma of the external ear from 1973 to 2012. RESULTS: The incidence of adenoid cystic carcinoma of the external ear was 0.004 per 100,000. The SEER database identified 66 patients meeting the inclusion criteria. Nodal metastasis was noted in 13.1% of patients, while 7.9% had distant metastasis. Distant metastasis was associated with worse overall survival (HR 10.18). However, nodal metastasis had no impact on overall survival (HR 0.15, p = 0.09). Surgery alone was associated with improved overall survival (HR 0.26), compared with combination surgery and radiotherapy, while radiotherapy alone was associated with worse overall survival (HR 20.12). Increasing age (HR 1.12) and black race (HR 6.83) were associated with worse overall survival, while female sex (HR 0.26) was associated with improved overall survival. CONCLUSION: ACC of the external ear is rare. Distant metastasis is a poor prognostic factor. However, nodal metastasis does not appear to impact survival. Advanced age, black race, and male sex are also poor prognostic factors. Surgical resection alone is associated with better survival than combination surgical resection and radiation, or radiotherapy alone.

Ceruminous adenocarcinoma: An analysis of the Surveillance Epidemiology and End Results (SEER) database.

OBJECTIVES: Ceruminous adenocarcinoma is a rare malignancy. However, due to the paucity of cases, this has been difficult to study. Using a population-based national database, patient demographics and survival trends were analyzed to further elucidate the management of this malignancy. METHODS: The SEER database was queried for patients diagnosed with ceruminous adenocarcinoma between 1973 and 2010. RESULTS: Twenty-two patients were identified in the database. The average age of diagnosis was between 60 and 64 years. All of the patients underwent surgical resection of the primary malignancy. Eight patients (36%) also had postoperative radiation. CONCLUSIONS: Ceruminous adenocarcinoma is uncommon but may not have as poor a prognosis as previously thought. Surgical resection alone appears to be a reasonable treatment option. Larger prospective studies are needed, but database analysis like this may provide clarity on the management of uncommon diseases.

Pathology and Epidemiology of Ceruminous Gland Tumors among Endangered Santa Catalina Island Foxes (Urocyon littoralis catalinae) in the Channel Islands, USA.

In this study, we examined the prevalence, pathology, and epidemiology of tumors in free-ranging island foxes occurring on three islands in the California Channel Islands, USA. We found a remarkably high prevalence of ceruminous gland tumors in endangered foxes (Urocyon littoralis catalinae) occurring on Santa Catalina Island (SCA)--48.9% of the dead foxes examined from 2001-2008 had tumors in their ears, and tumors were found in 52.2% of randomly-selected mature (≥ 4 years) foxes captured in 2007-2008, representing one of the highest prevalences of tumors ever documented in a wildlife population. In contrast, no tumors were detected in foxes from San Nicolas Island or San Clemente Island, although ear mites (Otodectes cynotis), a predisposing factor for ceruminous gland tumors in dogs and cats, were highly prevalent on all three islands. On SCA, otitis externa secondary to ear mite infection was highly correlated with ceruminous gland hyperplasia (CGH), and tumors were significantly associated with the severity of CGH, ceruminous gland dysplasia, and age group (older foxes). We propose a conceptual model for the formation of ceruminous gland tumors in foxes on SCA that is based on persistent, ubiquitous infection with ear mites, and an innate, over exuberant inflammatory and hyperplastic response of SCA foxes to these mites. Foxes on SCA are now opportunistically treated with acaricides in an attempt to reduce mite infections and the morbidity and mortality associated with this highly prevalent tumor.

[Clinical characteristics of malignant tumours originating in the external ear]. / Características clínicas de los tumores malignos originados en el pabellón auricular.

BACKGROUND: Skin tumours that originate in the external ear are common in individuals with type 1 skin and phenotype 1 and 2. The skin cancer is associated with chronic or intermittent, but intense sunlight. The most common malignant tumour is basal cell carcinoma, followed by squamous cell carcinoma and melanoma. The diagnosis of squamous cell skin cancer in head and neck area is usually made in the advanced stages and has a poor prognosis. MATERIAL AND METHODS: A cross-sectional, retrospective analysis was performed on the database of patients with skin cancer of the external ear treated between 2011 and 2014. Histology type, stage, rate of clinical and occult metastases, and rate of loco-regional recurrence were evaluated. RESULTS: Of the 42 patients included there were, 25 squamous cell carcinomas, 11 basal cell carcinomas, and 6 invasive melanomas. The rate of lymph node metastases in patients with squamous cell carcinoma was 32%, mostly in the parotid and peri-parotid region, 7% of them with capsular rupture, 2/17 were staged as cN0, and 11.7% had occult metastases. All patients with nodal metastasis were classified as T2 with ulceration. None of the patients with basal cell carcinoma had lymph node metastases. All melanomas were superficial extension type with mean level of Breslow of 3 mm. All underwent lymphatic mapping and sentinel node biopsy, with only one having metastases in the sentinel node. CONCLUSION: The most frequent tumour in the external ear in this series was squamous cell carcinoma. The possibility of lymph node metastases is associated with tumour size (T). Node dissection should be systematic in patients with T2 or greater.

