Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: an EORTC Gynaecological Cancer Cooperative Group Study
(2000) European Journal of Cancer — Vol. 36, n° 2, p. 194-199 (2000)
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- Abstract
- The objective of this phase II study was to assess the efficacy and toxicity of vinorelbine administered as a single agent in the treatment of chemonaive cervical cancer patients. 46 patients (41 eligible) with crucial cancer (epidermoid or adenocarcinoma) and measurable metastatic and/or recurrent disease localised outside irradiated areas were treated with weekly intravenous (i.v.) vinorelbine 30 mg/m(2) infused over 20 min. No prior chemotherapy was allowed. Median age was 53 years (range: 33-73), and performance status 1 (0-2). 31 patients (76%) had prior radiation therapy. There were 7 partial responders (17, 95% confidence interval (CI) 7-32) and 8 stable diseases (20%). Median duration of response was 5 months (4-11). Granulocytopenia was the major toxicity, with 47% of patients exhibiting grade 3 or 3 toxicity. Dose reduction and/or treatment delay vr as necessary in 28 patients (78%). Peripheral neuropathy reported in 10 patients was mild (grade 1 in 9 patients and grade 7 in 1 patient. In conclusion, single agent vinorelbine has moderate activity in recurrent or metastatic cervical cancer. but its reduced neurotoxicity warrants further study in combination with cisplatin. (C) 2000 Elsevier Science Ltd. All rights reserved.
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Lhomme, C., Vermorken, JB., Mickiewicz, E., Chevalier, B., Alvarez, A., Mendiola, C., Pawinski, A., Lentz, MA., & Pecorelli, S. (2000). Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: an EORTC Gynaecological Cancer Cooperative Group Study. European Journal of Cancer, 36(2), 194-199. https://doi.org/10.1016/S0959-8049(99)00237-3 (Original work published 2000)