Antwerp University Hospital, Edegem, Belgium
Marc Peeters , Tae Won Kim , Jin Li , Stefano Cascinu , Paul Ruff , Attili Venkatasatya Suresh , Anne Thomas , Sergei Tjulandin , Xuesong Guan , Tien Hoang , Yong Jiang Hei , Timothy Jay Price
Background: The phase 3 ASPECCT trial of pts with chemorefractory WT KRAS exon 2 mCRC demonstrated that pmab was noninferior to cmab for overall survival (OS). A previous subgroup analysis of hazard ratios (HRs) suggested that pts who had received prior bev (any line, at any point before study start) in the pmab arm may have had better outcomes vs pts in the cmab arm (Price, 2014). Methods: Pts were randomized 1:1 to receive pmab or cmab. The subset of pts who had received prior bev were analyzed based on the final analysis of ASPECCT. Results: 999 pts were randomized and treated: 499 pmab and 500 cmab. The prior bev subset included 126 pts in the pmab arm (25%) and 132 pts in the cmab arm (26%). Pts in the pmab arm had longer median OS and progression-free survival (PFS) and higher objective response rates (ORR) compared with pts in the cmab arm. Results are shown (table). After adjustment for baseline covariates including ECOG performance status, number of metastatic sites, and baseline LDH, OS HR was 0.65 (95%CI=0.49-0.85) with pmab vs cmab in pts who had received prior bev. Pts in the pmab and cmab arms who did not receive prior bev had similar OS, PFS, and ORR. Post-progression antitumor therapy was similar between the pmab (47%) and cmab arms (52%) in pts who received prior bev. Conclusions: In ASPECCT, pts with WT KRASexon 2 mCRC who received prior bev-containing regimens may have derived greater benefit with pmab versus cmab monotherapy. Clinical trial information: NCT01001377
Prior Bev Treatment | No Prior Bev Treatment | |||
---|---|---|---|---|
Pmab (N = 126) | Cmab N = 132) | Pmab (N = 373) | Cmab (N = 368) | |
OS, events (%) | 108 (85.7) | 122 (92.4) | 338 (90.6) | 334 (90.8) |
Median (95% CI), mos | 11.3 (9.3-14.2) | 9.8 (8.3-11.7) | 10.0 (9.1-11.2) | 9.9 (9.0-11.1) |
Hazard ratio (95% CI) | 0.73 (0.56-0.96) | 1.02 (0.87-1.19) | ||
PFS, events (%) | 124 (98.4) | 130 (98.5) | 362 (97.1) | 360 (97.8) |
Median (95% CI), mos | 4.7 (3.2-4.9) | 3.2 (3.0-4.8) | 3.8 (3.2-4.8) | 4.7 (3.3-4.8) |
Hazard ratio (95% CI) | 0.84 (0.66-1.08) | 1.03 (0.89-1.19) | ||
ORR, % (95% CI)* | 22.3 (15.3-30.8) | 15.0 (9.3-22.4) | 21.9 (17.8-26.5) | 21.5 (17.4-26.1) |
*Evaluable pts.
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Abstract Disclosures
2016 ASCO Annual Meeting
First Author: Marc Peeters
2018 Gastrointestinal Cancers Symposium
First Author: Hiroya Taniguchi
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Toshiharu Hirose
2023 ASCO Annual Meeting
First Author: Kathrin Heinrich