title: Capecitabine in the treatment of metastatic renal cell carcinoma.
abstract: To evaluate the therapeutic effects and systemic toxicities of a capecitabine-based home therapy regimen in patients with metastatic renal cell carcinoma, 30 patients were enrolled in a phase II clinical trial. Treatment consisted of oral capecitabine combined with subcutaneous recombinant human interferon-alpha 2a, recombinant human interleukin-2 and oral 13-cis-retinoic acid. There were two (7%) complete responses (CRs) and eight (27%) partial remissions (PRs), for an overall objective response rate of 34% (95% CI 17-53%). Except one, all responses are ongoing, with a median duration of 9+ and 8+ months for CRs and PRs, respectively. Additionally, 12 patients (40%) reached stable disease. Eight patients (27%) showed continued disease progression despite treatment. Therapy was well tolerated and was given in the outpatient setting. Capecitabine-related World Health Organization (WHO) grade 2 and 3 toxicities were observed in five and two patients respectively, and were limited to fatigue, nausea/vomiting, diarrhoea, stomatitis, dermatitis and hand-and-foot syndrome. The substitution of capecitabine for 5-FU in the pre-existing biochemotherapy regimen did not result in a reduced therapeutic efficacy and showed significant anti-tumour activity in patients with advanced renal cell carcinoma.
authors.affiliation: Department of Haematology and Oncology, Medizinische Hochshule Hannover, Carl-Neuberg-Strasse 1, Hannover, 30625, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Oevermann
authors.forename: J
authors.initials: J
authors.lastname: Buer
authors.forename: R
authors.initials: R
authors.lastname: Hoffmann
authors.forename: A
authors.initials: A
authors.lastname: Franzke
authors.forename: A
authors.initials: A
authors.lastname: Schrader
authors.forename: T
authors.initials: T
authors.lastname: Patzelt
authors.forename: H
authors.initials: H
authors.lastname: Kirchner
authors.forename: J
authors.initials: J
authors.lastname: Atzpodien
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D000069287:Capecitabine; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use / Q000633:toxicity; D007376:Interleukin-2 / Q000627:therapeutic use / Q000633:toxicity; D015474:Isotretinoin / Q000627:therapeutic use / Q000633:toxicity; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008113:Liver Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins; D003841:Deoxycytidine; D000069287:Capecitabine; D015474:Isotretinoin; D005472:Fluorouracil