1614P - Ocular adverse effects (OAES) of molecularly targeted agents (MTAs) approved in oncology: a systematic review

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Complications of Treatment
Presenter Olivier Huillard
Authors O. Huillard1, S. Bakalian2, C. Levy2, L. Desjardins2, L. Lumbroso2, S. Pop2, M. Sablin3, V. Dieras3, C. Le Tourneau3
  • 1Institut Curie, 75005 - Paris/FR
  • 2Department Of Ophthalmology, Institut Curie, Paris/FR
  • 3Department Of Medical Oncology, Clinical Trial Unit, Institut Curie, 75005 - Paris/FR

Abstract

Background

MTAs display different toxicity profiles than conventional cytotoxic agents, with primarily non-hematological toxicity. This study aimed to describe the OAEs reported with the use of MTAs approved in oncology.

Methods

EMEA and FDA product information files (PIFs) were reviewed including all MTAs approved in oncology as of January 1st, 2012. Incidence, severity and types of OAEs were recorded. OAEs reported in these files were compared to the ones described in the publications of the trials that led to drug approval.

Results

OAEs were reported in the PIFs for 14 out of the 16 reviewed MTAs (88%). 44 different types of OAEs were reported in the PIFs, 30% and 52% being items appearing in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3 and 4, respectively. Common OAEs occurring with a frequency ranging from 1 to 10% were reported for 75% of MTAs. The most common reported OAEs were increased lacrimation, dry eye, blurred vision, ocular hyperemia, eyelash changes, eye pain, eye irritation, eye pruritus, eyelid irritation, conjunctivitis, eyelid edema, blepharitis, keratitis, periorbital edema, amblyopia, conjunctival hemorrhage, eye hemorrhage, eye infection, eye edema and eyelid infection. Serious OAEs (Grade ≥3 or with a warning in the PIFs) were reported for 62.5% of the MTAs, and included conjunctivitis, periorbital edema, keratitis, eyelid edema, blepharitis, papilledema, uveitis, cataract, irititis, episcleritis, scleritis, corneal perforation, and retinal vein occlusion. All these serious OAEs were uncommon with a frequency ranging from 0.1% to 1%. Intriguingly, OAEs were reported in the publications of the corresponding pivotal trials for only 5 out of the 14 MTAs for which OAEs were reported in the PIFs.

Conclusions

MTAs display frequent and varied OAEs that sometimes clearly lack precision in their descriptions. These OAEs can be severe and are not well captured by the NCI CTCAE. Finally, these OAEs are not well reported in the publications of the pivotal clinical trials. Efficient collaboration between clinical trial conductors and ophthalmologists should help defining and handling the OAEs occurring in patients treated with MTAs.

Disclosure

All authors have declared no conflicts of interest.