Best timing of EGFR re-challenge by monitoring the mutant allele of KRAS/NRAS in liquid biopsy

Conditions

Patients with RAS/BRAF V600E wild-type unresectable advanced or recurrent colorectal cancer who have been treated with anti-EGFR monoclonal antibody

Yoshinori Kagawa, Hiroya Taniguchi, Daisuke Kotani, Tadayoshi Hashimoto, Hideaki Bando et al. (20 authors)

Journal of Clinical Oncology2025-05-283 citations

10.1200/jco.2025.43.16_suppl.3514

Plasma <i>RAS</i> dynamics and anti-EGFR rechallenge efficacy in patients with <i>RAS/BRAF</i> wild-type metastatic colorectal cancer: REMARRY and PURSUIT trials.

Yoshinori Kagawa, Daisuke Kotani, Hideaki Bando, Naoki Takahashi, Tetsuya Hamaguchi et al. (20 authors)

Journal of Clinical Oncology2022-06-0122 citations

10.1200/jco.2022.40.16_suppl.3518

REMARRY and PURSUIT trials: liquid biopsy-guided rechallenge with anti-epidermal growth factor receptor (EGFR) therapy with panitumumab plus irinotecan for patients with plasma RAS wild-type metastatic colorectal cancer.

Nakajima H, Kotani D, Bando H, Kato T, Oki E, Shinozaki E, Sunakawa Y, Yamazaki K, Yuki S, Nakamura Y, Yamanaka T, Yoshino T, Ohta T, Taniguchi H, Kagawa Y.

2021-06-0727 citations

10.1186/s12885-021-08395-2

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Unresectable advanced colorectal adenocarcinoma confirmed by histological diagnosis. 2) RAS (KRAS/NRAS) and BRAF V600E wild type analyzed by tumor tissue. 3) Participants in GOZILA Study (UMIN000029315). 4) Complete or partial response to previous chemotherapy including anti-EGFR antibody (cetuximab or panitumumab). 5) Documentation of progression to previous anti-EGFR antibody within 2 months after last anti-EGFR antibody administration. 6) Patients who are able to be obtained blood sample before following treatment. 7) ECOG 0 or 1. 8) Age >= 20 year old. 9) Life expectancy of at least 12 weeks. 10) Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1) Severe comorbidity. (a) Active multiple cancer (b) Uncontroled central nervous system or leptomeningeal metastasis (c) Mental illness or mental symptoms that would interfere with participation in the study 2) Any patients who are regarded as inadequate for anti-EGFR monoclonal antibody re-challenge by investigators. 3) Intolerant to previous irinotecan therapy. 4) Comorbidity or history of severe pulmonary disease. 5) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. 6) Active HCV or HIV infection. 7) Any other patients who are regarded as inadequate for study enrollment by investigators.

Design outcomes

Primary

Measure	Time frame
The dynamics of the positive RAS mutations rate by circulating tumor DNA analysis using OncoBEAM RAS CRC KIT	—

Countries

Japan

Contacts

Public ContactHiromichi Nakajima

National Cancer Center Hospital East Department of experimental therapeutics

hiromina@east.ncc.go.jp04-7133-1111

Outcome results