Sirolimus use and risk of cutaneous squamous cell carcinoma (SCC) in solid organ transplant recipients (SOTRs)

J Am Acad Dermatol. 2015 Sep;73(3):444-50. doi: 10.1016/j.jaad.2015.05.029. Epub 2015 Jun 30.

Abstract

Background: Little is known about the use of sirolimus for primary prevention of cutaneous squamous cell carcinoma (SCC) among solid organ transplant recipients (SOTRs).

Objective: We examined the association between sirolimus exposure and incident SCC risk among SOTRs within Kaiser Permanente Northern California.

Methods: Using a retrospective cohort of all Kaiser Permanente Northern California members given a diagnosis of SOTR from 2000 through 2010, we evaluated incident posttransplantation SCC risk in relation to sirolimus exposure. Sirolimus use was determined from electronic pharmacy records, and incident posttransplantation SCCs were identified from health plan electronic pathology records. We used extended Cox regression to examine the independent association between receipt of sirolimus and risk of SCC.

Results: Among 3539 SOTRs, 488 were exposed to sirolimus and 47 developed an incident SCC. SCC risk was not associated with ever use of sirolimus (adjusted hazard ratio 1.18, 95% confidence interval 0.84-1.16) or cumulative duration of sirolimus exposure (adjusted hazard ratio 2.75, 95% confidence interval 0.84-9.04, comparing long-term users with nonusers).

Limitations: No information was available for some known SCC risk factors, such as skin type and sun exposure.

Conclusions: Among a large cohort of SOTRs, sirolimus exposure was not associated with a reduction in incident posttransplantation SCC risk.

Keywords: immunosuppression; nonmelanoma skin cancer; pharmacoepidemiology; sirolimus; solid organ transplantation; squamous cell carcinoma.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Squamous Cell / epidemiology*
  • Carcinoma, Squamous Cell / etiology
  • Carcinoma, Squamous Cell / physiopathology
  • Cohort Studies
  • Confidence Intervals
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Incidence
  • Male
  • Middle Aged
  • Organ Transplantation / adverse effects*
  • Organ Transplantation / methods
  • Proportional Hazards Models
  • Reference Values
  • Retrospective Studies
  • Risk Assessment
  • Sensitivity and Specificity
  • Sirolimus / administration & dosage*
  • Skin Neoplasms / epidemiology*
  • Skin Neoplasms / etiology
  • Skin Neoplasms / physiopathology
  • Transplant Recipients / statistics & numerical data*
  • Treatment Outcome

Substances

  • Immunosuppressive Agents
  • Sirolimus