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 toxicity of vinorelbine administered as a single agent in the treatment of chemonaive cervical cancer patients. 46 patients (41 eligible) with cervical cancer (epidermoid or adenocarcinoma) and measurable metastatic and/or recurrent...

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Autores principales: Lhommé, C., Vermerken, J.B., Mickiewicz, E., Chevalier D', B., Alvarez, A., Mendiola, C., Pawinski, A., Lentz, M.A., Pecorelli, S.
Formato: JOUR
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Acceso en línea:http://hdl.handle.net/20.500.12110/paper_09598049_v36_n2_p194_Lhomme
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spelling todo:paper_09598049_v36_n2_p194_Lhomme2023-10-03T15:53:10Z Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study Lhommé, C. Vermerken, J.B. Mickiewicz, E. Chevalier D', B. Alvarez, A. Mendiola, C. Pawinski, A. Lentz, M.A. Pecorelli, S. Cervical cancer Chemotherapy Phase II Vinorelbine navelbine adult advanced cancer aged article cancer chemotherapy cancer radiotherapy clinical article clinical trial female granulocytopenia human peripheral neuropathy phase 2 clinical trial priority journal recurrent cancer uterine cervix carcinoma Adult Aged Antineoplastic Agents, Phytogenic Constipation Female Humans Middle Aged Neoplasm Recurrence, Local Neutropenia Time Factors Uterine Cervical Neoplasms Vinblastine 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 cervical 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/m2 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 4 toxicity. Dose reduction and/or treatment delay was necessary in 28 patients (78%). Peripheral neuropathy reported in 10 patients was mild (grade 1 in 9 patients and grade 2 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. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_09598049_v36_n2_p194_Lhomme
institution Universidad de Buenos Aires
institution_str I-28
repository_str R-134
collection Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA)
topic Cervical cancer
Chemotherapy
Phase II
Vinorelbine
navelbine
adult
advanced cancer
aged
article
cancer chemotherapy
cancer radiotherapy
clinical article
clinical trial
female
granulocytopenia
human
peripheral neuropathy
phase 2 clinical trial
priority journal
recurrent cancer
uterine cervix carcinoma
Adult
Aged
Antineoplastic Agents, Phytogenic
Constipation
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
Neutropenia
Time Factors
Uterine Cervical Neoplasms
Vinblastine
spellingShingle Cervical cancer
Chemotherapy
Phase II
Vinorelbine
navelbine
adult
advanced cancer
aged
article
cancer chemotherapy
cancer radiotherapy
clinical article
clinical trial
female
granulocytopenia
human
peripheral neuropathy
phase 2 clinical trial
priority journal
recurrent cancer
uterine cervix carcinoma
Adult
Aged
Antineoplastic Agents, Phytogenic
Constipation
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
Neutropenia
Time Factors
Uterine Cervical Neoplasms
Vinblastine
Lhommé, C.
Vermerken, J.B.
Mickiewicz, E.
Chevalier D', B.
Alvarez, A.
Mendiola, C.
Pawinski, A.
Lentz, M.A.
Pecorelli, S.
Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
topic_facet Cervical cancer
Chemotherapy
Phase II
Vinorelbine
navelbine
adult
advanced cancer
aged
article
cancer chemotherapy
cancer radiotherapy
clinical article
clinical trial
female
granulocytopenia
human
peripheral neuropathy
phase 2 clinical trial
priority journal
recurrent cancer
uterine cervix carcinoma
Adult
Aged
Antineoplastic Agents, Phytogenic
Constipation
Female
Humans
Middle Aged
Neoplasm Recurrence, Local
Neutropenia
Time Factors
Uterine Cervical Neoplasms
Vinblastine
description 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 cervical 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/m2 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 4 toxicity. Dose reduction and/or treatment delay was necessary in 28 patients (78%). Peripheral neuropathy reported in 10 patients was mild (grade 1 in 9 patients and grade 2 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.
format JOUR
author Lhommé, C.
Vermerken, J.B.
Mickiewicz, E.
Chevalier D', B.
Alvarez, A.
Mendiola, C.
Pawinski, A.
Lentz, M.A.
Pecorelli, S.
author_facet Lhommé, C.
Vermerken, J.B.
Mickiewicz, E.
Chevalier D', B.
Alvarez, A.
Mendiola, C.
Pawinski, A.
Lentz, M.A.
Pecorelli, S.
author_sort Lhommé, C.
title Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
title_short Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
title_full Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
title_fullStr Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
title_full_unstemmed Phase II trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: An EORTC Gynaecological Cancer Cooperative Group Study
title_sort phase ii trial of vinorelbine in patients with advanced and/or recurrent cervical carcinoma: an eortc gynaecological cancer cooperative group study
url http://hdl.handle.net/20.500.12110/paper_09598049_v36_n2_p194_Lhomme
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