This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Pignata, S. Articles by Tramontana, S. Search for Related Content PubMed PubMed Citation Articles by Pignata, S. Articles by Tramontana, S. Social Bookmarking                            What's this?

Phase II Study of Cisplatin and Vinorelbine as First-Line Chemotherapy in Patients With Carcinoma of the Uterine Cervix

From the Divisione di Oncologia Medica B, Divisione di Radioterapia, Ufficio Sperimentazioni Cliniche Controllate, and Divisione di Ginecologia, Istituto Nazionale Tumori, Napoli; II Clinica Ostetrica e Ginecologica, Policlinico, Università di Bari; and Metodologia Epidemiologica Clinica, Seconda Università di Napoli, Napoli, Italy.

Address reprint requests to Sandro Pignata, MD, Divisione di Oncologia Medica B, Istituto Nazionale Tumori, Fondazione Pascale, Via M Semmola, 80131 Napoli, Italy

PURPOSE: To evaluate the activity and toxicity of the combination of cisplatin (80 mg/m² day 1) and vinorelbine (25 mg/m² days 1 and 8) in patients with carcinoma of the uterine cervix that has not been previously treated with chemotherapy.

PATIENTS AND METHODS: Fifty patients with cervical cancer were enrolled onto this study (27 stage IB-III, 23 stage IVB-recurrent). A two-stage optimal Simon design was applied. Thirteen responders of 29 treated patients were required to proceed beyond the first stage, and 28 responders were needed overall.

RESULTS: Hematologic toxicity was mild, with neutropenia being the most frequent side effect. Nonhematologic toxicity was frequent but never severe; one patient had grade 3 peripheral neurotoxicity. Objective responses were recorded for 32 patients (64%): 11 patients (22%) achieved a complete response (CR) and 21 patients (42%) achieved a partial response (PR). The response rate was 81.5% in patients with IB-III stage (25.9% CR rate) and 43.5% in patients with IVB-recurrent disease (17.4% CR rate). Responses were seen both in stage IVB patients (one CR and two PRs, for an overall rate of 37.5%) and in patients with recurrent disease (three CRs + four PRs, for an overall rate of 46.7%).

CONCLUSION: The combination of cisplatin and vinorelbine is an active regimen in the treatment of patients with early-stage and advanced carcinoma of the uterine cervix. The hematologic and nonhematologic toxicity of this combination is mild.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				H. J. Long III Management of Metastatic Cervical Cancer: Review of the Literature J. Clin. Oncol., July 10, 2007; 25(20): 2966 - 2974. [Abstract] [Full Text] [PDF]

				I. van Luijk, C Coens, M. van der Burg, A Kobierska, M Namer, C Lhomme, P Zola, G Zanetta, J. Vermorken, and For the Gynecological Cancer Group of the European Phase II study of bleomycin, vindesine, mitomycin C and cisplatin (BEMP) in recurrent or disseminated squamous cell carcinoma of the uterine cervix Ann. Onc., February 1, 2007; 18(2): 275 - 281. [Abstract] [Full Text] [PDF]

				M. Morris, J. A. Blessing, B. J. Monk, R. McGehee, and D. H. Moore Phase II Study of Cisplatin and Vinorelbine in Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study J. Clin. Oncol., August 15, 2004; 22(16): 3340 - 3344. [Abstract] [Full Text] [PDF]

				D. H. Moore, J. A. Blessing, R. P. McQuellon, H. T. Thaler, D. Cella, J. Benda, D. S. Miller, G. Olt, S. King, J. F. Boggess, et al. Phase III Study of Cisplatin With or Without Paclitaxel in Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study J. Clin. Oncol., August 1, 2004; 22(15): 3113 - 3119. [Abstract] [Full Text] [PDF]

				A. Duenas-Gonzalez, C. Lopez-Graniel, A. Gonzalez-Enciso, L. Cetina, L. Rivera, I. Mariscal, G. Montalvo, E. Gomez, J. de la Garza, G. Chanona, et al. A phase II study of multimodality treatment for locally advanced cervical cancer: neoadjuvant carboplatin and paclitaxel followed by radical hysterectomy and adjuvant cisplatin chemoradiation Ann. Onc., August 1, 2003; 14(8): 1278 - 1284. [Abstract] [Full Text] [PDF]

				P. G. Rose Combined-Modality Therapy of Locally Advanced Cervical Cancer J. Clin. Oncol., May 15, 2003; 21(90100): 211s - 217. [Abstract] [Full Text] [PDF]

				A. Duenas-Gonzalez, C. Lopez-Graniel, A. Gonzalez-Enciso, A. Mohar, L. Rivera, A. Mota, R. Guadarrama, G. Chanona, and J. de la Garza Concomitant chemoradiation versus neoadjuvant chemotherapy in locally advanced cervical carcinoma: results from two consecutive phase II studies Ann. Onc., August 1, 2002; 13(8): 1212 - 1219. [Abstract] [Full Text] [PDF]

				M. Friedlander and M. Grogan Guidelines for the Treatment of Recurrent and Metastatic Cervical Cancer Oncologist, August 1, 2002; 7(4): 342 - 347. [Abstract] [Full Text] [PDF]