2019 ASCO Annual Meeting!
Session: Developmental Immunotherapy and Tumor Immunobiology
Type: Poster Session
Time: Saturday June 1, 8:00 AM to 11:00 AM
Location: Hall A
Organ dysfunction (dys) and clinical outcomes in patients (pts) treated with immune checkpoint inhibitors (ICIs).
Immune Checkpoint Inhibitors
Developmental Immunotherapy and Tumor Immunobiology
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #213)
J Clin Oncol 37, 2019 (suppl; abstr 2569)
Author(s): QI LIU, Elad Sharon, Issam Zineh, Diqiong (Joan) Xie, Shrujal S. Baxi, Chao Liu, Jizu Zhi, Aracelis Z. Torres, Anala Gossai, Rajeshwari Sridhara, Brian Booth, Gideon Michael Blumenthal, Shiew-Mei Huang, Sean Khozin; US Food and Drug Administration, Silver Spring, MD; National Cancer Institute, Bethesda, MD; U.S. Food and Drug Administration, Silver Spring, MD; Flatiron Health, New York, NY; FDA, Silver Spring, MD
Background: ICIs (anti-PD-L1/PD-1/CTLA-4) are approved in multiple cancers. The impact of organ dys on the pharmacokinetics of ICIs is known, but associated clinical outcomes are not well characterized. We compared real-world (rw) clinical outcomes in ICI-treated pts by liver and renal function. Methods: This retrospective study used longitudinal, patient-level data from community practices in the Flatiron Health electronic-health record (EHR)-derived database. We included pts diagnosed with advanced cancers (NSCLC, renal cell, melanoma, gastric/esophageal, or head and neck) on or after 1/1/2011, treated with an ICI with follow-up through 12/31/2018 and with baseline liver or renal function results in the EHR ≤30 days prior to ICI start. Organ function was stratified as normal, mild, moderate, or severe dys based on NCI CTCAE. We computed unadjusted median estimates for rw time to treatment discontinuation (rwTTD) for any reason and overall survival (OS) across baseline groups using the Kaplan-Meier method. Results: Of 15,979 pts, we identified 12,978/12,840 pts with evaluable renal/liver function, respectively; median follow-up was 5.1 mos and median age was 69.0 yrs (IQR: 61.0, 76.0) for both. Most pts had NSCLC (69.4/69.0%), were men (60.1/60.0%), white (73.5/73.6%), and diagnosed at stage IV (58.7%/58.6%). Most ICI was given in 1st-line (42.3/42.1%) (outcomes in Table). Conclusions: Pts with categorically worse baseline liver function had progressively worse on-treatment outcomes, including shorter OS, which differed from trends in renal dys. Whether baseline dys is prognostic or predictive of ICI outcomes should be further investigated in addition to reasons for discontinuation. Clinical outcomes (unadjusted median times, mos [95% CI]) by organ function.
|RENAL, n (%)||10,996 (84.7)||1,593 (12.3)||324 (2.5)||65 (0.5)|
|OS||10.0 (9.6, 10.4)||11.4 (10.6, 12.4)||10.0 (7.9, 11.8)||8.2 (7.4, 14.8)|
|rwTTD||3.4 (3.2, 3.4)||3.7 (3.3, 4.1)||3.4 (3.1, 4.2)||3.4 (2.1, 7.3)|
|LIVER, n (%)||11,116 (86.6)||1,495 (11.6)||159 (1.2)||70 (0.5)|
|OS||10.8 (10.4, 11.2)||6.8 (5.8, 7.6)||3.3 (2.0, 5.8)||2.2 (1.3, 4.3)|
|rwTTD||3.6 (3.4, 3.7)||2.3 (2.3, 2.8)||1.8 (0.9, 2.3)||0.9 (0.5, 1.4)|