The objective of this study was to determine if the addition of @entity6303 (MA), a modulator of @entity1262 -mediated drug resistance, to first-line cytotoxic therapy in @entity1 with limited and advanced stage @entity151 ( @entity151 ) would improve median time to disease progression and median overall survival. Secondary outcomes evaluated were response rates and @entity1 symptom profile. Between 1992 and 1995, 130 eligible @entity1 were randomized in a double-blind fashion to receive standard first-line therapy consisting of alternating courses of @entity786 / @entity632 / @entity1891 and @entity2879 / @entity900 (and thoracic radiotherapy for limited stage @entity1 ), along with either placebo or MA 160 mg t.i.d. for 8 days commencing 3 days before initiation of each cycle of chemotherapy. Treatment was continued for a maximum of six cycles. A total of 130 eligible @entity1 were randomized, 65 to each arm. Fifty-two per cent of @entity1 had limited disease and 48% had advanced disease. The median time to disease progression in limited stage disease was 46 weeks in the placebo arm and 43 weeks in the MA arm (P = 0.71) and in advanced stage disease was 28 weeks in the placebo arm and 27 weeks in the MA arm (P = 0.92). The median overall survival in limited stage disease was 75 weeks in the placebo arm and 75 weeks in the MA arm (P = 0.56) and in advanced stage disease was 41 weeks in the placebo arm and 39 weeks in the MA arm (P = 0.96). There was no consistent statistical difference in response rates or @entity1 symptom profiles between the two treatment arms. The addition of MA, in the dose and schedule used, to standard first-line cytotoxic therapy in @entity151 did not result in a significant improvement in response rates, symptom profile, median time to disease progression or overall survival.

Results of a phase III, double-blind, placebo-controlled trial of @entity6303 modulation of @entity1262 -mediated drug resistance in the first-line management of XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity632 :: ('MESH:D004317', 'Chemical') :: ['doxorubicin'] @entity1262 :: ('5243', 'Gene') :: ['P-glycoprotein'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity2879 :: ('MESH:D005047', 'Chemical') :: ['etoposide'] @entity6303 :: ('MESH:D019290', 'Chemical') :: ['megestrol acetate'] @entity1891 :: ('MESH:D014750', 'Chemical') :: ['vincristine'] @entity151 :: ('MESH:D055752', 'Disease') :: ['SCLC', 'small-cell lung cancer']
@entity151 :: (MESH:D055752,Disease) :: ['small-cell lung carcinoma']
