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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-01-21

AUTHORS

Khurum Khan, Joo Ern Ang, Naureen Starling, Francesco Sclafani, Krunal Shah, Ian Judson, L. Rhoda Molife, Udai Banerji, Johann S. de Bono, David Cunningham, Stan B. Kaye

ABSTRACT

BackgroundConventional 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.MethodsPatient, 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.ResultsNinety-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 μmol/l, HR1.7, p = 0.016) were prognostic of overall survival.ConclusionPhase 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. More... »

PAGES

621-629

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10120-013-0328-9

DOI

http://dx.doi.org/10.1007/s10120-013-0328-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1000268376

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24445485


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