Background The BTOG2 trial was a phase III randomised clinical trial in the treatment of advanced NSCLC. It investigated the optimal dose of cisplatin (50 vs 80 mg/m2 3-weekly), in combination with gemcitabine, and whether carboplatin (AUC6-Wright) could safely and effectively be substituted for the optimal cisplatin dose. The protocol recommended cisplatin given as an out-patient regimen designed to ensure diuresis while maintaining electrolytic balance. A previously reported audit by these authors, 48% of hospitals surveyed were admitting NSCLC patients for cisplatin /gemcitabine chemotherapy.
Methods Between April 2005 and November 2009, 909 patients were randomised to receive cisplatin, in the UK and Ireland, as part of BTOG2. The trial mandated submission of proposed chemotherapy delivery schedules to ensure standard parameters in terms of: total duration of delivery, mandatory use of mannitol, short 1-h delivery of cisplatin and total fluid volume <4 l. Data mining was used to investigate AEs relating to renal function, electrolyte imbalance and ototoxicity. AEs that could feasibly be related to the manner in which cisplatin was administered.
Results 2853 treatment cycles were available for analysis. Average treatment duration decreased from nearly 9 to 6 h and total fluid volume from as much as 7 to <4 l. As a result of participating in BTOG2, 97% of surveyed hospitals were able to deliver cisplatin in a day case setting. Toxicities feasibly related to the manner in which cisplatin was administered were comparable to the current available literature with <1% experiencing grade >2.
Conclusion Current NHS Tariffs in the UK quote a 60% higher price for patients being inpatient cisplatin treatment as opposed to outpatient. With the prima facie case that patients prefer outpatient treatment, it is important to achieve the maximum benefit from the existing drugs in a clinically deliverable way. The results indicate that administering cisplatin via a short hydration schedule of <6 h, even at 80 mg/m2, is safe. It is unlikely that the many hospitals who changed their practice would have done so without the support of a running randomised controlled trial.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.