Abstract 457P
Background
The metastatic colorectal cancer (mCRC) prognostic score (mCCS) predicts overall survival (OS) of patients (pts) with mCRC at start of 1st-line therapy (Marschner N, et al. Colorectal Dis. 2019). Based on 5 clinical routine parameters, i.e. tumor stage, tumor grading and lymph node (LN) ratio (affected LNs / total number of resected LNs) at primary diagnosis, primary tumor resectability and number of metastatic sites at start of 1st-line treatment, pts were assigned to three prognostic risk groups with decreasing OS from low to intermediate and high risk group. VALIDATE (NCT03043950) prospectively validates the mCCS in a large patient cohort with RAS wildtype (WT) mCRC.
Methods
In this multicenter, non-interventional study VALIDATE (partially funded by AMGEN GmbH) RAS-WT mCRC pts receiving 1st-line panitumumab + FOLFIRI/FOLFOX were allocated to three risk groups according to mCCS. This pre-planned interim analysis (IA) was performed 12 months after 250th pts in. Patient characteristics, effectiveness and safety were evaluated by descriptive analyses.
Results
At data-base cut (Jan 14, 2020) for this IA, 234 pts from 81 sites in Germany were evaluable. Median age was 66.5 years, 73.5% of pts were male and 75.2% of pts had ECOG performance status 0/1. 62.0% of pts were diagnosed with a colon tumor and 82.9% of tumors were left-sided.
Most common adverse drug reactions (all grade, MedDRA v20.0) were dermatitis acneiform (22.7%), rash (8.2%), diarrhea (7.7%), dry skin (6.4%) and rash maculo-papular (5.6%). Table: 457P
| Total | Low risk | Intermediate risk | High risk | |
| ORR | 55.1% | 48.6% | 54.5% | 61.8% |
| Secondary resection rate | 16.2% | 10.0% | 23.9% | 13.2% |
| Median PFS (months) | 9.8 (8.6-11.6) | 9.5 (7.2-11.6) | 11.5 (8.6-14.4) | 8.8 (7.9-12.3) |
| 12-month PFS rate | 42.1% (35.0-49.1%) | 36.0% (23.6-48.5%) | 48.5% (36.3-59.6%) | 40.7% (28.5-52.5%) |
Conclusions
The VALIDATE IA showed favourable effectiveness for panitumumab plus FOLFIRI/FOLFOX in the total population and in all mCCS risk groups in clinical routine in Germany. The secondary resection rate of about 16% was in line with recent study results. No new safety signals emerged. mCCS predicting OS will be validated in the final analysis.
Clinical trial identification
NCT03043950.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO AG, Freiburg, Germany.
Funding
AMGEN GmbH.
Disclosure
C.D. Fichter, K. Potthoff, N.W. Marschner, H.U. Siebenbach, B. Timm: Full/Part-time employment: IOMEDICO AG. A. Köhler: Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen. N.W. Marschner: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Leadership role: iOMEDICO AG. All other authors have declared no conflicts of interest.