Rociletinib-associated cataracts in EGFR-mutant NSCLC

  • Piotrowska Z
  • Liu E
  • Varga A
  • et al.
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Abstract

Background: Rociletinib (roci) is a T790M‐selective EGFR TKI. Among pts on the phase I/II TIGER‐X study, we observed late‐onset, quickly progressive cataracts (cats). We retrospectively contacted pts to assess the incidence of cats among pts treated at our centers, including those beyond the 30‐day post‐roci protocol follow‐up (FU) period. Methods: To identify pts at risk for roci‐associated cats, we excluded pts with pre‐existing cats or prior cat surgery, pts treated with sub‐therapeutic roci doses (< 900 mg BID free base (FB), and those who lived < 120 days from roci initiation. We attempted to contact all pts at risk in Mar 2016 to update FU. Associations between cat surg and age, gender, starting roci dose, time on roci, presence of hyperglycemia and maximum Hgb A1c were tested with Fisher's Exact and Student's T‐tests. Results: Of 284 pts enrolled at the participating sites through Feb 2015, 205 were at risk for cats (135 F, 70 M). The median age was 59 years (range 29‐86). The median duration of roci exposure was 7.8 mos (range 0.3‐29.5). Pts received starting BID roci doses of 900 mg FB (10 pts) or 500 (55), 625 (73), 750 (62) and 1000 (5) mg HBr tablets. Median FU was 10.4 mos. 69 (34%) pts developed cats; 53 (26%) required surgical repair. Among those successfully contacted for longterm FU, the rate of cats was 69/104 (66%). The median time from initial roci exposure to first cat surg was 14.0 mos (95% CI, 2.8‐29.6). Roci‐associated cats frequently progressed to hypermature, surgical cats in wks to mos. Surgery was often more complex than typical senile cats, with increased risk of high intralenticular pressure and need for specialized intraop techniques. Variables significantly associated with an increased risk of cat surg included hyperglycemia (p = 0.043), maximum Hgb A1c (p = 0.022), and duration of roci exposure (OR 1.25; p = <0.001) Conclusions: Roci is associated with a high risk (34%) of late‐onset cataracts, with a median latency of 14 mos from initial drug exposure to surgery. Higher rates of cats may be observed with more complete late FU. The cats appear to have a more rapid course than typical senile cats. Delayed surgical repair may result in increased risk of intraop complications. Roci‐treated pts with longterm survival should be screened for cataracts.

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Piotrowska, Z., Liu, E., Varga, A., Thakur, M., Narayanan, V., Liu, S. V., … Sequist, L. V. (2016). Rociletinib-associated cataracts in EGFR-mutant NSCLC. Annals of Oncology, 27, vi428. https://doi.org/10.1093/annonc/mdw383.39

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