HEFT Repository

Exclusion of Gastrointestinal Cancer Patients With Prior Cancer From Clinical Trials: Is This Justified?

Smyth, Elizabeth C and Tarazona, Noelia and Peckitt, Clare and Armstrong, Edward and Mansukhani, Sonia and Cunningham, David and Chau, Ian (2016) Exclusion of Gastrointestinal Cancer Patients With Prior Cancer From Clinical Trials: Is This Justified? Clinical colorectal cancer, 15 (2). e53-9. ISSN 1938-0674. This article is accessible to all HEFT staff and students via NICE journals and databases http://www.nice.org.uk/about/what-we-do/evidence-services/journals-and-databases by using their HEFT Athens login IDs

Full text not available from this repository.
Official URL: http://www.clinical-colorectal-cancer.com/article/...

Abstract

BACKGROUND

Strict eligibility criteria are necessary to maintain patient safety and scientific validity in clinical trials. However, this may lead to impaired generalizability of results. As survival in gastrointestinal (GI) cancer relates mainly to the GI malignancy, we hypothesized that previous cancers do not impact on survival and are not a rational exclusion criterion.

MATERIALS AND METHODS

Patients treated with chemotherapy for a GI cancer in 2006 were identified from the electronic patient record at the Royal Marsden Hospital, London. Chart review was performed and patient age, gender, GI cancer stage, prior cancer stage, clinical trial availability/eligibility, and dates of cancer recurrence, death, and last follow-up were collated.

RESULTS

A total of 697 patients were identified. Fifty-four patients (8%) had a prior cancer; commonly breast (26%), prostate (17%), or colon (9%); most were stage I (42%) or II (37%). Two hundred ninety-seven (65%) patients had GI cancer recurrence, 7 (12%) patients had relapse of a prior cancer. Five hundred four (72%) patients have died, 170 (24%) are alive with no cancer, and 23 (3%) patients are alive with cancer. A total of 476 (94%) died of GI cancer, 2 (0.3%) of their prior cancer. Of all patients, 489 (70%) had an available trial, but 30% of patients with a prior cancer were ineligible for this reason. Overall and GI-cancer-specific survival were comparable for patients with/without a prior cancer.

CONCLUSIONS

Survival for patients with a GI cancer requiring chemotherapy relates to the GI cancer and rarely a prior cancer. These patients should not be excluded from clinical trial participation.

Item Type: Article
Additional Information: This article is accessible to all HEFT staff and students via NICE journals and databases http://www.nice.org.uk/about/what-we-do/evidence-services/journals-and-databases by using their HEFT Athens login IDs
Subjects: QZ Pathology. Oncology
WI Digestive system. Gastroenterology
Divisions: Planned IP Care > Oncology and Clinical Haematology
Related URLs:
Depositing User: Mrs Yolande Brookes
Date Deposited: 11 Jan 2017 16:01
Last Modified: 11 Jan 2017 16:01
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/1096

Actions (login required)

View Item View Item