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  • May 9, 2020
    Delayed intraoperative radiotherapy vs whole breast radiotherapy

    Long-term (five-year) follow-up of TARGIT-A, a prospective phase III randomized trial of 1153 patients ≥ age 45 with invasive ductal carcinoma of the breast no larger than 3.5cm status post breast-conservation surgery randomized to delayed intraoperative radiation therapy (IORT) delivered as second operative procedure via reopening of lumpectomy site vs external beam radiation therapy (EBRT). Primary outcome: Noninferiority margin of 2.5% local recurrence (LR) rate at 5 years. 581 patients were randomized to IORT, 572 to EBRT. Delayed IORT was not non-inferior to EBRT. The 5-year LR rate was 3.96% for IORT vs 1.05% for EBRT (statistically significant). At long-term follow-up at median 9 years, the following measures were not statistically significantly different between groups: LR-free survival, mastectomy-free survival, distant disease-free survival, overall survival. Conclusion: patients treated with delayed IORT after lumpectomy had a higher rate of local recurrence compared to patients treated with EBRT, though no difference in mastectomy-free survival, distant disease-free survival, or overall survival.  

    (Open Access)

    Reference (PubMed Link): Vaidya JS, Bulsara M, Saunders C, et al. Effect of delayed targeted intraoperative radiotherapy vs whole-breast radiotherapy on local recurrence and survival: Long-term results from the targit-a randomized clinical trial in early breast cancer. JAMA Oncol 2020;6:e200249.

    Key Institution: Multi-Institution (TARGIT-A trial)
    Keywords: Breast cancer, intraoperative radiotherapy, whole breast irradiation

  • Apr 9, 2020
    FAST-Forward phase 3 non-inferiority trial of 5 fraction hypofractionated breast RT

    This trial was a randomized phase 3 non-inferiority trial which compared standard hypofractionated (40 Gy in 15 fx) to two ultra-hypofractionated regimens (26 Gy and 27 Gy in 5 weekly fx). Over 4000 patients were included and were T1-T3, N0-2, M0, any hormone and HER2 status allowed, after both breast conserving surgery and mastectomy.  No nodal coverage was allowed but 10 Gy or 16 Gy boost was allowed in 2 Gy fractions (25% received boost across all arms). Ipsilateral breast recurrence at5 years was found to be noninferior in both 26 and 27 Gy groups, and clinician as well as patient and photographic assessments of breast cosmesis were noninferior in the26 Gy group. There was also no difference in distant relapse or mortality between arms at 5 years. Of note very low risk patients (aged ≥65 years, pT1, grade 1 or 2, estrogen receptor [ER] positive, HER2 negative, pN0, M0) were excluded part way through the trial to increase the event rate. Overall, this trial showed very favorable results for the 26 Gy in 5 fx group with a moderate follow up in a favorable group of patients

    (Open Access)

    Reference (PubMed Link): Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial.

    Key Institution: Multi-Institutional
    Keywords: Hypofractionated, breast cancer

  • Dec 20, 2019
    APBI non-inferior to whole breast irradiation -- late toxicity and poor cosmesis more likely after APBI

    This paper reports on a randomized controlled trial of women >40 years old with DCIS or N0 breast cancer treated with lumpectomy and randomized to external beam APBI (38.5Gy/10fx BID) or whole breast RT (WBI)(45.4/16fx or 50Gy/25fx). Primary outcomes were ipsilateral breast tumor recurrence (IBTR). 2135 women enrolled with median follow-up of 8.6 years. 8-year cumulative rates of IBTR were 3.0% with APBI and 2.8% with WBI, not significantly different. Acute >grade 2 toxicity occurred in 28% in APBI and 45% in WBI (p<0.0001). Late >grade 2 toxicity was 32% in APBI and 13% in WBI (p<0.0001). Adverse cosmesis was more common after APBI at 3 years (absolute difference 11.3%), 5 years (16.5%) and 7 years (17.7%). Overall, APBI had non-inferior IBTR compared to WBI. Although there was less acute toxicity with APBI, there was increased late toxicity as well as adverse cosmesis (potentially related to the BID fractionation schedule). 

