6111 - Quality of life during 1st-line FOLFOXIRI+/- panitumumab in RAS wild-type metastatic colorectal cancer: Results from the randomized VOLFI trial (AIO KRK-0109)

Background

This trial evaluated activity and safety of mFOLFOXIRI + panitumumab (P) vs FOLFOXIRI in ECOG 0-1, primarily non-resectable mCRC patients. Here, we report the quality of life data.

Methods

Prospective 2:1 randomized, phase II trial comparing mFOLFOXIRI (Ox 85 mg/m2, Iri 150 mg/m2, 5FU 3000mg/m2 cont. 48h, LV 200 mg/m2) + P 6 mg/KG (arm A) with FOLFOXIRI (Ox 85 mg/m2, Iri 165 mg/m2, 5FU 3200mg/m2 cont. 48h, LV 200 mg/m2; arm B), both arms q2w. Cohort 1: irresectable mCRC; cohort 2: chance of secondary resection of metastatic lesions. Primary endpoint was ORR, secondary endpoints were secondary resection rate (cohort 2), toxicity, quality of life (QoL, QLQ-C30). Between-treatment differences in QoL were assessed from baseline to disease progression, and to discontinuation of 1st-line treatment, using analysis of covariance (ANCOVA).

Results

A total of 96 patients were randomized (63 arm A, 33 arm B). There were significantly higher ORR (87.3% vs. 60.6%, p = 0.004), ETS (85.7% vs 60.0%, p = 0.01) and DpR (58.9% vs. 40.9%) in the P arm compared to FOLFOXIRI alone. QoL analyses was performed in 51 patients in arm A and 26 patients in arm B. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Although significantly more secondary resections of metastases were achieved in the P arm of cohort 2 (75.0% vs. 36.4%, p = 0.05), QoL was not different between cohorts 1 and 2 and the treatment arms, respectively. Toxicity or patient wish as the reason for end of therapy were not different between the treatment arms A and B (12.7% vs. 21.2% and 0% vs 6.1%, respectively). Grade III/IV toxicities were numerically higher in the P arm (81.3% vs. 66.7%). This increase was mainly due to toxicities such as diarrhea (25.0% vs 12.1%), mucositis (9.4 vs. 0%), rash (14.1% vs. 0%), and fatigue (7.8% vs. 0%).

Conclusions

mFOLFOXIRI plus P results in significantly higher response rates compared to FOLFOXIRI in RAS wild-type mCRC. Although toxicity was increased, QL reporting was similar in both arms. Therefore, intensive upfront therapy with modified FOLFIRINOX+P represents a valuable treatment option in patients with the need of a highly active 1st-line therapy.

Clinical trial identification

NCT01328171.

Editorial acknowledgement

Legal entity responsible for the study

Arbeitsgemeinschaft Internistische Onkologie (AIO).

Funding

Amgen.

Disclosure

M. Geissler: Honoraria (institution), Advisory / Consultancy: Amgen. D. Modest: Honoraria (institution), Advisory / Consultancy: Amgen. V. Heinemann: Honoraria (institution), Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest.