From: Evidence reviews for breast radiotherapy
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Study | Trial | Additional inclusion/exclusion criteria | Interventions/comparison |
---|---|---|---|
Blamey 2013 | BASO II |
Aged <70 with primary operable unilateral invasive breast cancer (N0, M0) Histological grade 1 or specific good prognosis tumours Maximum tumour size 20mm No previous cancer except adequately treated basal cell carcinoma of the skin Excluded if pregnant or lactating Excluded if other diseases precluded adequate surgery, adjuvant therapy, or follow-up |
|
Holli 2009 |
Age >40 years Tumour 20mm or less, grade 1 or 2. PR status positive. Low cell proliferation rate Excluded if extensive intraductal component or axillary node metastases |
Intervention arm (RT-): segmental breast resection (1 cm margins) and levels I and II dissection of ipsilateral axilla. Control arm (RT+): segmental breast resection (1 cm margins) and levels I and II dissection of ipsilateral axilla. Whole breast radiotherapy total 50 Gy within 5 weeks using 2 Gy daily fractions. | |
Hughes 2013 | CALGB 9343 |
≥70 years with stage I, N0, ER+ breast cancer No history of cancer other than in situ cervical or non-melanoma skin cancer within 5 years Initially included tumours up to 4cm but reduced to 2cm |
Intervention arm (RT-): lumpectomy with a clear margin (no ink on tumour). 20 mg tamoxifen per day for 5 years initiated during or after irradiation. Control arm (RT+): lumpectomy with a clear margin (no ink on tumour). 20 mg tamoxifen per day for 5 years initiated during or after irradiation. RT included tangential fields to the entire breast followed by an electron boost to the lumpectomy site. |
Kunkler 2015 | PRIME II |
≥65 years with T1-T2, N0 hormone receptor positive breast cancer Receiving neoadjuvant hormonal treatment Excluded if history of in-situ or invasive breast cancer of either breast or previous malignant disease in the past year, other than non-melanomatous skin cancer or carcinoma in situ of the cervix |
Intervention arm (RT-): No details for breast conserving surgery procedures provided (except ≥1mm margins). Tamoxifen (20 mg daily for 5 years) as the standard adjuvant endocrine treatment but other forms allowed. Control arm (RT+): No details for breast conserving surgery procedures provided (except ≥1mm margins). Tamoxifen (20 mg daily for 5 years) as the standard adjuvant endocrine treatment but other forms allowed. RT total dose 40–50Gy in 15–25 fractions over 3–5 weeks. Boost permitted but not required. |
Wickberg 2014 | Uppsala/Orebro |
≤80 years with unifocal stage 1 invasive breast cancer |
Intervention arm (RT-): sector resection and axilla dissected to levels I and II Control arm (RT-): sector resection and axilla dissected to levels I and II. Radiotherapy total dose of 54Gy in 27 fractions |
Williams 2011 | PRIME |
≥ 65 years with T0–2, N0 unilateral breast cancer Receiving adjuvant endocrine therapy. Medically suitable to attend for all treatments and follow-up. Excluded if pure in situ carcinoma or previous/concurrent malignancy within 5 years other than non-melanomatous skin cancer or carcinoma in situ of cervix Excluded if grade 3 cancer | BCS complete excision – further details not reported |
BASO, British Association of Surgical Oncologists; BCS, Breast conservation surgery; CALGB, Cancer and Leukemia Group B; ER, oestrogen receptor; Gy, gray; PRIME, Postoperative Radiotherapy in Minimum-Risk Elderly; RT, radiotherapy; WLE, wide local excision
From: Evidence reviews for breast radiotherapy
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.