The full name of the trial is "A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer". Its common name is PARAMOUNT. Its ClinicalTrials.gov identifier is NCT00789373.
Purpose
The PARAMOUNT trial investigated whether treatment with a maintenance dose of pemetrexed would inhibit the growth of non-small-cell lung carcinoma and improve survival rates after first-line therapy with pemetrexed plus cisplatin. For patients with advanced non-small cell lung carcinoma, maintenance therapy is sometimes used when the initial chemotherapy does not lead to improvement. An alternative would be administering a second chemotherapy if the disease progresses. A significant number of patients do not survive long enough for a second treatment if their disease progresses. When maintenance therapy is used it may or may not consist of a different drug than the initial chemotherapy. Studies prior to PARAMOUNT had shown pemetrexed, an antifolate, had been an effective therapy for patients with NSCLC when used either as an initial chemotherapy with cisplatin or as a maintenance drug when not part of the initial therapy. The PARAMOUNT study was designed to measure the extent of the efficacy when a patient received pemetrexed maintenance therapy after cisplatin/pemetrexed initial therapy. The study would measure progression-free survival of patients and survival irrespective of whether the cancer had progressed. An additional study goal would be to check the extent to which measurement of thymidylate synthase - the naturally produced enzyme on which pemetrexed acts - could predict the efficacy of pemetrexed in these cases.
Outcome
PARAMOUNT found that maintenance therapy with pemetrexed for patients with advanced non-squamous NSCLC was an effective and well tolerated treatment option in those patients who had not had progress after initial therapy with pemetrexed plus cisplatin. The average life of all participants receiving the experimental treatment increased more than 13 months as compared to the control group. The results of this trial should not be generalized beyond the scope of the research and the trial design must be considered to interpret these results. The result of this trial did not change the fact that the concept of maintenance therapy remains controversial and complicated.
