In the single randomised controlled trial examined (Shinchi et al, 2002), there was survival advantage for chemoradiation followed by chemotherapy, over BSC (1 trial, 31 patients, HR 0.28; 95% CI 0.13 0.60).
A cost-effectiveness analysis was performed to analyse azacitidine vs. the three CCR options assessed in the AZA-001 clinical trial (BSC, LDC and SDC).
The clinical care provided in the BSC arms of cancer clinical trials is haphazard; study results are difficult to interpret or misleading at worst and hard to generalise at best.
What happens when clinical trials do not standardise BSC based on widely published, evidence-based supportive and palliative care, or when they do not carefully delineate what constitutes their BSC arm?
We also thank the trial coordinators, Umesh Chathuranga, BSc (Pharmacy), Lalith Senarathna, M Med Sci (Clin Epi, Mohammed Ashrofdeenn, BPharm, and Fahim Mohamed, BPharm MAppMgt (Health) for their role in data collection and clinical auditing.
Owing to these emerging views, four randomised trials of combination chemotherapy vs BSC were conducted.
The definition of active/best supportive care (ASC/BSC) is adapted from the description of supportive care in a key trial of active chemotherapy vs BSC in the second-line setting (Cunningham et al, 1998).
The analysis focused on the 357 eligible patients with UC who were enroled onto the phase III randomised controlled trial, which compared vinflunine plus BSC with BSC alone (L00070 IN 302), with an updated median follow-up of now 45.4 months (Bellmunt et al, 2009).
The crossover of BSC patients to the cetuximab arm of the trial was not mandated by the study protocol.
The second, trial 710 or IBREESE ('Iressa' vs BSC: a Randomised Evaluation of Effect on pulmonary Symptom Endpoint), has pulmonary symptom improvement rate as the primary end point.
