Abstract | BACKGROUND: METHODS: Five subjects with EMCS and MCS received trabectedin treatment in the randomized phase 2 study. Three MCS subjects were allocated to the BSC group. Objective response and progression-free survival (PFS) were assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by central radiology imaging review. RESULTS: The median follow-up time of the randomized phase 2 study was 22.7 months, and one subject with MCS was still receiving trabectedin treatment at the final data cutoff. The median PFS was 12.5 months (95 % CI: 7.4-not reached) in the trabectedin group, while 1.0 months (95 % CI: 0.3-1.0 months) in MCS subjects of the BSC group. The six-month progression-free rate was 100 % in the trabectedin group. One subject with MCS showed partial response, and the others in the trabectedin group showed stable disease. Overall survival of EMCS and MCS subjects was 26.4 months (range, 10.4-26.4 months) in the trabectedin group. At the final data cutoff, two of five subjects were still alive. CONCLUSIONS: This sub-analysis shows that trabectedin is effective for patients with EMCS and MCS compared with BSC. The efficacy results were better than previously reported data of TRS. These facts suggest that trabectedin become an important choice of treatment for patients with advanced EMCS or MCS who failed or were intolerable to standard chemotherapy. TRIAL REGISTRATION: The randomized phase 2 study is registered with the Japan Pharmaceutical Information Center, number JapicCTI-121850 (May 31, 2012).
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Authors | Hideo Morioka, Shunji Takahashi, Nobuhito Araki, Hideshi Sugiura, Takafumi Ueda, Mitsuru Takahashi, Tsukasa Yonemoto, Hiroaki Hiraga, Toru Hiruma, Toshiyuki Kunisada, Akihiko Matsumine, Michiro Susa, Robert Nakayama, Kazumasa Nishimoto, Kazutaka Kikuta, Keisuke Horiuchi, Akira Kawai |
Journal | BMC cancer
(BMC Cancer)
Vol. 16
Pg. 479
(07 14 2016)
ISSN: 1471-2407 [Electronic] England |
PMID | 27418251
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antineoplastic Agents, Alkylating
- Dioxoles
- Tetrahydroisoquinolines
- Trabectedin
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Topics |
- Adult
- Aged
- Antineoplastic Agents, Alkylating
(therapeutic use)
- Bone Neoplasms
(drug therapy, mortality)
- Chondrosarcoma
(drug therapy, mortality)
- Chondrosarcoma, Mesenchymal
(drug therapy, mortality)
- Dioxoles
(therapeutic use)
- Disease-Free Survival
- Humans
- Kaplan-Meier Estimate
- Middle Aged
- Neoplasms, Connective and Soft Tissue
(drug therapy, mortality)
- Tetrahydroisoquinolines
(therapeutic use)
- Trabectedin
- Treatment Outcome
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