Vincent Crosby1, Catherine D'Souza1, Carina Bristow1, Amy Proffitt1, Asmah Hussain1, Vanessa Potter2, Ivo Hennig2, Richard O'Connor3, Vickie Baracos4, Andrew Wilcock5. 1. Department of Palliative Care, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. 2. Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. 3. Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. 4. Department of Oncology, Division of Palliative Care Medicine, University of Alberta, Edmonton, AB, T6G 1Z2, Canada. 5. Department of Clinical Oncology, Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, UK. andrew.wilcock@nottingham.ac.uk.
Abstract
PURPOSE: Current methods of dosing platinum-based chemotherapy are suboptimal. Potentially, taking lean body mass into account may help. To inform the design of a future study, we first examined the feasibility and acceptability of such an approach using dual-energy X-ray absorptiometry (DEXA) and explored aspects suggestive of over- and under-dosing. METHODS:Patients with lung cancer offeredplatinum-based chemotherapy over 1 year were identified and, if eligible, invited to take part in a prospective feasibility study. Questionnaires examined acceptability of the DEXA scan and of a future study that randomized between traditional dosing and one adjusted according to body composition. Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively. RESULTS: Of the 173 patients offered chemotherapy, 123 (71%) were ineligible, mostly because of failing entry criteria (84, 49%). Of the 50 approached, 18 (36%) participated, most receiving carboplatin, with 17 providing data. All found a DEXA scan acceptable; other assessments were fully completed, except nadir and pre-chemotherapy blood counts. Most (94%) were prepared to take part in a future study, although the additional hospital visits for a nadir blood count were unpopular with some. Five (29%) patients experienced six episodes of DLT which resulted in discontinuation (3), dose reduction (2) or change to a less toxic regimen (1). Nine (60%) patients experienced either no (2) or inconsistent (7) neutropenia. CONCLUSIONS: A randomized trial appears acceptable and feasible in patients receivingcarboplatin. Adjustment of our entry criteria and avoiding a hospital visit for a nadir blood count should aid recruitment.
RCT Entities:
PURPOSE: Current methods of dosing platinum-based chemotherapy are suboptimal. Potentially, taking lean body mass into account may help. To inform the design of a future study, we first examined the feasibility and acceptability of such an approach using dual-energy X-ray absorptiometry (DEXA) and explored aspects suggestive of over- and under-dosing. METHODS:Patients with lung cancer offered platinum-based chemotherapy over 1 year were identified and, if eligible, invited to take part in a prospective feasibility study. Questionnaires examined acceptability of the DEXA scan and of a future study that randomized between traditional dosing and one adjusted according to body composition. Dose-limiting toxicity (DLT) and a lack of neutropenia explored potential over- and under-dosing, respectively. RESULTS: Of the 173 patients offered chemotherapy, 123 (71%) were ineligible, mostly because of failing entry criteria (84, 49%). Of the 50 approached, 18 (36%) participated, most receiving carboplatin, with 17 providing data. All found a DEXA scan acceptable; other assessments were fully completed, except nadir and pre-chemotherapy blood counts. Most (94%) were prepared to take part in a future study, although the additional hospital visits for a nadir blood count were unpopular with some. Five (29%) patients experienced six episodes of DLT which resulted in discontinuation (3), dose reduction (2) or change to a less toxic regimen (1). Nine (60%) patients experienced either no (2) or inconsistent (7) neutropenia. CONCLUSIONS: A randomized trial appears acceptable and feasible in patients receiving carboplatin. Adjustment of our entry criteria and avoiding a hospital visit for a nadir blood count should aid recruitment.
Entities:
Keywords:
Chemotherapy; Lean body mass; Lung cancer; Pharmacology; Toxicity
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