Τίτλος:
Sequential gemcitabine and cisplatin followed by docetaxel as first-line treatment of advanced urothelial carcinoma: A multicenter phase II study of the Hellenic Oncology Research Group
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: The purpose of this study was to investigate the toxicity and efficacy of the sequential administration of gemcitabine (GMB) in combination with cisplatin (CDDP) followed by docetaxel (Taxotere) as first-line treatment of advanced urothelial carcinoma. Patients and methods: Patients [aged ≤70 years and performance status (PS) (Eastern Cooperative Oncology Group) 0-2] with previously untreated locally advanced/recurrent or metastatic urothelial carcinoma were eligible. Study treatment consisted of GMB (1000 mg/m2, days 1 and 8) and CDDP (70 mg/m2, day 1) (GP regimen), every 21 days for a total of four cycles followed by docetaxel (D; 100 mg/m2, day 1) every 21 days for four cycles. Results: Thirty-eight patients with a median age of 67 years were enrolled; 67% of them had PS 0 and 87% stage IV disease. Patients received a median of four GP and four D cycles per patient. Grade 3-4 neutropenia occurred in 27% and 63% patients with GP and D, respectively. Grade 3-4 thrombocytopenia occurred in 11% of patients, only with the GP regimen. Other toxic effects were mild. There was no toxic death. The objective response rate was 55.2% [95% CI: 39.45%-71.07%]. Five patients had complete response (13.15%) and 16 patients had partial response (42.1%), while nine patients had disease stabilization (23.7%) (intention-to-treat analysis). After a median follow-up period of 13 months (range 1.5-40.5 months), the median time to progression was 6.8 months (range 1-40.5 months), the median overall survival 13 months (range 1.5-40.5 months), and the 1-year survival rate 55.3%. Conclusion: The sequential administration of GP followed by D is active and well tolerated as first-line treatment of advanced urothelial carcinoma and merits to be further evaluated. © 2006 Oxford University Press.
Συγγραφείς:
Boukovinas, I.
Androulakis, N.
Vamvakas, L.
Papakotoulas, P.
Ziras, N.
Polyzos, A.
Kalykaki, A.
Kotsakis, A.
Xenidis, N.
Gioulmbasanis, I.
Mavroudis, D.
Georgoulias, V.
Περιοδικό:
Annals of Oncology
Λέξεις-κλειδιά:
analgesic agent; antiemetic agent; carboplatin; cisplatin; docetaxel; gemcitabine; recombinant granulocyte colony stimulating factor, adult; advanced cancer; aged; anemia; area under the curve; article; bladder carcinoma; blood toxicity; cancer growth; cancer staging; clinical article; clinical trial; confidence interval; constipation; controlled clinical trial; controlled study; disease severity; drug blood level; drug dose regimen; drug fatality; drug hypersensitivity; drug response; fatigue; febrile neutropenia; female; follow up; human; male; multicenter study; nausea and vomiting; nephrotoxicity; neutropenia; overall survival; phase 2 clinical trial; priority journal; recurrent cancer; stomatitis; survival rate; thrombocytopenia, Adult; Aged; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Deoxycytidine; Female; Greece; Humans; Kaplan-Meiers Estimate; Male; Middle Aged; Neoplasm Staging; Patient Compliance; Taxoids; Treatment Outcome; Urologic Neoplasms
DOI:
10.1093/annonc/mdl286
