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Clinical Trial
. 2014 Mar 18;110(6):1438-45.
doi: 10.1038/bjc.2014.74. Epub 2014 Feb 18.

Epidemiology and natural history of central venous access device use and infusion pump function in the NO16966 trial

E Chu  1 , D Haller  2 , T Cartwright  3 , C Twelves  4 , J Cassidy  5 , W Sun  1 , M W Saif  6 , E McKenna  7 , S Lee  7 , H-J Schmoll  8
Affiliations
Clinical Trial

Epidemiology and natural history of central venous access device use and infusion pump function in the NO16966 trial

E Chu et al. Br J Cancer. .

Abstract

Background: Central venous access devices in fluoropyrimidine therapy are associated with complications; however, reliable data are lacking regarding their natural history, associated complications and infusion pump performance in patients with metastatic colorectal cancer.

Methods: We assessed device placement, use during treatment, associated clinical outcomes and infusion pump performance in the NO16966 trial.

Results: Device replacement was more common with FOLFOX-4 (5-fluorouracil (5-FU)+oxaliplatin) than XELOX (capecitabine+oxaliplatin) (14.1% vs 5.1%). Baseline device-associated events and post-baseline removal-/placement-related events occurred more frequently with FOLFOX-4 than XELOX (11.5% vs 2.4% and 8.5% vs 2.1%). Pump malfunctions, primarily infusion accelerations in 16% of patients, occurred within 1.6-4.3% of cycles. Fluoropyrimidine-associated grade 3/4 toxicity was increased in FOLFOX-4-treated patients experiencing a malfunction compared with those who did not (97 out of 155 vs 452 out of 825 patients), predominantly with increased grade 3/4 neutropenia (53.5% vs 39.8%). Febrile neutropenia rates were comparable between patient cohorts±malfunction. Efficacy outcomes were similar in patient cohorts±malfunction.

Conclusions: Central venous access device removal or replacement was common and more frequent in patients receiving FOLFOX-4. Pump malfunctions were also common and were associated with increased rates of grade 3/4 haematological adverse events. Oral fluoropyrimidine-based regimens may be preferable to infusional 5-FU based on these findings.

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Figures

Figure 1
Figure 1
Distribution of patient data. Abbreviations: BL=baseline (placement on/before the start of treatment); Post-BL=post-baseline (placement after the start of treatment).
Figure 2
Figure 2
Kaplan–Meier curve of time to first CVAD placement among patients with first CVAD placements after treatment start, treated with FOLFOX-4±bevacizumab/placebo or XELOX±bevacizumab/placebo (patients in the safety population who had placement data).
Figure 3
Figure 3
Kaplan–Meier curve of time from first CVAD placement to first CVAD replacement among patients with first replacement (after first removal), treated with FOLFOX-4±bevacizumab/placebo or XELOX±bevacizumab/placebo (patients in the safety population who had placement data).
Figure 4
Figure 4
Cumulative incidence of CVAD-related complications (patients in the safety population who had placement data).
Figure 5
Figure 5
Percentages of pump malfunctions by pump type (safety populations for the FOLFOX-4, FOLFOX-4+placebo and FOLFOX+bevacizumab groups).
See this image and copyright information in PMC

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