Epidemiology and natural history of central venous access device (CVAD) use and infusion pump performance among patients (pts) treated for metastatic colorectal cancer (mCRC): Analysis from the NO16966 trial.

Abstract

e14010 Background: A paucity of data on the natural history of CVADs in solid tumor pts, including mCRC, exists in the literature. CVAD use is associated with frequent and serious adverse events (AEs) in pts with hematologic malignancies, often occurring early (3-4 months after placement). Here we report the largest prospective evaluation of CVAD use and associated outcomes in mCRC. Methods: The NO16966 study employed a 2x2, placebo-controlled design. Pts without prior treatment for mCRC were randomized to receive infusional 5-FU/LV plus oxaliplatin (FOLFOX4) or capecitabine plus oxaliplatin (XELOX) and placebo or bevacizumab. Data were prospectively collected regarding CVAD placement/removal/replacement, associated AEs, pump malfunctions, and adherence to oral capecitabine. Analyses were descriptive; no formal statistical tests were performed. Results: CVAD placement data were available for 1341/1998 (67%) pts. Overall, 1194 pts had CVADs placed (FOLFOX4: n=797; XELOX: n=397) at baseline. Fewer XELOX pts required removal/replacement (8.8% vs 19.3%). Median time to first replacement was shorter with FOLFOX4 (133 days [95% CI: 105-155] vs 170 days [90-365]). Associated AEs were more frequent with FOLFOX4 (11.5% vs 2.4%), as were chronic AEs (7-9% vs 1-3%) with similar trends for infection and administration site AEs. Pump type used was split evenly across cycles (programmable vs single use). Malfunctions during fluoropyrimidine infusion occurred in 16% of FOLFOX4 pts, mostly with single use pumps. Pts treated with oral capecitabine showed high levels of adherence. Conclusions: CVAD-associated complications, need for replacement and pump malfunctions during treatment were common. XELOX-treated pts required fewer placements/replacements and experienced fewer associated AEs. Oral fluoropyrimidine regimens could reduce CVAD use and associated complications in the front-line treatment of mCRC. These observations may be relevant to the adjuvant setting as most events occur soon after placement. As adjuvant therapy is curative, any risk of potentially serious complications should be minimized.