Abstract
Background
The literature examining decision-making related to treatment and reconstruction for women with breast cancer has established that patient, clinical, and facility factors all play a role.
Objectives
The aim of this study was to use the National Cancer Database to determine how patient, clinical, and facility factors influence: (1) the receipt of immediate breast reconstruction; and (2) the type of immediate breast reconstruction received (implant-based, autologous, or a combination).
Methods
A total of 638,772 female patients with breast cancers (Tis-T3, N0-N1, or M0) who between 2004 and 2017 received immediate reconstruction following mastectomy were identified in the National Cancer Database. Univariate and multivariate logistic regression models were applied to identify characteristics associated with immediate breast reconstruction and type of reconstruction.
Results
Immediate breast reconstruction was more frequently associated with patients of White race, younger age, with private insurance, with lesser comorbidities, who resided in zip codes with higher median incomes or higher rates of high-school graduation, in urban areas, with Tis to T2 disease, or with involvement of <4 lymph nodes (all odds ratios [ORs] > 1.1). Negative predictors of immediate breast reconstruction were insurance status with Medicaid, Medicare, other government insurance, and none or unknown insurance (all ORs < 0.79). Implant-based reconstruction was associated with non-Black race, uninsured status, completion of higher education, undifferentiated disease, and stage T0 disease (all ORs > 1.10).
Conclusions
These findings confirm some previous studies on what patient, clinical, and facility factors affect decision-making, but also raise new questions that relate to the impact of third-party payer on receipt and type of reconstruction postmastectomy for breast cancer.
Breast cancer is the most commonly diagnosed cancer in women living in the United States. Today, for those tumors amenable to surgical resection, surgical treatment allows a choice between breast conservation surgery and mastectomy because both approaches have been shown to be equally efficacious.1 The past 10 years have seen a rise in mastectomies, and even more surprisingly, contralateral prophylactic mastectomies.2-6 The women electing for this option tend to be primarily young, Caucasian, have higher incomes, have a family history of breast cancer, and have been diagnosed at a later stage of disease.1,2,7-9
Recent years have also seen refinements in breast reconstruction techniques after mastectomy with implant-based and autologous tissue–based approaches for those women who decide that reconstruction is the right option for them. Women who chose reconstruction reported improved long-term satisfaction, increased quality of life, and superior body image.10-14 These findings are magnified when women opt for immediate reconstruction, when possible, over a delayed procedure,15 while also having the added benefit of requiring only 1 surgery. Small studies have shown that women opting for reconstruction also tend to be young, Caucasian, educated, privately insured, and live closer to hospital centers.16-20
The literature examining decision-making related to treatment and reconstruction for women with breast cancer has established that patient, clinical, and facility factors all play a role; 16,21,22 however, such publications are limited to single institutions or collaborations between a few sites, and rarely touch upon the differing reconstruction options. Utilizing the National Cancer Database (NCDB),23,24 which is comprised of data from over 1500 US cancer programs accounting for 70% to 80% of all newly diagnosed breast cancer cases, will allow for increased generalizability of the results when analyzing these choices. The aims of this NCDB-based study were to determine, following either unilateral or bilateral mastectomy, what factors influence: (1) the receipt of immediate breast reconstruction; and (2) the type of immediate breast reconstruction (implant-based, autologous, or a combination) received.
METHODS
Patient Population
This study used the most recent 2017 NCDB Participant User File for patients diagnosed with breast cancer between 2004 and 2017. Investigation occurred between December 4, 2020 and August 20, 2021. The study population was defined as all female patients with Tis to T3 or N0 to N1 breast cancer receiving subcutaneous mastectomy, total mastectomy, and modified radical mastectomy. Exclusions were made for patients with T4, N2 to N3, or metastatic disease. The following patient characteristics were examined: race (White, Black, other), age (<40, 40-60, >60 years), insurance status (none, private, government), median income based on residence zip code (<$38,000, $38,000-$47,999, $48,000-$62,999, >$63,000), education level/percentage with no high-school degree based on residence zip code (≥21%, 13.0%-20.9%, 7%-12.9% <7.0%), great circle distance from treatment facility, residency area (rural, metro, urban), and Charlson-Deyo score (0/1, 2+). The following disease characteristics were examined: invasion (in situ, invasive), tumor grade (differentiated, nondifferentiated), tumor staging (Tis, T1, T2, T3), and lymph node involvement (0, <4, ≥4). Facility characteristics examined were: facility type (community, academic) and facility regional location (New England, Atlantic, East Central, West Central, Mountain Pacific).
