Tumors in the Randomized German AIO study KRK-0306

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1 FOLFIRI plus Cetuximab versus FOLFIRI plus Bevacizumab as First- Line Treatment for Patients with Metastatic Colorectal Cancer (mcrc): Analysis of Patients with KRAS-Mutated Tumors in the Randomized German AIO study KRK-0306 S. Stintzing 1, A. Jung², J. Neumann², L. Fischer von Weikersthal³, T. Decker 4, U. Vehling-Kaiser 5, E. Jäger 6, T. Heintges 7, C. Stoll 8, D.P. Modest 1, T. Kirchner 2, W. Scheithauer 9, V. Heinemann 1 1 Department of Medicine III, University Hospital Grosshadern, University of Munich, ²Pathologisches Institut der LMU München, ³Gesundheitszentrum St. Marien, Amberg, 4 Onkologie Ravensburg, 5 Onkologische Praxis, Landshut, 6 Department of Hematology and Onkology, Krankenhaus Nordwest Frankfurt/Main 7 Department of Medicine II, Städtisches Klinikum Neuss, 8 Department of Medicine IV, Klinikum Bayreuth GmbH, 9 Department of Internal Medicine I & Comprehensive Cancer Center, Medical University Vienna, Austria

2 Abstract Background: The German AIO study KRK-0306 is a randomized phase III trial investigates the efficacy and safety of cetuximab and FOLFIRI versus bevacizumab and FOLFIRI in the first-line treatment of mcrc. Until September 2008, patients without knowledge of their KRAS mutational status had been enrolled. Here, results of the subgroup of patients with mcrcs carrying a mutated KRAS gene are presented. Methods: Until September 2008 a total of 336 mcrc patients were randomized to FOLFIRI (irinotecan 180mg/m², folinic acid 400mg/m², 5-FU 400mg/m² bolus application, day 1 followed by continuous infusion of 2,400mg/m² 5-FU over 46h) every two weeks plus cetuximab (400mg/m² day 1, followed by 250mg/m² weekly = arm A) or bevacizumab (5mg/kg every two weeks = arm B). At the time of analysis KRAS mutation was documented in 96 patients (ITT population). The primary endpoint of this study was objective response rate (ORR). Secondary endpoints were progression free survival (PFS), overall survival (OS), rate of secondary liver resections, toxicity and safety. Results (updated for OS data): Median follow-up was 21.1 months. At the time of analysis, KRAS mutation was documented in 97 patients (ITT population). In patients assessable for treatment efficacy (on treatment until the first tumor assessment) receiving arm A (n=41) versus arm B (n=46), ORR was 43.9% versus 47.8%. In the ITT population PFS was 7.5 months versus 8.9 months, and OS (80.5% of events occurred) was 22.7 months versus 18.7 months, respectively, indicating no significant differences between the two treatment arms (HR 0.86). A total of 8 patients (9.2%) reached surgical resectability for metastases. The most common grade 3/4 toxicities (arm A versus arm B) were exanthema (20% versus 0%), hypertension (8% versus 21.7%) and thromboembolic events (8% versus 17.4%). In arm A skin rash grade 1-4 was associated with a trend towards longer PFS (3.5 versus 7.6 months, logrank p=0.108). 60day mortality rate for the whole study population was 1%.

3 Design of Investigation Until September 2008 patients were recruited into the trial independent of KRAS mutation status Since October 2008 only patients with KRAS wild-type tumors are included The present analysis is exclusively devoted to patients with KRAS-mutated tumors

4 Study Design FOLFIRI + Cetuximab metastatic colorectal cancer R FOLFIRI + Bevacizumab FOLFIRI Irinotecan 180 mg/m² iv, min day 1 Folinic acid 400 mg/m² iv, 120 min day 1 5-FU 400 mg/m² iv bolus day 1 5-FU 2,400 mg/m² iv, 46 h days 1-2 q 2 wks Arm A: Cetuximab initial dose 400 mg/m² iv, 120 min, then 250 mg/m² iv,60 min, wkly Arm B: Bevacizumab 5 mg/kg iv, min day 1, q 2 wks

