FOLFOX plus panitumumab or FOLFOX alone as additive therapy following R0/1 resection of RAS wild-type colorectal cancer liver metastases: The PARLIM trial (AIO KRK 0314).

Authors

null

Dominik Paul Modest

Department of Medicine III, University Hospital, LMU Munich, Munich, Germany

Dominik Paul Modest , Meinolf Karthaus , Stefan Kasper , Nicolas Moosmann , Verena Keitel , Alexander Kiani , Ludwig Fischer von Weikersthal , Jens Uhlig , Lutz Jacobasch , Martin Fuchs , Florian Kaiser , Christian A. Lerchenmuller , Christian Junghanss , Swantje Held , Kathrin Heinrich , Andreas Jung , Arndt Stahler , Sebastian Stintzing , Volker Heinemann

Organizations

Department of Medicine III, University Hospital, LMU Munich, Munich, Germany, Hematology, Oncology, and Palliative Medicine, Klinikum Neuperlach and Harlaching, Munich, Germany, Universitätsklinikum Essen (AöR), Essen, Germany, Krankenhaus Barmherzige Brüder, Dept. Hematology and Oncology, Regensburg, Germany, University of Düsseldorf, Düsseldorf, Germany, Klinikum Bayreuth GmbH, Medizinische Klinik IV, Bayreuth, Germany, Department of Oncology, Gesundheitszentrum St. Marien GmbH, Amberg, Germany, Medical Practice for Hematology and Oncology Muldental, Naunhof, Germany, Onkologische Schwerpunktpraxis, Dresden, Germany, Department of Gastroenterology, Hepatology and Gastrointestinal Oncology, Klinikum Bogenhausen, Munich, Germany, VK&K Studienzentrum, Landshut, Germany, Group Practice of Hematology and Oncology, Muenster, Germany, Department of Hematology and Oncology, University Hospital, Rostock, Germany, ClinAssess GmbH, Leverkusen, Germany, Department of Medicine III, University Hospital, LMU Munich, München, Germany, Munich, Germany, Department of Pathology, University of Munich, Munich, Germany, Medical Department,, Munich, Germany, Medical Department, Division of Hematology, Oncology, and Tumor Immunology (CCM), Charité Universitätsmedizin Berlin, Berlin, Germany, University Hospital Munich, LMU Munich, Munich, Germany

Research Funding

Pharmaceutical/Biotech Company
AMGEN, University of Munich (LMU)

Background: This trial investigates the addition of panitumumab to chemotherapy with fluorouracil/ folinic acid and oxaliplatin (FOLFOX) in a 2:1 randomized, controlled, open label, phase II trial in RAS wild-type colorectal cancer patients with R0/1-resected liver metastases. Methods: The primary endpoint was progression-free survival (PFS) two years after randomisation. The experimental arm (12 wks of biweekly mFOLFOX6 plus panitumumab followed by 12 wks of panitumumab alone) was considered active if the 2-year-PFS rate was ≥65%. Based on historical data, a 2-year-PFS rate of 50% was estimated in the control arm (12 wks of biweekly FOLFOX). The trial was performed with a power of 80% and an alpha of 0.05. Secondary endpoints included overall survival (OS) and toxicity. The trial is registered with ClinicalTrials.gov, NCT01384994. Results: The full analysis set consists of 70 patients (pts) in the experimental arm and 36 pts in the control arm. The 2-year-PFS rate was 34.3% with FOLFOX plus panitumumab and failed to meet the primary endpoint. The 2-year-PFS rate in the control arm was 25%. In the experimental arm, a more favourable outcome was observed with regard to PFS (HR: 0.72, 95%CI 0.45-1.17; P = 0.18) and OS (HR: 0.76 (95% CI 0.34-1.71, P = 0.51) which did, however, not reach the level of significance. Updated data including toxicity and subgroup analyses might be presented at the meeting Conclusions: The PARLIM trial clearly failed to demonstrate a PFS rate of 65% after resection of colorectal liver metastases 2 years after randomisation, potentially indicating that the generally high frequency of recurrence and the choice of primary endpoint did not correspond in this study population. However, a trend for improved PFS and OS by the addition of panitumumab to 12 wks of FOLFOX followed by 12 wks panitumumab maintenance therapy may support future trials with ant-EGFR antibodies in this specific treatment setting. Clinical trial information: NCT01384994

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Advanced Disease

Clinical Trial Registration Number

NCT01384994

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 3553)

DOI

10.1200/JCO.2021.39.15_suppl.3553

Abstract #

3553

Poster Bd #

Online Only

Abstract Disclosures