| Title: |
Study protocol of the FIRE-8 (AIO-KRK/YMO-0519) trial: a prospective, randomized, open-label, multicenter phase II trial investigating the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer |
| Authors: |
Sommerhäuser, G.; Kurreck, A.; Stintzing, S.; Heinemann, V.; von Weikersthal, L. Fischer; Dechow, T.; Kaiser, F.; Karthaus, M.; Schwaner, I.; Fuchs, M.; Modest, D. P. |
| Contributors: |
Sommerhäuser, G.; Kurreck, A.; Stintzing, S.; Heinemann, V.; von Weikersthal, L. Fischer; Dechow, T.; Kaiser, F.; Karthaus, M.; Schwaner, I.; Fuchs, M.; Modest, D. P. |
| Publication Year: |
2022 |
| Collection: |
Georg-August-Universität Göttingen: GoeScholar |
| Description: |
Background Initial systemic therapy for patients with metastatic colorectal cancer (mCRC) is usually based on two- or three-drug chemotherapy regimens with fluoropyrimidine (5-fluorouracil (5-FU) or capecitabine), oxaliplatin and/or irinotecan, combined with either anti-VEGF (bevacizumab) or, for RAS wild-type (WT) tumors, anti-EGFR antibodies (panitumumab or cetuximab). Recommendations for patients who are not eligible for intensive combination therapies are limited and include fluoropyrimidine plus bevacizumab or single agent anti-EGFR antibody treatment. The use of a monochemotherapy concept of trifluridine/ tipiracil in combination with monoclonal antibodies is not approved for first-line therapy, yet. Results from the phase II TASCO trial evaluating trifluridine/ tipiracil plus bevacicumab in first-line treatment of mCRC patients and from the phase I/II APOLLON trial investigating trifluridine/ tipiracil plus panitumumab in pre-treated mCRC patients suggest favourable activity and tolerability of these new therapeutic approaches. Methods FIRE-8 ( NCT05007132 ) is a prospective, randomized, open-label, multicenter phase II study which aims to evaluate the efficacy of first-line treatment with trifluridine/tipiracil (35 mg/m 2 body surface area (BSA), orally twice daily on days 1–5 and 8–12, q28 days) plus either the anti-EGFR antibody panitumumab (6 mg/kg body weight, intravenously on day 1 and 15, q28 days) [arm A] or (as control arm) the anti-VEGF antibody bevacizumab (5 mg/kg body weight, intravenously on day 1 and 15, q28 days) [arm B] in RAS WT mCRC patients. The primary objective is to demonstrate an improved objective response rate (ORR) according to RECIST 1.1 from 30% (control arm) to 55% with panitumumab. With a power of 80% and a two-sided significance level of 0.05, 138 evaluable patients are needed. Given an estimated drop-out rate of 10%, 153 patients will be enrolled. Discussion To the best of our knowledge, this is the first phase II trial to evaluate the efficacy of ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
9892 |
| DOI: |
10.1186/s12885-022-09892-8 |
| Availability: |
https://resolver.sub.uni-goettingen.de/purl?gro-2/113835; https://doi.org/10.1186/s12885-022-09892-8 |
| Rights: |
info:eu-repo/semantics/openAccess ; CC BY 4.0 ; https://creativecommons.org/licenses/by/4.0 |
| Accession Number: |
edsbas.2E53A62F |
| Database: |
BASE |