Administration of pemetrexed immediately following gemcitabine as front-line therapy in advanced non-small cell lung cancer: A phase II trial

Gemcitabine combined with either pemetrexed or paclitaxel in the treatment of advanced non-small cell lung cancer

“…As regards to the tolerability of the GA regimen, severe neutropenia (36%), and febrile neutropenia (14%) were the main hematologic side effects of this treatment. In our hands, occurrence of neutropenia was slightly lower than that observed in other phase II studies using the same schedule (ranging from 40% to 69%) [21][22][23][24], but frequency of febrile neutropenia was close to the highest rate even reported by others (ranging from 5% to 15%). The haematologic as well as the non-haematologic toxicity of the GA regimen was manageable.…”

“…The same schedule B of the previous trial was also assessed by Treat et al in 53 patients: these investigators reported a 33% RR, a PFS of 3.3 months, and an OS of 10.3 months. Neutropenia (43%) and dyspnoea (15%) were the most frequent severe adverse events [24]. On the contrary, West et al reported on a series of 54 patients treated with the schedule C, but with pemetrexed following GEM on day 8.…”

Schedule-Dependent Synergistic Effect of Pemetrexed Combined with Gemcitabine against Malignant Pleural Mesothelioma and Non-Small Cell Lung Cancer Cell Lines

“…Considering these preclinical findings including ours, both schedules of sequential administration of MTA and GEM may be clinically acceptable in the treatment of patients with NSCLC, while it is difficult to determine what is the optimal regimen for each patient. Indeed, 2 phase II trials in which the sequence GEM followed by MTA was applied on day 1 (and GEM alone on day 8) exhibited low toxicity and acceptable median survival [24,26] . On the other hand, Ma et al [25] performed a randomized phase II trial comparing 3 schedules of MTA and GEM in advanced NSCLC and suggested that a schedule of MTA followed by GEM on day 1 (and GEM alone on day 8) was optimal.…”

“…Several randomized clinical trials have shown that a combination therapy including GEM has an equivalent efficacy and less or equal toxicity compared with other regimens in patients with NSCLC [20][21][22] , and thus, GEM is one of the most important agents in the treatment of NSCLC. A phase I study of GEM in combination with MTA was performed [23] , and subsequently, 3 phase II trials of GEM/ MTA combination in patients with advanced NSCLC have already been reported [24][25][26] . These trials demonstrated acceptable results with an overall response rate ranging from 15.5 to 31.0%, a median survival time from 10.1 to 11.8 months and tolerable toxicities for outpatient use.…”

A phase II trial of pemetrexed and gemcitabine as first line therapy for poor performance status and/or elderly patients with stage IIIB/IV non-small cell lung cancer

“…Preclinical and clinical studies have shown synergy between pemetrexed and gemcitabine in the treatment of locally advanced or metastatic NSCLC, with a favorable tolerability profile relative to other doublets [7,20,21], and an encouraging toxicity profile for elderly patients. Most trials of this combination have varied the drug sequence on a 21-day schedule [21,22], but a recent phase I study examined a biweekly schedule in order to establish a maximum-tolerated dose in patients with solid tumors [23].…”