The incidence of infections is poorly studied in patients (pts) with neuroendocrine (NET) tumors treated with everolimus (eve) outside of clinical trials. We aimed to evaluate the incidence and risk factors for opportunistic infections (OpI) or any serious infection among eligible pts.
Retrospective multicenter Latin American cohort of consecutive pts with advanced NET who received at least one dose of eve. Duration of eve, comorbidities, organ dysfunctions, institution, type of prior treatment and concurrent immunosuppressive condition were tested for possible associations with serious (grade 3-5) infections in univariate and multivariable logistic regression models.
111 pts from 5 centers were included: most were men (57.7%) and had pancreatic NET (49.5%). The median duration of eve treatment was 8.9 months and 30 (27%) pts required a dose reduction of eve due to any toxicity. The median overall survival of pts was 54.3 months. In a median follow-up of 32.9 months, 34 (30.6%) pts experienced infections of any grade, 24 (21.6%, 95% confidence interval [CI]: 12.9 – 28.5%) pts had a serious infection and 8 (7.2%, 95% CI: 2.6 – 12.6%) had at least one OpI. Among pts with OpI, the pathogens were Candida sp, Toxoplasma gondi, Pneumocystis sp and Cryptococcus sp; the most common serious infections were pneumonia and gastrointestinal infection. Eight pts (7.2%) died and all deaths were deemed as related to eve. The multivariable analysis identified eve duration (every 6-month increase; Odds Ratio [OR]: 1.26, 95%CI: 1.02-1.55; p = 0.04) and Charlson comorbidity score (OR: 1.47, 95% CI: 1.03-2.08; p = 0.03) as independent risk factors for serious infection.
Infections are more frequent in NET pts using eve than previously reported by clinical trials - 2% had serious infections in the RADIANT-3 trial. Pts on eve should be closely monitored for infections, especially those receiving eve for several months.
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J.M. O’Connor: Honoraria (self): Novartis. R.P. Riechelmann: Honoraria (self): Novartis. All other authors have declared no conflicts of interest.