Impact of FOLFOXIRI and bevacizumab (bev) compared to FOLFOX and bev on health related quality of life (HRQOL) in patients with metastatic colorectal cancer (MCRC): Analysis of the CHARTA-AIO 0209 trial.

Media type: E-Article

Title: Impact of FOLFOXIRI and bevacizumab (bev) compared to FOLFOX and bev on health related quality of life (HRQOL) in patients with metastatic colorectal cancer (MCRC): Analysis of the CHARTA-AIO 0209 trial

Contributor: Quidde, Julia; Schmoll, Hans-Joachim; Garlipp, Benjamin; Junghanss, Christian; Leithaeuser, Malte; Vogel, Arndt; Schaefers, Michael; Kaiser, Ulrich; Hoeffkes, Heinz-Gert; Florschütz, Axel; Rüssel, Jörn; Kanzler, Stephan; Edelmann, Thomas; Forstbauer, Helmut; Goehler, Thomas; Hannig, Carla; Hildebrandt, Bert; Bokemeyer, Carsten; Steighardt, Jörg; Stein, Alexander

imprint: American Society of Clinical Oncology (ASCO), 2017

Language: English

DOI: 10.1200/jco.2017.35.15_suppl.3544

ISSN: 1527-7755; 0732-183X

Keywords: Cancer Research ; Oncology

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Footnote:

Description: 3544 Background: FOLFOXIRI/bev is a highly efficacious first line regimen in MCRC. Despite higher rates of neutropenia, diarrhea and stomatitis, FOLFOXIRI/bev is tolerable and feasible in MCRC patients. To date nothing is known about the impact of this regimen on HRQOL. Methods: 250 patients were randomized to FOLFOX/bev (arm A) or FOLFOXIRI/bev (arm B). HRQOL were assessed at baseline, every 8 weeks during induction treatment (6 months) and every 12 weeks during maintenance treatment, using the EORTC QLQ-C30, QLQ-CR29 and QLQ-CIPN20. The mean values of every score were calculated as the average of week 8, 16 and 24 assessment. Test concerning mean values were performed as t-test, with global type I error set at 0.05. HRQOL deterioration and improvement rates were analyzed and compared between treatment groups using chi² tests. Results: For HRQOL analysis, 237 patients were eligible (arm A: 118; arm B: 119). Compliance rate with the HRQOL questionnaires was 95.4% at baseline, 72.6% at week 8, 59.5 % at week 16 and 43.5% at week 24. Whereas mean global quality of life score (GHS/QOL) was similar between arm A and B (59.8 vs. 58.8; p = 0.726), mean scores for nausea/vomiting (9.4 vs. 16.0; p = 0.015) and diarrhea (23.7 vs. 32.1; p = 0.051) significantly or borderline significantly favored arm A during induction period. Furthermore, at week 8 scores of nausea/vomiting (9.2 versus 17.3, p = 0.006) appetite loss (19.5 vs. 29.4; p = 0.035) and financial problems (18.3 vs. 29.5; p = 0.021) and at the end of treatment physical functioning (75.0 vs. 65.8; p = 0.048) were significantly better for arm A compared to arm B. No significant differences were observed in the remaining EORTC scores. The rates of deterioration and improvement between baseline and week 8 of at least 10 points in the EORTC scores were similar (e.g. deterioration-rate GHS/QOL score 21.5% vs. 26.5% for arm A vs. B; p = 0.461). Conclusions: Although no remarkable detriment in HRQOL was noted, the better efficacy of FOLFOXIRI/bev compared to FOLFOX/bev is associated with a decrease in mainly gastrointestinal QOL scores. Further subgroup-analyses will be presented at the meeting. Clinical trial information: NCT01321957.

Access State: Open Access

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