Patient-Reported Outcomes 10 years after Breast-Conserving Surgery for Early-Stage Breast Cancer

Abstract

Background:

Patient-reported outcomes (PROs) are a critical component of value-based care. Limited data exist describing long-term PROs in patients undergoing breast-conserving surgery (BCS).

Methods:

Patients undergoing surgery for stage 0-III breast cancer at our institution from 2002–2012 who agreed to be contacted were invited to participate in a cross-sectional PRO study. Health-related quality of life outcomes using BREAST-Q, EORTC QLQ-C30 and EORTC QLQ-BR45 were collected. Patients reporting chemotherapy within 6 months of receiving the survey were excluded. For this work, we focused on patients who underwent BCS. Multivariable linear regression was performed to identify factors associated with PRO scores, adjusting for age, time since surgery, anatomic stage, molecular subtype, receipt of systemic and/or radiation therapy (RT), locoregional recurrence or contralateral breast cancer.

Results:

Among 562 interested and eligible patients, 437 (78%) responded; median time from surgery to survey completion was 10.4 years (interquartile range: 8.0–13.5). Median age at surgery was 53 years (standard deviation 9.8 years), ≥90% were White, had upfront surgery for early-stage disease and completed adjuvant RT. Physical and psychological well-being scores were generally high, with more variation seen for sexual well-being and satisfaction with breasts.

Discussion:

This study provides long-term PRO data for patients treated with BCS, demonstrating the ongoing association of breast cancer surgery with quality of life in the survivorship period and highlighting the importance of examining PROs beyond the perioperative period. These data also provide important reference values for the interpretation of PROs among women treated with BCS as we move towards value-based care.

Background

Patient-reported outcomes (PROs) are increasingly recognized as an important element in surgical decision making in breast cancer care. While the number of publications that include PROs has increased over time¹, the majority of studies focus on patients having mastectomy with reconstruction, as this was the first validated module in the widely used BREAST-Q instrument.² However, the majority of women in the United States receive breast-conserving surgery (BCS)³ and there is a dearth of published data related to PROs in BCS. As mastectomy and breast-conserving therapy have equivalent oncologic outcomes, robust PRO data for BCS is critical to inform clinical care and surgical decision making.⁴ Further, while available PRO data generally provide interpretation of scores for short-term outcomes (within 2 years), reference values for long-term PROs following BCS are critically important to allow for better understanding of outcomes in the survivorship period particularly given long-term impacts of radiation therapy.^5,6

There is also growing interest in using PROs to assess value of care for patients with breast cancer, with value calculated by measuring the outcomes of care in relation to cost⁷. As such, defining important outcomes of care and setting standards for how they should be measured is critically important. In order to help define the outcomes that should be used when calculating value of care and to provide a framework for comparison and context for measurement, the International Consortium for Health Outcomes Measurement (ICHOM), a non-profit organization that partners with patients, healthcare providers and health researchers, has developed a specific standard set of patient-centered outcome measures for a number of medical conditions including breast cancer. Measured outcomes include clinical outcomes (i.e. survival and recurrence) and PROs related to overall health and quality of life, with PROs comprising 75% of the measured outcomes. Given the significant weight given to PROs in the value calculation, having reference values for PROs after breast cancer surgery is critical to being able to understand differences in value of care.⁸

In this study, we evaluated PROs in a large cross-sectional cohort of women who underwent BCS from 2002–2012 in order to identify demographic and treatment-related factors that impact long-term quality of life and to define reference values for long-term PROs following BCS.

