論文

査読有り 国際誌
2018年10月

R-THP-COP versus R-CHOP in patients younger than 70 years with untreated diffuse large B cell lymphoma: A randomized, open-label, noninferiority phase 3 trial.

Hematological oncology
  • Takeshi Hara
  • ,
  • Takeshi Yoshikawa
  • ,
  • Hideko Goto
  • ,
  • Michio Sawada
  • ,
  • Toshiki Yamada
  • ,
  • Kenji Fukuno
  • ,
  • Senji Kasahara
  • ,
  • Yuhei Shibata
  • ,
  • Takuro Matsumoto
  • ,
  • Ryoko Mabuchi
  • ,
  • Nobuhiko Nakamura
  • ,
  • Hiroshi Nakamura
  • ,
  • Soranobu Ninomiya
  • ,
  • Junichi Kitagawa
  • ,
  • Nobuhiro Kanemura
  • ,
  • Yasuhito Nannya
  • ,
  • Naoki Katsumura
  • ,
  • Takeshi Takahashi
  • ,
  • Yusuke Kito
  • ,
  • Tsuyoshi Takami
  • ,
  • Tatsuhiko Miyazaki
  • ,
  • Tamotsu Takeuchi
  • ,
  • Masahito Shimizu
  • ,
  • Hisashi Tsurumi

36
4
開始ページ
638
終了ページ
644
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1002/hon.2524

Pirarubicin (tetrahydropyranyl adriamycin [THP]) is an anthracyclin with less cardiotoxicity than doxorubicin (DOX). We previously reported the efficacy and safety of R-THP-COP consisting of rituximab (R), THP, cyclophosphamide (CPA), vincristine (VCR), and prednisolone (PSL) for diffuse large B cell lymphoma (DLBCL) in phase 2 studies. Here, we prospectively compared the efficacy and safety of the R-THP-COP and standard R-CHOP regimen (consisting of R, CPA, DOX, VCR, and PSL) in a noninferiority phase 3 trial. This prospective, randomized phase 3 study included patients younger than 70 years of age with previously untreated DLBCL. The regimen consisted of R (day 1), DOX, or THP (day 3), CPA (day 3), VCR (day 3), and PSL for 5 days every 3 weeks for 6 to 8 cycles. Between July 5, 2006 and June 11, 2013, 81 patients were randomly assigned to the treatment groups (R-CHOP group, 40 patients; R-THP-COP group, 41 patients). R-THP-COP was noninferior to R-CHOP, as assessed by the primary endpoint of complete response rate (85% vs 85% respectively). With a median follow-up of 75.2 months, the 5-year overall survival was 87% in the R-CHOP group and 82% in the R-THP-COP group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.31-2.49; P = .82). The 5-year progression-free survival was 74% in the R-CHOP group and 79% in the R-THP-COP group (HR: 1.37, 95% CI: 0.56-3.55; P = .49). No grade 3 cardiac side effects were observed in either group. No serious late adverse reactions were observed in either group, with the exception of therapy-related acute myeloid leukemia in the R-THP-COP group. These data indicate that R-THP-COP is noninferior to R-CHOP with regard to clinical response, and has an acceptable safety profile. Thus, this regimen may be an alternative therapy to R-CHOP.

リンク情報
DOI
https://doi.org/10.1002/hon.2524
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29882279

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