Phase II Study of Second-line Chemotherapy With Paclitaxel, Gemcitabine, and Cisplatin for Advanced Urothelial Carcinoma

Anticancer Res. 2020 Mar;40(3):1613-1618. doi: 10.21873/anticanres.14109.

Abstract

Background/aim: To evaluate the efficacy and toxicity of paclitaxel, gemcitabine, and cisplatin (TGP) as second-line treatment for advanced urothelial carcinoma (UC).

Patients and methods: This study comprised advanced UC progressed after first-line cisplatin-based chemotherapy. Advanced UC was defined as a non-resectable (T4b, any N or any T, or N2-3) or metastatic disease. Twenty-one patients were included in this study. TGP was administered every 3 weeks. The primary endpoint was objective response rate (ORR); the secondary end points were progression-free survival (PFS), overall survival (OS), and toxicity.

Results: The ORR with TGP was 23.8%; the median PFS and OS were 4 and 8.4 months, respectively. The primary side effect was myelosuppression. Grade 3-4 neutropenia and thrombocytopenia were observed in 71.4% and 42.9%, respectively. There were no toxic deaths.

Conclusion: TGP is moderately effective and tolerable as second-line chemotherapy for patients with UC.

Keywords: Advanced urothelial carcinoma; cisplatin; gemcitabine; paclitaxel; second-line chemotherapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / pharmacology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / pharmacology
  • Cisplatin / therapeutic use*
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / pharmacology
  • Deoxycytidine / therapeutic use
  • Female
  • Gemcitabine
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / pharmacology
  • Paclitaxel / therapeutic use*
  • Urologic Neoplasms / drug therapy*
  • Urologic Neoplasms / pathology

Substances

  • Deoxycytidine
  • Paclitaxel
  • Cisplatin
  • Gemcitabine