Methods

This study was approved by the Institutional Review Board at the Dana-Farber Cancer Institute (DFCI). Patients treated at DFCI in the Breast Oncology Center are approached for participation in a prospective registry which allows for collection of blood, tissue, and other biologic specimens as well as clinical data. Patients are asked at the time of consent if they agree to be recontacted for future research. From this registry, we identified English-speaking patients ages 18 and older who were treated for Stage 0-III breast cancer from 2002–2012. From September 2018 to March 2019, we sent a recruitment letter inviting participation in a survey study to the last known physical or email address of 4,019 potentially eligible patients. Consent was obtained from those who expressed interest in participating. After consent, patients were asked to self-report their breast surgery type (lumpectomy, mastectomy, mastectomy with reconstruction) and whether they had received chemotherapy, breast cancer surgery or radiation within the last 6 months. Those who reported receiving chemotherapy, breast cancer surgery or radiation within the last 6 months were not administered questionnaires. Patients receiving endocrine therapy were eligible to be administered questionnaires. Questionnaires reflecting the ICHOM Standard Set, including the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23, EORTC QLQ-C30 and BREAST-Q were completed by mail, email, or telephone per patient preference. The survey was closed to entry May 2019. We excluded patients whose self-reported surgery type did not agree with what could be verified in our medical record review, those who received their surgery outside of our institution and those who died within one year of survey completion. For this study, patients who had mastectomy were also excluded.

Demographic, tumor, and treatment variables were obtained from the registry database, including age at first surgery, surgery date, race, highest level of education, marital status, treatment sequence (upfront surgery vs. neoadjuvant systemic therapy), tumor stage, nodal status, histology, grade, hormone receptor status, HER2 status, breast surgery laterality (unilateral vs. bilateral), receipt of radiation, receipt of chemotherapy and receipt of endocrine therapy. TNM stage was constructed (using 5^th, 6^th, and 7^th editions of AJCC Cancer Staging Manual dependent upon date of diagnosis) using the pT and pN stage for patients treated with upfront surgery and using the cT and cN stage for patients treated with neoadjuvant systemic therapy. Oncologic outcomes including local, regional, or distant breast cancer recurrence, contralateral breast cancer, and vital status were ascertained from medical record review.

For this study, the primary outcomes of interest were BREAST-Q scores on three well-being modules (physical, psychological, and sexual) and the satisfaction with breasts module. These modules are scored from 0–100 with higher scores indicating better outcomes, and all modules are scored independently.⁹ The BREAST-Q was selected for the primary outcome because the satisfaction with breasts module is the only surgery specific patient-reported outcome measure (PROM) included in the ICHOM standard set. We chose to include the physical, psychological, and sexual well-being modules of the BREAST Q as well, as we suspected they may better reflect long term outcomes of local therapy. We also included scores for global health status, physical function, and pain on the EORTC QLQ-C30 survey and scores for body image, sexual function, and breast symptoms on the EORTC QLQ-BR23 survey. These surveys are scored on a scale of 0–100, with higher scores on functional assessments indicating higher function and higher scores on assessments of symptoms indicating more symptoms.¹⁰

Statistical Analysis

Demographic, tumor, and treatment characteristics were compared between patients who completed at least one module of the questionnaires (“responders”) and those who expressed interest in participating but did not return responses to any questionnaires (“non-responders”), using chi-squared tests. The distribution of scores on each PROM were graphically represented using histograms and the mean, standard deviation, median and interquartile ranges (IQR) were reported. For each of the four BREAST-Q modules, we performed univariable linear regression analyses to evaluate factors associated with PROs. Variables demonstrating significant associations on univariable analysis as well as those considered to have clinical relevance were included in multivariable linear regression models. All models included age, race, education level, time since surgery, tumor stage, nodal status, hormone receptor status, HER2 status, treatment sequence, receipt of radiation, receipt of chemotherapy, receipt of endocrine therapy, occurrence of locoregional recurrence and occurrence of contralateral breast cancer. For all hypothesis testing, a p-value of ≤0.05 was defined as statistically significant. Statistical analyses were performed in Stata/IC Version 16.1 (College Station: Texas).

Results

Among 4,019 patients who were sent a mailed invitation for participation, 1,253 (31.2%) replied expressing interest in participating. Of those, 126 (10.1%) were excluded for the following reasons: 91 had all surgery at an outside, 4 patients passed away within a year of taking the survey, 14 had clinical T4 disease, and 17 had reported surgery that did not match medical records. Of the 1,126 who expressed interest and were eligible, 564 (50.1%) had mastectomy and were excluded from this study. The 562 patients undergoing BCS who expressed interest in participating make up our study cohort. Of these, 437 (77.8%) ultimately responded to the questionnaires, 125 (22.2%) did not.

