GI-Cancer: Tumor-side predicts outcome
The randomized phase II VOLFI trial of the AIO (Arbeitsgemeinschaft internistische Onkologie) evaluated the activity and safety of mFOLFOXIRI + panitumumab versus FOLFOXIRI in patients with RAS wild-type metastatic colorectal cancer, primarily non-resectable mCRC patients.
The trial was a prospective 2:1 randomized, multi-center, phase II trial including cohort 1 (patients with irresectable mCRC) and cohort 2 (patients with chance of secondary resection of metastatic lesions). The primary endpoint was the overall response rate (ORR), secondary endpoints consisted of secondary resection rate, disease control rate (DCR), progression free survival (PFS), overall survival (OS), toxicity and quality of life.
In total, 96 patients were randomized (63 in Arm A, 33 in Arm B). Overall, ORR in arm A was significantly higher than in arm B (85.7 % vs. 54.5 %). However, tumor sidedness also played a part in response rates: left-sided tumors had a higher response rate (90.6 % arm A, 60.0% arm B) compared to right-sided tumors (60 % arm A, 50 % arm B). High secondary resection rates were observed and toxicity proved manageable in younger fit patients.