Table 1 Treatment characteristics, demographic and clinic-biological data of ICI-related hypophysites recorded in the French Pharmacovigilance Database (FPVD) until May 2018.
Patients | Immune Check Point Inhibitor(s) (ICI) | |||
|---|---|---|---|---|
ipilimumab (ipi) | nivolumab (nivo) | Pembrolizumab (pembro) | ipilimumab + nivolumab (ipi + nivo) | |
Number of cases | 40 | 28 | 13 | 13 |
Women n (%) | 21 (52·5) | 12 (49·9) | 7 (53·8) | 9 (69·2) |
Age (mean ± SD) (years) | 68·4 (±15·2) | 62·8 (±9·8) | 65·4 (±15·8) | 55·5 (±13·7) |
Body Mass Index (mean ± SD) (kg/m2) | 27·1 (±4·9) | 23·7 (±4·42) | 22·3 (±3·9) | 25·37 (±3·94) |
Previous immunotherapy (n) | 2 | 1 | 1 | 0 |
ICI treatment (median [min-max]) | ||||
Number of courses | 4[1–7] | 10[1–33] | 7[1–19] | 3[2–4] |
Dose per course (mg) | 235 [150–330] | 242 [123–354] | 136 [88–190] | ipi 7460–90 + nivo 229 [190–260] |
Cumulated dose before hypophysitis (mg) | 756 [495–1140] | 1901 [294–8910] | 616 [120–3610] | ipi 255 [146–300] + nivo 770 [438–924] |
Time of onset (days) | 79 [14–506] | 155·5 [5–552] | 184 [6–686] | 119 [18–500] |
Indication | ||||
Melanoma | 40 | 7 | 13 | 11 |
Non small cell type lung cancer | 0 | 17 | 0 | 1 |
Small cell type lung cancer | 0 | 1 | 0 | 0 |
Colorectal cancer | 0 | 1 | 0 | 0 |
Renal cell carcinoma | 0 | 2 | 0 | 0 |
Pleural mesothelioma | 0 | 0 | 0 | 1 |
Hypophysitis severity/outcome/MRI | ||||
Grade 1 | 0 | 0 | 0 | 0 |
Grade 2 | 9 | 4 | 4 | 4 |
Grade 3 | 17 | 22 | 9 | 9 |
Grade 4 | 5 | 2 | 0 | 0 |
Grade 5* | 3 | 0 | 0 | 0 |
Recovered | 1 | 0 | 1 | 0 |
MRI with pituitary enlargement | 7 | 2 | 1 | 6 |
Management | ||||
Levothyroxine supplementation | 15 | 1 | 1 | 3 |
Hydrocortisone supplementation | 32 | 28 | 13 | 12 |
Other supplementation | 1 | 0 | 0 | 0 |
Immunotherapy continuation | 4 | 14 | 8 | 9 |
