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Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306
BACKGROUND: This randomised phase II/III trial aimed to determine whether perioperative chemotherapy with gemcitabine plus docetaxel (GD) is non-inferior to the standard Adriamycin plus ifosfamide (AI) in terms of overall survival (OS) in patients with soft tissue sarcoma (STS). METHODS: Patients wi...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9553903/ https://www.ncbi.nlm.nih.gov/pubmed/35871234 http://dx.doi.org/10.1038/s41416-022-01912-5 |
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author | Tanaka, Kazuhiro Machida, Ryunosuke Kawai, Akira Nakayama, Robert Tsukushi, Satoshi Asanuma, Kunihiro Matsumoto, Yoshihiro Hiraga, Hiroaki Hiraoka, Koji Watanuki, Munenori Yonemoto, Tsukasa Abe, Satoshi Katagiri, Hirohisa Nishida, Yoshihiro Nagano, Akihito Suehara, Yoshiyuki Kawashima, Hiroyuki Kawano, Masanori Morii, Takeshi Hatano, Hiroshi Toguchida, Junya Okuma, Tomotake Takeyama, Masanobu Takenaka, Satoshi Akisue, Toshihiro Furuta, Taisuke Emori, Makoto Hiruma, Toru Outani, Hidetatsu Yamamoto, Tetsuji Kataoka, Tomoko Fukuda, Haruhiko Ozaki, Toshifumi Iwamoto, Yukihide |
author_facet | Tanaka, Kazuhiro Machida, Ryunosuke Kawai, Akira Nakayama, Robert Tsukushi, Satoshi Asanuma, Kunihiro Matsumoto, Yoshihiro Hiraga, Hiroaki Hiraoka, Koji Watanuki, Munenori Yonemoto, Tsukasa Abe, Satoshi Katagiri, Hirohisa Nishida, Yoshihiro Nagano, Akihito Suehara, Yoshiyuki Kawashima, Hiroyuki Kawano, Masanori Morii, Takeshi Hatano, Hiroshi Toguchida, Junya Okuma, Tomotake Takeyama, Masanobu Takenaka, Satoshi Akisue, Toshihiro Furuta, Taisuke Emori, Makoto Hiruma, Toru Outani, Hidetatsu Yamamoto, Tetsuji Kataoka, Tomoko Fukuda, Haruhiko Ozaki, Toshifumi Iwamoto, Yukihide |
author_sort | Tanaka, Kazuhiro |
collection | PubMed |
description | BACKGROUND: This randomised phase II/III trial aimed to determine whether perioperative chemotherapy with gemcitabine plus docetaxel (GD) is non-inferior to the standard Adriamycin plus ifosfamide (AI) in terms of overall survival (OS) in patients with soft tissue sarcoma (STS). METHODS: Patients with localised high-risk STS in the extremities or trunk were randomised to receive AI or GD. The treatments were repeated for three preoperative and two postoperative courses. The primary endpoint was OS. RESULTS: Among 143 enrolled patients who received AI (70 patients) compared to GD (73 patients), the estimated 3-year OS was 91.4% for AI and 79.2% for GD (hazard ratio 2.55, 95% confidence interval: 0.80–8.14, P = 0.78), exceeding the prespecified non-inferiority margin in the second interim analysis. The estimated 3-year progression-free survival was 79.1% for AI and 59.1% for GD. The most common Grade 3–4 adverse events in the preoperative period were neutropenia (88.4%), anaemia (49.3%), and febrile neutropenia (36.2%) for AI and neutropenia (79.5%) and febrile neutropenia (17.8%) for GD. CONCLUSIONS: Although GD had relatively mild toxicity, the regimen—as administered in this study—should not be considered a standard treatment of perioperative chemotherapy for high-risk STS in the extremities and trunk. CLINICAL TRIAL REGISTRATION: jRCTs031180003. |
format | Online Article Text |
id | pubmed-9553903 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-95539032022-10-13 Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 Tanaka, Kazuhiro Machida, Ryunosuke Kawai, Akira Nakayama, Robert Tsukushi, Satoshi Asanuma, Kunihiro Matsumoto, Yoshihiro Hiraga, Hiroaki Hiraoka, Koji Watanuki, Munenori Yonemoto, Tsukasa Abe, Satoshi Katagiri, Hirohisa Nishida, Yoshihiro Nagano, Akihito Suehara, Yoshiyuki Kawashima, Hiroyuki Kawano, Masanori Morii, Takeshi Hatano, Hiroshi Toguchida, Junya Okuma, Tomotake Takeyama, Masanobu Takenaka, Satoshi Akisue, Toshihiro Furuta, Taisuke Emori, Makoto Hiruma, Toru Outani, Hidetatsu Yamamoto, Tetsuji Kataoka, Tomoko Fukuda, Haruhiko Ozaki, Toshifumi Iwamoto, Yukihide Br J Cancer Article BACKGROUND: This randomised phase II/III trial aimed to determine whether perioperative chemotherapy with gemcitabine plus docetaxel (GD) is non-inferior to the standard Adriamycin plus ifosfamide (AI) in terms of overall survival (OS) in patients with soft tissue sarcoma (STS). METHODS: Patients with localised high-risk STS in the extremities or trunk were randomised to receive AI or GD. The treatments were repeated for three preoperative and two postoperative courses. The primary endpoint was OS. RESULTS: Among 143 enrolled patients who received AI (70 patients) compared to GD (73 patients), the estimated 3-year OS was 91.4% for AI and 79.2% for GD (hazard ratio 2.55, 95% confidence interval: 0.80–8.14, P = 0.78), exceeding the prespecified non-inferiority margin in the second interim analysis. The estimated 3-year progression-free survival was 79.1% for AI and 59.1% for GD. The most common Grade 3–4 adverse events in the preoperative period were neutropenia (88.4%), anaemia (49.3%), and febrile neutropenia (36.2%) for AI and neutropenia (79.5%) and febrile neutropenia (17.8%) for GD. CONCLUSIONS: Although GD had relatively mild toxicity, the regimen—as administered in this study—should not be considered a standard treatment of perioperative chemotherapy for high-risk STS in the extremities and trunk. CLINICAL TRIAL REGISTRATION: jRCTs031180003. Nature Publishing Group UK 2022-07-23 2022-11-01 /pmc/articles/PMC9553903/ /pubmed/35871234 http://dx.doi.org/10.1038/s41416-022-01912-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as 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. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Tanaka, Kazuhiro Machida, Ryunosuke Kawai, Akira Nakayama, Robert Tsukushi, Satoshi Asanuma, Kunihiro Matsumoto, Yoshihiro Hiraga, Hiroaki Hiraoka, Koji Watanuki, Munenori Yonemoto, Tsukasa Abe, Satoshi Katagiri, Hirohisa Nishida, Yoshihiro Nagano, Akihito Suehara, Yoshiyuki Kawashima, Hiroyuki Kawano, Masanori Morii, Takeshi Hatano, Hiroshi Toguchida, Junya Okuma, Tomotake Takeyama, Masanobu Takenaka, Satoshi Akisue, Toshihiro Furuta, Taisuke Emori, Makoto Hiruma, Toru Outani, Hidetatsu Yamamoto, Tetsuji Kataoka, Tomoko Fukuda, Haruhiko Ozaki, Toshifumi Iwamoto, Yukihide Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title | Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title_full | Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title_fullStr | Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title_full_unstemmed | Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title_short | Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306 |
title_sort | perioperative adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase ii/iii study jcog1306 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9553903/ https://www.ncbi.nlm.nih.gov/pubmed/35871234 http://dx.doi.org/10.1038/s41416-022-01912-5 |
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