3003 ORAL cetuximab plus irinotecan in patients (pts) with metastatic colorectal cancer (mCRC) failing prior oxaliplatin-based therapy: the EPIC trial
Document Type
Article
Department
Haematology and Oncology, East Africa
Abstract
Background: Cetuximab, an IgG1 MAb targeting the EGFR, is active in irinotecan-refractory mCRC in combination with irinotecan. The multina- tional, randomized, phase III trial, EPIC, was designed to demonstrate the impact of cetuximab on survival in pts with EGFR-expressing mCRC failing prior oxaliplatin and fluoropyrimidine therapy. The primary objective was overall survival (OS). Secondary objectives included progression-free survival (PFS), overall response rate (RR), safety and quality of life (QoL).
Methods: Pts with ECOG PS 2, were randomized to Arm A (cetuximab 400 mg/m2 initial dose, then 250 mg/m2 weekly and irinotecan 350 mg/m2 q 3 weeks) or Arm B (irinotecan 350 mg/m2 q 3 weeks). Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire.
Results: 1298 pts were randomized (648 to Arm A and 650 to Arm B): 62.9% pts male, median age 62 years, and 94% had an ECOG PS of 0−1. Efficacy (OS, PFS, RR) is shown in the table. 47% pts in Arm B received post-study cetuximab (87% of these in combination with irinotecan). Median OS in Arm A was found to be correlated to the presence of acne-like rash: gr 0: 5.8 mo, gr 1/2: 11.7 mo, gr 3/4: 15.6 mo. The most common grade 3/4 adverse events (AEs) were neutropenia (31.8% Arm A, 25.4% Arm B) anddiarrhea (28.4% Arm A, 15.7% Arm B); acneiform rash was significantly more common in Arm A (8.0% vs 0.2%). Baseline HRQoL scores for social functioning, fatigue, dyspnea, and appetite loss, showed significant differences in favor of Arm A. Pts in Arm A had significantly improved Global Health Status (p = 0.047), and 10/15 HRQoL scales, including pain (p = 0.006), nausea/vomiting (p < 0.001), insomnia (p < 0.001), and physical (p = 0.023) and cognitive functioning (p = 0.008).
Conclusions: Cetuximab plus irinotecan in mCRC pts who failed on oxaliplatin resulted in a significantly longer PFS, higher RR and improved QoL than irinotecan alone. The observed safety profile was as anticipated. Overall survival was similar between the two arms but this may result from the substantial post-study use of cetuximab.
Publication (Name of Journal)
EJC Supplements
DOI
http://dx.doi.org/10.1016%2FS1359-6349(07)70931-X
Recommended Citation
Scheithauer, W.,
Sobrero, A.,
Lenz, H.,
Maurel, J.,
Lutz, M.,
Middleton, G.,
Saleh, M.,
Zubel, A.,
Williams, K.,
Burris III, H.
(2007). 3003 ORAL cetuximab plus irinotecan in patients (pts) with metastatic colorectal cancer (mCRC) failing prior oxaliplatin-based therapy: the EPIC trial. EJC Supplements, 4(5).
Available at:
https://ecommons.aku.edu/eastafrica_fhs_mc_haematol_oncol/20
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Comments
This work was published before the author joined Aga Khan University.