Clinical Research Papers:

Oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX) as second-line therapy for patients with advanced urothelial cancer

Sheng Zhang _, Hongxi Xue and Qiang Chen

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Oncotarget. 2016; 7:58579-58585. https://doi.org/10.18632/oncotarget.10463

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Sheng Zhang1, Hongxi Xue2, Qiang Chen3

1Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China

2Rizhao City Hospital of Traditional Chinese Medicine, Rizhao, China

3Department of Clinical Biochemistry, School of Public Health, Taishan Medical University, Tai’an, China

Correspondence to:

Sheng Zhang, email: [email protected]

Keywords: urothelial cancer, oxaliplatin, leucovorin, 5-fluorouracil, clinical trial

Received: February 08, 2016    Accepted: June 30, 2016    Published: July 07, 2016


There is currently no standard treatment for metastatic urothelial cancer after failure of cisplatin-based therapy. The present retrospective study investigated the efficacy and safety of oxaliplatin plus 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOX) in locally advanced or metastatic urothelial cancer patients following cisplatin-based treatment. Thirty-three patients who had received one or two cisplatin-based regimens were treated with oxaliplatin (85 mg/m2) as a 2-h infusion on day 1, LV (200 mg/m2) as a 2-h infusion followed by bolus 5-FU (400 mg/m2) on day 1, or a 44-h continuous 5-FU (1,200 mg/m2) infusion. Patients were a mean of 67 years old with two involved organs. Metastases were mostly in the lung (43%), lymph nodes (51%) and liver (46%). Based on an intention-to-treat analysis, nine patients achieved a partial response, with an overall response rate of 27%. Eight (24%) patients had stable disease. Mean progression-free survival was 3 months and mean overall survival was 6.1 months. Toxicity was mild to moderate with grade 3 or 4 neutropenia, thrombocytopenia and neuropathy occurring in 5 (15%), 4 (12%) and 2 (6%) patients, respectively. This study demonstrated that oxaliplatin plus 5-FU/LV was a well-tolerated second-line regimen with moderate activity in patients pretreated with cisplatin-based therapeutics.

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