title: Retrospective inter- and intra-patient evaluation of trabectedin after best supportive care for patients with advanced translocation-related sarcoma after failure of standard chemotherapy.
abstract: OBJECTIVE
  Our randomised phase II study showed the clinical benefit of trabectedin compared with best supportive care (BSC) in patients with advanced translocation-related sarcomas after the failure of standard chemotherapy. The aim of the present study was to evaluate efficacy and safety of trabectedin in the identical patients crossed over to trabectedin after disease progression in the BSC arm of the randomised study.
  
  
  METHODS
  This was a single-arm study of the BSC patients of the randomised study in whom disease progressed. Trabectedin (1.2 mg/m(2)) was administered over 24 h on day 1 of a 21-d treatment cycle. The efficacy and safety of trabectedin after BSC were evaluated and retrospectively compared with the results of the randomised study.
  
  
  RESULTS
  Thirty patients crossed over to trabectedin. Median progression-free survival (PFS) was 7.3 months (95% confidence interval [CI]: 2.9-9.1) after crossover compared with 0.9 months (95% CI: 0.9-1.0) at BSC in the randomised study. PFS in the present study was comparable to that of the trabectedin arm in the randomised study. The number of patients with growth modulation index ≥1.33 was 25 (86%). Individual tumour volume was decreased in 11 patients after crossover. Adverse drug reactions (ADRs) were observed in 27 patients (96.4%). ADRs of grade III-IV were mainly bone marrow suppression and abnormal liver functions.
  
  
  CONCLUSIONS
  Trabectedin was revealed to be effective and well tolerated in the identical patients crossed over to trabectedin after disease progression in BSC. The present study is registered with the Japan Pharmaceutical Information Center, number JapicCTI-121853.
authors: Department of Orthopaedic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka 537-8511, Japan. Electronic address: nobaraki@nifty.com.
authors: Nobuhito
authors: N
authors: Araki
authors: Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan.
authors: Shunji
authors: S
authors: Takahashi
authors: Department of Orthopaedic Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan; Department of Physical Therapy, Nagoya University School of Health Sciences, Nagoya 461-8673, Japan.
authors: Hideshi
authors: H
authors: Sugiura
authors: Department of Orthopaedic Surgery, Osaka National Hospital, Osaka 540-0006, Japan.
authors: Takafumi
authors: T
authors: Ueda
authors: Division of Orthopaedic Surgery, Chiba Cancer Center, Chiba 260-8717, Japan.
authors: Tsukasa
authors: T
authors: Yonemoto
authors: Division of Orthopaedic Surgery, Shizuoka Cancer Center Hospital, Shizuoka 411-8777, Japan.
authors: Mitsuru
authors: M
authors: Takahashi
authors: Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo 160-8582, Japan.
authors: Hideo
authors: H
authors: Morioka
authors: Department of Orthopaedic Surgery, Hokkaido Cancer Center, Hokkaido 003-0804, Japan.
authors: Hiroaki
authors: H
authors: Hiraga
authors: Department of Musculoskeletal Tumor Surgery, Kanagawa Cancer Center, Yokohama 241-8515, Japan.
authors: Toru
authors: T
authors: Hiruma
authors: Department of Medical Materials for Musculoskeletal Reconstruction, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama 700-8558, Japan.
authors: Toshiyuki
authors: T
authors: Kunisada
authors: Department of Orthopedic Surgery, Mie University Graduate School of Medicine, Mie 514-8507, Japan.
authors: Akihiko
authors: A
authors: Matsumine
authors: Department of Musculoskeletal Oncology, Rare Cancer Center, National Cancer Center Hospital, Tokyo 104-0045, Japan.
authors: Akira
authors: A
authors: Kawai
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D018592:Cross-Over Studies; D004149:Dioxoles / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D057915:Drug Substitution; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D000077606:Trabectedin; D014178:Translocation, Genetic; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
keywords: Crossover; Intra-patient; Retrospective analysis; Soft tissue sarcoma; Trabectedin; Translocation-related sarcoma