Your browser doesn't support javascript.
loading
Evaluation of the representativeness and generalizability of Japanese clinical trials for localized rectal/colon cancer: Comparing participants in the Japan Clinical Oncology Group study with patients in Japanese registries.
Miyamoto, Kenichi; Wakabayashi, Masashi; Mizusawa, Junki; Nakamura, Kenichi; Katayama, Hiroshi; Higashi, Takahiro; Inomata, Masafumi; Kitano, Seigo; Fujita, Shin; Kanemitsu, Yukihide; Fukuda, Haruhiko.
Affiliation
  • Miyamoto K; Department of Hematology, National Cancer Center Hospital East, Chiba, Japan; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. Electronic address: sp9y5nm9@gmail.com.
  • Wakabayashi M; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Mizusawa J; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Nakamura K; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Katayama H; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
  • Higashi T; Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
  • Inomata M; Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita, Japan.
  • Kitano S; Oita University, Oita, Japan.
  • Fujita S; Department of Surgery, Tochigi Cancer Center, Tochigi, Japan.
  • Kanemitsu Y; Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
  • Fukuda H; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Eur J Surg Oncol ; 46(9): 1642-1648, 2020 09.
Article de En | MEDLINE | ID: mdl-32340817
ABSTRACT

INTRODUCTION:

It is unclear if clinical trial results including patients who meet trial eligibility criteria, are applicable to actual patients in daily practice (generalizability). Moreover, the extent to which are trial participants different from patients seen in daily practice (representativeness) is also unclear. The aim of this study was to evaluate the representativeness of the patients registered in randomized clinical trials to patients in daily practice and examine the generalizability of trial results to daily practice.

METHODS:

We compared the results of surgical trials conducted by the Japan Clinical Oncology Group with data from two Japanese cancer registries, representing patients seen in daily practice. We compared overall survival (OS) between trial participants and registry patients to evaluate representativeness of trial participants. We then compared the OS of registry patients who received open surgery (OP) and laparoscopic surgery (LAP) to evaluate the generalizability of trial results.

RESULTS:

We analyzed 3051 patients (701 in JCOG0212, 2350 registry patients) with rectal cancer and 3116 patients (1057 in JCOG0404, 2059 registry patients) with colon cancer. Trial participants tended to possess lower clinical stages. Multivariable analyses revealed registry patients with significantly worse survival compared with trial participants. The hazard ratio of LAP to OP among registry patients was 0.305 (95% CI; 0.048-2.188), which did not meet the prespecified generalizability criteria of 0.9.

CONCLUSIONS:

Our results failed to ensure either the representativeness or generalizability of clinical trial results, compared to daily practice. Careful considerations are required when applying trial results to patients in daily practice.
Sujet(s)
Mots clés

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Tumeurs du rectum / Laparoscopie / Colectomie / Tumeurs du côlon / Proctectomie / Lymphadénectomie Type d'étude: Clinical_trials / Prognostic_studies Limites: Adult / Aged / Female / Humans / Male / Middle aged Pays/Région comme sujet: Asia Langue: En Journal: Eur J Surg Oncol Sujet du journal: NEOPLASIAS Année: 2020 Type de document: Article

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Tumeurs du rectum / Laparoscopie / Colectomie / Tumeurs du côlon / Proctectomie / Lymphadénectomie Type d'étude: Clinical_trials / Prognostic_studies Limites: Adult / Aged / Female / Humans / Male / Middle aged Pays/Région comme sujet: Asia Langue: En Journal: Eur J Surg Oncol Sujet du journal: NEOPLASIAS Année: 2020 Type de document: Article