Source: DGNews  |  Posted 1 year ago

By Cameron Johnston

CHICAGO -- June 6, 2010 -- Combination-therapy carboplatin plus paclitaxel significantly improves overall survival and progression-free survival in elderly patients with lung cancer compared with single-agent gemcitabine or vinorelbine therapy, according to study results reported at the 2010 Annual Meeting of the American Society for Clinical Oncology (ASCO).

These findings should be considered a "practice-changing" development and will represent a new paradigm in the way lung cancer is treated in most of the world, noted Elisabeth Quoix, MD, University Hospital, Strasbourg, France, speaking here on June 5 at a plenary session.

In this study, 451 patients (mean age 77 years [range: 70-89]), who had lung cancer that could not be irradiated, were treated with either vinorelbine (30 mg/m² on days 1 and 8 of a 21-day cycle) or gemcitabine (1,150 mg/m²) as single agents, or with the combination therapy of carboplatin (area under the curve 6 every 4 weeks) plus paclitaxel (90 mg/m² on days 1 and 8 of a 21-day cycle).

The patients were more or less matched for baseline disease characteristics and for demographic make-up.

The study was to have enrolled 520 patients, but was stopped when 451 were enrolled and an interim analysis reported that the combination therapy was far superior to single-drug treatment.

At the plenary session, data from 313 patients were reported. Patients who received the combination therapy had a median overall survival of 10.4 months compared with 6.2 months for patients who received either of the monotherapies. Median progression-free survival also favoured patients in the combination-therapy arm (6.3 vs 3.2 months, respectively).

Dr. Quoix said these data were "quite unusual" compared with similar studies conducted in the past. A 4-month improvement in median survival time is an enormous achievement, she noted, since oncologists would normally view an improvement of just 2 months to be a practice-changing event.

Data from this study suggest that, in the older population, the combination therapy is "just as good as" the single-agent therapy, Dr. Quoix said.

Adverse events and drug-related toxicities were significantly more frequent in the combination-therapy arm, with 47.8% of these patients experiencing moderate to severe neutropenia, compared with 12.2% in the single-agent arm. There was no significant difference in the number of early deaths between the 2 arms that resulted from treatment, however.

The number of nonhaematologic toxicities was lower than what previously had been reported in other studies, Dr. Quoix noted.

[Presentation title: Weekly Paclitaxel Combined With Monthly Carboplatin Versus Single Agent Therapy in Patients Aged 70 to 89: IFCT-0501 Randomized Phase III Study in Advanced Non-Small Cell Lung Cancer (NSCLC). Abstract 2]