Weekly, high-dose XXXX in advanced lung carcinoma: a phase II study with pharmacokinetics by the @entity5 and @entity1778 Group B.

@entity1 @entity137 @entity5 @entity16 @entity1149 @entity1311 @entity1778 @entity413 @entity3028 @entity420 @entity4854 @entity2359
BACKGROUND: The @entity5 and @entity1778 Group B conducted a Phase II trial to evaluate the efficacy, @entity137 , and pharmacokinetics of @entity1311 administered at a maximum dose density for @entity1 with chemotherapy-na  ve, advanced-stage @entity1149 ( @entity1149 ). METHODS: @entity1 with Stage IIIB/IV or recurrent @entity1149 , a performance status (PS) score of 0-1, and no history of chemotherapy exposure were eligible. @entity1311 , 150 mg/m(2), was administered over 3 hours during Weeks 1-6 of an 8-week cycle. Doses were modified for ANC < 1500/microL or for >or= Grade 2 @entity16 on the day of therapy. Treatment continued until @entity137 or disease progression. Pharmacokinetics were assessed at Weeks 1, 3, and 5 of Cycle 1. RESULTS: Thirty-eight @entity1 (median age, 64 years; range, 31-81 years) were treated. There were 21 males (PS = 0 for 17). Eleven @entity1 had received previous radiation, 2 had brain metastases, 25 had @entity420 , 23 had Stage IV disease, 6 had StageIIIB disease, and 9 had recurrent disease. Grade 3-4 @entity3028 occurred in 39% of @entity1 . There were no deaths due to @entity137 . Grade 2 or 3 @entity16 occurred in 29% and 24% of @entity1 , respectively. Ten (27%) @entity1 had Grade 3 @entity4854 ( @entity413 concentration > 250 mg/dL). There were 16 partial responses (42%; 95% confidence interval [CI], 26-59%). The median survival period was 12.3 months (95% CI, 7.9-19.6%), and the 1-year and 2-year survival rates were 52% (95% CI, 39-71%) and 26% (95% CI, 15-45%), respectively. @entity1311 pharmacokinetics were consistent with published values and clearance was not induced. Older age and @entity4854 were associated with greater @entity2359 . CONCLUSIONS: @entity1311 at 150 mg/m(2) per week x 6 every 8 weeks can be administered safely in the cooperative group setting. These Phase II data are comparable to those associated with combination therapy. The weekly dose-dense schedule may be more active than conventional schedules.
