title: Phase II trial of combined regional hyperthermia and gemcitabine for locally advanced or metastatic pancreatic cancer.
abstract: OBJECTIVE
  Despite advances in cancer therapy, treating pancreatic cancer remains one of the major challenges in the field of medical oncology. We conducted this phase II study to evaluate the efficacy and safety of regional hyperthermia combined with gemcitabine for the treatment of unresectable advanced pancreatic cancer.
  
  
  METHODS
  Eligibility criteria included histologically proven, locally advanced or metastatic pancreatic cancer. Gemcitabine was administered intravenously at a dose of 1000 mg/m(2) on days 1, 8, and 15 every 4 weeks. Regional hyperthermia was performed once weekly, 1 day preceding or following gemcitabine administration. The primary end point was the 1-year survival rate. Secondary objectives were determination of tumour response and safety.
  
  
  RESULTS
  We enrolled 18 patients with advanced pancreatic cancer between November 2008 and May 2010. The major grade 3-4 adverse events were neutropenia and anaemia; however, there were no episodes of infection. The objective response rate (ORR) and disease control rate (ORR + stable disease) were 11.1% and 61.1%, respectively. Median overall survival (OS) was 8 months, and the 1-year survival rate was 33.3%. Median OS of patients with locally advanced pancreatic cancer was 17.7 months.
  
  
  CONCLUSIONS
  Regional hyperthermia combined with gemcitabine is well tolerated and active in patients with locally advanced pancreatic cancer.
authors: Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors: Takeshi
authors: T
authors: Ishikawa
authors: Satoshi
authors: S
authors: Kokura
authors: Naoyuki
authors: N
authors: Sakamoto
authors: Takashi
authors: T
authors: Ando
authors: Eiko
authors: E
authors: Imamoto
authors: Takeshi
authors: T
authors: Hattori
authors: Hirokazu
authors: H
authors: Oyamada
authors: Naomi
authors: N
authors: Yoshinami
authors: Masafumi
authors: M
authors: Sakamoto
authors: Kazutomo
authors: K
authors: Kitagawa
authors: Yoko
authors: Y
authors: Okumura
authors: Naohisa
authors: N
authors: Yoshida
authors: Kazuhiro
authors: K
authors: Kamada
authors: Kazuhiro
authors: K
authors: Katada
authors: Kazuhiko
authors: K
authors: Uchiyama
authors: Osamu
authors: O
authors: Handa
authors: Tomohisa
authors: T
authors: Takagi
authors: Hiroaki
authors: H
authors: Yasuda
authors: Junichi
authors: J
authors: Sakagami
authors: Hideyuki
authors: H
authors: Konishi
authors: Nobuaki
authors: N
authors: Yagi
authors: Yuji
authors: Y
authors: Naito
authors: Toshikazu
authors: T
authors: Yoshikawa
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine