Treatment until progression: Data of the “on-treatment” population of the FIRE-3 (AIO KRK-0306) study.

Authors

Sebastian Stintzing

Sebastian Stintzing

Department of Hematology and Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University Hospital Grosshadern, LMU Munich, Munich, Germany

Sebastian Stintzing , Ludwig Fischer von Weikersthal , Thomas Decker , Alexander Kiani , Ursula Vehling-Kaiser , Salah-Eddin Al-Batran , Tobias Heintges , Christian Lerchenmueller , Christoph Kahl , Gernot Seipelt , Frank Kullmann , Martina Stauch , Carsten Hielscher , Swantje Held , Dominik Paul Modest , Markus H. Moehler , Werner Scheithauer , Andreas Jung , Thomas Kirchner , Volker Heinemann

Organizations

Department of Hematology and Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, University Hospital Grosshadern, LMU Munich, Munich, Germany, Department of Oncology, Gesundheitszentrum St. Marien GmbH, Amberg, Germany, Onkologie Ravensburg, Ravensburg, Germany, Klinikum Bayreuth, Bayreuth, Germany, Practice for Medical Oncology, Landshut, Germany, Krankenhaus Nordwest, Frankfurt, Germany, Städtisches Klinikum Neuss Lukaskrankenhaus GmbH, Medical Department II, Neuss, Germany, Gemeinschaftspraxis fuer Haematologie und Onkologie, Muenster, Germany, Department for Hematology, Klinikum Magdeburg, Magdeburg, Germany, Onkologische Schwerpunktpraxis, Bad Soden, Germany, Klinikum Weiden, Weiden, Germany, Onkologische Schwerpunktpraxis Kronach, Kronach, Germany, Hematology and Oncology, Stralsund, Germany, ClinAssess GmbH, Leverkusen, Germany, Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany, Johannes-Gutenberg University Mainz, Mainz, Germany, Medical University of Vienna, Vienna, Austria, Department of Pathology, University of Munich, Munich, Germany, Department of Pathology, Ludwig-Maximilians University of Munich, Munich, Germany, Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians University of Munich, Munich, Germany

Research Funding

No funding sources reported

Background: The FIRE-3 study (AIO KRK-0306) was designed as a randomized multicenter trial to compare the efficacy of FOLFIRI plus cetuximab (cet) to FOLFIRI plus bevacizumab (bev) as first-line treatment in KRAS WT mCRC patients. FOLFIRI plus cet as first-line treatment of KRAS WT mCRC patients resulted in comparable overall response rates (ORR) and progression free survival (PFS) when compared to FOLFIRI plus bev. Overall survival (OS) was significantly longer in the FOLFIRI plus cet arm. Methods: In this exploratory analysis outcome parameters were calculated in dependence of progression during antibody treatment. As reported before by Saltz et al. (ASCO GI 2007) an “on study treatment” population was defined using all RAS wild-type pts that were treated until progression or death occurred. To exclude early progressing patients the analysis was also performed in patients with a PFS >6 months. Results: See Table. Conclusions: In general, patients progressing during 1st-line treatment had a shorter PFS and OS than patients that had progressed after stop of treatment for any cause. Patients that discontinued treatment for other reasons than progression had a significantly longer median OS when treated with FOLFIRI plus cetuximab in first-line when compared to FOLFIRI plus bevacizumab. This effect was also seen after exclusion of early progressors (PFS <6 mo).

All patientsMedian PFS
(95% CI)
pMedian OS
(95% CI)
p
PFS event during
treatment
FOLFIRI + Cet (n= 72 )7.6
(6.1-9.7)
0.9422.6
(17.3-27.9)
0.50
FOLFIRI + Bev (n= 74 )7.4
(6.0-9.0)
20.8
(15.5-23.7)
PFS event after
treatment
FOLFIRI + Cet (n= 106 )10.8
(10.0-13.3)
0.5938.3
(27.1-45.0)
0.01
FOLFIRI + Bev (n= 111)11.7
(10.3-13.1)
28.2
(24.8-33.3)
Patients PFS >6monthsMedian PFS
(95% CI)
pMedian OS
(95% CI)
p
PFS event during
treatment
FOLFIRI + Cet (n= 46 )11.0
(8.8-12.2)
0.8527.9
(23.6-33.8)
0.85
FOLFIRI + Bev (n= 46)9.9
(9.0-11.7)
26.1
(23.1-31.5)
PFS event after
treatment
FOLFIRI + Cet (n= 91 )12.4
(10.5-14.1)
0.3538.7
(36.4-49.8)
0.002
FOLFIRI + Bev (n= 100)12.4
(11.1-13.4)
28.8
(25.6-35.0)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Citation

J Clin Oncol 33, 2015 (suppl; abstr 3589)

DOI

10.1200/jco.2015.33.15_suppl.3589

Abstract #

3589

Poster Bd #

82

Abstract Disclosures