Bevacizumab with 5-fluorouracil, leucovorin, and oxaliplatin versus bevacizumab with capecitabine and oxaliplatin for metastatic colorectal carcinoma: results of a large registry-based cohort analysis

Abstract

BackgroundData from the Czech national registry were analysed retrospectively to describe treatment outcomes for capecitabine and oxaliplatin (XELOX) regimen with bevacizumab versus 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimen with bevacizumab in the first-line therapy for metastatic colorectal cancer (mCRC).MethodsA national registry containing anonymised individual data on patients treated with targeted therapies was used as a data source. In total, 2,191 mCRC patients who received a first-line therapy with bevacizumab combined with either FOLFOX regimen (n = 1,218, 55.6%) or XELOX regimen (n = 973, 44.4%) were included in the present analysis.ResultsNo statistically significant difference in survival was observed between the two groups, with median overall survival (OS) of 27.0 months (95% confidence interval [CI] 24.6-29.5 months) and 30.6 months (95% CI 27.8-33.4 months) for FOLFOX/bevacizumab and XELOX/bevacizumab, respectively (p = 0.281). Median progression-free survival (PFS) was 11.4 months (95% CI 10.7-12.1 months) for FOLFOX/bevacizumab and 11.5 months (95% CI 10.8-12.3 months) for XELOX/bevacizumab (p = 0.337). The number of metastatic sites was identified as the most significant predictor of PFS and, together with the presence/absence of metastatic disease at diagnosis, also for OS.ConclusionsAccording to this large registry-based analysis, XELOX and FOLFOX regimens have similar effectiveness for use in combination with bevacizumab in the first-line treatment of mCRC. Multiple metastatic sites and the presence of metastatic disease at diagnosis were the strongest negative predictors of OS regardless of backbone chemotherapy regimen.

Discontinuation of first-line bevacizumab in metastatic colorectal cancer: the BEAWARE Italian Observational Study

“…14,15 While this topic was beyond the focus of the BEAWARE study, in the future it would be important to investigate what happens in Italian daily practice to patients who do not interrupt bevacizumab at PD, both in terms of survival and safety. Finally, median PFS was 10.3 months, in line with previous observational studies reporting a median time to progression between 9.9 and 11.5 months, 16,17,19,20,22 as well as with randomized trials showing a median PFS ranging from 8.5 to 12.1 months. 3,4,[23][24][25][26] In addition, the short period of treatment of patients interrupting for ADR in our study confirms that bevacizumab toxicity, if present, occurs early during treatment.…”

Collection, transport and storage procedures for blood culture specimens in adult patients: recommendations from a board of Italian experts

“…-Perform hand hygiene -Collect all the necessary materials and place them on a clean tray (checking the expiration dates of all the items to be used) -Mark the optimal filling volume on the vials -Wear gloves -Apply the tourniquet -Perform antisepsis of the pre-selected site for sampling with 2% chlorhexidine in 70% isopropyl alcohol (disposable sterile applicator) for 30 s -Allow to dry for 30 s -Do not palpate the vein again (if the maneuver is necessary, wear sterile gloves) -Remove the stopper from the vial for blood culture and disinfect (2% chlorhexidine in 70% isopropyl alcohol) -Allow to dry for 30 s -Withdraw blood using a safety butterfly needle with an adapter for the collection of blood directly into the vials -A complete blood culture sampling comprises at least 4-6 vials (2-3 sets) -Keep the vial upright under the patient's arm -Fill every vial with approximately 10 mL of blood (adult patients), filling the aerobic vial first and then the anaerobic vial -Remove the tourniquet as soon as the blood begins to flow or within 2 min from application -Remove the vials gradually as they are filled and shake them gently -Activate the safety system of the needle used on removal from the vein -Dispose of the needle in the appropriate rigid container for sharp waste -Carry out hemostasis with a dry swab -Remove the gloves and perform hand hygiene -Mark all the necessary information on the vials (number of the sample, sampling site, time and date) -Indicate execution of blood culture sampling in the patient's medical record -Send the vials to the laboratory immediately -If available, immediately place the vials into the satellite incubators Modified from [13]. a process that includes several steps from sample withdrawal to incubation [8,24,48,69,[78][79][80]. The process involves various health personnel, who must operate in agreement with good clinical practice within a multidisciplinary team.…”

BATON-CRC: A Phase II Randomized Trial Comparing Tivozanib Plus mFOLFOX6 with Bevacizumab Plus mFOLFOX6 in Stage IV Metastatic Colorectal Cancer

“…Bevacizumab/mFOL-FOX6 is considered to be a standard treatment for mCRC, and the combination has been used as a comparison arm in several first-line mCRC clinical trials, including those involving panitumumab (24), cediranib (25), axitinib (26), cetuximab (19,27), and XELOX (capecitabine and oxaliplatin)/SOX (oxaliplatin and S-1; refs. 28,29). In the current study at the interim futility analysis, the efficacy of tivozanib/mFOLFOX6 was comparable with that of bevacizumab/mFOLFOX6 with a PFS of 9.4 versus 10.7 months (HR ¼ 1.091; CI, 0.693-1.718; P ¼ 0.706) and ORR 45.2% versus 43.2%; the post hoc final analysis of PFS was 9.8 versus 9.5 months (HR ¼ 0.908; CI, 0.624-1.301; P ¼ 0.598).…”