Phase II Study of Third-Line Panitumumab Rechallenge in Patients with Metastatic Wild-Type KRAS Colorectal Cancer Who Obtained Clinical Benefit from First-Line Panitumumab-Based Chemotherapy: JACCRO CC-09.

Abstract

BACKGROUND:

Regorafenib and trifluridine/tipiracil are standard third-line chemotherapies for colorectal cancer patients, but their efficacy is limited. Anti-epidermal growth factor receptor antibody rechallenge has been reported to be promising for patients who have obtained clinical benefit from first-line cetuximab-based chemotherapy. Moreover, panitumumab showed non-inferior efficacy to cetuximab.

OBJECTIVE:

This study assessed the efficacy and safety of third-line panitumumab rechallenge in patients with metastatic KRAS exon 2 wild-type metastatic colorectal cancer who obtained clinical benefit from first-line panitumumab-based chemotherapy.

PATIENTS AND METHODS:

This was a prospective, multicenter, phase II trial conducted from October 2013 to August 2017. Major eligibility criteria included KRAS exon 2 wild-type and achievement of complete response, partial response, or continued stable disease for at least 6 months in first-line panitumumab-based therapy. Irinotecan plus panitumumab treatment was continued until disease progression or unacceptable toxicity was observed. The primary endpoint was the 3-month progression-free survival (PFS) rate.

RESULTS:

Twenty-five patients were enrolled in this study. Their median age was 66.5 years, and the 3-month PFS rate was 50.0% (95% confidence interval 30.0-70.0). The median PFS and overall survival were 3.1 months and 8.9 months, respectively. The response rate and disease control rate were 8.3% and 50.0%, respectively. Common grade 3/4 adverse events were acneiform rash (17%), hypomagnesemia (13%), and dry skin (13%). No treatment-related deaths occurred.

CONCLUSION:

Irinotecan plus panitumumab rechallenge is a promising third-line treatment regimen in patients with metastatic wild-type KRAS colorectal cancer.

CLINICAL TRIAL IDENTIFICATION:

UMIN000015916.

• Authors: Akihito Tsuji, Masato Nakamura, Takanori Watanabe, Dai Manaka, Hiroshi Matsuoka, Masato Kataoka, Masahiro Takeuchi, Wataru Ichikawa, Masashi Fujii
• Journal: Targeted oncology (Target Oncol) Vol. 16 Issue 6 Pg. 753-760 (11 2021) ISSN: 1776-260X [Electronic] France
• PMID: 34718946 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

Chemical References

• KRAS protein, human
• Panitumumab
• Irinotecan
• Proto-Oncogene Proteins p21(ras)
• Cetuximab

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Cetuximab (therapeutic use)
• Clinical Trials, Phase II as Topic
• Colonic Neoplasms (drug therapy)
• Colorectal Neoplasms (pathology)
• Humans
• Irinotecan (pharmacology, therapeutic use)
• Multicenter Studies as Topic
• Panitumumab (pharmacology, therapeutic use)
• Prospective Studies
• Proto-Oncogene Proteins p21(ras) (genetics)