Abstract P2-19-10: Quality of life following mastectomy and breast reconstruction (QUEST): Learning from two feasibility randomized controlled clinical trials

Abstract

Background: Breast reconstruction (BRR) aims to improve health related quality of life (HRQL) after mastectomy, but with poor evidence to date informing the optimal type or timing of surgery to guide shared-decision making. Systematic reviews show the paucity of randomised trials (RCT) with only two-singe centre RCTs. Although, an RCT has theoretical advantages, there have been concerns that clinicians may not share clinical equipoise regarding recommending types of BRR surgery that is sensitive to patient preferences. The aim of the QUEST trials (CRUK/08/027) was to determine the optimal types of latissimus dorsi (LD) BRR (Trial A) when there is no expectation for post-mastectomy radiotherapy (PMRT), and timings of LDBRR when PMRT is recommended (Trial B), that would benefit HRQL during five years post-operatively. As this was the first attempt at a multi-centre RCT, the main trial was preceded by a feasibility phase to demonstrate that recruitment was achievable and that randomization was acceptable to patients. An embedded qualitative study, the QUEST Perspective Study (QPS) assessed the perceptions of equipoise of patients and health care professionals (HCPs) for the types of surgery. Methods: QUEST comprised two parallel phase III multicentre feasibility RCTs to assess HRQL impact of the type of LDBRR when PMRT is unlikely (Trial A, LD - implant assisted (LDI) versus extended autologous LD (ALD)). Trial B evaluated optimal timings of LDBRR comparing staged - delayed ALD (skin-preserving sub-pectoral expander implant then ALD) to immediate ALD when PMRT was likely. Eligible patients comprised mastectomy recommended for invasive breast cancer or DCIS in the context of technical feasibility for ALD and preferred synchronous breast reduction. The primary endpoint was the proportion of eligible women approached who accepted randomisation. QPS explored patients and HCPs’ acceptability of the trial and randomisation using semi-structured telephone interviews and questionnaires. Results: The QUEST trials opened in May 2011 with 15 UK centres participating. After 18 months of recruitment, 17 patients had been entered in Trial A and 8 in trial B with acceptance rates of 19% (17/88) and 22% (8/36) for trial A and B respectively. Patient preference was the predominant reason for eligible patients approached about the trial not being randomised with 47 of the 88 (53%) for Trial A and 22 of 36 (61%) eligible for Trial B, declining for that reason. Patient acceptance rates for randomisation increased from 19% during the first 6 months to 29% from 7-12 months for Trial A; corresponding figures for Trial B were 11% and 27%. The recruitment challenges and funding cessation caused the Trial Steering Committee to recommend trial closure in December 2012. Conclusion: Despite the need for clinical evidence, patients retained strong preferences for breast reconstruction type and timing, amidst ‘standardised’ trial processes. Patient acceptance rates did improve during the trial, but it was not possible to meet target recruitment within the constraints of a feasibility trial. Funding for this NCRN portfolio trial (92581226) was from Cancer Research UK (CRUK) and BUPA Foundation funding for QPS. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-19-10.