Among responders, median age was 53 (IQR 47–60) and median time from surgery to survey was 10.4 years (IQR 8.0–13.5 years). Most responders were White (91%), married (68%), had a college education or higher (65%), generally had early-stage, node-negative disease and underwent upfront surgery (91 %) followed by adjuvant radiation (92%). Most responders had hormone receptor-positive (84%) and HER2-negative (92%) disease. Just over half (54%) received endocrine therapy only for systemic therapy and 32% received adjuvant chemotherapy (Table 1). Breast cancer events were uncommon; 20 (4.6%) responders developed a contralateral breast cancer, five (1%) experienced a locoregional recurrence, two (0.5%) experienced both locoregional and distant recurrences and four (1%) developed distant recurrence only.

Table 1.

Clinical, Pathologic and Treatment Data for Responders and Non-responders having Breast-Conserving Surgery (BCS) and Expressing Interest in Completing Surveys

	Responders (N=437)	Non-Responders (N=125)	p-value
Age at first surgery			0.767
<45	70 (16.0%)	19 (15.2%)
45–49	92 (21.1%)	20 (16.0%)
50–54	80 (18.3%)	23 (18.4%)
55–59	84 (19.2%)	27 (21.6%)
60–65	57 (13.0%)	21 (16.8%)
>65	54 (12.4%)	15 (12.0%)
Race			0.293
Asian	5 (1.1%)	3 (2.4%)
Black	10 (2.3%)	3 (2.4%)
Other/Unknown	25 (5.7%)	4 (3.2%)
White	397 (90.9%)	115 (92.0%)
Hispanic/Latino Ethnicity			0.750
No	428 (97.9%)	121 (96.8%)
Yes	7 (1.6%)	3 (2.4%)
Unknown	2 (0.5%)	1 (0.8%)
Education			0.083
High School or less	42 (9.6%)	5 (4.0%)
College or more	285 (65.2%)	92 (73.6%)
Unknown	110 (25.2%)	28 (22.4%)
Marital status			0.083
Single/Divorced/Widowed	122 (27.9%)	47 (37.6%)
Married/Living as Married	295 (67.5%)	75 (60.0%)
Unknown	20 (4.6%)	3 (2.4%)
Stage a			0.836
Stage 0	77 (17.6%)	21 (16.8%)
Stage I	204 (46.7%)	65 (52.0%)
Stage II	135 (30.9%)	35 (28.0%)
Stage III	11 (2.5%)	2 (1.6%)
Can’t calculate	10 (2.3%)	2 (1.6%)
Tumor Stage b			0.548
Tis	77 (17.6%)	21 (16.8%)
T1	270 (61.8%)	86 (68.8%)
T2	86 (19.7%)	17 (13.6%)
T3	3 (0.7%)	1 (0.8%)
Tx	1 (0.2%)	0 (0%)
Nodal status b			0.824
Negative	345 (77.8%)	95 (76.0%)
Positive	88 (20.1%)	28 (22.4%)
Unknown	9 (2.1%)	2 (1.6%)
Tumor Morphology			0.808
Ductal carcinoma in situ	77 (17.6%)	21 (16.8%)
Invasive ductal cancer (IDC)	280 (64.1%)	85 (68.0%)
Invasive lobular cancer (ILC)	29 (6.6%)	5 (4.0%)
Mixed (IDC and ILC)	41 (9.4%)	12 (9.6%)
Other/Unknown	10 (2.3%)	2 (1.6%)
Grade of invasive disease			0.206
Low	80 (22.2%)	21 (20.2%)
Intermediate	16 (44.7%)	37 (35.6%)
High	104 (28.9%)	40 (38.5%)
Unknown	15 (4.2%)	6 (5.8%)
Hormone receptor (HR) status			0.577
Positive	369 (84.4%)	104 (83.2%)
Negative	58 (13.3%)	16 (12.8%)
Unknown	10 (2.3%)	5 (4.0%)
HER2 status (invasive)			0.002
Negative	312 (71.4%)	76 (60.8%)
Positive	36 (8.2%)	24 (19.2%)
Unknown/not tested	89 (20.4%)	25 (20.0%)
Treatment sequencing			0.148
Upfront surgery	398 (91.1%)	112 (89.6%)
Neoadjuvant chemotherapy	34 (7.8%)	12 (9.6%)
Neoadjuvant other therapyc	5 (1.1%)	0 (0%)
Unknown	0 (0%)	1 (0.8%)
Bilateral breast conservation			0.640
No	419 (95.9%)	121 (96.8%)
Yes	18 (4.1%)	4 (3.4%)
Axillary surgery			0.954
Sentinel lymph node biopsy (SLNB) alone	251 (57.4%)	73 (58.4%)
Axillary lymph node dissection (+/− SLNB)	105 (24.0%)	29 (23.2%)
None	80 (18.3%)	23 (18.4%)
Unknown	1 (0.2%)	0 (0%)
Receipt of chemotherapy
Yes	170 (38.9%)	52 (41.6%)	0.801
No	249 (57.0%)	69 (55.2%)
Unknown	18 (4.1%)	4 (3.2%)
Receipt of endocrine therapy (among HR+ or HR unknown)
Yes	324 (85.5%)	94 (86.2%)	0.973
No	23 (6.1%)	6 (5.5%)
Unknown	32 (8.4%)	9 (8.3%)
Adjuvant radiation therapy
Yes	402 (92.0%)	116 (92.8%)	0.766
No	35 (8.0%)	9 (7.2%)
Recurrence during follow-up
Yes	10 (2.3%)	8 (6.4%)	0.021
No	427 (97.7%)	117 (93.6%)
Contralateral breast cancer during follow-up
Yes	20 (4.6%)	3 (2.4%)	0.279
No	417 (95.4%)	122 (97.6%)

