Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: an EORTC Gynaecological Cancer Cooperative Group Study

The objective of this phase II study was to assess the efficacy and toxicit y of vinorelbine administered as a single agent in the treatment of chemona ive 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 intrave nous (i.v.) vinorelbine 30 mg/m(2) infused over 20 min. No prior chemothera py was allowed. Median age was 53 years (range: 33-73), and performance sta tus 1 (0-2). 31 patients (76%) had prior radiation therapy. There were 7 pa rtial responders (17, 95% confidence interval (CI) 7-32) and 8 stable disea ses (20%). Median duration of response was 5 months (4-11). Granulocytopeni a was the major toxicity, with 47% of patients exhibiting grade 3 or 3 toxi city. 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.