Purpose: To evaluate the activity and toxicity of the combination of cisplatin and vinorelbine in patients with recurrent carcinoma of the vulva that has not been previously treated with chemotherapy. Patients and Methods: Sixteen women with a median age of 65 years (range 43–79) with recurrent vulvar carcinoma were enrolled in the study. Nine patients had local recurrent disease (perineum, vagina and/or vulva), whereas 7 had disease in the groin; 9 patients had received prior radiotherapy. Cisplatin was administered intravenously on day 1 and vinorelbine was given on day 1 immediately after cisplatin and on day 8. Results: A total of 68 cycles of chemotherapy were administered. Fifteen women were assessed for response. Objective responses were recorded in 6 patients (40%) – with 4 patients (27%) achieving a complete response and 2 (13%) achieving a partial response –, whereas 4 patients (27%) had stable disease and 5 had progressive disease. The median progression-free survival was 10 months (range 3–17), whereas the overall survival from the beginning of the chemotherapy was 19 months (range 1–30). Due to the small number of patients, no significant correlation with site of recurrence could be found. Conclusion: The combination of cisplatin and vinorelbine is a well-tolerated and active regimen in the treatment of patients with recurrent vulvar carcinoma.

1.
Jemal A, Thomas A, Murray T, Thun M: Cancer statistics, 2002. CA Cancer J Clin 2002;52:23–47.
2.
Beller U, Sideri M, Maisonneuve P, Benedet JL, Heintz AP, Ngan HY, et al: Carcinoma of the vulva. J Epidemiol Biostat 2001;6:155–173.
3.
Gadducci A, Cionini L, Romanini A, Fanucchi A, Genazzani AR: Old and new perspectives in the management of high-risk, locally advanced or recurrent, and metastatic vulvar cancer. Crit Rev Oncol Hematol 2006;60:227–241.
4.
Deppe G, Cohen CJ, Bruckner HW: Chemotherapy of squamous cell carcinoma of the vulva: a review. Gynecol Oncol 1979;7:345–348.
5.
Winter R, Petru E, Pickel H: Chemotherapy in vulvar cancer; in Angioli R, Benedetti Panici P, Kavanagh JJ, Pecorelli S, Penalver M (eds): Chemotherapy for Gynecological Neoplasms. Current Therapy and Novel Approaches. New York, Marcel Dekker, 2004, pp 617–624.
6.
Leveque D, Jehl F: Clinical pharmacokinetics of vinorelbine. Clin Pharmacokinet 1996;31:184–197.
7.
Depierre A, Chastang C, Quoix E, Lebeau B, Blanchon F, Paillot N, et al: Vinorelbine versus vinorelbine plus cisplatin in advanced non-small cell lung cancer: a randomized trial. Ann Oncol 1994;5:37–42.
8.
Le Chevalier T, Brisgand D, Douillard JY, Pujol JL, Alberola V, Monnier A, et al: Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. J Clin Oncol 1994;12:360–367.
9.
Morris M, Brader KR, Levenback C, Burke TW, Atkinson EN, Scott WR, et al: Phase II study of vinorelbine in advanced and recurrent squamous cell carcinoma of the cervix. J Clin Oncol 1998;16:1094–1098.
10.
Di Vagno G, Cormio G, Pignata S, Scambia G, Di Stefano MG, Tambaro R, et al: Cisplatin and vinorelbine as neoadjuvant chemotherapy in locally advanced cervical cancer: a phase II study. Int J Gynecol Cancer 2003;13:308–312.
11.
Pignata S, Silvestro G, Ferrari E, Selvaggi L, Perrone F, Maffeo A, et al: Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix. J Clin Oncol 1999;17:756–760.
12.
Petterson F: 21st annual report on the results of treatment in gynecological cancer. Int J Gynecol Obstet 1991;36(suppl 1):27–130.
13.
Fleming TR: One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982;38:143–151.
14.
Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 1981;47:207–214.
15.
Tsavaris N, Kopterides P, Kosmas C, Efthymiou A, Skopelitis H, Dimitrakopoulos A, et al: Gabapentin monotherapy for the treatment of chemotherapy-induced neuropathic pain: a pilot study. Pain Med 2008;9:1209–1216.
16.
Shimizu Y, Hasumi K, Masubuchi K: Effective chemotherapy consisting of bleomycin, vincristine, mitomycin C, and cisplatin (BOMP) for a patient with inoperable vulvar cancer. Gynecol Oncol 1990;36:423–427.
17.
Durrant KR, Mangioni C, Lacave AJ, George M, van der Burg ME, Guthrie D, et al: Bleomycin, methotrexate, and CCNU in advanced inoperable squamous cell carcinoma of the vulva: a phase II study of the EORTC Gynaecological Cancer Cooperative Group (GCCG). Gynecol Oncol 1990;37:359–362.
18.
Wagenaar HC, Colombo N, Vergote I, Hoctin-Boes G, Zanetta G, Pecorelli S, et al: Bleomycin, methotrexate, and CCNU in locally advanced or recurrent, inoperable, squamous-cell carcinoma of the vulva: an EORTC Gynaecological Cancer Cooperative Group Study. European Organization for Research and Treatment of Cancer. Gynecol Oncol 2001;81:348–354.
19.
Thigpen JT, Blessing JA, Homesley HD, Lewis GC Jr: Phase II trials of cisplatin and piperazinedione in advanced or recurrent squamous cell carcinoma of the vulva: a Gynecologic Oncology Group Study. Gynecol Oncol 1986;23:358–363.
20.
Muss HB, Bundy BN, Christopherson WA: Mitoxantrone in the treatment of advanced vulvar and vaginal carcinoma. A Gynecologic Oncology Group Study. Am J Clin Oncol 1989;12:142–144.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.