Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix

Sandro Pignata, Giustino Silvestro, Ettore Ferrari, Luigi Selvaggi, Francesco Perrone, Antonio Maffeo, Pasquale Frezza, Giovanni Di Vagno, Gennaro Casella, Paolo Ricchi, Gennaro Cormio, Ciro Gallo, Francesco Iodice, Frank Romeo, Roberta Fiorentino, Giovanni Fortuna, Sergio Tramontana

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Abstract

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.

Original languageEnglish
Pages (from-to)756-760
Number of pages5
JournalJournal of Clinical Oncology
Volume17
Issue number3
Publication statusPublished - Mar 1999

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Cervix Uteri
Cisplatin
Carcinoma
Drug Therapy
vinorelbine
Neutropenia
Uterine Cervical Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix. / Pignata, Sandro; Silvestro, Giustino; Ferrari, Ettore; Selvaggi, Luigi; Perrone, Francesco; Maffeo, Antonio; Frezza, Pasquale; Di Vagno, Giovanni; Casella, Gennaro; Ricchi, Paolo; Cormio, Gennaro; Gallo, Ciro; Iodice, Francesco; Romeo, Frank; Fiorentino, Roberta; Fortuna, Giovanni; Tramontana, Sergio.

In: Journal of Clinical Oncology, Vol. 17, No. 3, 03.1999, p. 756-760.

Research output: Contribution to journalArticle

Pignata, S, Silvestro, G, Ferrari, E, Selvaggi, L, Perrone, F, Maffeo, A, Frezza, P, Di Vagno, G, Casella, G, Ricchi, P, Cormio, G, Gallo, C, Iodice, F, Romeo, F, Fiorentino, R, Fortuna, G & Tramontana, S 1999, 'Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix', Journal of Clinical Oncology, vol. 17, no. 3, pp. 756-760.
Pignata, Sandro ; Silvestro, Giustino ; Ferrari, Ettore ; Selvaggi, Luigi ; Perrone, Francesco ; Maffeo, Antonio ; Frezza, Pasquale ; Di Vagno, Giovanni ; Casella, Gennaro ; Ricchi, Paolo ; Cormio, Gennaro ; Gallo, Ciro ; Iodice, Francesco ; Romeo, Frank ; Fiorentino, Roberta ; Fortuna, Giovanni ; Tramontana, Sergio. / Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 3. pp. 756-760.
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abstract = "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.",
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T1 - Phase II study of cisplatin and vinorelbine as first-line chemotherapy in patients with carcinoma of the uterine cervix

AU - Pignata, Sandro

AU - Silvestro, Giustino

AU - Ferrari, Ettore

AU - Selvaggi, Luigi

AU - Perrone, Francesco

AU - Maffeo, Antonio

AU - Frezza, Pasquale

AU - Di Vagno, Giovanni

AU - Casella, Gennaro

AU - Ricchi, Paolo

AU - Cormio, Gennaro

AU - Gallo, Ciro

AU - Iodice, Francesco

AU - Romeo, Frank

AU - Fiorentino, Roberta

AU - Fortuna, Giovanni

AU - Tramontana, Sergio

PY - 1999/3

Y1 - 1999/3

N2 - 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.

AB - 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.

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