^aStaging as per AJCC 5th-7th edition, depending on date of diagnosis

^bRepresents pathologic status for upfront surgery or unknown treatment sequencing patients, and clinical status for neoadjuvant patients

^cIncludes neoadjuvant endocrine therapy or non-chemotherapy drug (e.g. biologic, immunotherapy) given in neoadjuvant fashion (on or off trial)

The clinical characteristics of responders and non-responders were generally similar with the exception that there were fewer responders with HER2+ breast cancer (8.2% vs. 19.2%, p=0.002) and more responders who were recurrence free (97.5% vs. 93.6%, p=0.02).

BREAST-Q Scores

436 (99.7%) responders completed the physical well-being module, with a mean score of 88.5 and a standard deviation of 15.7. (Figure 1a) For the psychological well-being module, among 436 (99.7%) responders, the mean score was 82.5 with a standard deviation 18.4. (Figure 1b) For sexual well-being, among 370 (84.7%) responders the mean score was 63.1 with a standard deviation of 22.7. (Figure 1c) And for the satisfaction with breasts module, among 434 (99.3%) responders the mean score was 63.8 with a standard deviation of 20.3 (Figure 1d).

Figure 1.

BREAST-Q 10 years after Breast-Conserving Surgery for Early-Stage Breast Cancer (2002–2012)

• 1a. BREAST-Q Physical Well-being Score (N=436)

• 1b. BREAST-Q Psychological Well-being Score (N=436)

• 1c. BREAST-Q Sexual Well-being Score (N=370)

• 1d. BREAST-Q Satisfaction With Breasts Score (N=434)

Univariable and Multivariable Analysis of Factors Associated with BREAST-Q Score

Factors associated with each BREAST-Q score in univariable and multivariable analyses are shown in eTables 1–4.