Outcomes of Interest
The primary outcome was defined as receipt of immediate breast reconstruction. Secondary outcome was defined as type of immediate breast reconstruction received: tissue-based vs implant-based vs combined.
Statistical Analysis
Statistical analysis was conducted with SAS version 9.4 (SAS Institute, Cary, NC), and with SAS macros developed by the Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute.25 Descriptive statistics for each variable were reported. Univariate (UVA) analysis and multivariate (MVA) analyses were performed. UVA association between each covariate for each study cohort was done using the chi-square test for categoric factors and analysis of variance (ANOVA) for numerical factors. An MVA logistic regression model was fitted to predict reconstruction vs none, and type of reconstruction. The MVA models was built by a backward variable selection method applying an α = 0.1 removal criterion.
RESULTS
Patient, Tumor, and Facility Characteristics
For women diagnosed with breast cancer between 2004 and 2017, the NCDB reported 638,772 women who underwent mastectomy. The characteristics of the patients during this period are summarized in Table 1. Patients were primarily White (82.6%), and tended to be older, with 50.4% falling into the 40- to 60-year age range category, and 42.1% of cases being >60 years old. The mean age was 57.8 years (range, 18-90 years). Most had private insurance (58.8%); however, 30.5% had Medicare. Patients tended to be better off (37.9% with income ≥$63,000), live in neighborhoods with higher levels of high-school completion (32.4% where only 7%-12.9% did not have a high-school education), and reside in metro areas (86.6%). Most patients (96.6%) tended to have a Charlson-Deyo score of 0/1. Most tumors were found at earlier stages (T1, 41.3%; T2, 41.3%) with the majority having no lymph node involvement (73.2%). Mastectomies were performed equally at community cancer programs (48.6%) and academic research programs (43.9%), with most facilities located in the Atlantic region (34.0%). Patients resided on average 24.68 miles (great circle distance) from the treating facility (range, 0 to >500 miles). Of the sample of patients receiving mastectomies, 42.1% had immediate breast reconstruction. The reconstructions primarily consisted of implant-based reconstruction (40.0%) and tissue-based reconstruction (31.6%).
Table 1.
Descriptive Statistics—Variable of Interest
| Variable | Level | N = 638,772 |
|---|---|---|
| Race | White | 527,459 (82.6) |
| Black | 70,730 (11.1) | |
| Others/unknown | 40,583 (6.4) | |
| Age at diagnosis (years) | <40 | 48,176 (7.5) |
| 40-60 | 321,679 (50.4) | |
| >60 | 268,917 (42.1) | |
| Primary payer | Not insured | 11,617 (1.8) |
| Private insurance | 375,430 (58.8) | |
| Medicaid | 41,576 (6.5) | |
| Medicare | 194,582 (30.5) | |
| Other government | 7352 (1.2) | |
| Insurance status unknown | 8215 (1.3) | |
| Census median income quartiles 2008-2012 | <$38,000 | 84,399 (14.8) |
| $38,000-$47,999 | 119,428 (21.0) | |
| $48,000-$62,999 | 149,973 (26.3) | |
