BACKGROUND: The optimal combination of chemotherapy with radiation therapy for treatment locally advanced @entity1149 ( @entity1149 ) remains an open issue. This randomized phase II study compared @entity136 in two different schedules and @entity900 - as induction chemotherapy, followed by radiation therapy concurrent with @entity900 and etoposid. @entity1 AND METHODS: Eligible @entity1 had microscopically confirmed inoperable non-metastatic @entity1149 ; fulfilled the standard criteria for platin-based chemotherapy; and signed informed consent. @entity1 were treated with 3 cycles of induction chemotherapy with @entity136 and @entity900 . Two different aplications of @entity136 were compared: @entity1 in arm A received @entity136 at 1250 mg/m(2) in a standard half hour i.v. infusion on days 1 and 8; @entity1 in arm B received @entity136 at 250 mg/m(2) in prolonged 6-hours i.v. infusion on days 1 and 8. In both arms, @entity900 75 mg/m(2) on day 2 was administered. All @entity1 continued treatment with radiation therapy with 60-66 Gy concurrent with @entity900 50 mg/m(2) on days 1, 8, 29 and 36 and etoposid 50 mg/m(2) on days 1-5 and 29-33. The primary endpoint was response rate (RR) after induction chemotherapy; secondary endpoints were @entity137 , progression-free survival (PFS) and @entity1349 ( @entity1349 ). RESULTS: From September 2005 to November 2010, 106 @entity1 were recruited to this study. No statistically signifficant differences were found in RR after induction chemotherapy between the two arms (48.1% and 57.4%, p = 0.34). @entity137 profile was comparable and mild with grade 3/4 @entity1398 as primary @entity137 in both arms. One @entity1 in arm B suffered from acute peripheral @entity63 grade 4 and an amputation of lower limb was needed. With a median follow-up of 69.3 months, progression-free survival and median survival in arm A were 15.7 and 24.8 months compared to 18.9 and 28.6 months in arm B. The figures for 1- and 3-year @entity1349 were 73.1% and 30.8% in arm A, and 81.5 % and 44.4% in arm B, respectively. CONCLUSIONS: Among the two @entity900 -based doublets of induction chemotherapy for inoperable @entity1149 , both schedules of @entity136 have a comparable @entity137 profile. Figures for RR, PFS and @entity1349 are among the best reported in current literature. While there is a trend towards better efficacy of the treament with prolonged infusion of @entity136 , the difference between the two arms did not reach statistical significance.

Induction @entity136 in standard dose or prolonged low-dose with @entity900 followed by concurrent radiochemotherapy in locally advanced XXXX : a randomized phase II clinical trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity'] @entity63 :: ('MESH:D007511', 'Disease') :: ['ischemia'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity1149 :: (MESH:D002289,Disease) :: ['non-small cell lung cancer']
