NCCTG phase I/II trial (N9943) of gemcitabine and pemetrexed in patients with biliary tract or gallbladder carcinoma: Phase II results

Autor:	Anthony J. Jaslowski, Nathan R. Foster, John W. Kugler, Fernando Quevedo, R. F. Marschke, Steven R. Alberts, Robert R. McWilliams, E. L. Friedman, J. R. Sande
Rok vydání:	2007
Předmět:	Oncology Cancer Research medicine.medical_specialty business.industry Gallbladder medicine.disease Gastroenterology Gemcitabine medicine.anatomical_structure Phase i ii Pemetrexed Biliary tract Internal medicine medicine Overall survival Carcinoma In patient business medicine.drug
Zdroj:	Journal of Clinical Oncology. 25:4578-4578
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2007.25.18_suppl.4578
Popis:	4578 Background: Gemcitabine is commonly used in patients with cholangiocarcinoma with a response rate of 20–30% and median overall survival of 6–10 months. Pemetrexed’s mechanism of action and tolerability in patients with hepatic dysfunction makes it a potential agent for cholangiocarcinoma. Methods: Patients with unresectable, previously untreated biliary tract cancers were eligible for participation. Patients received pemetrexed 500 mg/m2 IV over 10 minutes and gemcitabine 800 mg/m2 IV at 10 mg/m2/minute on days 1 and 15 of an every 4 week schedule with vitamin B12 and folate supplementation. The primary end-point is 6-month survival with a planned accrual of 59 patients. Results: 58 eligible patients are included in this analysis. 93% had metastatic disease. Median age was 61 (range: 40 - 81). Median follow-up was 6.5 months (range: 3.3 - 23.2). Median of 3 cycles of treatment was given (range: 1 - 10). Reasons for stopping treatment included disease progression (57%), adverse events (20%), refusal (17%), death on- study (4%), and other medical problems (2%). 6-month survival was 52% (95% CI: 40 - 68%). Median survival was 6.3 months (95% CI: 5.4 - 8.0 months) and median time-to-progression was 3.8 months (2.4 - 5.0). 46 of 58 patients (79%) experienced at least one grade 3+ AE (at least possible attribution), and 26 patients (45%) experienced at least one grade 4 AE (at least possible attribution), most of which were due to grade 4 neutropenia. Conclusions: This study shows similar results to what would be expected with gemcitabine alone. The addition of pemetrexed, as with other agents, has not significantly enhanced the activity of gemcitabine. Supported by NIH Grant CA25224- 18. [Table: see text] No significant financial relationships to disclose.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::06d292f007d50693369f41bb8686a5a3 https://doi.org/10.1200/jco.2007.25.18_suppl.4578 Zobrazit plný text záznamu