Perioperative Adriamycin plus ifosfamide vs. gemcitabine plus docetaxel for high-risk soft tissue sarcomas: randomised, phase II/III study JCOG1306

Kazuhiro Tanaka, Ryunosuke Machida, Akira Kawai, Robert Nakayama, Satoshi Tsukushi, Kunihiro Asanuma, Yoshihiro Matsumoto, Hiroaki Hiraga, Koji Hiraoka, Munenori Watanuki, Tsukasa Yonemoto, Satoshi Abe, Hirohisa Katagiri, Yoshihiro Nishida, Akihito Nagano, Yoshiyuki Suehara, Hiroyuki Kawashima, Masanori Kawano, Takeshi Morii, Hiroshi HatanoJunya Toguchida, Tomotake Okuma, Masanobu Takeyama, Satoshi Takenaka, Toshihiro Akisue, Taisuke Furuta, Makoto Emori, Toru Hiruma, Hidetatsu Outani, Tetsuji Yamamoto, Tomoko Kataoka, Haruhiko Fukuda, Toshifumi Ozaki, Yukihide Iwamoto

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalBritish Journal of Cancer
DOIs
Publication statusAccepted/In press - 2022

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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