Detailed Sub-study Analysis of the SECRAB Trial: Quality of Life, Cosmesis and Chemotherapy Dose Intensity

Fernando, I.N.; Lax, S.; Bowden, S.J.; Ahmed, I.; Steven, J.H.; Churn, M.; Brunt, A.M.; Agrawal, R.K.; Canney, P.; Stevens, A.; Rea, D.W.

Abstract

Aims
SECRAB was a prospective, open-label, multicentre, randomised phase III trial comparing synchronous to sequential chemoradiotherapy (CRT). Conducted in 48 UK centres, it recruited 2297 patients (1150 synchronous and 1146 sequential) between 2 July 1998 and 25 March 2004. SECRAB reported a positive therapeutic benefit of using adjuvant synchronous CRT in the management of breast cancer; 10-year local recurrence rates reduced from 7.1% to 4.6% (P = 0.012). The greatest benefit was seen in patients treated with anthracycline–cyclophosphamide, methotrexate, 5-fluorouracil (CMF) rather than CMF. The aim of its sub-studies reported here was to assess whether quality of life (QoL), cosmesis or chemotherapy dose intensity differed between the two CRT regimens.

Materials and methods
The QoL sub-study used EORTC QLQ-C30, EORTC QLQ-BR23 and the Women's Health Questionnaire. Cosmesis was assessed: (i) by the treating clinician, (ii) by a validated independent consensus scoring method and (iii) from the patients' perspective by analysing four cosmesis-related QoL questions within the QLQ-BR23. Chemotherapy doses were captured from pharmacy records. The sub-studies were not formally powered; rather, the aim was that at least 300 patients (150 in each arm) were recruited and differences in QoL, cosmesis and dose intensity of chemotherapy assessed. The analysis, therefore, is exploratory in nature.

Results
No differences were observed in the change from baseline in QoL between the two arms assessed up to 2 years post-surgery (Global Health Status: –0.05; 95% confidence interval –2.16, 2.06; P = 0.963). No differences in cosmesis were observed (via independent and patient assessment) up to 5 years post-surgery. The percentage of patients receiving the optimal course-delivered dose intensity (≥85%) was not significantly different between the arms (synchronous 88% versus sequential 90%; P = 0.503).

Conclusions
Synchronous CRT is tolerable, deliverable and significantly more effective than sequential, with no serious disadvantages identified when assessing 2-year QoL or 5-year cosmetic differences.

Citation

Fernando, I., Lax, S., Bowden, S., Ahmed, I., Steven, J., Churn, M., …Rea, D. (2023). Detailed Sub-study Analysis of the SECRAB Trial: Quality of Life, Cosmesis and Chemotherapy Dose Intensity. Clinical Oncology, 35(6), 397-407. https://doi.org/10.1016/j.clon.2023.03.007

• Journal Article Type: Article
• Acceptance Date: Mar 20, 2023
• Online Publication Date: Mar 20, 2023
• Publication Date: 2023-06
• Publicly Available Date: May 30, 2023
• Journal: Clinical Oncology
• Print ISSN: 0936-6555
• Electronic ISSN: 1433-2981
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 35
• Issue: 6
• Pages: 397-407
• DOI: https://doi.org/10.1016/j.clon.2023.03.007
• Keywords: Breast cancer; chemotherapy; clinical trial; cosmesis; dose intensity; quality of life; radiotherapy; secondary outcomes; SECRAB
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0936655523001140