Elsevier

Lung Cancer

Volume 55, Issue 3, March 2007, Pages 337-341
Lung Cancer

Randomized trial of drip infusion versus bolus injection of vinorelbine for the control of local venous toxicity

https://doi.org/10.1016/j.lungcan.2006.10.016Get rights and content

Summary

Vinorelbine is a moderate vesicant that is well known to cause local venous toxicity such as drug induced-phlebitis. We conducted a prospective randomized trial to determine whether a 1-min bolus injection (1 min bolus) of vinorelbine reduced the incidence of local venous toxicity compared with a 6-min drip infusion (6 min infusion). Non-small cell lung cancer patients who were to receive chemotherapy containing vinorelbine were randomly assigned to receive either 6 min infusion or 1 min bolus of the drug. All infusions were administered through a peripheral vein. Local venous toxicity was evaluated at each infusion up to two cycles. Eighty-three patients were randomized into the study and 81 of them assessable for analysis. One hundred thirty-eight infusions to 40 patients in 6 min infusion and 135 infusions to 41 patients in 1 min bolus were delivered. Vinorelbine induced-local venous toxicity was observed in 33% of patients in 6 min infusion and 24% in 1 min bolus. There was no statistically significant difference between the two arms (P = 0.41). The incidence of local venous toxicity per infusions was 16% (22 of 138 infusions) in 6 min infusion and 11% (15 of 135 infusions) in 1 min bolus (P = 0.47). No severe local venous toxicity was seen in either arm. In this study, the administration of in 1 min bolus of vinorelbine did not significantly reduce the incidence of local venous toxicity compared with 6 min infusion. Further studies for the control of local venous toxicity of vinorelbine are warranted.

Introduction

Vinorelbine is a second-generation semi-synthetic vinca alkaloid whose antitumor activity is related to its ability to depolymerize microtubules and disrupt the mitotic spindle apparatus [1]. Vinorelbine has been shown to have clearly higher activity and lower neurotoxicity than the other vinca alkaloids, and is currently one of the most active agents for the treatment of non-small cell lung cancer (NSCLC) or other solid tumors [2], [3], [4].

Vinorelbine is most commonly administered through a peripheral vein as drip infusion over a period of between 6 and 10 min [5]. However, vinorelbine is a moderate vesicant that is well documented to cause local venous toxicity such as drug induced-phlebitis and venous irritation, and its incidence of approximately 30% has been reported in patients who received vinorelbine via a 6–10 min drip infusion [6], [7]. Although local venous toxicity is not life threatening, it can result in discomfort or pain and can be a disincentive of chemotherapy to the patients. Therefore local venous toxicity should be managed effectively to decrease patient discomfort.

Recently, a retrospective study on drug induced-phlebitis with bolus injection of vinorelbine has been reported. In the analysis of 39 patients who received the administration of bolus injection of vinorelbine, drug induced-phlebitis occurred in only 1 of 39 patients (2.6%). The results suggested that the administration of bolus injection of vinorelbine might decrease the incidence of drug induced-phlebitis when compared common drip infusion [8]. Furthermore, shortening the infusion time of vinorelbine has also been reported to reduce the incidence of drug induced-phlebitis [9], although a randomized trial evaluating the bolus injection of vinorelbine has not been performed.

We conducted a prospective randomized trial to determine whether a 1-min bolus injection (1 min bolus) of vinorelbine reduced the incidence of local venous toxicity compared with a 6-min drip infusion (6 min infusion). In addition, we assessed the incidence of acute lower back pain, which has been reported to occur in shorter time infusions of vinorelbine [10] as other toxicity.

Section snippets

Patient eligibility

Patients who had histological or cytological evidence of cancer, and planned to receive vinorelbine-containing chemotherapy as peripheral infusion, were eligible for this study. The patients were required to be 20 years of age or older and have an Eastern Cooperative Oncology Group performance status (PS) of 0–2. Patients were excluded if they had previous treatment with vinorelbine, medical condition that required regular use of steroids, or were pregnant or nursing. All patients provided

Patient characteristics

Between October 2002 and April 2003, 83 patients were enrolled and randomly assigned into the study. Baseline patient characteristics according to treatment group are shown in Table 1. The two treatment groups were well balanced in regards to age, PS, chemotherapy regimens, and BMI. All patients had advanced NSCLC and no prior chemotherapy. Two patients were not assessable for analysis because they refused to receive chemotherapy after randomization.

Treatment delivery is shown in Table 2. One

Discussion

Local venous toxicity such as drug induced-phlebitis is one of the discomforting toxicities for patients in cancer chemotherapy. Vinorelbine is generally well tolerated and can be administered safely in an outpatient setting; however, it is a moderate vesicant with the potential to cause local venous toxicity. In our study, the incidence of local venous toxicity with the 6-min drip infusion of vinorelbine, which was used as control arm, was 33%, a similar frequency as found in past reports [6],

Acknowledgement

This work was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health, Labour and Welfare, Japan.

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