605TiP - Randomized phase II study of maintenance treatment with 5-FU/FA plus panitumumab vs 5-FU/FA alone after induction (mFOLFOX6 plus panitumumab) in pa...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Colon and Rectal Cancer
Presenter Dominik Paul Modest
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors D.P. Modest1, S. Kasper2, S. Stintzing3, N. Prasnikar4, L. Müller5, K. Caca6, E. Gökkurt7, L. Fischer von Weikersthal8, H. Kopp9, T. Trarbach10
  • 1Med. Klinik Iii Klinikum Großhadern, Ludwig Maximilians University - Grosshadern, 81377 - München/DE
  • 2Medical Oncology, University Hospital Essen Westdeutsches Tumorzentrum, 45147 - Essen/DE
  • 3Hematology And Oncology, Ludwig Maximilians University - Grosshadern, 81377 - München/DE
  • 4Oncology, AK Asklepios Klinik Altona, Hamburg/DE
  • 5Onkologie, Onkologie UnterEms, 26789 - Leer/DE
  • 6Klinik F. Innere Medizin, Gastroenterologie, Hämato-onkologie, Klinikum Ludwigsburg Hämatologie/Onkologie, Palliativmedizin, 71640 - Ludwigsburg/DE
  • 7Hope Eppendorf, Facharztzentrum Eppendorf, 20249 - Eppendorf/DE
  • 8Oncology, Klinikum St. Marien Amberg, Amberg/DE
  • 9Klinik Für Innere Medizin Ii, Universitätsklinikum Tübingen, 72076 Tübingen - Tübingen/DE
  • 10Center For Tumor Biology And Integrative Medicine, Hospital Wilhelmshaven, Wilhelmshaven/DE

Abstract

Background

Combination chemotherapy plus anti-EGFR (epidermal growth factor receptor) antibody is approved for first-line therapy in metastatic colorectal cancer in patients with RAS wild type tumors. The combination of FOLFOX with panitumumab has led to significantly better outcome when compared to chemotherapy alone. The cumulative oxaliplatin toxicity resulting in dose limiting neurotoxicity has led to the development of maintenance strategies. For FOLFOX plus bevacizumab treated patients a maintenance concept with 5-FU plus bevacizumab has been established by multiple clinical trials. For the use of FOLFOX plus panitumumab, no clear maintenance concept has been defined. The PanaMa study is evaluating the concept of limiting the application of chemotherapeutic agents while continuing with a maintenance treatment including an anti-EGFR antibody. As the EGFR antibody panitumumab is approved for first-line therapy in metastatic colorectal cancer in RAS wild-type patients, this study aims to investigate whether addition of a target agent, i. e., panitumumab, to a standard maintenance backbone (5-fluorouracil plus leucovorin) can add / maintain clinical benefit.

Trial design

Primary Objectives: Efficacy of panitumumab plus 5-FU/FA as maintenance after 12 weeks with mFOLFOX6 plus panitumumab in the first-line treatment of RAS wild-type metastatic colorectal cancer patients compared to 5-FU/FA maintenance alone in terms of progression-free survival (superiority design in favour of the combination arm). Secondary Objectives: •Time from randomization until failure of treatment strategy (death/progression) •Progression-free survival of re-induction •Objective response after induction and during maintenance and re-induction •Overall survival •Safety •Health and skin related Quality of life Sample size Approx. 380 patients will be enrolled. 252 patients should be accrued for randomisation to reach the required number of 218 events (PD or death after treatment with maintenance).

Clinical trial identification

NCT01991873

Legal entity responsible for the study

AIO Studien gGmbH

Funding

AIO Studien gGmbH, funding from AMGEN

Disclosure

D.P. Modest: Honoraria: Amgen, Merck, Roche, Bayer. Travel support: Amgen, Merck, Sanofi, Bayer, Research grant: Amgen, Merck, Roche. S. Kasper: Receipt of grants/research supports: Merck. Receipt of honoraria or consultation fees: Amgen, Merck. S. Stintzing: Receipt of honoraria or consultation fees: Amgen, Roche, Merck KgaA, Sanofi, Bayer. N. Prasnikar: Receipt of grants/research supports: Celgene. Receipt of honoraria or consultation fees: Amgen, Lilly. T. Trarbach: Honoraria/Speakers bureau: Amgen, Merck, Roche, Sanofi, Novartis, Lilly. Travel support: Amgen, Merck, Roche, Sanofi, Novartis, Lilly. Research support: Amgen, Merck, Roche, Sanofi. All other authors have declared no conflicts of interest.