Capecitabine in Combination with Endocrine Therapy as Maintenance Therapy after Bevacizumab Plus Paclitaxel Induction Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: KBCSG-TR1214

Cancers

Junji Tsurutani¹  Mitsuhiko Iwamoto²  Satoshi Morita³  Miki Yamaguchi⁴  Hirotaka Morishima⁵  Tsutomu Takashima⁶  Takahiro Nakayama⁷  Katsuhide Yoshidome⁸  Masahiko Ikeda⁹  Tomomi Yamada^1,10  Fumie Fujisawa^1,11  Tetsuhiro Yoshinami^1,11  Yoshifumi Komoike^1,12  Norikazu Masuda^1,13  Makiko Mizutani^1,13  Hiroyuki Yasojima^1,13  Jun Yamamura^1,14  Fuminori Aki^1,15 

[1] Advanced Cancer Translation Research Institute, Showa University, 1-5-8 Hatanodai, Shinagawa-ku 142-8555, Tokyo, Japan;Breast and Endocrine Surgery, Osaka Medical College, 2-7 Daigakumachi, Takatsuki-shi 569-8686, Osaka, Japan;Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-shi 606-8507, Kyoto, Japan;Department of Breast Surgery, JCHO Kurume General Hospital, 21 Kushiharamachi, Kurume-shi 830-0013, Fukuoka, Japan;Department of Breast Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kitaku, Sakai-shi 591-8025, Osaka, Japan;Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka City University, 1-4-3 Asahi-machi, Abeno-ku, Osaka-shi 545-8585, Osaka, Japan;Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka-shi 541-8567, Osaka, Japan;Department of Breast and Endocrine Surgery, Osaka Police Hospital, 10-31 Kitayama-cho, Tennouji-ku, Osaka-shi 543-0035, Osaka, Japan;Department of Breast and Thyroid Surgery, Fukuyama City Hospital, 5-23-1 Zao-cho, Fukuyama-shi 721-8511, Hiroshima, Japan;Department of Medical Innovation, Osaka University Hospital, 2-2, Yamadaoka, Suita-shi 565-0871, Osaka, Japan;Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka-shi 541-8567, Osaka, Japan;Department of Medicine, Kindai University Hospital, 377-2 Ohnohigashi, Osaka-Sayama-shi 589-8511, Osaka, Japan;Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuou-ku, Osaka-shi 540-0006, Osaka, Japan;Department of Surgery, Sakai City Medical Center, 1-1-1 Ebaraji-cho, Nishi-ku, Sakai-shi 593-8304, Osaka, Japan;Ito Surgical Mammary Gland Clinic, 12-10 Fudaba, Kochi-shi 781-0085, Kochi, Japan;

关键词: advanced and metastatic breast cancer;    bevacizumab;    capecitabine;    endocrine therapy;    hormone receptor positive;    HER2-negative breast cancer;   

DOI  :  10.3390/cancers13174399

来源: DOAJ

【 摘 要 】

Optimal treatment strategies for hormone receptor (HR)-positive, HER2-negative advanced and/or metastatic breast cancer (AMBC) remain uncertain. We investigated the clinical usefulness of adding capecitabine to maintenance endocrine therapy after induction chemotherapy and the efficacy of reinduction chemotherapy. Patients who had received bevacizumab–paclitaxel induction therapy and did not have progressive disease (PD) were randomized to maintenance therapy with endocrine therapy alone (group E) or endocrine plus capecitabine (1657 mg/m²/day on days 1–21, q4w) (group EC). In case of PD after maintenance therapy, patients received bevacizumab–paclitaxel reinduction therapy. Ninety patients were randomized. The median progression-free survival (PFS) under maintenance therapy (primary endpoint) was significantly longer in group EC (11.1 {95% CI, 8.0–11.8} months) than in group E (4.3 {3.6–6.0} months) (hazard ratio, 0.53; p < 0.01). At 24 months from the induction therapy start, the overall survival (OS) was significantly longer in group EC than in group E (hazard ratio, 0.41; p = 0.046). No difference was found in the time to failure of strategy (13.9 and 16.6 months in groups E and EC, respectively). Increased capecitabine-associated toxicities in group EC were tolerable. Addition of capecitabine to maintenance endocrine therapy may be a beneficial option after induction chemotherapy for HR-positive, HER2-negative AMBC patients.

【 授权许可】

Unknown