title: Phase II study of the effectiveness and safety of trastuzumab and paclitaxel for taxane- and trastuzumab-naïve patients with HER2-positive, previously treated, advanced, or recurrent gastric cancer (JFMC45-1102).
abstract: Paclitaxel is a standard second-line gastric cancer treatment in Japan. Trastuzumab could be active as second-line chemotherapy for taxane/trastuzumab-naïve patients with epidermal growth factor 2 (HER2)-positive advanced gastric cancer. Patients aged ≥20 years with HER2-positive, previously treated (except for trastuzumab and taxane), unresectable or recurrent gastric adenocarcinoma underwent combined trastuzumab (first and subsequent doses of 8 and 6 mg kg-1, respectively, every 3 weeks) and paclitaxel (days 1, 8, 15, every 4 weeks) treatment. Study endpoints were best overall response, progression-free survival, overall survival, and safety. From September 2011 to March 2012, 47 Japanese patients were enrolled. Forty patients discontinued treatment after a median of 128.5 (range 4-486) days. Complete and partial responses were obtained in one and 16 patients (response rate of 37% [95% CI 23-52]), respectively. Median progression-free survival and overall survival were 5.1 (95% CI 3.8-6.5) and 17.1 (95% CI 13.5-18.6) months, respectively. Grade 3/4 adverse events were neutropenia (32.6%), leukopenia (17.4%), anemia (15.2%) and hypoalbuminemia (8.7%). There was no clinically significant cardiotoxicity or cumulative toxicity. Three (disturbed consciousness, pulmonary fibrosis, and rapid disease progression) grade 5 events occurred. In conclusion, trastuzumab combined with paclitaxel was well tolerated and was a promising regimen for patients with HER2-positive, previously treated, advanced or recurrent gastric cancer.
authors: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors: Kazuhiro
authors: K
authors: Nishikawa
authors: Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
authors: Tsunehiro
authors: T
authors: Takahashi
authors: Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine, Tokyo, Japan.
authors: Hiromasa
authors: H
authors: Takaishi
authors: Department of Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
authors: Akira
authors: A
authors: Miki
authors: Department of Surgery, Saga University, Faculty of Medicine, Saga, Japan.
authors: Hirokazu
authors: H
authors: Noshiro
authors: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors: Takaki
authors: T
authors: Yoshikawa
authors: Department of Surgery, Keiyukai Sapporo Hospital, Sapporo, Japan.
authors: Yasunori
authors: Y
authors: Nishida
authors: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors: Satoru
authors: S
authors: Iwasa
authors: Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors: Hiroto
authors: H
authors: Miwa
authors: Department of Gastroenterology, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan.
authors: Toshiki
authors: T
authors: Masuishi
authors: Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
authors: Narikazu
authors: N
authors: Boku
authors: Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
authors: Yasuhide
authors: Y
authors: Yamada
authors: Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors: Yasuhiro
authors: Y
authors: Kodera
authors: Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan.
authors: Kazuhiro
authors: K
authors: Yoshida
authors: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors: Satoshi
authors: S
authors: Morita
authors: Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
authors: Junichi
authors: J
authors: Sakamoto
authors: Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
authors: Shigetoyo
authors: S
authors: Saji
authors: Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
authors: Yuko
authors: Y
authors: Kitagawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000378:metabolism; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D016019:Survival Analysis; D000068878:Trastuzumab / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab
keywords: human epidermal growth factor receptor; paclitaxel; recurrence; stomach neoplasms; trastuzumab