Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306
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Published:2022-07-23
Issue:8
Volume:127
Page:1487-1496
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ISSN:0007-0920
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Container-title:British Journal of Cancer
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language:en
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Short-container-title:Br J Cancer
Author:
Tanaka KazuhiroORCID, 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 YoshihiroORCID, 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
Abstract
Abstract
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.
Funder
Japan Agency for Medical Research and Development National Cancer Center Research and Development Fund
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Oncology
Reference31 articles.
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