Shortened Hydration Protocol for ABC02 Chemotherapy Regimen
Research type
Research Study
Full title
A prospective study of tolerance comparing the current hydration regimen for the ABC02 chemotherapy regimen versus a shorter hydration
IRAS ID
214262
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
2 years, 2 months, 24 days
Research summary
Following publication, in 2010 in the New England Journal of Medicine, the ABCO2 regimen has become the global routine standard of care in the treatment of bile duct cancers (cholangiocarcinomas) and gallbladder cancers. The study showed an overall survival advantage of 3.6 months with the addition of the low dose cisplatin to the standard gemcitabine alone regimen.
The regimen includes a long hydration schedule based on historical use of high doses of cisplatin before the modern era of anti-emetics or anti sickness. The regimens remained conservative with copious volumes of hyper hydration for fear of the historical nephrotoxicity. These regimens take eight hours for delivery and risk fluid overload often requiring diuretic management.The ABC02 regimen is unique as the doses of cisplatin used are the lowest in any chemotherapy regimen at just 25/mg/m2/day on day 1 and day 8 of a 21 day cycle. The rates of nausea and vomiting were extremely low. Rates of significant kidney dysfunction were extremely low at less than 2% which is in keeping with non-drug related events and indeed were comparable to that seen in the gemcitabine alone arm. However, due to the original concerns regarding nephrotoxicity the patients were kept on the day unit for 6-8 hours for each day of treatment. It is logical that in this day of modern anti-sickness medication and with such low dose cisplatin a shorter hydration regimen should be assessed for tolerability, as in many hospitals they are already doing this without a formal quantitative understanding of the real risk. This could improve patient satisfaction and save the Trust time and money.REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1629
Date of REC Opinion
12 Dec 2018
REC opinion
Further Information Favourable Opinion