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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
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.
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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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