Medical Oncology, Japanese Red Cross Musashino Hospital. 1-26-1 Kyonan-cho, Musashino-shi, Tokyo, 180-8610, Japan.
Breast and Endocrine Surgery, University of Tsukuba Hospital/ Ibaraki Prefectural Central Hospital. 6528 Koibuchi, Kasama City, Ibaraki, 309-1793, Japan.
Surg Oncol. 2021 Mar;36:51-55. doi: 10.1016/j.suronc.2020.11.008. Epub 2020 Nov 20.
Neoadjuvant systemic therapy (NST) induces tumor shrinkage and boosts the chance of breast-conserving thearpy (BCT) in patients with breast cancer. However, only a few trials have evaluated the effect of NST in conversion from BCT ineligibility to BCT eligibility in HER2-positive breast cancer.
We conducted the surgical sub-study of a phase II randomized trial, which compared standard neoadjuvant treatment or an experimental treatment modified according to the interim Ki-67 evaluation in women with stage II or III HER2-positive breast cancer. The treating surgeons assessed eligibility for BCT before and after NST. We evaluated the change in BCT eligibility following NST. We also analyzed the type of surgery performed and the success rate of BCT.
Two hundred six patients were included in this study. Of these, 44.0% were considered BCT candidates at baseline, while 69.8% were deemed eligible for BCT after NST (P < 0.001). Among non-BCT candidates at baseline, 46% successfully converted to BCT candidates. Of 139 patients deemed eligible for BCT following NST, 84.2% attempted BCT, and successful BCT, defined as tumor-free at all surgical margins, was achieved in 96.8% of patients. Different treatment arms did not affect the rate of post-NST BCT eligibility (70.0% vs 69.7%).
This study demonstrated that NST resulted in an absolute increase of 25.8% in the rate of BCT eligibility in HER2-positive breast cancer. About a half of non-BCT candidates converted to BCT candidates. BCT was successful in most patients who attempted BCT. There were still patients who chose mastectomy even though they were deemed eligible for BCT. Patients considered BCT-ineligible due to large tumor size most likely converted to BCT-eligible with NST. On the other hand, NST had less impact on the surgical indication of patients with multicentric disease or probable poor cosmetic outcome.
新辅助全身治疗(NST)可使肿瘤缩小,并增加 HER2 阳性乳腺癌患者保乳治疗(BCT)的机会。然而,仅有少数试验评估了 NST 对将 HER2 阳性乳腺癌患者从不适合 BCT 转变为适合 BCT 的效果。
我们开展了一项 II 期随机试验的外科亚研究,该试验比较了标准新辅助治疗或根据中期 Ki-67 评估修改的实验性治疗,纳入了 II 期或 III 期 HER2 阳性乳腺癌女性。治疗外科医生在 NST 前后评估 BCT 的适合性。我们评估了 NST 后 BCT 适合性的变化。我们还分析了所行手术的类型和 BCT 的成功率。
本研究纳入了 206 例患者。其中,44.0%的患者在基线时被认为是 BCT 候选者,而 69.8%的患者在 NST 后被认为适合 BCT(P<0.001)。在基线时非 BCT 候选者中,有 46%成功转为 BCT 候选者。在 139 例被认为适合 NST 后 BCT 的患者中,84.2%尝试了 BCT,且在 96.8%的患者中成功实现了无肿瘤切缘的 BCT。不同的治疗臂并不影响 NST 后 BCT 适合性的比率(70.0% vs 69.7%)。
本研究表明,NST 使 HER2 阳性乳腺癌患者的 BCT 适合性绝对增加了 25.8%。大约一半的非 BCT 候选者转为 BCT 候选者。大多数尝试 BCT 的患者都成功进行了 BCT。尽管被认为适合 BCT,但仍有患者选择了乳房切除术。由于肿瘤较大而被认为不适合 BCT 的患者,最有可能通过 NST 转为适合 BCT。另一方面,NST 对多中心疾病或可能预后不佳的患者的手术指征影响较小。