Single-Agent Vinorelbine: Response Rates and Survival in Inoperable Lung Cancer
ABSTRACT & COMMENTARY
Synopsis: One hundred twenty patients with inoperable non-small-cell lung cancer were treated with weekly vinorelbine (Navelbine). Objective responses were observed in 27 patients (22%). Median survival was six months, and survival at one year was 38%. Twenty patients had survival of longer than 18 months. Vinorelbine is a useful agent in the management of lung cancer and consideration of initial treatment with this agent is warranted in patients with advanced disease.
Source: Julien S, et al. The Oncologist 2000;5:115-119.
Over a ten-year period at the pulmonary unit of University Hospital in Besancon, France, 120 patients with inoperable lung cancer were treated with single-agent vinorelbine administered weekly. These 120 patients represented about 11% of the lung cancer patients treated at this center during this period. Patients had either unresectable primary disease, metastatic disease, or were considered too frail for a surgical approach.
Vinorelbine was administered weekly at two different doses (25 mg/m2 or 30 mg/m2). Prognostic variables, such as age, tumor stage, presence and site of metastatic disease, and response to chemotherapy, were analyzed in the context of survival.
The population was primarily male (114 vs 6 females) and the mean age was 65 years (range, 39-84 years). Seventy-five percent of patients had a performance score (PS) of 0 or 1, but 37% had weight loss of 5 kg or more at the time of presentation. Histologically, 70% had squamous cell tumors, 22% had adenocarcinomas, and 8% had large cell carcinomas.
Of the 120 patients, 27 (22.5%) had measurable regression, four had complete responses, and 23 had partial responses. Twenty of the 120 patients survived more than 18 months from the time of initial treatment with vinorelbine. In univariate analysis, factors that were associated with survival 18 months or more were an absence of weight loss, good performance status, and objective response to chemotherapy. In multivariate analysis, only objective response to chemotherapy proved to be an independent prognostic factor for survival with a hazard ratio of 6.37; 95% CI = 2.09-19.4 (P < 0.0001).
The median disease-free survival for treated patients was 2.5 months and median overall survival was six months. Survival at one, two, and three years was 30.8%, 11.7%, and 4.2%, respectively. Ten patients had a duration of response greater than one year, and two patients had a duration of response greater than two years.
Thus, single-agent vinorelbine proved to be active in patients with inoperable non-small-cell cancer, and for those patients with demonstrable response, survival beyond 18 months was not uncommon.
COMMENT BY WILLIAM B. ERSHLER, MD
Lung cancer patients included in this report had a bad prognosis from the start. They had unresectable primary tumors, metastatic disease, or were too frail to undergo surgery. They received a single agent (vinorelbine) weekly at a moderate, but not high, dose. Drug-related toxicity, although not specifically discussed in this report, was probably minimal. Although the data do not allow us to conclude that survival of treated patients was greater as a whole than similar patients who receive no chemotherapy, it is likely that this would be the case if a prospective clinical trial had been undertaken. In fact, a recently reported prospective, randomized trial of vinorelbine (vs best supportive care) for elderly non-small-cell lung cancer patients did show significantly better quality of life and survival for the treated patients.1
The data point out that single-agent chemotherapy is a reasonable approach for many patients with lung cancer. More aggressive combinations may possibly produce better response rates but this is yet to be established. However, this report nicely demonstrates that for those 22% with advanced disease objectively determined to have either partial or complete response, survival of greater than 18 months is not uncommon.
Thus, single-agent, weekly administered vinorelbine is a reasonable therapeutic approach for patients with advanced lung cancer. Clearly, additional prospective clinical trials will be needed to define under which circumstances this approach should be favored over more aggressive combinations or new agents.
Reference
1. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst 1999;91:66-72.
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