title: Effect of pre-operative short course famotidine on tumor infiltrating lymphocytes in colorectal cancer: a double blind, placebo controlled, prospective randomized study.
abstract: BACKGROUND
  Pilot studies have shown that histamine H2 receptor antagonists augment the natural immunity against cancer in colorectal and gastric cancer by enhancing lymphocytic infiltration in the tumors. However, a study of adjuvant ranitidine failed to show a significant benefit in colorectal cancer, possibly because of the immunosuppression exerted by blood transfusion and post-operative infections. The pre-operative use of H2 receptor antagonists may therefore be of greater benefit. Except for a pilot study using cimetidine, there are no trials that have evaluated the effect of pre-operative H2 receptor antagonists on tumor infiltrating lymphocytes in colorectal cancer.
  
  
  OBJECTIVE
  To evaluate the efficacy of famotidine in augmenting tumor infiltrating lymphocytes in colorectal cancer.
  
  
  METHODS
  Double blind, placebo controlled, prospective randomized study.
  
  
  METHODS
  Twenty-three patients with resectable colorectal cancer were randomized to receive famotidine (n = 11) or placebo (n = 12). Famotidine was given for 1 week pre-operatively in a dose of 40 mg per day p.o. After resection, the specimens were analyzed histologically for lymphocytic infiltration by a pathologist blinded to the two groups. Lymphocytic infiltration more than 50 cells per high power field, involving more than 50% of the tumor-normal tissue interface was considered significant.
  
  
  RESULTS
  The two groups were comparable for age, gender, pre-operative carcino embryonic antigen (CEA) levels and pathological stage. Significant lymphocytic infiltration was seen in 63.6% (7 of 11) patients in the study group compared to only 8.5% (1 of 12) patients in the placebo group (P = 0.005). Despite fewer recurrences and a longer survival in the study group, the difference was not significant.
  
  
  CONCLUSIONS
  This study shows that pre-operative famotidine may significantly enhance lymphocytic infiltration in colorectal cancer and may have potential for use as an anticancer agent in colorectal cancer.
authors.affiliation: Department of Gastrointestinal Surgery, All India Institute of Medical Sciences, New Delhi, India. sorabhkapoor@hotmail.com
authors.forename: Sorabh
authors.initials: S
authors.lastname: Kapoor
authors.forename: Sujoy
authors.initials: S
authors.lastname: Pal
authors.forename: Peush
authors.initials: P
authors.lastname: Sahni
authors.forename: Siddharth
authors.initials: S
authors.lastname: Dattagupta
authors.forename: Tushar
authors.initials: T
authors.lastname: Kanti Chattopadhyay
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001803:Blood Transfusion; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000401:mortality / Q000601:surgery; D004311:Double-Blind Method; D015738:Famotidine / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D006801:Humans; D016246:Lymphocytes, Tumor-Infiltrating / Q000187:drug effects* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010919:Placebos; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies
chemical_list: D000970:Antineoplastic Agents; D006635:Histamine H2 Antagonists; D010919:Placebos; D015738:Famotidine