More than 70% of women with multiple tumors in a single breast reported good or excellent satisfaction with the cosmetic results of breast-conserving therapy, Alliance (ACOSOG) Z11102 investigators reported at the 2020 American Society of Breast Surgeons (ASBrS) Virtual Scientific Session.¹

In fact, the outcomes for these women were as good as those reported by patients undergoing breast-conserving therapy for unifocal disease in previous studies, said lead researcher Kari M. Rosenkranz, MD, of Dartmouth-Hitchcock Medical Center. “Our patients were equally satisfied with their cosmetic outcomes, and we expect that with increasing adoption of oncoplastic techniques, cosmetic outcomes will continue to improve,” she said.

“Our patients were equally satisfied with their cosmetic outcomes, and we expect that with increasing adoption of oncoplastic techniques, cosmetic outcomes will likely continue to improve.”

— Kari M. Rosenkranz, MD

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Reluctance to Perform ­Lumpectomy

“Based on improvements in breast imaging, the diagnosis of multiple ipsilateral breast cancer is increasing, yet surgeons remain reluctant to perform breast-conserving therapy in this population,” said Dr. Rosenkranz. “This is based on historical retrospective studies showing higher rates of local recurrence as well as concerns about the potential for worse cosmetic outcomes in women who may require a larger volume of excision or multiple incisions.”

She continued: “One question in the surgeon’s mind, when doing breast-conserving therapy for multiple ipsilateral breast cancer, is whether the patient will be happy with the cosmetic results. Historically, we may have counseled these patients that this will be such a big volume of excision they may prefer mastectomy…. Based on these concerns as well as the potential risk of cancer recurrence, many surgeons, therefore, recommend mastectomy for women with [multiple ipsilateral breast cancer].”

There are good reasons to avoid mastectomy, if possible, she continued. Mastectomy with or without reconstruction can lead to diminished body image, reduced quality of life, lower self-esteem, and difficulty coping for some women—consequences that might be avoided by breast-conserving therapy, if it can be done safely. No prospective trial, however, has assessed the oncologic safety or cosmetic success of breast-conserving therapy for multiple ipsilateral breast cancer, she said.

With this in mind, the Alliance Z11102 trial was designed as a single-arm, multi-institutional prospective study. The study’s main objective is to assess cancer recurrence with breast conservation in patients with multiple ipsilateral breast cancer (data are immature), but it may also validate that preserving the breast is both oncologically safe and yields reasonable cosmetic outcomes, which were secondary endpoints, she said.

Alliance Z11102 Details

The study recruited 216 women with two to three malignant lesions in the same breast separated by at least 2 cm of normal breast tissue. The largest lesion had to be < 5 cm and the lesions could be excised through one incision or multiple incisions. Women underwent breast-conserving therapy with nodal staging and whole-breast irradiation with ≥ 60 Gy to all tumor beds and optional use of regional nodal irradiation, adjuvant chemotherapy, and oncologic closure techniques (per physician). Patients were monitored for disease progression every 6 months for 5 years after the end of radiotherapy.

Cosmetic Assessment

Investigators used two tools to gather cosmetic outcome data. The first was the breast cosmesis survey, a 4-point Likert scale with ratings from “poor” to “excellent.” The second was the BREAST-Q breast-conserving therapy module, which converts survey questions to a score of 0 to 100, with higher numbers indicating better outcomes; it assesses changes related to both surgery and radiation. Patients were administered both surveys at 30 days and at 6, 12, 18, 24, 36, 48, and 60 months.

The researchers looked for associations among cosmesis and age, largest tumor size, highest tumor grade, disease stage, number of surgical incisions, number of surgeries to achieve negative margins, and percentage of the breast receiving 60 Gy of radiation.

High Satisfaction in Majority of Patients

The women were followed a median of 49 months. Participation in the surveys was good until the 3-year point, when only about half the patients were still completing the surveys.

Of the 216 patients, 178 (82.4%) had routine closure without oncoplastic techniques. Nineteen (8.8%) simultaneously had contralateral symmetry procedures.

In the breast cosmesis survey, a rating of “good or excellent” was given by 74.9% of patients at 1 year, by 70.6% at 2 years, and by 70.3% at 3 years. Only 3.7% reported outcomes to be “poor” at 3 years, Dr. Rosenkranz said.

Patient BREAST-Q scores were similarly strong, with an expected slight drop in the section examining the effects of radiation at 6 and 12 months, when its impact is most severe. The average score was 71 (out of 100), indicating that the majority of patients were satisfied, she said.

“Similarly, when you look at the BREAST-Q responses you see that the majority of patients were satisfied with the appearance of the breast,” she said, citing an average score of 73. “We see little effect of radiation [on BREAST-Q scores], and we can see that physical well-being scores were also quite favorable.”

In the univariate analysis of the breast cosmesis survey results, no significant predictor of better or worse cosmesis was identified from a list of almost a dozen potential factors. The same was true for the BREAST-Q evaluation.

“We found no single variable to be predictive of cosmetic satisfaction in this patient population,” she said.

Outcomes Mirror Those for Unifocal Disease

Z11102 patient satisfaction with cosmetic outcome following breast-conserving therapy for multifocal disease was compared to that of patients with unifocal disease in six recent studies. The comparison found their outcomes to be as good.

“While patient-reported outcomes in this study look promising, it’s difficult to really interpret the data without a comparative cohort. For this reason, given the single-arm design, we used studies with similar methodology to contextualize the results of this study,” she said.

Studies involved patients with unifocal disease who underwent breast-conserving therapy and had 3 years of follow-up. Approximately the same percentage of patients (70%–73%) reported good/excellent results on the 4-point breast cosmesis survey.

Other studies using the BREAST-Q instrument (0–100 scale) have reported median breast satisfaction scores of 68 to 76; the current study’s median score was 74. One study of mastectomy with implants actually showed a lower breast satisfaction score.

Study Limitations

Dr. Rosenkranz acknowledged that there were limitations in this study. Its single-arm design may have led to the accrual of patients with an underlying bias toward breast-conserving therapy, who therefore had an artificially inflated sense of satisfaction when they were able to retain the breast, she suggested.

In addition, there was diminishing compliance with the surveys over time and a lack of control arms of patients with either unifocal disease or multiple ipsilateral breast cancer who underwent mastectomy rather than breast-conserving therapy. This lack of such controls compelled the researchers to compare cosmetic outcomes to prior studies, she said.

“With that said, we did find that patient-reported outcomes confirm [breast-conserving therapy] for [multiple ipsilateral breast cancer] as an acceptable surgical option from a cosmetic perspective,” she concluded. “Patients report high rates of satisfaction with their breasts, physical well-being, and little effect of radiation up to 5 years after treatment.” 

DISCLOSURE: Dr. Rosenkranz reported no conflicts of interest.

REFERENCE

1. Rosenkranz K, Ballman K, McCall L, et al: Cosmetic outcomes following breast conservation surgery and radiation for multiple ipsilateral breast cancer: Data from the Alliance Z11102 study. 2020 American Society of Breast Surgeons Virtual Scientific Session.