Complications of microsurgery of vestibular schwannoma.

BACKGROUND: The aim of this study was to analyze complications of vestibular schwannoma (VS) microsurgery. MATERIAL AND METHODS: A retrospective study was performed in 333 patients with unilateral vestibular schwannoma indicated for surgical treatment between January 1997 and December 2012. Postoperative complications were assessed immediately after VS surgery as well as during outpatient followup. RESULTS: In all 333 patients microsurgical vestibular schwannoma (Koos grade 1: 12, grade 2: 34, grade 3: 62, and grade 4: 225) removal was performed. The main neurological complication was facial nerve dysfunction. The intermediate and poor function (HB III-VI) was observed in 124 cases (45%) immediately after surgery and in 104 cases (33%) on the last followup. We encountered disordered vestibular compensation in 13%, permanent trigeminal nerve dysfunction in 1%, and transient lower cranial nerves (IX-XI) deficit in 6%. Nonneurological complications included CSF leakage in 63% (lateral/medial variant: 99/1%), headache in 9%, and intracerebral hemorrhage in 5%. We did not encounter any case of meningitis. CONCLUSIONS: Our study demonstrates that despite the benefits of advanced high-tech equipment, refined microsurgical instruments, and highly developed neuroimaging technologies, there are still various and significant complications associated with vestibular schwannomas microsurgery.

Incidence and survival for Merkel cell carcinoma in Queensland, Australia, 1993-2010.

IMPORTANCE: Merkel cell carcinoma (MCC) is an uncommon but highly invasive form of skin cancer. The mechanisms that cause MCC are yet to be fully determined. OBJECTIVES: To compare the incidence and survival rates of MCC in Queensland, Australia, known to be a high-risk area, with MCC incidence and survival elsewhere in the world. We also analyzed incidence trends and differences in survival by key demographic and clinical characteristics. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of population-based administrative data for MCC collected by the Queensland Cancer Registry and supplemented with detailed histopathologic data. Deidentified records were obtained of all Queensland residents diagnosed as having MCC during the period from 1993 to 2010. A subsample of histopathologic records were reviewed by a senior dermatopathologist to determine the potential for misclassification. A total of 879 eligible cases of MCC were included in the study. MAIN OUTCOMES AND MEASURES: Incidence rates were directly age standardized to the 2000 United States Standard Population. Trends were examined using Joinpoint software with results expressed in terms of the annual percentage change. The period method was used to calculate 5-year relative survival, and adjusted hazard ratios were obtained from multivariate Poisson models. RESULTS: There were 340 cases of MCC diagnosed in Queensland between 2006 and 2010, corresponding to an incidence rate of 1.6 per 100,000 population. Men (2.5 per 100,000) had higher incidence than women (0.9 per 100,000), and rates peaked at 20.7 per 100,000 for persons 80 years or older. The overall incidence of MCC increased by an average of 2.6% per year from 1993 onwards. Relative survival was 41% after 5 years, with significantly better survival found for those younger than 70 years at diagnosis (56%-60%), those with tumors on the face or ears (51%), and those with stage I lesions (49%). CONCLUSIONS AND RELEVANCE: Incidence rates for MCC in Queensland are at least double those of any that have been previously published elsewhere in the world. It is likely that Queensland's combination of a predominantly white population, outdoor lifestyle, and exposure to sunlight has played a role in this unwanted result. Interventions are required to increase awareness of MCC among clinicians and the public.

Pathologic features of pediatric head and neck melanoma.

