Show simple item record

dc.contributor.authorGeldart, T
dc.contributor.authorChester, J
dc.contributor.authorCasbard, A
dc.contributor.authorCrabb, S
dc.contributor.authorElliott, Tony
dc.contributor.authorProtheroe, A
dc.contributor.authorHuddart, R
dc.contributor.authorMead, G
dc.contributor.authorBarber, J
dc.contributor.authorJones, R
dc.contributor.authorSmith, J
dc.contributor.authorCowles, R
dc.contributor.authorEvans, J
dc.contributor.authorGriffiths, G
dc.date.accessioned2015-01-22T15:29:37Z
dc.date.available2015-01-22T15:29:37Z
dc.date.issued2014-11-20
dc.identifier.citationSUCCINCT: An open-label, single-arm, non-randomised, phase 2 trial of Gemcitabine and Cisplatin chemotherapy in combination with Sunitinib as first-line treatment for patients with advanced urothelial carcinoma. 2014: Eur Urolen
dc.identifier.issn1873-7560
dc.identifier.pmid25465968
dc.identifier.doi10.1016/j.eururo.2014.11.003
dc.identifier.urihttp://hdl.handle.net/10541/338689
dc.description.abstractGemcitabine and cisplatin chemotherapy (GC regimen) represents a standard treatment for advanced urothelial carcinoma. We performed an open-label, single-arm, non-randomised, phase 2 trial evaluating the addition of sunitinib to standard GC chemotherapy (SGC regimen). Overall, 63 treatment-naïve participants were recruited and received up to six 21-d cycles of cisplatin 70mg/m(2) (intravenously [IV], day 1) and gemcitabine 1000mg/m(2) (IV, days 1 and 8) combined with sunitinib 37.5mg (orally, days 2-15). Following review of toxicity after the first six patients, the sunitinib dose was reduced to 25mg for all patients. Overall response rate was 64%, with response noted in 37 of 58 patients. At 6 mo, 30 of 58 assessable patients (52%; 90% confidence interval [CI], 40-63%) were progression free. Median overall survival was 12 mo (95% CI, 9-15) and was heavily influenced by Bajorin prognostic group. Grade 3-4 toxicities were predominantly haematologic and limited the deliverability of the triple SGC regimen. The trial did not meet its prespecified primary end point of >60% patients progression free at 6 mo. Cumulative myelosuppression led to treatment delays of gemcitabine and cisplatin and dose reduction and/or withdrawal of sunitinib in the majority of cases. The triple-drug combination was not well tolerated. Phase 3 evaluation of the triple SGC regimen in advanced transitional cell carcinoma is not recommended.
dc.languageENG
dc.rightsArchived with thanks to European urologyen
dc.titleSUCCINCT: An open-label, single-arm, non-randomised, phase 2 trial of Gemcitabine and Cisplatin chemotherapy in combination with Sunitinib as first-line treatment for patients with advanced urothelial carcinoma.
dc.typeArticleen
dc.contributor.departmentRoyal Bournemouth Hospital, Bournemouth, UKen
dc.identifier.journalEuropean Urologyen
html.description.abstractGemcitabine and cisplatin chemotherapy (GC regimen) represents a standard treatment for advanced urothelial carcinoma. We performed an open-label, single-arm, non-randomised, phase 2 trial evaluating the addition of sunitinib to standard GC chemotherapy (SGC regimen). Overall, 63 treatment-naïve participants were recruited and received up to six 21-d cycles of cisplatin 70mg/m(2) (intravenously [IV], day 1) and gemcitabine 1000mg/m(2) (IV, days 1 and 8) combined with sunitinib 37.5mg (orally, days 2-15). Following review of toxicity after the first six patients, the sunitinib dose was reduced to 25mg for all patients. Overall response rate was 64%, with response noted in 37 of 58 patients. At 6 mo, 30 of 58 assessable patients (52%; 90% confidence interval [CI], 40-63%) were progression free. Median overall survival was 12 mo (95% CI, 9-15) and was heavily influenced by Bajorin prognostic group. Grade 3-4 toxicities were predominantly haematologic and limited the deliverability of the triple SGC regimen. The trial did not meet its prespecified primary end point of >60% patients progression free at 6 mo. Cumulative myelosuppression led to treatment delays of gemcitabine and cisplatin and dose reduction and/or withdrawal of sunitinib in the majority of cases. The triple-drug combination was not well tolerated. Phase 3 evaluation of the triple SGC regimen in advanced transitional cell carcinoma is not recommended.


Files in this item

This item appears in the following Collection(s)

Show simple item record