Mount Sinai Comprehensive Cancer Center, Miami Beach, FL
Jacqueline Claudia Barrientos , Jeff Porter Sharman , Meghan E. Gutierrez , Linda Wu , Zaina P. Qureshi , Anat Raz , Vincent Girardi , Maoko Naganuma , Nilanjan Ghosh
Background: informCLL is a large, US-based, prospective, observational registry of pts with CLL/SLL initiating treatment (tx) in the era after approval of ibrutinib (Ibr). Here, we report real-world tx patterns and outcomes by race and line of therapy (LOT) from the final analysis of informCLL. Methods: Pts with CLL/SLL who initiated FDA-approved tx were enrolled between 10/2015 and 6/2019. Baseline characteristics, tx patterns, time to next tx (TTNT), OS, and safety are summarized by race (focus on Black and White pts) and LOT (first-line [1L] or relapsed/refractory [R/R], with focus on 1L). Results: Of 1459 eligible pts enrolled, 105 were Black (1L, n=58; R/R, n=47), 1323 were White (1L, n=779; R/R, n=544), and 31 were of other races (Asian [n=6], Native American [n=4], other/not reported [n=21]). Relative to White pts, 1L-treated Black pts were younger (median age 65 vs 70 y) and had worse performance status (ECOG status ≥1: 59% vs 50%), more advanced disease (Rai stage III-IV: 55% vs 46%), shorter time from diagnosis to 1L tx (median 7 vs 19 mo), and lower rates of del(17p) among tested pts (6% vs 13%). Across race, Ibr was the most common 1L tx (Black, n=29 [50%]; White, n=346 [44%]) followed by CIT (Black, n=25 [43%]; White, n=331 [42%]). With median follow-up of approximately 32 mo in 1L-treated pts, the estimated rate of freedom from next-line therapy at 36 mo was similar between Black and White pts across all-treated pts and among Ibr-treated subgroups (Table). Estimated 36-mo OS rates in all-treated pts were also similar by race, with a high OS rate observed among Ibr-treated Black pts (97% at 36 mo). In multivariate analyses (MVA) in 1L-treated pts, male gender, poorer ECOG status, and increased comorbidity burden were independent predictors of decreased OS while race was not associated with OS. In 1L Ibr-treated pts, the only factor associated with decreased OS in MVA was longer time from diagnosis to 1L tx. Rates of serious AEs and AEs leading to tx discontinuation appeared similar across race (Table). Conclusions: Although historical retrospective studies from the pre-novel agent era have shown poorer clinical outcomes among Black pts with CLL relative to non-Black pts, results from informCLL show similar or potentially improved outcomes, including OS, among 1L Ibr-treated Black pts relative to White pts. These results suggest that access to novel agents such as Ibr may in part overcome historical disparities in clinical outcomes by race in pts with CLL. Clinical trial information: NCT02582879.
Outcomes with 1L tx | Black all-treated | White all-treated | Black Ibr-treated | White Ibr-treated |
---|---|---|---|---|
# of pts, n | 58 | 779 | 29 | 346 |
Median follow-up, mo | 32.5 | 31.7 | 33.5 | 31.3 |
Median duration of 1L tx, mo | 5.5 | 4.9 | 25.2 | 23.5 |
36-mo estimate of freedom from next-line therapy, % | 73 | 72 | 72 | 75 |
36-mo OS rate, % | 87 | 83 | 97 | 85 |
Serious AEs, % | 28 | 29 | 45 | 38 |
AEs leading to tx discontinuation, % | 14 | 25 | 24 | 36 |
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