| >=$63,000 | 215,713 (37.9) | |
| Missing | 69,259 | |
| Percentage with no high-school degree 2008-2012 | ≥21% | 85,650 (15.0) |
| 13.0%-20.9% | 133,788 (23.5) | |
| 7.0%-12.9% | 184,437 (32.4) | |
| <7.0% | 165,838 (29.1) | |
| Missing | 69,059 | |
| County of residence 2013 | Metro | 539,177 (86.6) |
| Urban | 73,497 (11.8) | |
| Rural | 9693 (1.6) | |
| Missing | 16,405 | |
| Charlson-Deyo score | 0/1 | 617,038 (96.6) |
| 2+ | 21,734 (3.4) | |
| Behavior | Carcinoma in situ | 106,641 (16.7) |
| Invasive | 532,131 (83.3) | |
| Grade | Differentiated | 580,222 (90.8) |
| Undifferentiated | 4041 (0.6) | |
| Cell type not determined | 54,509 (8.5) | |
| Tumor staging | T0 | 112,610 (18.4) |
| T1 | 252,905 (41.3) | |
| T2 | 228,983 (37.4) | |
| T3 | 17,588 (2.9) | |
| Missing | 26,686 | |
| Number of regional lymph nodes positive | None | 452,525 (73.2) |
| <4 | 156,547 (25.3) | |
| ≥4 | 9328 (1.5) | |
| Missing | 20,372 | |
| Facility type | Community cancer program | 310,321 (48.6) |
| Academic/research program | 280,275 (43.9) | |
| Unknown (age, <40 years) | 48,176 (7.5) | |
| Facility location | New England | 27,851 (4.4) |
| Atlantic | 216,997 (34.0) | |
| East Central | 144,083 (22.6) | |
| West central | 102,927 (16.1) | |
| Mountain Pacific | 98,738 (15.5) | |
| Unknown (age, <40 years) | 48,176 (7.5) | |
| Great circle distance | Mean | 24.68 |
| Median | 9.90 | |
| Minimum | 0.00 | |
| Lower quartile | 4.70 | |
| Upper quartile | 20.90 | |
| Maximum | 5064.10 | |
| Standard deviation | 92.72 | |
| Missing | 68,708.00 | |
| Performance of immediate breast reconstruction | Without | 370,051 (57.9) |
| With | 268,721 (42.1) | |
| Type of immediate breast reconstruction | Recon not otherwise specified | 39,241 (16.2) |
| Tissue | 76,550 (31.6) | |
| Implant | 96,651 (40.0) | |
| Combined tissue + implant | 29,484 (12.2) | |
| Missing | 396,846 |
Values are n (%).
Factors That Influence Immediate Breast Reconstruction
According to UVA (Table 2), all factors were found to be associated with immediate breast reconstruction (P < 0.001); however, this is likely due to the large sample size of the study. When looking at the MVA (Table 3), patient factors that predicted immediate reconstruction were White race (odds ratio [OR], 1.15), younger age (<40 years OR, 4.35; 40-60 years OR, 2.73), residence in zip codes of higher median incomes (≥$63,000 OR, 1.95; $48,000-$62,999 OR, 1.35; $38,000-$47,999 OR, 1.14), and in neighborhoods with higher percentages of high-school completion (<7% did not complete OR, 1.19), living in a metro area (OR, 1.50) and urban area (OR, 1.17), and Charlson-Deyo score of 0/1 (OR, 1.73). Disease characteristics that predicted reconstruction are in situ behavior (OR, 1.49), lower T staging (T1 OR, 2.23; T2 OR, 1.47), and less lymph node involvement (0 node OR, 1.47; <4 nodes OR, 1.39). Of note, factors that negatively predicted immediate reconstruction included no insurance (OR, 0.34), Medicaid (OR, 0.53), Medicare (OR, 0.41), other government insurance (OR, 0.79), and unknown insurance (OR, 0.52).
Table 2.
