title: [Nab-Paclitaxel plus Gemcitabine Hydrochloride in Patients with Metastatic or Recurrent Pancreatic Cancer - A Single Institution Experience].
abstract: BACKGROUND
  Pancreatic adenocarcinoma is one of the leading causes of cancer deaths in Japan.Albumin -bound paclitaxel (nab-paclitaxel)plus gemcitabine hydrochloride(GEM)combination chemotherapy provided significant improvements in the overall and progression-free survival in a phase III trial in Europe and America and a phase II trial in Japan.As a result, this combination therapy was approved for use in Japan.
  
  
  METHODS
  We evaluated the efficacy of nab-paclitaxel plus GEM with metastatic or recurrent pancreatic cancer.Between December 2014 and March 2016, 11 patients received nab-paclitaxel plus GEM as follows: nab-paclitaxel(125mg/m2 of body-surface area)followed by GEM(1,000mg/m2)on days 1, 8, and 15 every 4 weeks.The treatment was continued until disease progression, unacceptable adverse events, discontinuation as decided by the investigators, or patient refusal.
  
  
  RESULTS
  The mean age was 65.6 years(range, 48-75 years), and 8 out of 11 patients were men.Ten patients had an Eastern Cooperative Oncology Group(ECOG)performance status(PS)of 0.Ten patients had metastatic disease.Only 4 patients had no prior therapy.The mean duration of treatment was 10.2 weeks(range, 2-41 weeks).The relative dose intensities of nab-paclitaxel and GEM were 90.6%(66.7-100%)and 87.5%(62.9-100%), respectively.The major Grade 3 or 4 hematological toxicities were leucopenia(54.5%), neutropenia(36.4%), anemia (27.3%), and thrombocytopenia(18.2%).The major grade 2 or 3 non-hematological toxicities were fatigue(45.6%), skin rash(27.3%), peripheral sensory neuropathy(9.1%), anorexia(9.1%), and stomatitis(9.1%).There were no treatmentrelated deaths.Interstitial lung disease was not observed.The 6 month progression-free and overall survival rate were 25.7% and 66.7%, respectively. The disease control rate was 90.9%(complete response, n=0; partial response, n=1; stable disease, n=9; progressive disease, n=1).
  
  
  CONCLUSIONS
  Nab-paclitaxel plus GEM is well tolerated and associated with efficacy and improved survival outcomes.Nab -paclitaxel plus GEM can be the standard treatment for patients with metastatic pancreatic adenocarcinoma.
authors.affiliation: Dept. of Surgery, Kansai Rosai Hospital.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takeda
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Katsura
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ohmura
authors.forename: Takuya
authors.initials: T
authors.lastname: Sakamoto
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Akiyama
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Kuwahara
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morimoto
authors.forename: Tomo
authors.initials: T
authors.lastname: Ishida
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Oneda
authors.forename: Kouhei
authors.initials: K
authors.lastname: Murakami
authors.forename: Atsushi
authors.initials: A
authors.lastname: Naito
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Kagawa
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takeno
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kato
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
mesh_terms: D000368:Aged; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine