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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Japan
2016
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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. |
format | Online Article Text |
id | pubmed-5124439 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
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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