Univariate Association with Immediate Breast Reconstruction vs No Reconstruction
| Performance of immediate breast reconstruction | |||||
|---|---|---|---|---|---|
| Covariate | Statistics | Level | Without (N = 370,051) | With (N = 268,721) | Parametric P valuea |
| Race | N (col %) | White | 301,031 (81.3) | 226,428 (84.3) | <0.001 |
| N (col %) | Black | 44,721 (12.1) | 26,009 (9.7) | ||
| N (col %) | Others/unknown | 24,299 (6.6) | 16,284 (6.1) | ||
| Age at diagnosis (years) | N (col %) | <40 | 17,315 (4.7) | 30,861 (11.5) | <0.001 |
| N (col %) | 40-60 | 143,699 (38.8) | 177,980 (66.2) | ||
| N (col %) | >60 | 209,037 (56.5) | 59,880 (22.3) | ||
| Primary payer | N (col %) | Not insured | 8474 (2.3) | 3143 (1.2) | <0.001 |
| N (col %) | Private insurance | 166,633 (45) | 208,797 (77.7) | ||
| N (col %) | Medicaid | 27,049 (7.3) | 14,527 (5.4) | ||
| N (col %) | Medicare | 158,568 (42.9) | 36,014 (13.4) | ||
| N (col %) | Other government | 3918 (1.1) | 3434 (1.3) | ||
| N (col %) | Insurance status unknown | 5409 (1.5) | 2806 (1) | ||
| Census median income quartiles 2008-2012 | N (col %) | <$38,000 | 60,685 (18.2) | 23,714 (10) | <0.001 |
| N (col %) | $38,000-$47,999 | 80,058 (24.1) | 39,370 (16.6) | ||
| N (col %) | $48,000-$62,999 | 90,395 (27.2) | 59,578 (25.2) | ||
| N (col %) | ≥$63,000 | 101,538 (30.5) | 114,175 (48.2) | ||
| Percentage with no high-school degree 2008-2012 | N (col %) | ≥21% | 59,333 (17.8) | 26,317 (11.1) | <0.001 |
| N (col %) | 13.0-20.9% | 86,457 (26) | 47,331 (20) | ||
| N (col %) | 7.0-12.9% | 107,436 (32.3) | 77,001 (32.5) | ||
| N (col %) | <7.0% | 79,590 (23.9) | 86,248 (36.4) | ||
| County of residence 2013 | N (col %) | Metro | 302,850 (83.8) | 236,327 (90.6) | <0.001 |
| N (col %) | Urban | 51,505 (14.2) | 21,992 (8.4) | ||
| N (col %) | Rural | 7253 (2) | 2440 (0.9) | ||
| Charlson-Deyo score | N (col %) | 0/1 | 352,564 (95.3) | 264,474 (98.4) | <0.001 |
| N (col %) | 2+ | 17,487 (4.7) | 4247 (1.6) | ||
| Behavior | N (col %) | Carcinoma in situ | 50,450 (13.6) | 56,191 (20.9) | <0.001 |
| N (col %) | Invasive | 319,601 (86.4) | 212,530 (79.1) | ||
| Grade | N (col %) | Differentiated | 337,407 (91.2) | 242,815 (90.4) | <0.001 |
| N (col %) | Undifferentiated | 2375 (0.6) | 1666 (0.6) | ||
| N (col %) | Cell type not determined | 30,269 (8.2) | 24,240 (9) | ||
| Tumor staging | N (col %) | T0 | 53,531 (15.1) | 59,079 (23) | <0.001 |
| N (col %) | T1 | 140,748 (39.6) | 112,157 (43.7) | ||
| N (col %) | T2 | 148,546 (41.8) | 80,437 (31.3) | ||
| N (col %) | T3 | 12,598 (3.5) | 4990 (1.9) | ||
| Number of regional lymph nodes positive | N (col %) | None | 252,562 (70.7) | 199,963 (76.6) | <0.001 |
| N (col %) | <4 | 98,885 (27.7) | 57,662 (22.1) | ||
| N (col %) | >=4 | 5832 (1.6) | 3496 (1.3) | ||
| Facility type | N (col %) | Community cancer program | 201,732 (54.5) | 108,589 (40.4) | <0.001 |
| N (col %) | Academic/research program | 151,004 (40.8) | 129,271 (48.1) | ||
| N (col %) | Unknown (age, <40 years) | 17,315 (4.7) | 30,861 (11.5) | ||
| Facility location | N (col %) | New England | 15,036 (4.1) | 12,815 (4.8) | <0.001 |
| N (col %) | Atlantic | 120,496 (32.6) | 96,501 (35.9) | ||
| N (col %) | East Central | 91,348 (24.7) | 52,735 (19.6) | ||
| N (col %) | West central | 64,984 (17.6) | 37,943 (14.1) | ||
| N (col %) | Mountain Pacific | 60,872 (16.4) | 37,866 (14.1) | ||
| N (col %) | Unknown (age, <40 years) | 17,315 (4.7) | 30,861 (11.5) | ||
| Great circle distance | N | 333,053 | 237,011 | <0.001 | |
| Mean | 23.1 | 26.9 | |||
| Median | 9.3 | 10.6 | |||
| Minimum | 0 | 0 | |||
| Lower quartile | 4.3 | 5.2 | |||
| Upper quartile | 20.6 | 21.4 | |||
| Maximum | 4852.4 | 5064.1 | |||
| Standard deviation | 83.3 | 104.5 |
col%, column percentage. aThe parametric P value is calculated by analysis of variance for numerical covariates and chi-square test for categoric covariates.