5 Consort Diagram 336 patients randomly assigned arm A 169 patients (cetuximab + FOLFIRI) arm A 53 patients (cetuximab + FOLFIRI) KRAS codon 12 and 13 mutated 100 patients arm B 167 patients (bevacizumab + FOLFIRI) arm B 47 patients (bevacizumab + FOLFIRI) 2 pts not treated due to KRAS mutation 1 pt. not treated arm A 50 patients (cetuximab + FOLFIRI) 97 patients intent to treat population - evaluable for toxicity all pts. treated arm B 47 patients (bevacizumab + FOLFIRI) early dropout patients (before first tumor assesment) - 9 pts. due to KRAS mutation 87 patients evaluable regarding response 41 patients arm A 46 patients arm B early dropout patients (before first tumor assesment) -1 pt. early death

6 Study Objectives Primary Endpoint: Objective response rate (ORR) Secondary Endpoints: Progression-free survival Disease control rate (CR+PR+SD) Tolerability and grade 3/4 toxicity

7 Patient Characteristics I FOLFIRI + Cetuximab FOLFIRI + Bevacizumab Total Characteristics No. % No. % p* No. % No. of patients Age, years Median Range Patients >65 years KRAS mutation KRAS codon KRAS codon Sex Female Male ECOG ** * Fisher s exact test; **Spearman correlation coefficient

8 Patient Characteristics II FOLFIRI + Cetuximab FOLFIRI + Bevacizumab Total Characteristics No. % No. % p* No. % No. of patients Primary tumor site Colon Rectum Colon and Rectum Prior therapy Adjuvant chemotherapy Radiotherapy Disease sites Liver Liver limited Lung Lymph node Peritoneum Other No. of disease sites > unknown * Fisher s exact test

9 Treatment Administration Parameter FOLFIRI + Cetuximab FOLFIRI + Bevacizumab Total No. of patients Duration of therapy (months) Median Range Missing n= n= n=5 Treatment cycles per patient Median Range No. % No. % P-value* Evaluable treatment cycles Cycles with dose reduction Cycles with treatment delay <

10 Reasons for Treatment Discontinuation Parameter Total (n=87) FOLFIRI + Cetuximab (n= 41) FOLFIRI + Bevacizumab (n=46) n % n % n % Progression Death Toxicity Surgery Patient wish Physician s decision Other Missing data

11 NCI-CTC Grade 3/4 Hematologic Toxicity (per patient analysis) ITT population FOLFIRI + Cetuximab FOLFIRI + Bevacizumab No. % No. % p-value* No. of patients Anemia Thrombopenia Leucopenia Neutropenia * Fisher s exact test

12 NCI CTC Grade 3/4 Non-Hematologic Toxicity (per patient analysis) ITT population FOLFIRI + Cetuximab FOLFIRI + Bevacizumab p-value* No. % No. % No. of patients Acneiform exanthema <0.01 Hypertension Nausea Infection Diarrhea Deep vein thrombosis Stomatitis Liver toxicity Pulmonary embolism Pain Hypokalemia Hemorrhage Any thrombus

13 Best Response Treated according to protocol population FOLFIRI + Cetuximab FOLFIRI + Bevacizuimab No. % No. % p-value* Patients evaluated Complete response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) Response rate (ORR) 95% CI ( ) ( ) 0.83 Disease control rate (DCR) 95% CI ( ) ( ) 1.0

14 Best Response in Patients with Tumors Bearing KRAS Codon 12 versus KRAS Codon 13 Mutations Treated to protocol population FOLFIRI + Cetuximab KRAS KRAS codon 12 codon 13 FOLFIRI + Bevacizumab KRAS KRAS codon 12 codon 13 No. % No. % No. % No. % No. of patients CR PR SD PD ORR DCR

15 Progression-Free Survival probability of survival FOLFIRI Cetuximab 7.5mo Bevacizumab 8.9mo p = 0.86 (log-rank) Hazard Ratio = 1.0 number at risk Time Since Study Entry (months)

16 Overall Survival probability of survival FOLFIRI Cetuximab 22.7mo Bevacizumab 18.7mo p = 0.55 (log rank) Hazard Ratio = 0.86 number at risk Time Since Study Entry (months)

17 Conclusion No difference in efficacy and survival can be observed in patients with KRAS mutated tumors treated with FOLFIRI and cetuximab or bevacizumab

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