title: Non small cell lung cancer (NSCLC). A prospective randomized trial with alternating chemotherapy CEP/MEC' versus no treatment.
abstract: From April 1985 to September 1987, 92 patients with advanced NSCLC were randomized to receive cytotoxic chemotherapy, Arm A (treated), or supportive care, Arm B (control). Chemotherapy consisted of the CEP combination (cyclophosphamide 500 mg/m2 i.v. day 1; epirubicin 50 mg/m2 i.v. day 1; cisplatin 80 mg/m2 i.v. day 1) alternated every 4 weeks with the MEC' combination (methotrexate 30 mg/m2 i.v. day 1; etoposide 200 mg/m2 i.v. day 1; CCNU 70 mg/m2 per os, day 1) until progression. Eight-nine patients (44 treated and 45 controls) were eligible for survival and 77 evaluable for response (38 treated and 39 controls). Response rate was: in Arm A, 8/38 (21%) partial response, 20/38 (53%) stable disease and 10/38 (26%) progressive disease; in Arm B, 18/39 (46%) stable disease and 21/39 (54%) progressive disease. Median time to progression was 4 months (range = 1-14) for treated and 2 months (range = 1-9) for controls (P = 0.001). Median survival was 8.5 months (range = 1+ to 25) for Arm A versus 5 months (range = 1+ to 28+) for Arm B; this difference was not statistically significant (Breslow test: chi-square = 2.75, P = 0.097; Mantel-Cox: chi-square = 0.32, P = 0.56). Treatment related toxicity was gastrointestinal WHO grade 3 in 22/102 (22%) CEP courses and in 10/91 (11%) MEC' courses respectively. Other observed side-effects were not clinically important. From these data our treatment was not clearly superior to supportive care in prolonging survival. This suggests the need for the inclusion of a control group in future chemotherapeutic trials of NSCLC.
authors.affiliation: Clinica Oncologica, Università di Ancona, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Cellerino
authors.forename: D
authors.initials: D
authors.lastname: Tummarello
authors.forename: E
authors.initials: E
authors.lastname: Porfiri
authors.forename: F
authors.initials: F
authors.lastname: Guidi
authors.forename: P
authors.initials: P
authors.lastname: Isidori
authors.forename: M
authors.initials: M
authors.lastname: Raspugli
authors.forename: B
authors.initials: B
authors.lastname: Biscottini
authors.forename: G
authors.initials: G
authors.lastname: Fatati
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation
chemical_list: D015251:Epirubicin; D005047:Etoposide; D008130:Lomustine; D003520:Cyclophosphamide; D002945:Cisplatin; D008727:Methotrexate