25P - Real World analysis for immune related side effects in 3000 patients (25P)

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Colon Cancer
Rectal Cancer
Presenter Laura Mitrofan
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors L. Mitrofan1, T. Moehler2, M. Ruiz3
  • 1Global Oncology, IMS Health, 92088 - Paris/FR
  • 2Oncology, Medical Strategy And Science, QuintilesIMS, 63263 - Neu-Isenburg/DE
  • 3Oncology, Medical Strategy And Science, QuintilesIMS, 328033 - Madrid/ES



Cancer immunotherapy prompted a paradigm shift in oncology, in which therapeutic agents are used to target immune cells rather than cancer cells. Sooner or later, immune oncology (IOs) drugs will be standard of care in multiple indications and with the use of these drugs it comes a unique set of possible side effects named immune related side effects (IRSE) not encountered previously. On the top of this, the usage of non-harmonized terminologies to report and describe IRSE add even more complexity.


This study used QuintilesIMS syndicated cross sectional surveys collecting anonymized patient-level data. Data collected in Germany, France, UK and Spain between July 2016 and June 2017 was used to describe SE of 2,998 patients currently IOs treated. Their reporting relies exclusively on the usage of secondary data (a predefined list) and no primary data is generated or collected.


Of the 2,998 patients (sample number) IOs currently treated populations, 7.9% patients are under clinical trials. The split by mechanism of action is 2% vs. 92% vs. 16% vs. 0, 2% for PDL1 vs. PD1 vs. CTLA-4 and OTHER (KIR2DL1 inhibitor, anti CD137), respectively. IO-IO, IO-CHEMO combination and IO mono are received by 10%, 2% and 88% of patients, respectively. 70% of patients are not displaying any side effects when treated with IO mono or IO-CHEMO (n = 2686), but this percentage drops at 51% when treated with IO-IO combination (n = 312). With 41%, gastrointestinal disorders are most encountered SE during IO treatments (diarrhea counts for 56% from this group), followed by skin and subcutaneous tissue disorders with 27%. Metabolism and nutrition disorders counts for 20% while general disorders and administrative site conditions counts for 15%. Vascular and blood/lymphatic system counts for 11% each. Other side effects includes hepatobiliary disorders (5%); eye disorders (1%), investigations like weight change and cachexia (9%), nervous system disorders (5%) and others (11%).


Higher SE profile for IO-IO combinations might limit their usage, despite their benefit. Additional investigations are required to reveal whether sequence rather than combination is the solution for an improved ratio benefit/risk.

Clinical trial identification


Legal entity responsible for the study





All authors have declared no conflicts of interest.