Satisfaction with Breasts

For satisfaction with breasts, in univariable analyses multiple factors were significantly associated with scores. Longer time since surgery (Β=−0.73; 95% CI −1.3 to −0.1; Ρ=0.016), intermediate vs. low-grade tumor (Β=−8.7; 95% CI −14.1 to −3.2; Ρ=0.002), T2 vs. T1 tumor size (Β=−5.10; 95% CI −10.1 to −0.1; Ρ=0.044), and receiving endocrine therapy (Β=−−5.20; 95% CI −10.2 to −0.2; Ρ=0.041) were associated with lower scores while increasing age (Β=0.22 per year; 95% CI 0.02 to 0.4; Ρ=0.035) and not receiving radiation (Β=7.41; 95% CI 0.4 to 14.4; Ρ=0.038) were associated with higher scores. Other demographic, clinical and treatment covariates did not show statistically significant associations with satisfaction with breasts. In multivariable analysis, only T2 vs.T1 tumor size (Β=−6.97; 95% CI −12.6 to −1.3; Ρ=0.016) remained significantly associated with lower scores for satisfaction with breasts (Figure 2a). For the remaining variables, adjusted effect estimates were generally similar though not statistically significant, except for receipt of radiation, in which the effect was substantially attenuated (eTable 1).

Figure 2.

Adjusted associations of demographic, tumor, and treatment factors with BREAST-Q scores 10 years after breast-conserving surgery (2002–2012)

• 2a. Satisfaction with Breasts Score

• 2b. Physical Well-Being Score

• 2c. Psychological Well-being Score

• 2d. Sexual Well-being Score

Abbreviation: HR-negative, hormone receptor-negative

Physical well-being

In univariable analyses, having hormone receptor-negative breast cancer was associated with worse physical well-being (Β=−6.93; 95% CI, −11.24 to −2.61; Ρ= 0.002) while older age was associated with higher physical well-being (Β=0.25 per year; 95% CI, 0.1 to 0.4; Ρ= 0.001). In multivariable analyses, relationships with having hormone receptor-negative breast cancer (Β=−8.96; 95% confidence interval (CI), −16.7 to −1.2; Ρ= 0.02) and older age (Β=0.17 per year; 95% CI, −0.04 to 0.34; Ρ= 0.055) persisted (Figure 2b). Other demographic, treatment and clinical factors did not show statistically significant associations with physical well-being (eTable 2).

Psychological well-being

In univariable analyses, having a larger tumor (T2 vs. T1) was associated with worse psychological well-being (Β=−5.89; 95% CI, −10.34 to −1.53; Ρ= 0.010) while older age was associated with higher psychological well-being (Β=0.26 per year; 95% CI, 0.08 to 0.44; Ρ= 0.004). In multivariable analyses, the same relationships with older age (Β= 0.31 per year; 95% CI 0.1 to 0.5; Ρ=0.004) and larger tumor size (T2 vs. T1) (Β=−5.76; 95% CI −10.9 to −0.6; Ρ=0.028) persisted(Figure 2c). Other demographic, clinical and treatment factors were not associated with psychological well-being (eTable 3).

Sexual well-being

In univariable analyses, non-White race (B=14.09, 95% CI 2.75 to 25.43, P=0.015) was significantly associated with higher scores for sexual well-being. In multivariable analyses, older age (Β=0.29 per year; 95% CI 0.01 to 0.6; Ρ=0.044), longer time since surgery (Β=1.01; 95% CI 0.2 to 1.8; Ρ=0.012) and non-White race (B=16.4, 95% CI 5.1 to 27.8, P=0.005) were associated with significantly higher scores for sexual well-being. Having Tis disease (vs. T1) was associated with borderline worse sexual well-being (B=−15.6, 95% CI −31.3 to 0.14, P=0.052) (Figure 2d). Other demographic, clinical and treatment covariates did not show statistically significant associations with sexual well-being (eTable 4).

