Annals of Oncology 14:455-460, 2003
© 2003 European Society for Medical Oncology
Original Paper |
ALIMTA® (pemetrexed disodium) as second-line treatment of non-small-cell lung cancer: a phase II study
1 Department of Pulmonary Diseases, Vrije Universiteit Medical Center Amsterdam, The Netherlands; 2 Division of Pulmonary Medicine, Helsinki University Central Hospital, Finland; 3 Zentralkrankenhaus Gauting, Gauting; 4 Thorax Hospital, Heidelberg, Germany; 5 Sydney Cancer Center, Sydney, Australia
Received 11 June 2002; revised 7 August 2002; accepted 10 September 2002
Background:
The purpose of this study was to evaluate ALIMTA® (pemetrexed disodium, LY231514), a multi-targeted antifolate with first-line activity against non-small-cell lung cancer (NSCLC), in a second-line setting.
Patients and methods:
Patients with NSCLC were eligible for this phase II study if they had progressive disease within 3 months after first-line chemotherapy or progression while being treated with first-line chemotherapy. In 81 patients studied, two cohorts of patients were assigned based on whether the first-line therapy had included a platinum regimen. ALIMTA was administered at 500 mg/m2 by 10-min intravenous infusion once every 21 days.
Results:
The response rate in the 79 evaluable patients with poor prognostic features was 8.9% [95% confidence interval (CI) 2.6% to 15.1%]. The response rate in the platinum-pretreated group was 4.5% and 14.1% in the non-platinum-pretreated group. The median duration of response was 6.8 months (95% CI 3.4–7.8 months, 0% censoring). The median survival time was 5.7 months (95% CI 4.0–8.3 months, 7.6% censoring). The probability of survival for at least 6 months was estimated to be 48%. The median time to disease progression was 2 months (95% CI 1.4–2.8 months, 0% censoring). The principal toxicity was myelosuppression, which was reversible.
Conclusions:
ALIMTA is active in a second-line setting in non-platinum-pretreated NSCLC patients progressing within 3 months of first-line chemotherapy. This study demonstrates that it is possible to evaluate new drugs against NSCLC in a second-line setting.
Key words: non-small-cell lung cancer, pemetrexed, second-line chemotherapy
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