title: Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer.
abstract: OBJECTIVE
  NK105 is a new drug delivery system formulation for paclitaxel (PTX) whose recommended dose (RD) is 150 mg PTX equivalent/m(2) administered every 3 weeks, as determined in a phase I trial. This study aimed to evaluate the efficacy and safety of NK105 in patients with advanced gastric cancer after failure of first-line chemotherapy.
  
  
  METHODS
  Eligible patients had measurable disease and one chemotherapeutic regimen except taxane. NK105 (150 mg PTX equivalent/m(2)) was administered by a 30-minute intravenous infusion every 3 weeks without anti-allergic premedication until disease progression, unacceptable toxicity or patient refusal. The primary efficacy endpoint was best overall response rate (ORR) post baseline. The secondary endpoints were progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS). All adverse events were reported using CTCAE v3.0.
  
  
  RESULTS
  Between November 2007 and July 2009, 57 patients were enrolled and 56 were evaluable for efficacy. Two complete responses and 12 partial responses were observed for an ORR of 25%. The median PFS was 3.0 months, the median TTF was 2.8 months, and the median OS was 14.4 months. Drug related toxicity was mainly mild (grades 1-2) to severe (grades 3-4); other data: neutropenia (64.9%); leukopenia (17.5%); lymphopenia (8.8%); neuropathy-sensory (1.8%); fatigue (3.5%); and stomatitis (1.8%). There were no treatment-related deaths.
  
  
  CONCLUSIONS
  This study of NK105 (150 mg PTX equivalent/m(2)) proves the concept for the modest activity and tolerability of a new drug delivery system formulation for PTX. A phase III trial will be evaluated to clarify survival benefit.
authors: Gastrointestinal Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku 104-0045, Tokyo, Japan. kenkato@ncc.go.jp
authors: Ken
authors: K
authors: Kato
authors: Keisho
authors: K
authors: Chin
authors: Takaki
authors: T
authors: Yoshikawa
authors: Kensei
authors: K
authors: Yamaguchi
authors: Yasushi
authors: Y
authors: Tsuji
authors: Taito
authors: T
authors: Esaki
authors: Kenji
authors: K
authors: Sakai
authors: Masami
authors: M
authors: Kimura
authors: Tetsuya
authors: T
authors: Hamaguchi
authors: Yasuhiro
authors: Y
authors: Shimada
authors: Yasuhiro
authors: Y
authors: Matsumura
authors: Ryuji
authors: R
authors: Ikeda
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D003710:Demography; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008823:Micelles; D008875:Middle Aged; D053758:Nanoparticles / Q000737:chemistry*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D008823:Micelles; C500671:NK105; D017239:Paclitaxel