title: Efficacy and safety of re-induction therapy with bevacizumab and paclitaxel for metastatic breast cancer.
abstract: BACKGROUND
  In many trials (including E2100), bevacizumab (Bmab) monotherapy has been continued if toxicity of paclitaxel (PTX) becomes unacceptable during combined treatment with Bmab and PTX. When progression occurs on Bmab monotherapy, one possible option is re-induction with the combination of Bmab and PTX (rBP therapy), because PTX was previously stopped due to toxicity rather than progression. However, we have no data about rBP therapy. Therefore, we investigated the efficacy and safety of rBP therapy in this study.
  
  
  METHODS
  We retrospectively investigated 46 patients who started Bmab and PTX between October 2011 and April 2013 at our institution.
  
  
  RESULTS
  After induction with Bmab and PTX, 19 patients subsequently received Bmab monotherapy and 12 patients received rBP therapy. The overall response rate and clinical benefit rate of rBP therapy was 25 % (3/12) and 58 % (7/12), respectively, while the median time to failure of rBP therapy was 174 days (95 % CI 49-273). The median overall survival time of the 46 patients was 777 days (95 % CI 543-NA). Adverse events of grade 3 or worse associated with rBP therapy were neutropenia (25 %), fatigue (8 %), and gastrointestinal bleeding (8 %).
  
  
  CONCLUSIONS
  This is the first report about rBP therapy, which was found to be both safe and effective. The OS of all 46 patients in this study (including 12 patients given rBP therapy) was better than in past reports. Selecting rBP therapy for patients with progression on Bmab monotherapy might have contributed to better overall survival, but a randomized controlled trial will be needed to confirm these findings.
authors.affiliation: Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan. yosinami-te@mc.pref.osaka.jp.
authors.forename: Tetsuhiro
authors.initials: T
authors.lastname: Yoshinami
authors.affiliation: Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Toshinari
authors.initials: T
authors.lastname: Yagi
authors.affiliation: Department of Breast Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Okuno
authors.affiliation: Department of Breast Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Nobuyoshi
authors.initials: N
authors.lastname: Kittaka
authors.affiliation: Department of Breast Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Ishitobi
authors.affiliation: Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Naotoshi
authors.initials: N
authors.lastname: Sugimoto
authors.affiliation: Department of Breast Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakayama
authors.affiliation: Department of Breast Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tamaki
authors.affiliation: Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan.
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000068258:Bevacizumab; D017239:Paclitaxel
keywords: Bevacizumab with paclitaxel; Metastatic breast cancer; Re-induction therapy