A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer.
dc.contributor.author | Hussain, SA | en |
dc.contributor.author | Stocken, DD | en |
dc.contributor.author | Riley, P | en |
dc.contributor.author | Palmer, DH | en |
dc.contributor.author | Peake, DR | en |
dc.contributor.author | Geh, JI | en |
dc.contributor.author | Spooner, D | en |
dc.contributor.author | James, ND | en |
dc.date.accessioned | 2018-01-22T11:18:29Z | |
dc.date.available | 2018-01-22T11:18:29Z | |
dc.date.issued | 2004-08-31 | en |
dc.identifier.issn | 0007-0920 | en |
dc.identifier.uri | http://hdl.handle.net/10026.1/10635 | |
dc.description.abstract |
A randomised phase III trial of MVAC (methotrexate, vincristine, doxorubicin, cisplatin) vs gemcitabine and cisplatin (GC) (G 1000 mg m(-2) days 1, 8, and 15 plus C 70 mg m(-2) day 2, q 4 wks) indicated GC had similar efficacy and lower toxicity (JCO 2000). Significant haematologic toxicities in the GC arm occurred on day 15, necessitating dose adjustments in 37% of cycles. We conducted a phase I/II dose escalation trial using GC on a 21-day cycle, with G and C split between days 1 and 8. The objective of the study to define maximum-tolerated dose and dose-limiting toxicity (DLT), objective response rate, and overall survival. In all, 32 patients with locally advanced, relapsed, or metastatic disease received: dose level 1, G/C 1000/35; level 2, 1100/35; level 3, 1200/35; level 4, 1200/45 mg m(-2) (G and C given on days 1 and 8 every 3 wks). A total of 19 patients had glomerular filtration rate <60 ml min(-1) and 19 patients had metastatic disease. Dose-limiting toxicity was haematologic (grade 4 thrombocytopenia) at dose level 2. Of 151 cycles, at day 15, platelets were <100 in 61 cycles; neutrophils <0.5, platelets <50 in 26 cycles. Only seven cycles were deferred due to haematological toxicity; four for renal toxicity (chemotherapy instituted posthydration). Overall response rate was 65.5% on an intention-to-treat analysis (75% [21/28] for assessable patients), with four complete responses (12.5%) and 17 partial responses (53%). After the median follow-up of 17.2 months (range 13.1-32.4 months), 12 patients remain alive. The overall median survival was 16 months (range 10.1-26.6 months). G plus C every 3 weeks is active and well tolerated in an outpatient setting, even in patients receiving prior platinum-based regimens and with poor renal reserve. | en |
dc.format.extent | 844 - 849 | en |
dc.language | eng | en |
dc.language.iso | eng | en |
dc.subject | Adult | en |
dc.subject | Aged | en |
dc.subject | Antineoplastic Agents | en |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | en |
dc.subject | Carcinoma, Transitional Cell | en |
dc.subject | Cisplatin | en |
dc.subject | Deoxycytidine | en |
dc.subject | Female | en |
dc.subject | Humans | en |
dc.subject | Kidney | en |
dc.subject | Kidney Function Tests | en |
dc.subject | Lymphatic Metastasis | en |
dc.subject | Male | en |
dc.subject | Maximum Tolerated Dose | en |
dc.subject | Middle Aged | en |
dc.subject | Outpatients | en |
dc.subject | Treatment Outcome | en |
dc.subject | Urinary Bladder Neoplasms | en |
dc.subject | Viscera | en |
dc.title | A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer. | en |
dc.type | Journal Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/15292922 | en |
plymouth.issue | 5 | en |
plymouth.volume | 91 | en |
plymouth.publication-status | Published | en |
plymouth.journal | Br J Cancer | en |
dc.identifier.doi | 10.1038/sj.bjc.6602112 | en |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine | |
dc.publisher.place | England | en |
dc.rights.embargoperiod | Not known | en |
rioxxterms.versionofrecord | 10.1038/sj.bjc.6602112 | en |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | en |
rioxxterms.type | Journal Article/Review | en |