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Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass

BACKGROUND: We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy. SUBJECTS AND METHODS: The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP...

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Autores principales: Shoji, Tadahiro, Takatori, Eriko, Furutake, Yoko, Takada, Anna, Nagasawa, Takayuki, Omi, Hideo, Kagabu, Masahiro, Honda, Tatsuya, Miura, Fumiharu, Takeuchi, Satoshi, Kumagai, Seisuke, Yoshizaki, Akira, Sato, Akira, Sugiyama, Toru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Japan 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124439/
https://www.ncbi.nlm.nih.gov/pubmed/27342833
http://dx.doi.org/10.1007/s10147-016-1008-7
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author Shoji, Tadahiro
Takatori, Eriko
Furutake, Yoko
Takada, Anna
Nagasawa, Takayuki
Omi, Hideo
Kagabu, Masahiro
Honda, Tatsuya
Miura, Fumiharu
Takeuchi, Satoshi
Kumagai, Seisuke
Yoshizaki, Akira
Sato, Akira
Sugiyama, Toru
author_facet Shoji, Tadahiro
Takatori, Eriko
Furutake, Yoko
Takada, Anna
Nagasawa, Takayuki
Omi, Hideo
Kagabu, Masahiro
Honda, Tatsuya
Miura, Fumiharu
Takeuchi, Satoshi
Kumagai, Seisuke
Yoshizaki, Akira
Sato, Akira
Sugiyama, Toru
author_sort Shoji, Tadahiro
collection PubMed
description BACKGROUND: We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy. SUBJECTS AND METHODS: The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m(2) was intravenously administered on day 1 and CPT-11 at 70 mg/m(2) was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS). RESULTS: The antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6–93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210–334) and 500 ml (range, 393–898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors. CONCLUSION: NAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis.
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spelling pubmed-51244392016-12-09 Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass Shoji, Tadahiro Takatori, Eriko Furutake, Yoko Takada, Anna Nagasawa, Takayuki Omi, Hideo Kagabu, Masahiro Honda, Tatsuya Miura, Fumiharu Takeuchi, Satoshi Kumagai, Seisuke Yoshizaki, Akira Sato, Akira Sugiyama, Toru Int J Clin Oncol Original Article BACKGROUND: We examined the efficacy and safety of neoadjuvant chemotherapy (NAC) with the CPT-11 + CDDP regimen in combination with radical hysterectomy. SUBJECTS AND METHODS: The subjects were 42 patients with stages IB2 to IIIB squamous cell carcinoma of the uterine cervix with a bulky mass. CDDP at 70 mg/m(2) was intravenously administered on day 1 and CPT-11 at 70 mg/m(2) was intravenously administered on days 1 and 8 of a 21-day cycle. In principle, two cycles were administered followed by radical hysterectomy. We examined antitumor efficacy, adverse events, completion rate of radical hysterectomy, operative time, surgical blood loss, progression-free survival (PFS), and overall survival (OS). RESULTS: The antitumor effect was complete response in 7 patients, partial response in 28, stable disease in 6, and progressive disease in 1; the response rate was 83.3 % (95 % confidence interval, 68.6–93.0). Grade 3 or more severe neutropenia, anemia, and platelet count decreases were noted in 23 (54.8 %), 4 (9.5 %), and 1 (2.4 %) patient, respectively. Grade 3 nausea occurred in 3 patients (7.1 %), vomiting in 1 (2.4 %), and grade 3 febrile neutropenia in 2 (7.1 %). The completion rate of radical hysterectomy was 88.1 %. The median operative time and surgical blood loss were 260 min (range, 210–334) and 500 ml (range, 393–898), respectively. The 5-year PFS rate was 67.2 %, and the 5-year OS rate was 68.0 %. In multivariate analysis, lymph node metastasis before NAC [hazard ratio (HR), 34.88] and non-response to NAC (HR 30.58) were significant prognostic factors. CONCLUSION: NAC with the CDDP/CPT-11 regimen achieves a high antitumor efficacy with moderate adverse reactions, allowing safe radical hysterectomy, and is thus considered to be a useful therapeutic method that can improve prognosis. Springer Japan 2016-06-24 2016 /pmc/articles/PMC5124439/ /pubmed/27342833 http://dx.doi.org/10.1007/s10147-016-1008-7 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Shoji, Tadahiro
Takatori, Eriko
Furutake, Yoko
Takada, Anna
Nagasawa, Takayuki
Omi, Hideo
Kagabu, Masahiro
Honda, Tatsuya
Miura, Fumiharu
Takeuchi, Satoshi
Kumagai, Seisuke
Yoshizaki, Akira
Sato, Akira
Sugiyama, Toru
Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title_full Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title_fullStr Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title_full_unstemmed Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title_short Phase II clinical study of neoadjuvant chemotherapy with CDDP/CPT-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
title_sort phase ii clinical study of neoadjuvant chemotherapy with cddp/cpt-11 regimen in combination with radical hysterectomy for cervical cancer with a bulky mass
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5124439/
https://www.ncbi.nlm.nih.gov/pubmed/27342833
http://dx.doi.org/10.1007/s10147-016-1008-7
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