Outcomes by hypomagnesemia (hypomag) in the randomized phase III ASPECCT trial of patients (pts) with chemofractory wild-type (WT) KRAS exon 2 metastatic colorectal cancer (mCRC).

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, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, Fudan University Cancer Hospital, Shanghai, China, Universita Politecnica delle Marche, 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 Cancer Research Center of RAMS, Moscow, Russia, Amgen, Inc., Thousand Oaks, CA, Queen Elizabeth Hospital, University of Adelaide, Woodville, Australia

Research Funding

Pharmaceutical/Biotech Company

Background: ASPECCT demonstrated that panitumumab (pmab) was noninferior to cetuximab (cmab) for overall survival (OS). Ad hoc analyses from ASPECCT suggested that hypomag was associated with better outcomes for pmab and cmab (Price 2015). However, results from the phase 3 NCIC CTG/AGITG CO.17 trial indicated hypomag at day 28 was associated with worse outcomes for cmab (Vickers 2013). Methods: Patients (pts) with chemorefractory WT KRASexon 2 mCRC were randomized 1:1 to receive pmab or cmab. Ad hoc analyses by hypomag were performed from the final analysis of ASPECCT at week 5, consistent with the NCIC CTG/AGITG CO.17 trial analysis (Vickers, 2013). Results: 999 pts were treated: 496 received pmab and 503 received cmab. Any grade hypomag was 29.0% and grade ≥3 was 7.3% in the pmab arm vs 19.3% and 2.8% in the cmab arm, respectively. In the pmab arm, 1.2% of pts discontinued treatment and 5% of pts had dose modifications due to hypomag vs 0.4% and 3% in the cmab arm, respectively. Efficacy results by hypomag are shown (Table). Conclusions: In ASPECCT, rates of hypomag were higher in the pmab vs the cmab arm. Pts who developed any grade hypomag with pmab or cmab had longer median OS compared with those pts who did not. Consistent with previous analyses, development of hypomag at week 5 was associated with worse median OS for cmab. Clinical trial information: NCT01001377

Pmab
Cmab
NMedian
OS - mos
(95% CI)
HR (95% CI)NMedian
OS - mos
(95% CI)
HR (95% CI)
Any Grade Hypomag*14413.6 (11.6–15.4)0.63
(0.51-0.78)
9712.6 (10.2–14.8)0.71
(0.56–0.90)
No Hypomag3528.7 (8.0–9.8)4069.3 (8.3–10.1)
Worst Grade 2-4
Hypomag
6913.6 (11.4–15.4)1.12
(0.78-1.60)
3710.3 (8.0-14.8)1.31
(0.83-2.05)
Worst Grade 1
Hypomag
7513.9 (10.6-19.1)6012.6 (11.0-17.3)
Any Grade Hypomag
at Wk 5
3712.0 (6.3-14.6)1.20
(0.83-1.73)
238.1 (6.0-10.3)1.67
(1.09-2.56)
No Hypomag at Wk 540311.3 (10.1-12.4)41710.5 (9.6-11.7)
≥20% Decrease in Mg
Levels at Wk 5
5410.8 (7.3-14.3)1.18
(0.87-1.61)
367.3 (4.9-8.6)2.16
(1.52-3.08)
<20% Decrease in Mg
Levels at Wk 5
38411.3 (10.3-12.6)40210.8 (9.8-12.0)

*Refers to patients who developed hypomag anytime during the study.

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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 507)

DOI

10.1200/jco.2016.34.4_suppl.507

Abstract #

507

Poster Bd #

A20

Abstract Disclosures