    Reference (PubMed Link): Whelan TJ, Julian JA, Berrang TS, et al. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (rapid): A randomised controlled trial. Lancet 2019;394:2165-2172.

    Key Institution: Multi-Institution (Canada, Australia, NZ)
    Keywords: Breast cancer, APBI, whole breast irradiation

  • Dec 14, 2019
    10-year follow-up of post-lumpectomy APBI vs whole-breast radiotherapy: NSABP B-39/RTOG 0413

    Breast-conserving surgery (lumpectomy) is a surgical oncologic resection where a localized, early stage, breast cancer is removed with a limited amount of surrounding tissue. This technique requires the supplementation of post-operative whole-breast radiation to reduce the risk of local recurrence. This was previously established to be equivalent to a modified radical mastectomy from a recurrence standpoint but spares the extensive morbidity and aesthetic changes associated with the surgery. Recently, efforts have been made to reduce both the quantity of normal breast exposed to radiation as well as the duration of the course in the adjuvant setting. Now resulting are the outcomes from a phase III randomized trial comparing whole-breast irradiation (WBI) to accelerated partial breast irradiation (APBI). Eligible patients were adult women with early stage (up to 3 positive lymph nodes) breast cancer who underwent lumpectomy with negative surgical margins. WBI was delivered to 50 Gy in 25 daily fractions with a supplemental tumor bed boost as decided by the treating clinicians. APBI was administered with either external-beam radiation to 38.5 Gy in 10 fractions over 5 treatment days or with brachytherapy to 34 Gy. Randomization stratification occurred according to stage, menopausal and hormone-receptor status as well as intention to receive chemotherapy. The primary outcome of in-breast tumor recurrence was analyzed in the intention-to-treat population. With a total of 4216 women enrolled across both arms, it was found that APBI did not meet the statistical criteria for equivalence to WBI with respect to the primary outcome of local recurrence. However, the weight of the clinical relevance of this result is controversial given it constituted an absolute difference of less than 1% in the 10-year cumulative incidence of local recurrence between the groups. Therefore, although strictly speaking APBI has a statistically significant increase in local recurrence, the value of this increase is minimal (< 1%) and may clinically permit its use in some women as an acceptable and more convenient regimen with similar toxicity profile per this trial. 

    Reference (PubMed Link): Vicini FA, Cecchini RS, White JR, et al. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: A randomised, phase 3, equivalence trial. Lancet 2019;394:2155-2164.

    Key Institution: NRG Oncology
    Keywords: accelerated partial breast irradiation (APBI), whole-breast RT, early-stage breast cancer, breast conserving surgery 

  • Nov 20, 2019
    Lumpectomy plus partial breast reirradiation may be good alternative to mastectomy for recurrent breast cancer

    This multicenter, single-arm, prospective phase 2 trial assessed the effectiveness and safety of partial breast reirradiation after a second lumpectomy, to determine if it is an acceptable alternative to mastectomy. A total of 65 patients with ipsilateral recurrence after a second lumpectomy were enrolled, with the treatment of 3-dimentional conformal external beam partial breast reirradiation. Median follow-up was 5.5 years. The radiation dose was 1.5 Gy twice daily for 30 fractions. 58 patients were evaluable for the study, and 4 patients had breast cancer recurrence with 5-year cumulative incidence of 5%. Both distant-metastasis-free survival and overall survival rates were 95%. 4 patients (7%) had grade 3 toxicity and none had grade 4 toxicity. This study concluded that second breast conservation is an effective alternative to mastectomy.   

    Reference (PubMed Link): Arthur DW, Winter KA, Kuerer HM, et al. Effectiveness of breast-conserving surgery and 3-dimensional conformal partial breast reirradiation for recurrence of breast cancer in the ipsilateral breast: The nrg oncology/rtog 1014 phase 2 clinical trial. JAMA Oncol 2019.

    Key Institution:  Multi-Institutional (USA)
    Keywords: Partial breast reirradiation, breast cancer, recurrence, second lumpectomy