To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with
advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.Eligible
patients had a performance status 0 to 2, previous treatment with one prior chemotherapy
regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed
500 mg/m2 intravenously (IV) day 1 with vitamin B12, folic acid, and dexamethasone
or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point
was overall survival.Five hundred seventy-one patients were randomly assigned. Overall
response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and
docetaxel, respectively. Median progression-free survival was 2.9 months for each
arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for
pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was
29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia
(40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia
with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4%
v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5%
v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%,
P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving
pemetrexed.Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes,
but with significantly fewer side effects compared with docetaxel in the second-line
treatment of patients with advanced NSCLC and should be considered a standard treatment
option for second-line NSCLC when available.