Although malignant melanoma is rare in children, its incidence is steadily increasing, and it is potentially lethal. Few studies have examined head and neck melanoma in children, and even fewer have focused on the histopathologic features of melanoma within this anatomic region. To further the understanding of this entity, we examined pathology specimens from nine subjects age 18 years and younger with an original diagnosis of head or neck melanoma. The anatomic locations of these primary melanomas were the face and nose (n = 4), scalp and neck (n = 4), and ear (n = 1). The cases included seven superficial spreading melanomas, one unclassified (possible nodular) melanoma, and one melanoma in situ. No melanomas demonstrating desmoplastic or spindle cell morphologies were noted upon review. Breslow depth ranged from 0 to 2.9 mm (mean 1.3 mm, median 0.6 mm), with Clark level ranging from I to V. Pagetoid scatter was found in eight cases. Other notable features included regression (n = 5), ulceration (n = 1), and associated melanocytic nevus (n = 4). We did not observe any small cell variants; all nine cases had an epithelioid appearance. Nor was any melanoma-associated mortality observed at last follow-up (mean 60.4 mos, median 48 mos, range 2-174 mos). These histopathologic features were consistent with adult-type melanoma, which is in agreement with other histopathologic studies of melanoma in children.

The oncology of otology.

OBJECTIVES/HYPOTHESIS: To describe the population of patients with malignancy affecting the ear canal and temporal bone. STUDY DESIGN: Retrospective review. METHODS: The charts of 157 patients with temporal bone cancer were reviewed for clinical outcomes. RESULTS: Between 1999 and 2009, 157 patients underwent temporal bone surgery for cancer involving the ear canal (n = 25), external ear with ear canal involvement (n = 26), periauricular skin (n = 40), parotid gland (n = 40), temporal bone (n = 13), and lateral skull base (n = 13). All surgeries involved one or more otologic approaches: mastoidectomy (28.0%), lateral temporal bone resection (TBR) (59.2%), subtotal TBR (2.5%), total TBR (3.2%), transtemporal approach (TTA) to the jugular foramen (8.2%), TTA to the middle fossa (5.7%), and TTA to the infratemporal fossa (3.2%). Cancers of the cartilaginous ear canal were managed with wide local excision of canal skin and cartilage in nine patients (5.7%). A combination of approaches was performed in 32 patients (20.4%). The 5-year overall survival rate was 58.0%. Patients whose disease was limited to the ear canal had significantly better overall survival than did patients who had skull base primaries (P = .02989), periauricular skin cancer (P = .00138), or temporal bone tumors (P = .02598). Patients with parotid tumors also had better overall survival than did those with periauricular skin tumors (P = .02357). CONCLUSIONS: Otologic surgery plays an important role in managing cancers that involve the ear canal, temporal bone, or lateral skull base. The specialty of otologic oncology is emerging as a defined area of practice.

Nonmelanoma skin cancer of the ear: frequency, patients' knowledge, and photoprotection practices.

BACKGROUND: Nonmelanoma skin cancer (NMSC) is the most common cancer in the world. Information about NMSC on the ear and photoprotection practices of the ear is limited. OBJECTIVE: To determine the frequency of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) at precise anatomical sites, with a special focus on the ear. To evaluate dermatology patients' knowledge about skin cancer, photoprotection practices, and use of photoprotection on the ear. METHODS: At a dermatology practice in Fresno, California, a retrospective chart review of 643 patients diagnosed with NMSC was performed and categorized into detailed anatomical sites. An anonymous questionnaire was given to patients aged 18 and older seen at this private practice. RESULTS: One thousand three hundred eleven NMSCs were biopsied and histologically confirmed. Of these, 538 were BCC (41%) and 773 (59%) were SCC. Seven hundred sixty-five tumors (58.4%) were on the head. The ear was the fifth most common site for NMSC on the head. The male:female ratio for NMSC of the ear was 17:1. There were 269 survey responses; 72.8% used sunscreen, but only 26.0% of those who used sunscreen always apply it to their ears. CONCLUSION: Directed public education about the ear as a high-risk, common site for NMSC is needed. The authors have indicated no significant interest with commercial supporters.

Cutaneous head and neck SCCs and risk of nodal metastasis - UK experience.