EORTC QLQ-C30 Scores

436 (99.7%) responders responded to the global health status questions (high score means better function) with a mean score of 84.6 and standard deviation of 16.8. Physical function questions (high score means better function) were answered by 435 (99.5%) responders with a mean score of 95.9 and standard deviation of 10.0. 436 (99.7%) responders responded to questions about pain (high score means high symptom burden) with a mean score of 8.4 and standard deviation of 16.1 (Figure 3).

Figure 3.

EORTC QLQ C30 10 years after Breast Conserving Surgery for Early-Stage Breast Cancer (2002–2012)

• 3a. EORTC QLQ30 Global Health Status (N=436)

• 3b. EORTC QLQ30 Physical Function (N=435)

• 3c. EORTC QLQ30 Pain Scores (N=436)

Abbreviation: EORTC, European Organisation for Research and Treatment of Cancer

EORTIC QLQ-BR23 Scores

434 (99.3%) responders responded to body image questions (high score means better body image) with a mean score 85.7 and standard deviation 18.4. Sexual function questions (high score means high function) were completed by 396 (90.6%) responders with a mean score of 30.4 and standard deviation of 25.8. Questions related to breast symptoms (high score means high symptom burden) were answered by 432 (98.9%) responders with a mean score of 8.7 and standard deviation of 11.2 (Figure 4).

Figure 4.

EORTC QLQ-BR23 10 years after Breast Conserving Surgery for Early-Stage Breast Cancer (2002–2012)

• 4a. EORTC BR23 Body Image (N=434)

• 4b. EORTC BR23 Sexual Function (N=396)

• 4c. EORTC BR23 Breast Symptoms (N=432)

Abbreviation: EORTC, European Organisation for Research and Treatment of Cancer

Discussion

In this large, cross-sectional study, PROMS included in the ICHOM standard set were used to collect patient-reported data related to satisfaction with breasts, as well as physical, psychosocial, and sexual well-being for more than 400 responders who underwent BCS at a median of 10 years prior to survey completion. The scores for physical and psychological well-being were generally high, while more variability was seen in scores for sexual well-being and satisfaction with breasts. These data are critically important to provide long-term clinical outcomes for breast conservation and inform patient counseling regarding surgical options. These data also provide information needed for calculation of value in healthcare, substantially adding to the published literature, which predominantly describes PROs in the early postoperative period. We elected to focus this work on PROs for patients having BCS to focus on reference values for this group of patients, rather than compare outcomes with those of mastectomy.

The importance in collecting long-term quality of life outcomes for breast cancer patients is evidenced by the differences seen in our cohort compared to previously published studies where assessments were performed after a shorter time from surgery. In many studies, “long-term” outcomes are defined as 1–2 years after surgery,¹¹ with few studies having data on patients more than 5 years out from their surgery.¹² However, data suggest that there is continued evolution of PROs, which makes counseling patients about these changes and being able to interpret these outcomes important for long-term survivorship care.¹³ Much of the previously published data about PROs after BCS come from Memorial Sloan Kettering Cancer Center, where BREAST-Q outcomes were assessed within two years following surgery. Compared to these studies, we saw similar values for psychosocial and sexual well-being at our longer follow-up.⁵ Importantly, with longer term follow up we saw clinically important differences, defined as score differences of at least 4 points, in two additional domains. Specifically, we identified lower satisfaction with breasts, yet higher scores for physical well-being, at our median follow up of greater than 10 years.⁵ These followup data provide critical information that is needed to fully understand long-termoutcomes of local therapy for patients with breast cancer.

As evidenced by the high numbers of patients that completed our surveys, these measures were felt to be acceptable to complete even a decade out from cancer surgery and we saw higher rates of completion of the sexual well-being BREAST-Q than in other studies, although it still had the lowest response rate ( 84.7%) of administered surveys in our study.¹⁴ Both the EORTC QLQ-BR23 and BREAST-Q showed greater variation in scores for sexual well-being than in other domains. Although scores are not directly comparable between the EORTC QLQ-BR23 and the BREAST-Q, the higher scores on the BREAST-Q may reflect the difference in the nature of the questions. Specifically the BREAST-Q asks about feeling sexually attractive or confident whereas the EORTC QLQ-BR23 questions are more about the act of having sex. While we did find that non-White race was associated with higher scores for BREAST-Q sexual well-being on multi-variable analyses, these numbers are too small to draw any significant conclusions. Despite the difficulties in obtaining these data, PROs are critical in their ability to elicit concerns related to sexuality that are challenging for patients and physicians to discuss, and our data suggest that this remains an important issue years after initial treatment.¹⁵

