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Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): primary results of a prospective two-arm study

医学 乳腺癌 保乳手术 前瞻性队列研究 放射治疗 乳房磁振造影 放射科 临床试验 神秘的 乳房切除术 外科 癌症 乳腺摄影术 内科学 病理 替代医学
作者
G. Bruce Mann,Anita Skandarajah,Nicholas Zdenkowski,Janemary Hughes,Allan Park,Dennis Petrie,Karinna Saxby,Sean M. Grimmond,Anand Murugasu,Andrew J. Spillane,Boon Chua,Heath Badger,Helen Braggett,Val Gebski,Arlene Mou,John P. Collins,Allison Rose
出处
期刊:The Lancet [Elsevier]
卷期号:403 (10423): 261-270 被引量:21
标识
DOI:10.1016/s0140-6736(23)02476-5
摘要

Background Adjuvant breast radiotherapy as a standard component of breast-conserving treatment for early cancer can overtreat many women. Breast MRI is the most sensitive modality to assess local tumour burden. The aim of this study was to determine whether a combination of MRI and pathology findings can identify women with truly localised breast cancer who can safely avoid radiotherapy. Methods PROSPECT is a prospective, multicentre, two-arm, non-randomised trial of radiotherapy omission in patients selected using preoperative MRI and postoperative tumour pathology. It is being conducted at four academic hospitals in Australia. Women aged 50 years or older with cT1N0 non-triple-negative breast cancer were eligible. Those with apparently unifocal cancer had breast-conserving surgery (BCS) and, if pT1N0 or N1mi, had radiotherapy omitted (group 1). Standard treatment including excision of MRI-detected additional cancers was offered to the others (group 2). All were recommended systemic therapy. The primary outcome was ipsilateral invasive recurrence rate (IIRR) at 5 years in group 1. Primary analysis occurred after the 100th group 1 patient reached 5 years follow-up. Quality-adjusted life-years (QALYs) and cost-effectiveness of the PROSPECT pathway were analysed. This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12610000810011). Findings Between May 17, 2011, and May 6, 2019, 443 patients with breast cancer underwent MRI. Median age was 63·0 years. MRI detected 61 malignant occult lesions separate from the index cancer in 48 patients (11%). Of 201 group 1 patients who had BCS without radiotherapy, the IIRR at 5 years was 1·0% (upper 95% CI 5·4%). In group 1, one local recurrence occurred at 4·5 years and a second at 7·5 years. In group 2, nine patients had mastectomy (2% of total cohort), and the 5-year IIRR was 1·7% (upper 95% CI 6·1%). The only distant metastasis in the entire cohort was genetically distinct from the index cancer. The PROSPECT pathway increased QALYs by 0·019 (95% CI 0·008–0·029) and saved AU$1980 (95% CI 1396–2528) or £953 (672–1216) per patient. Interpretation PROSPECT suggests that women with unifocal breast cancer on MRI and favourable pathology can safely omit radiotherapy. Funding Breast Cancer Trials, National Breast Cancer Foundation, Cancer Council Victoria, the Royal Melbourne Hospital Foundation, and the Breast Cancer Research Foundation.
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