title: Quality of life in the trastuzumab for gastric cancer trial.
abstract: BACKGROUND
  The Trastuzumab for Gastric Cancer phase III trial demonstrated that combining trastuzumab with chemotherapy significantly improved overall survival compared with chemotherapy alone in HER2-positive advanced gastric or gastroesophageal junction cancer. We report health-related quality of life (HRQoL) and quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) results from this trial.
  
  
  METHODS
  Patients were randomized to receive six cycles of chemotherapy given every 3 weeks (capecitabine or fluorouracil, plus cisplatin) either alone or combined with administration of trastuzumab every 3 weeks until disease progression. At each clinical visit, HRQoL was assessed using two European Organization for Research and Treatment of Cancer quality of life questionnaires, QLQ-C30 and QLQ-STO22. Q-TWiST methodology was applied retrospectively using the clinical data and utility coefficients.
  
  
  RESULTS
  Trastuzumab plus chemotherapy prolonged time to 10% definitive deterioration in all QLQ-C30 and QLQ-STO22 scores, including QLQ-C30 global health status versus chemotherapy alone, from 6.4 months to 10.2 months. In addition, trastuzumab plus chemotherapy extended Q-TWiST by 2.42 months compared with chemotherapy alone.
  
  
  CONCLUSIONS
  Compared with chemotherapy alone, trastuzumab plus chemotherapy prolongs time to deterioration of HRQoL and increases quality-adjusted survival in patients with HER2-positive gastric or gastroesophageal junction cancer.
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea tarohsatoh@hotmail.com taroh@cfs.med.osaka-u.ac.jp.
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Evgeny A
authors.initials: EA
authors.lastname: Gotovkin
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hamamoto
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Vladimir M
authors.initials: VM
authors.lastname: Moiseyenko
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Eric
authors.initials: E
authors.lastname: Van Cutsem
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Nedal
authors.initials: N
authors.lastname: Al-Sakaff
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Alexa
authors.initials: A
authors.lastname: Urspruch
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Julie
authors.initials: J
authors.lastname: Hill
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Harald A
authors.initials: HA
authors.lastname: Weber
authors.affiliation: Osaka University Graduate School of Medicine, Osaka, Japan; Seoul National University College of Medicine, Seoul, Republic of Korea; Ivanovo Regional Oncology Dispensary, Ivanovo, Russian Federation; Tochigi Cancer Center, Utsunomiya, Japan; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; Institute of Oncology, St. Petersburg, Russian Federation; National Cancer Center Hospital East, Kashiwa, Japan; University Hospital Gasthuisberg, Leuven, Belgium; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Roche Products, Sydney, New South Wales, Australia; Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hyun-Cheol
authors.initials: HC
authors.lastname: Chung
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000201:enzymology; D011795:Surveys and Questionnaires; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D002945:Cisplatin; D003841:Deoxycytidine; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Chemotherapy; Gastric cancer; HER2; Quality of life; Trastuzumab