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Large trial fails to confirm role for adjuvant chemo in NSCLC

A three-drug adjuvant regimen led to a 1% improvement in overall and progression-free survival.By Tammy Dotts

Staff Writer

January 2004

Adjuvant chemotherapy did not improve outcomes for patients with completely resected non-small-cell lung cancer (NSCLC) in the Adjuvant Lung Project Italy (ALPI) trial.

There were no significant differences in overall or progression-free survival between patients who received a three-drug adjuvant combination and those who received no treatment, said Giorgio V. Scagliotti, MD, PhD, from the University of Torino in Italy.


The ALPI investigators designed the trial to evaluate a regimen of mitomycin C, vindesine (Eldisine, Lilly Europe) and cisplatin (Platinol, Bristol-Myers Squibb) in patients with radically resected stage-1 to stage-3A NSCLC. The researchers chose the three-drug regimen after reports of its efficacy in the neoadjuvant setting.

Patients were recruited from January 1994 through January 1999 at 66 Italian centers and at five European centers outside Italy.

The trial was the “first large, prospective adjuvant study designed to detect reasonably small differences in survival that were in the range of those detected by a NSCLC meta-analysis,” Scagliotti said. The 1995 meta-analysis suggested a 5% improvement in the five-year survival rate following cisplatin-based adjuvant chemotherapy.

After surgery, 548 patients were randomized to receive adjuvant chemotherapy and 540 patients were randomized to receive no chemotherapy. The decision to use adjuvant radiotherapy was made at the individual participating centers according to existing policies. There were 238 patients in the chemotherapy arm and 232 patients in the observation arm who received radiotherapy.

The median duration of follow-up for all patients was 64.5 months.

Although the median overall survival was longer by 7.2 months with adjuvant chemotherapy — 55.2 months compared with 48.0 months — the difference was not significant. The hazard ratio was 0.96, which led to a 1% absolute increase in both the two-year and five-year overall survival rates with the use of adjuvant chemotherapy.

A hazard ratio of 0.89 for progression-free survival translated into a 4% absolute increase in both two-year and five-year progression-free survival rates. As with overall survival, the median progression-free survival was longer with adjuvant chemotherapy, but the difference was not significant: 36.5 months with adjuvant chemotherapy and 28.9 months without adjuvant chemotherapy.

Scagliotti did not believe that newer chemotherapy agents would improve the outcomes of the study. Although agents such as gemcitabine (Gemzar, Lilly), taxanes and vinorelbine (Navelbine, GlaxoSmithKline) can improve response and toxicity in advanced NSCLC when combined with cisplatin and compared with older regimens, they resulted in only marginally better survival, he said.

“It is unlikely the use of these new regimens as adjuvant treatment in early stages of NSCLC will greatly change the efficacy outcomes,” he said.

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