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• W2254976178 abstract "7053 Background: Pemetrexed and gemcitabine are synergistic in preclinical models. Each agent is active in MPM, but the combination has not been studied in this disease in the phase 2 setting. Methods: From 12/02 to 06/03, 53 chemo-naive patients with unresectable MPM were enrolled from 12 sites in the US. Treatment consisted of gemcitabine 1250 mg/m2 on days 1 and 8, with pemetrexed 500mg/m2 on day 8, followed by gemcitabine, every 21 days for a total of 6 cycles or until progressive disease. All patients received folic acid, vitamin B12 and steroid prophylaxis. Pathologic diagnosis included epithelial 68.3%, mixed 12.2%, sarcomatoid 7.3%, and unclassified/other 12.2%. Enrolled patients had a median age of 69.5 years (range: 36 - 88), PS 0:1:2 = 20%:61%:9.8%, and 90% were males. Results: Toxicity information is currently available on 41 patients. Cycle specific Grade 3/4 hematologic toxicities consisted of neutropenia 33.1%, anemia 1.7%, thrombocytopenia 1.7%, and febrile neutropenia 1.7%. Non-hematologic Grade 3/4 events (% of cycles) were fatigue (5%), neurotoxicity (3.3%), nausea (2.5%), asthenia (1.7%) with the following occurring in < 1% of cycles: vomiting, renal insufficiency, alopecia (grade 1), diarrhea, and rash. Of the 121 cycles administered, 15.7% (n=19) required dose reductions, resulting in a median dose intensity for gemcitabine and pemetrexed of 91.95% and 99.61%. Median number of doses/patient: gemcitabine = 4, pemetrexed = 3. Preliminary response rate=20% out of 34 evaluable patients; CR=0, PR=7 (20%-CI 9–38%), SD=18 (52.9%-CI 35–70%), PD=9 (26.5% CI 13–44%). To date, the clinical benefit rate = 72.9%. Conclusions: Pemetrexed plus gemcitabine in MPM has an encouraging toxicity profile which is manageable and comparable to other doublet combinations. Especially for the elderly patient with MPM (50% of trial population = 69.5 yrs), this combination of gemcitabine plus pemetrexed may prove a better-tolerated, viable alternative to cisplatin –pemetrexed. Early response data is promising and time-to-event, updated response, and survival information on all 53 patients will be forthcoming. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly & Co. Eli Lilly & Co. Eli Lilly & Co. Eli Lilly & Co. Eli Lilly & Co." @default.
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• W2254976178 date "2004-07-15" @default.
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• W2254976178 title "A phase 2 clinical trial of pemetrexed plus gemcitabine as front-line chemotherapy for patients with malignant pleural mesothelioma (MPM)" @default.
• W2254976178 doi "https://doi.org/10.1200/jco.2004.22.90140.7053" @default.
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