論文

査読有り
2019年4月

Thalidomide maintenance therapy in Japanese myeloma patients: a multicenter, phase II clinical trial (COMET study).

International journal of hematology
  • Hirokazu Murakami
  • ,
  • Tetsuhiro Kasamatsu
  • ,
  • Jun Murakami
  • ,
  • Toru Kiguchi
  • ,
  • Takeshi Kanematsu
  • ,
  • Daisuke Ogawa
  • ,
  • Hiroyuki Takamatsu
  • ,
  • Hiroshi Handa
  • ,
  • Shuji Ozaki
  • ,
  • Hirokazu Miki
  • ,
  • Takeshi Takahashi
  • ,
  • Takaaki Takeo
  • ,
  • Tatsuya Yamauchi
  • ,
  • Takanobu Morishita
  • ,
  • Hiroshi Kosugi
  • ,
  • Kazuyuki Shimizu

109
4
開始ページ
409
終了ページ
417
記述言語
英語
掲載種別
DOI
10.1007/s12185-019-02607-z

A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.

リンク情報
DOI
https://doi.org/10.1007/s12185-019-02607-z
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30701467