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SUCCINCT: 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

Geldart, Thomas, Chester, John D., Casbard, Angela C., Crabb, Simon, Elliott, Tony, Protheroe, Andrew, Huddart, Robert A., Mead, Graham, Barber, Jim, Jones, Robert J., Smith, Joanna D., Cowles, Robert, Evans, Jessica and Griffiths, Gareth 2015. SUCCINCT: 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. European Urology 67 (4) , pp. 599-602. 10.1016/j.eururo.2014.11.003

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Abstract

Gemcitabine 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 70 mg/m2 (intravenously [IV], day 1) and gemcitabine 1000 mg/m2 (IV, days 1 and 8) combined with sunitinib 37.5 mg (orally, days 2–15). Following review of toxicity after the first six patients, the sunitinib dose was reduced to 25 mg 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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords: Advanced urothelial tract transitional cell carcinoma; Phase 2; Clinical trial; First-line treatment; Sunitinib
Publisher: Elsevier
ISSN: 0302-2838
Funders: Cancer Research UK
Date of First Compliant Deposit: 30 March 2016
Date of Acceptance: 30 October 2014
Last Modified: 19 Mar 2019 22:50
URI: http://orca.cf.ac.uk/id/eprint/69330

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