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Pemetrexed Less Toxic than Docetaxel for Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer: Presented at WCLC

By Charlene Laino

VANCOUVER, BC -- August 20, 2003 -- Pemetrexed may be a better choice than docetaxel for second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC), a Phase III study shows.

Frances S. Shepherd, MD, senior staff physician, Princess Margaret Hospital, Toronto, Ontario, Canada, presented the findings here on August 12^th at the 10^th World Conference on Lung Cancer.

The study was designed to pit docetaxel, the standard second-line treatment for NSCLC, against pemetrexed, after the latter showed significant clinical activity as second-line therapy in Phase II studies (Smit et al. Ann Oncol. 2003 Mar;14(3):455-60. Clarke et al. Ann Oncol. 2002 May;13(5):737-41)

The researchers randomized 571 patients with NSCLC previously treated with chemotherapy to receive an intravenous infusion of either pemetrexed 500 mg/m² or docetaxel 75 mg/m² on Day 1 of a 21-day cycle, for a median of 4 cycles. Both groups also received dexamethasone, and the pemetrexed patients were given vitamin B12 injections and folic acid.

The 411 men and 160 women had a median age of 58 years. Almost 90% had a performance status of 0-1, and three fourths had recurrent Stage IV disease. Ninety-four percent had received one prior chemotherapy regimen, while the rest had two prior regimens. Ninety-one percent had prior platinum therapy and 27% had prior taxanes.

Median survival was 8.3 months in the pemetrexed arm and 7.9 months in the docetaxel arm. Both arms remained free of disease for an average of 2.9 months, Dr. Shepherd said.

Overall response rate was 9.1% in the pemetrexed group and 8.8% in the docetaxel group, a non-significant difference, she said.

However, patients in the pemetrexed arm were significantly less likely to have grade 3/4 toxicities, particularly those related to bone marrow suppression, compared with those on docetaxel, the study showed.

Grade 3 or 4 neutropenia developed in 5% of patients on pemetrexed versus 40% of those on docetaxel (P<.0001), the study showed, while neutropenic fever developed in 2% and 13% of patients, respectively (P<.0001).

Patients in the pemetrexed arm spent a total of 29 days hospitalized for neutropenic fever, compared with 192 days in the docetaxel arm, Dr. Shepherd said.

While the drugs are similar in efficacy, pemetrexed is clearly associated with a better risk/benefit ratio than docetaxel, she said.

Eli Lilly, maker of pemetrexed, helped fund the research.


[Study title: A Phase III Study of Pemetrexed vs. Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer who were Previously Treated with Chemotherapy. Abstract PL-5]

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