AIM: To identify the risk of developing metastases to regional nodes in patients with cutaneous squamous cell carcinomas (CSCCs) of the head and neck. METHODS: A retrospective study of patients with CSCC treated with surgical excision alone between 2000 and 2002 was performed. Demographic details of the patients, the site, size, differentiation, depth of invasion, clearance of surgical margins, and the presence of perineural or lymphovascular invasion of the lesion were documented. During the follow up period, patients with regional metastases were identified. The site of the metastasis and the time after the primary resection were documented and statistical analysis was performed using Chi-square and logistic regression analysis. RESULTS: One hundered and ninety-four patients were included and 218 CSCCs were excised in total during the period of 3 years. The scalp was the most common site of skin lesion, followed by the ear. The incidence of regional metastatic disease was found to be 5.15%. The parotid gland was the most common area of regional metastasis. No metastases occurred after the first 2 years of follow up. The pinna, the poor differentiation and incomplete excision margins were found to be associated with regional metastasis independently, with odds ratio of 16, 21, and 2 respectively. CONCLUSIONS: The rate of regional metastasis from CSCC remains low. The parotid gland was the most favoured metastatic site. Patients with poorly differentiated squamous cell carcinoma (SCC) located on the ear and incomplete excision margins were at the greatest risk for developing regional lymph node metastasis and require close follow up.

Middle ear cancer: a population-based study.

OBJECTIVES/HYPOTHESIS: Primary carcinoma of the middle ear is a rare clinical entity, best suited for evaluation using a population-based database. The objective of this study was to utilize the Surveillance, Epidemiology, and End Results (SEER) database to determine the incidence, treatment, and survival of middle ear carcinoma. STUDY DESIGN: Analysis of national cancer database. METHOD: Using SEER*Stat software, records for patients diagnosed with middle ear carcinoma between 1973 and 2004 were extracted from the SEER database. Five-year, observed survival was analyzed, with significant differences determined by the Wilcoxon statistic. RESULTS: The 5-year observed survival rate for the 215 patients in this study was 36.4%. Histologic subtypes included squamous cell carcinoma (62.8%), adenocarcinoma (18.2%), other carcinomas (13.0%), and noncarcinomas (6.0%), with 5-year survival rates of 23.9%, 65.0%, 60.0%, and 38.6%, respectively (P = .003). Of the 123 patients with known stage, 23.6% had local, 69.1% had regional, and 7.3% had distant disease, with their 5-year survival rates being 64.9%, 34.2%, and 0%, respectively (P < .001). Treatment included surgery (31.2%), radiation (16.3%), surgery and radiation (38.6%), or no treatment (8.4%) with 5-year survival of 69.2%, 14.6%, 26.4%, and 0%, respectively (P < .001). CONCLUSIONS: Patients with primary middle ear carcinoma have a relatively poor prognosis. However, subsets of patients, such as those with adenocarcinomas and with localized tumors, demonstrated significantly better survival. Surgery alone had significantly better survival than the other treatment groups, presumably due to less advanced disease in this treatment group. These data are useful in counseling patients and understanding the natural history of middle ear carcinoma.

Association between statin use and risk for keratinocyte carcinoma in the veterans affairs topical tretinoin chemoprevention trial.

BACKGROUND: Recent evidence suggests that statins may prevent cancer. OBJECTIVE: To quantify the association between statin use and the occurrence of keratinocyte carcinoma in high-risk veterans. DESIGN: Cohort study. SETTING: 6 Veterans Affairs medical centers. PARTICIPANTS: 1037 participants of the Veterans Affairs Topical Tretinoin Chemoprevention Trial, a randomized, multicenter, double-blind, vehicle-controlled trial of topical tretinoin, 0.1%, for prevention of keratinocyte carcinoma conducted from November 1998 to November 2004. MEASUREMENTS: Time to first occurrence of keratinocyte carcinoma on the face or ears. Participants using a statin at randomization, according to the Veterans Affairs Pharmacy Benefits Management database, were considered exposed. Study dermatologists conducted physical examinations at baseline and every 6 months during follow-up. The association between statin use at randomization and the outcome was evaluated by using propensity score matching (n = 608) and Cox proportional hazards regression (n = 1037). RESULTS: Among the 1037 participants, 37% used a statin at randomization (n = 397) for a median duration of at least 900 days over a median follow-up of 3.5 years. In the propensity score-matched analysis, statin use at randomization was not associated with keratinocyte carcinoma (rate ratio, 0.92 [95% CI, 0.73 to 1.16]), a finding that was consistent with the estimates derived from the Cox proportional hazards regression (rate ratio, 0.84 [CI, 0.70 to 1.02]). LIMITATIONS: The extent of residual confounding is unknown, and the confidence bounds around the measures of association were wide. These data may not be generalizable to lower-risk populations. CONCLUSION: These data show no conclusive or consistent relationship between long-term statin use and risk for keratinocyte carcinoma.