In this study we elected to collect data per the ICHOM standard set as this provides a framework to evaluate outcomes and support calculation of value of care for women after breast cancer treatment. ⁸ While the ICHOM dataset only includes the BREAST-Q module for satisfaction with breasts, we collected additional modules of the BREAST-Q with the thought that this PROM may be more sensitive to differences in long-term outcomes related to local therapies. We did, in fact, see this in our data. In general, women reported high levels of physical wellness in both the EORTC QLQ-C30 and the BREAST-Q physical well-being module, although scores were lower and had more variability in the BREAST-Q), which also specifically asks about arm symptoms. This may be related to arm morbidity following nodal surgery and/or radiation following breast conservation, as reports of PROMS specifically created to evaluate arm morbidity have demonstrated differences related to these treatment factors. ¹⁶ Very few responders appeared to report significant levels of pain or breast symptoms in our study, which may relate to longer time since surgery and may be less relevant to collect during longer follow-up periods. Lower scores in physical well-being were associated with hormone receptor negative disease, which could potentially be related to long-lasting physical impacts of chemotherapy.¹⁷ For the small group of patients reporting significant discomfort, it may be helpful to use a more specific PROM to assess for change in clinical status related to intervention.¹⁸

From the standpoint of body image, the EORTC QLC-BR23 demonstrated generally high scores for body image, while the BREAST-Q satisfaction with breast scores had more variation, supporting its inclusion in the ICHOM standard set to evaluate body image from a local therapy lens. However, the ICHOM set suggests only collecting this data for 2 years postoperatively.⁸ Our study suggests that satisfaction with breast continues to change over time, whereas other studies have suggested that scores may stabilize.¹⁹ It would not be unexpected that aesthetic changes related to surgery and radiation would evolve over time in women who have undergone breast conservation, perhaps particularly for those patients with larger tumors and/or larger volumes of resection, and consideration should be given to continuing to collect the BREAST-Q satisfaction with breast survey data annually to better describe long term outcomes beyond two years.

Our study does have limitations. This is single-institution data and cross-sectional, such that baseline data was not available, and baseline differences may significantly impact a patient’s decision to pursue breast conservation as well as postoperative quality of life. Our patients were mostly White, were treated at an academic medical center, generally had college educations and early-stage disease, so results may not be generalizable. Importantly, although a high percentage of women did complete the survey after indicating a desire to participate in the study, a large percentage of women contacted did not respond to our invitation and while there were not broad differences in these groups, the non-responders were more likely to have experienced a breast cancer recurrence. We also excluded patients who received chemotherapy within 6 months of survey, which may also contribute to the very low recurrence rates seen in our patients. Previous studies looking at PROs in breast cancer patients in the Netherlands, however, have not shown significant differences in patients treated for an initial breast cancer diagnosis versus those with a recurrence.¹⁴

Conclusion

This cross-sectional study of PROs in 437 women undergoing BCS with long-term follow-up provides important data to guide clinical care and enable assessment of value for patients being treated for breast cancer. The BREAST-Q appears to allow for more differentiation than other PROMs when evaluating outcomes of local therapy and, as such, it may be important to include additional BREAST-Q modules in the ICHOM standard set. Additionally, PROs continue to evolve as demonstrated by data collection in these patients over 10 years out from surgery, such that ongoing collection and evaluation of PROs during survivorship will be critical to inform long-term outcomes of local therapy for breast cancer.

Synopsis:

At >10 years from surgery, patients having breast-conserving surgery had high scores for physical and psychological well-being, with more variation seen in sexual well-being and satisfaction with breasts.