title: Phase II study of celecoxib with cisplatin plus etoposide in extensive-stage small cell lung cancer.
abstract: We performed a phase II trial to test whether a cyclooxygenase (COX-2) inhibitor, celecoxib, added to standard first-line combination chemotherapy (CT) and as maintenance therapy would improve outcomes in extensive-stage (ES) small-cell lung cancer (SCLC). This was a multicenter trial in CT-naive patients with ES-SCLC. They received standard cisplatin and etoposide (EP) up to 6 cycles and celecoxib 400 mg PO bid continuously until disease progression. Primary end points were response rate (RR), time to progression (TTP), and toxicity. Secondary were overall survival (OS) and quality of life. Of 74 expected patients, only 24 were enrolled and the study stopped earlier because of the published safety concerns about celecoxib. The patients, all male, were between 38 and 74 years. A total of 130 cycles of CT were administered. Toxicity associated with celecoxib was minimal. The RR was 56.5%. Median TTP and OS were 8.6 and 11.3 months, respectively. These data suggest that celecoxib may safely be combined with EP for treatment of ES-SCLC. This combination showed a promising activity and, despite the safety concerns regarding celecoxib, it would be interesting to further evaluate this regimen.
authors.affiliation: Department of Medical Oncology, Portuguese Institute of Oncology Francisco Gentil, Porto, Portugal. amfaraujo@netcabo.pt
authors.forename: António M F
authors.initials: AM
authors.lastname: Arúajo
authors.forename: Jose C
authors.initials: JC
authors.lastname: Mendez
authors.forename: Ana L
authors.initials: AL
authors.lastname: Coelho
authors.forename: Berta
authors.initials: B
authors.lastname: Sousa
authors.forename: Fernando
authors.initials: F
authors.lastname: Barata
authors.forename: Ana
authors.initials: A
authors.lastname: Figueiredo
authors.forename: Teresina
authors.initials: T
authors.lastname: Amaro
authors.forename: Isabel
authors.initials: I
authors.lastname: Azevedo
authors.forename: Marta
authors.initials: M
authors.lastname: Soares
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068579:Celecoxib; D002945:Cisplatin / Q000008:administration & dosage; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011174:Portugal; D011720:Pyrazoles / Q000008:administration & dosage; D011788:Quality of Life; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013030:Spain; D013449:Sulfonamides / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D005047:Etoposide; D000068579:Celecoxib; D002945:Cisplatin