Abstract 522P
Background
Ocular toxicities are emerging as important adverse events in patients treated with ADCs with significant impact on quality of life. There is a paucity of data on how best to detect and mitigate ocular toxicities in the clinical development of ADCs.
Methods
This is a retrospective audit of patients (pts) treated on early phase trials of ADCs within a dedicated drug development unit between January 2015 to December 2020. 95 pts were identified across seven clinical trials. Patient demographics, clinical variables, and ocular assessments were collected for analysis.
Results
31/95 (33%) pts developed ocular toxicities, 26/31 (84%) were grade 1 and 5/31 (16%) were grade 2. The majority of toxicities affected the eyelid 23/31 (74%), causing red eyes and tearing; and cornea 5/31(16%) presenting as ocular pain. No grade 3/4 toxicities or dose limiting toxicities were observed. Median time to onset of eye toxicities was 2 cycles (range 1-10 cycles). All patients who experienced ocular toxicities had ophthalmology review. 5/31 (16%) pts had transient deterioration in visual acuity and 18/31 (58%) pts had anterior eye findings detected on slit lamp examination. Lubricating eye drops were most commonly prescribed 21/31 (68%), followed by steroid eye drops 5/31 (16%) by an experienced ophthalmologist versed in the management of ocular toxicities seen on experimental early phase trials. Of the 95 pts included in this study, 33/95 (35%) received primary prophylaxis with either the use of cool eye masks or steroid eye drops prior to dosing. Of the 11/33 (33%) pts in this group who developed ocular symptoms, 10/11 (91%) were able to continue dosing. With the use of primary prophylaxis measures, the relative risk of treatment discontinuation due to significant eye toxicity was reduced by 53% (6.5% permanent discontinuation of ADC with no prophylaxis compared to 3% with the use of primary eye prophylaxis).
Conclusions
Ocular toxicities from novel ADCs can be successfully mitigated. Proactive early detection, collaboration with engaged ophthalmology specialists, and prompt institution of prophylactic measures can reduce morbidity.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.