Efficacy of panitumumab (pmab) vs. cetuximab (cmab) in patients (pts) with wild-type (WT) KRAS exon 2 metastatic colorectal cancer (mCRC) treated with prior bevacizumab (bev): Results from ASPECCT.

Authors

null

Marc Peeters

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

Organizations

Antwerp University Hospital, Edegem, Belgium, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, Fudan University Cancer Hospital, Shanghai, China, Clinica di Oncologia Medica, Università Politecnica delle Marche, A.O. Ospedali Riuniti, Ancona, Italy, University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa, Apollo Hospital, Hyderabad, India, Leicester Royal Infirmary, Leicester, United Kingdom, N. N. Blokhin Russian Cancer Research Center, Moscow, Russia, Amgen, Inc., Thousand Oaks, CA, Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia

Research Funding

Pharmaceutical/Biotech Company

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), mos11.3 (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), mos4.7 (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 Details

Meeting

2016 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Prevention, Diagnosis, and Screening

Clinical Trial Registration Number

NCT01001377

Citation

J Clin Oncol 34, 2016 (suppl 4S; abstr 519)

DOI

10.1200/jco.2016.34.4_suppl.519

Abstract #

519

Poster Bd #

B10

Abstract Disclosures