title: Analysis of esophagogastric cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase 1 trials.
abstract: BACKGROUND
  In phase 1 trials, an important entry criterion is life expectancy predicted to be more than 90 days, which is generally difficult to predict. The Royal Marsden Hospital (RMH) prognostic score that is determined by lactate dehydrogenase level, albumin level, and number of metastatic sites of disease was developed to help project patient outcomes. There have been no systematic analyses to evaluate the utility of the RMH prognostic score for esophagogastric cancer patients.
  
  
  METHODS
  All nonpediatric phase 1 oncology trials sponsored by the National Cancer Institute Cancer Therapy Evaluation Program that began between 2001 and 2013 were considered in this review.
  
  
  RESULTS
  Of 4722 patients with solid tumors, 115 patients were eligible for our analysis; 54 (47 %) with cancer of the esophagus, 14 (12 %) with cancer of the esopagogastric junction, and 47 (41 %) with stomach cancer. Eighty-six patients (75 %) had a good RMH prognostic score (0 or 1) and 29 patients (25 %) had a poor RMH prognostic score (2 or 3). Disease control rates were significantly different between patients with good and poor RMH prognostic scores (49 % vs 17 %; two-sided Fisher's exact test P = 0.004). The median treatment duration and overall survival for good and poor RMH prognostic score patients were significantly different (median treatment duration 2.1 months vs 1.2 months respectively, P = 0.016; median overall survival 10.9 months vs 2.1 months respectively, P < 0.001). In the multivariate analysis, age (60 years or older), Eastern Cooperative Oncology Group performance status (2 or greater), and the RMH prognostic score (2 or 3) were significant predictors of poor survival.
  
  
  CONCLUSIONS
  The RMH prognostic score is a strong tool to predict the prognosis of esophagogastric cancer patients who might participate in a phase 1 trial.
authors: Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA. hbando@east.ncc.go.jp.|Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. hbando@east.ncc.go.jp.|Course of Advanced Clinical Research of Cancer, Juntendo University Graduate School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. hbando@east.ncc.go.jp.
authors: Hideaki
authors: http://orcid.org/0000-0001-5041-2765
authors: H
authors: Bando
authors: Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.
authors: Larry
authors: L
authors: Rubinstein
authors: Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.
authors: Pamela
authors: P
authors: Harris
authors: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors: Takayuki
authors: T
authors: Yoshino
authors: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors: Toshihiko
authors: T
authors: Doi
authors: Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.|Course of Advanced Clinical Research of Cancer, Juntendo University Graduate School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
authors: Atsushi
authors: A
authors: Ohtsu
authors: Center for Global Health, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.
authors: John
authors: J
authors: Welch
authors: Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Bethesda, MD, 20892, USA.
authors: Naoko
authors: N
authors: Takebe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017321:Clinical Trials, Phase I as Topic; D004938:Esophageal Neoplasms / Q000209:etiology* / Q000401:mortality / Q000473:pathology / Q000628:therapy; D004943:Esophagogastric Junction / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D054547:National Cancer Institute (U.S.); D018579:Patient Selection; D011379:Prognosis; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000209:etiology* / Q000401:mortality / Q000473:pathology / Q000628:therapy; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States
keywords: Cancer Therapy Evaluation Program; Esophagogastric cancer; National Cancer Institute; Phase 1 trials; Royal Marsden Hospital prognostic score