Konference: 2010 35th Congress ESMO – účast ČR
Kategorie: Zhoubné nádory plic a průdušek
Téma: Proffered paper session: Chest tumors II
Číslo abstraktu: LBA17
Autoři: K. Kelly; C.G. Azzoli; J.D. Patel; G. Weems; prof. MUDr. Petr Zatloukal (1955-2012), CSc.
Background: Pralatrexate (FOLOTYN®), a folate analog
targeting dihydrofolate reductase, is approved in the US for the
treatment of relapsed/refractory peripheral T-cell lymphoma and has
demonstrated activity in NSCLC [Azzoli ESMO 2009]. Erlotinib is
approved for advanced NSCLC. The PDX-012 study compared
pralatrexate with erlotinib in advanced NSCLC after failure of
platinum-based therapy.
Methods: Pts were randomized 1:1 to pralatrexate (initially 230 mg/m˛, amended to 190 mg/m˛) IV days 1 and 15 of a 28-day cycle, or erlotinib 150-mg/day PO. The primary objective was to estimate overall survival (OS) in the overall population, primary analysis population (pralatrexate 190 mg/m˛ or erlotinib), and prespecified cohorts. Secondary objectives included PFS, RR, and safety. Key eligibility criteria: 1) Stage IIIB/IV NSCLC; 2) ≥1 prior platinum-based therapy; 3) ECOG 0-1; 4) smoking history ≥100 cigarettes.
Results: A difference occurred in OS in the overall population (n=201) and primary analysis population (n=166) favoring pralatrexate; reduction in the risk of death of 16% and 13%, [HR=0.84; 0.87, respectively]. In the overall population, the corresponding 6 and 12 mo survival rates for pralatrexate vs erlotinib were 56% vs 51%; 28% vs 18%, respectively. Consistency existed across most pt cohorts favoring pralatrexate, except for pts with squamous cell carcinoma (n=76; HR=1.06) and pts with prior pemetrexed (n=30; HR=1.15). The largest reductions in risk of death were in pralatrexate pts with non-squamous cell carcinoma (n=107; HR=0.65) and light smokers (n=37; HR=0.63). Consistent with previous studies, the most common G3-4 AE in pralatrexate pts was mucositis (23%). Other G3-4 AEs in >5% (but ≤10%) of pts were fatigue, anemia, dyspnea, neutropenia, and thrombocytopenia for pralatrexate; anemia, dyspnea, fatigue, and rash for erlotinib.
Conclusions: Pralatrexate demonstrated clinical activity with trends towards improved OS compared with erlotinib in the overall population and in defined cohorts of pts with advanced NSCLC. Additional data will be presented regarding secondary objectives and results in prespecified cohorts.
Disclosures: K. Kelly is a compensated principal investigator for Allos Therapeutics and a compensated advisor for Genentech; G. Weems is a co-author and has stock options in Allos Therapeutics; P. Zaloukal is study investigator for the PDX-012 trial. All other authors have declared no conflicts of interest.
Methods: Pts were randomized 1:1 to pralatrexate (initially 230 mg/m˛, amended to 190 mg/m˛) IV days 1 and 15 of a 28-day cycle, or erlotinib 150-mg/day PO. The primary objective was to estimate overall survival (OS) in the overall population, primary analysis population (pralatrexate 190 mg/m˛ or erlotinib), and prespecified cohorts. Secondary objectives included PFS, RR, and safety. Key eligibility criteria: 1) Stage IIIB/IV NSCLC; 2) ≥1 prior platinum-based therapy; 3) ECOG 0-1; 4) smoking history ≥100 cigarettes.
Results: A difference occurred in OS in the overall population (n=201) and primary analysis population (n=166) favoring pralatrexate; reduction in the risk of death of 16% and 13%, [HR=0.84; 0.87, respectively]. In the overall population, the corresponding 6 and 12 mo survival rates for pralatrexate vs erlotinib were 56% vs 51%; 28% vs 18%, respectively. Consistency existed across most pt cohorts favoring pralatrexate, except for pts with squamous cell carcinoma (n=76; HR=1.06) and pts with prior pemetrexed (n=30; HR=1.15). The largest reductions in risk of death were in pralatrexate pts with non-squamous cell carcinoma (n=107; HR=0.65) and light smokers (n=37; HR=0.63). Consistent with previous studies, the most common G3-4 AE in pralatrexate pts was mucositis (23%). Other G3-4 AEs in >5% (but ≤10%) of pts were fatigue, anemia, dyspnea, neutropenia, and thrombocytopenia for pralatrexate; anemia, dyspnea, fatigue, and rash for erlotinib.
Conclusions: Pralatrexate demonstrated clinical activity with trends towards improved OS compared with erlotinib in the overall population and in defined cohorts of pts with advanced NSCLC. Additional data will be presented regarding secondary objectives and results in prespecified cohorts.
Disclosures: K. Kelly is a compensated principal investigator for Allos Therapeutics and a compensated advisor for Genentech; G. Weems is a co-author and has stock options in Allos Therapeutics; P. Zaloukal is study investigator for the PDX-012 trial. All other authors have declared no conflicts of interest.
Datum přednesení příspěvku: 9. 9. 2010
