skip to main content
Show Results with:

Phase I trials in patients with relapsed, advanced upper gastrointestinal carcinomas: experience in a specialist unit

Gastric Cancer, 2014, Vol.17(4), pp.621-629 [Peer Reviewed Journal]

Full text available

  • Title:
    Phase I trials in patients with relapsed, advanced upper gastrointestinal carcinomas: experience in a specialist unit
  • Author: Khan, Khurum ; Ang, Joo ; Starling, Naureen ; Sclafani, Francesco ; Shah, Krunal ; Judson, Ian ; Molife, L. ; Banerji, Udai ; Bono, Johann ; Cunningham, David ; Kaye, Stan
  • Found In: Gastric Cancer, 2014, Vol.17(4), pp.621-629 [Peer Reviewed Journal]
  • Subjects: Experimental therapy ; Oesophago-gastric cancer ; Pancreatic cancer ; Prognosticator of overall survival (OS) ; Phase I trials ; Upper GI cancers (UGIC)
  • Language: English
  • Description: Byline: Khurum Khan (1,4), Joo Ern Ang (1,2,3), Naureen Starling (1,4), Francesco Sclafani (4), Krunal Shah (1), Ian Judson (1), L. Rhoda Molife (1,3), Udai Banerji (1,2,3), Johann S. Bono (1,2,3), David Cunningham (4), Stan B. Kaye (1,2,3) Keywords: Experimental therapy; Oesophago-gastric cancer; Pancreatic cancer; Prognosticator of overall survival (OS); Phase I trials; Upper GI cancers (UGIC) Abstract: Background Conventional therapeutic options for patients with advanced upper gastrointestinal cancers (UGIC) are limited. Following first-line treatments, some patients are offered experimental therapies, including participation in Phase I trials. This study aims to describe the experience of UGIC patients treated in a dedicated Phase I unit. Methods Patient, tumour and treatment characteristics, and clinical outcomes of UGIC patients treated consecutively at the Drug Development Unit, Royal Marsden Hospital, between 2005 and 2009, were recorded. Results Ninety-six patients who previously received a median of 2 (range 1--4) lines of chemotherapies were treated in 30 Phase I trials. Of 81 evaluable patients, 9 achieved RECIST-objective response (11 %) with a 6-month clinical benefit rate of 14 %. Median progression free and overall survival were 7.7 weeks [95 %CI 7.7 (6.4--9.0)] and 19.1 weeks (95 %CI 17.5--20.8), respectively. Grade 3 or 4 toxicities were observed in 37 patients (39 %) and led to trial discontinuation in 9 (9 %) no toxicity-related death was recorded. In the multivariate analysis, serum albumin (<35 g/dl, HR2.0, p = 0.002) and lactate dehydrogenase (>192 [micro]mol/l, HR1.7, p = 0.016) were prognostic of overall survival. Conclusion Phase I clinical trials can be considered a reasonable option in selected patients with relapsed UGIC. The use of objective prognosticators may improve selection and risk/benefit profile of patients. Author Affiliation: (1) Drug Development Unit, Sycamore House, The Royal Marsden NHS Foundation Trust, Sutton, SM2 5PT, UK (2) Division of Cancer Therapeutics, The Institute of Cancer Research, Sutton, SM2 5NG, UK (3) Division of Clinical Studies, The Institute of Cancer Research, Sutton, SM2 5NG, UK (4) Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, Sutton, SM2 5PT, UK Article History: Registration Date: 24/12/2013 Received Date: 14/05/2013 Accepted Date: 16/12/2013 Online Date: 21/01/2014 Article note: K. Khan and J.E. Ang contributed equally to this work and are joint first authors.
  • Identifier: ISSN: 1436-3291 ; E-ISSN: 1436-3305 ; DOI: 10.1007/s10120-013-0328-9

Searching Remote Databases, Please Wait