Quality of Life in Patients with mCRC Treated with mFOLFOXIRI and Panitumumab
At the congress of the European Society for Medical Oncology (ESMO) in September 2019, the results of the VOLFI study were presented, which also monitored the quality of life in patients with primarily unresectable wild-type (wt-RAS) metastatic colorectal cancer (mCRC) with an ECOG performance status of 0–1.
Methods and Study Goals
The prospective randomized phase II study VOLFI compared mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-fluorouracil 3000 mg/m2 continuous 48 hrs, leucovorin 200 mg/m2) in combination with panitumumab 6 mg/kg (arm A) versus FOLFOXIRI alone (oxaliplatin 85 mg/m2, irinotecan 165 mg/m2, 5-fluorouracil 3200 mg/m2 continuous 48 hrs, leucovorin 200 mg/m2 – arm B). Patients in both arms received treatment every 2 weeks. Cohort 1 included patients with unresectable mCRC, while patients in Cohort 2 had potential for secondary resection of metastatic lesions.
The primary goal was the objective response rate (ORR). Secondary goals included the secondary resection rate (in cohort 2), toxicity, and quality of life (QoL). Differences in QoL between treatment regimens were assessed from the start until disease progression and cessation/completion of first-line therapy using covariance analysis (ANCOVA).
Results
A total of 96 patients were randomized, with 63 in arm A and 33 in arm B. Arm A which included panitumumab showed a significantly higher ORR compared to FOLFOXIRI alone (87.3 vs. 60.6 %; p = 0.004), early tumor shrinkage (ETS: 85.7 vs. 60.0 %; p = 0.01), and depth of response (DpR: 58.9 vs. 40.9 %).
QoL analysis was conducted in 51 patients from arm A and 26 patients from arm B, showing no statistically significant differences between the treatment arms. Although arm A (with panitumumab) in cohort 2 achieved significantly more secondary resections of metastases (75.0 vs. 36.4 %; p = 0.05), QoL did not differ across cohorts 1 and 2 or between the treatment arms.
Similarly, the frequency of therapy discontinuation due to toxicity (A: 12.7 % vs. B: 21.2 %) or patient request (A: 0 % vs. B: 6.1 %) showed no significant differences. Grade 3/4 adverse events were more frequent in the panitumumab arm (81.3 vs. 66.7 %), mainly diarrhea (25.0 vs. 12.1 %), mucositis (9.4 vs. 0 %), rash (14.1 vs. 0 %), and fatigue (7.8 vs. 0 %).
Conclusion
The mFOLFOXIRI regimen in combination with panitumumab showed a significantly higher response rate in wt-RAS mCRC patients compared to FOLFOXIRI alone. Despite the increased toxicity, the quality of life was comparable between the two arms. Therefore, intensive treatment with the modified FOLFOXIRI regimen with panitumumab represents a valuable therapeutic option for patients requiring highly active first-line therapy.
(mir)
Source: Geissler M., Klingler T., Modest D. et al. Quality of life during 1st-line FOLFOXIRI +/- panitumumab in RAS wild-type metastatic colorectal cancer: results from the randomized VOLFI trial (AIO KRK-0109). Ann Oncol 2019; 30 (Suppl. 5): 580P, doi: 10.1093/annonc/mdz246.057.
Did you like this article? Would you like to comment on it? Write to us. We are interested in your opinion. We will not publish it, but we will gladly answer you.
