Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
An exploratory analysis based on tumor location of REACHIN, a randomized double-blinded placebo-controlled phase II trial of regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced (nonresectable) and metastatic biliary tract tumors.
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e15622)
Author(s): Anne Demols, Ivan Borbath, Marc Van Den Eynde, Ghislain Houbiers, Marc Peeters, Raphaël Maréchal, Thierry Delaunoit, Jean Charles. Goeminne, Stéphanie Laurent, Stephane Holbrechts, Marianne Paesmans, Jean-Luc Van Laethem; CUB Hôpital Erasme, Bruxelles, Belgium; Cliniques Universitaires St Luc Bruxelles, Bruxelles, Belgium; Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; CHC–Clinique Saint-Joseph, Liège, Belgium; Department of Oncology, Antwerp University Hospital, Edegem, Belgium; Erasme University Hospital, Brussels, Belgium; INDC Entité Jolimontoise, Haine-St-Paul, Belgium; Clinique et Maternité Saint Elisabeth, Namur, Belgium; Ghent University Hospital, Department of Gastroenterology, Ghent, Belgium; Service of Medical Oncology, Centre Hospitalier Universitaire Ambroise Paré, Mons, Belgium; Data Centre, Institut Jules Bordet - Université Libre de Bruxelles (ULB), Brussels, Belgium; Erasme Hospital, Brussels, Belgium
Background: The REACHIN trial met its primary endpoint of improving PFS for patients with biliary tract cancer (BTC) treated with regorafenib (R) as compared to placebo (P): Median (m) PFS for R was 3.0 months (mo) (95% CI: 2.3-4.9) and 1.5 mo (95% CI : 1.2-2.0) for P with an HR= 0.49 (95% CI: 0.29-0.81), p=0.005 (Demols A et al, ASCO-GI 2019, Abstr 345). We exploratory analyzed the benefit of R according to tumor location: intra-hepatic (ICC), extra-hepatic (ECC), gallbladder (GB) or peri-hilar (PH). Methods: Tumor locations were recorded at randomization of patients in REACHIN (NCT02162914), a multicenter double-blinded P-controlled randomized phase II study to evaluate the safety and efficacy of R in patients with locally advanced (non resectable) and metastatic histologically proven BTC, progressing after gemcitabine-platinum. We analyzed mPFS according to tumor location and their respective 95% CI. Results: 66 patients were randomized and the mPFS data are summarized in the table. Conclusions: Most of the patients had ICC location (64%). The mPFS in the P arm is similar according to the tumor location. Despite its exploratory value and the small number of patients per tumor location, R seems superior to P in ICC, GB and PH. Data in ECC are not conclusive. Additional biomarkers (FGFR, NGS analysis) are ongoing and will be presented at the meeting. Clinical trial information: NCT02162914
|N||mPFS (mo)||95% CI||N||mPFS (mo)||95% CI|