Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer

Summary

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy. Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.

Timeline

Start

2014-04

Primary completion

2023-02-18

Completion

2023-02-18

Outcome

Met primary endpoint

paper PFS of maintenance therapy was significantly improved with FU/FA plus Pmab (8.8 months v 5.7 months; HR, 0.72; 80% CI, 0.60 to 0.85; P = .014). PMID 34533973 ↗

Publications

• Stahler A, Modest DP, Stintzing S, Borelli B, Keller T, Held S, Fischer von Weikersthal L, Muller L, Graeven U, Decker T, Heintges T, Kahl C, Hoppe B, Kiani A, Kaiser F, Schwaner I, Fruehauf S, Karthaus M, Trarbach T, Klauschen F, Horst D, Cremolini C, Heinemann V. Individual Patient Data Meta-Analysis of Consensus Molecular Subtypes as Biomarkers of First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer. J Clin Oncol. 2026 Jan;44(1):31-41. doi: 10.1200/JCO-25-00596. Epub 2025 Nov 18.
• Ballhausen A, Swoboda S, Horst D, Fruehauf S, Graeven U, Muller L, Trarbach T, Fischer von Weikersthal L, Goekkurt E, Heinemann V, Kasper S, Kurreck A, Alig AHS, Reinacher-Schick AC, Bullinger L, Stahler A, Stintzing S, Jarosch A, Modest DP. Spatial Tumor Immune Microenvironment as a Prognostic and Predictive Biomarker in Anti-EGFR-Based Maintenance for RAS wt Metastatic CRC-The PanaMa (AIO KRK0212) Trial. Clin Cancer Res. 2025 Oct 1;31(19):4049-4058. doi: 10.1158/1078-0432.CCR-25-0879.
• Stahler A, Karthaus M, Fruehauf S, Graeven U, Muller L, Fischer von Weikersthal L, Caca K, Goekkurt E, Ballhausen A, Sommerhauser G, Alig AHS, Held S, Jarosch A, Horst D, Reinacher-Schick A, Kasper S, Heinemann V, Stintzing S, Trarbach T, Modest DP. Panitumumab plus 5-fluorouracil and folinic acid or 5-fluorouracil and folinic acid alone as maintenance therapy in RAS wild-type metastatic colorectal cancer (PanaMa, AIO KRK 0212): final efficacy analysis of a randomised, open-label, phase 2 trial. EClinicalMedicine. 2024 Dec 16;79:103004. doi: 10.1016/j.eclinm.2024.103004. eCollection 2025 Jan.
• Stahler A, Kind AJ, Sers C, Mamlouk S, Muller L, Karthaus M, Fruehauf S, Graeven U, Fischer von Weikersthal L, Sommerhauser G, Kasper S, Hoppe B, Kurreck A, Held S, Heinemann V, Horst D, Jarosch A, Stintzing S, Trarbach T, Modest DP. Negative Hyperselection of Resistance Mutations for Panitumumab Maintenance in RAS Wild-Type Metastatic Colorectal Cancer (PanaMa Phase II Trial, AIO KRK 0212). Clin Cancer Res. 2024 Apr 1;30(7):1256-1263. doi: 10.1158/1078-0432.CCR-23-3023.
• Ballhausen A, Karthaus M, Fruehauf S, Graeven U, Muller L, Konig AO, von Weikersthal LF, Sommerhauser G, Alig AHS, Goekkurt E, Meyer-Knees JW, Kurreck A, Stahler A, Held S, Kasper S, Heinrich K, Heinemann V, Stintzing S, Trarbach T, Modest DP. Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with fluorouracil and folinic acid with or without panitumumab as maintenance therapy: a prespecified secondary analysis of the PanaMa (AIO KRK 0212) trial. Eur J Cancer. 2023 Sep;190:112955. doi: 10.1016/j.ejca.2023.112955. Epub 2023 Jun 28.
• Stahler A, Hoppe B, Na IK, Keilholz L, Muller L, Karthaus M, Fruehauf S, Graeven U, Fischer von Weikersthal L, Goekkurt E, Kasper S, Kind AJ, Kurreck A, Alig AHS, Held S, Reinacher-Schick A, Heinemann V, Horst D, Jarosch A, Stintzing S, Trarbach T, Modest DP. Consensus Molecular Subtypes as Biomarkers of Fluorouracil and Folinic Acid Maintenance Therapy With or Without Panitumumab in RAS Wild-Type Metastatic Colorectal Cancer (PanaMa, AIO KRK 0212). J Clin Oncol. 2023 Jun 1;41(16):2975-2987. doi: 10.1200/JCO.22.02582. Epub 2023 Apr 5.
• Sommerhauser G, Kurreck A, Beck A, Fehrenbach U, Karthaus M, Fruehauf S, Graeven U, Mueller L, Koenig AO, V Weikersthal LF, Goekkurt E, Haas S, Stahler A, Heinemann V, Held S, Alig AHS, Kasper S, Stintzing S, Trarbach T, Modest DP. Depth of response of induction therapy and consecutive maintenance treatment in patients with RAS wild-type metastatic colorectal cancer: An analysis of the PanaMa trial (AIO KRK 0212). Eur J Cancer. 2023 Jan;178:37-48. doi: 10.1016/j.ejca.2022.09.011. Epub 2022 Oct 25.
• Modest DP, Karthaus M, Fruehauf S, Graeven U, Muller L, Konig AO, Fischer von Weikersthal L, Caca K, Kretzschmar A, Goekkurt E, Haas S, Kurreck A, Stahler A, Held S, Jarosch A, Horst D, Reinacher-Schick A, Kasper S, Heinemann V, Stintzing S, Trarbach T. Panitumumab Plus Fluorouracil and Folinic Acid Versus Fluorouracil and Folinic Acid Alone as Maintenance Therapy in RAS Wild-Type Metastatic Colorectal Cancer: The Randomized PANAMA Trial (AIO KRK 0212). J Clin Oncol. 2022 Jan 1;40(1):72-82. doi: 10.1200/JCO.21.01332. Epub 2021 Sep 17.

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