Table 3.
Multivariate Analysis with Immediate Breast Reconstruction vs No Reconstruction
| Performance of immediate breast reconstruction = with | |||||
|---|---|---|---|---|---|
| Covariate | Level | N | OR (95% CI) | OR P value | Type 3 P value |
| Race | White | 425,762 | 1.15 (1.13-1.17) | <0.001 | <0.001 |
| Others/unknown | 32,972 | 0.75 (0.73-0.78) | <0.001 | ||
| Black | 56,608 | — | — | ||
| Age at diagnosis (years) | <40 | 37,086 | 4.35 (4.23-4.46) | <0.001 | <0.001 |
| 40-60 | 257,578 | 2.73 (2.68-2.77) | <0.001 | ||
| >60 | 220,678 | — | — | ||
| Primary payer | Not insured | 9435 | 0.34 (0.33-0.36) | <0.001 | <0.001 |
| Medicaid | 33,932 | 0.53 (0.52-0.55) | <0.001 | ||
| Medicare | 159,837 | 0.41 (0.40-0.42) | <0.001 | ||
| Other government | 5813 | 0.79 (0.74-0.83) | <0.001 | ||
| Insurance status unknown | 6268 | 0.52 (0.49-0.55) | <0.001 | ||
| Private insurance | 300,057 | — | — | ||
| Census median income quartiles 2008-2012 | ≥$63,000 | 194,838 | 1.95 (1.90-2.00) | <0.001 | <0.001 |
| $48,000-$62,999 | 136,174 | 1.35 (1.32-1.39) | <0.001 | ||
| $38,000-$47,999 | 108,144 | 1.14 (1.11-1.17) | <0.001 | ||
| <$38,000 | 76,186 | — | — | ||
| Percentage with no high-school degree 2008-2012 | <7.0% | 149,992 | 1.19 (1.16-1.23) | <0.001 | <0.001 |
| 7.0%-12.9% | 166,746 | 1.06 (1.03-1.08) | <0.001 | ||
| 13.0%-20.9% | 121,027 | 1.05 (1.02-1.07) | <0.001 | ||
| ≥21% | 77,577 | — | — | ||
| County of residence 2013 | Metro | 446,463 | 1.50 (1.42-1.59) | <0.001 | <0.001 |
| Urban | 60,945 | 1.17 (1.10-1.24) | <0.001 | ||
| Rural | 7934 | — | — | ||
| Charlson-Deyo score | 0/1 | 497,518 | 1.73 (1.66-1.80) | <0.001 | <0.001 |
| 2+ | 17,824 | — | — | ||
| Behavior | Carcinoma in situ | 80,955 | 1.49 (1.41-1.57) | <0.001 | <0.001 |
| Invasive | 434,387 | — | — | ||
| Grade | Differentiated | 470,987 | 1.11 (1.08-1.13) | <0.001 | <0.001 |
| Undifferentiated | 3270 | 0.70 (0.65-0.76) | <0.001 | ||
| Cell type not determined | 41,085 | — | — | ||
| Tumor staging | T0 | 87,584 | 2.03 (1.91-2.17) | <0.001 | <0.001 |
| T1 | 214,851 | 2.23 (2.14-2.33) | <0.001 | ||
| T2 | 197,762 | 1.47 (1.41-1.53) | <0.001 | ||
| T3 | 15,145 | — | — | ||
| Number of regional lymph nodes positive | None | 377,533 | 1.47 (1.38-1.56) | <0.001 | <0.001 |
| <4 | 131,905 | 1.39 (1.31-1.47) | <0.001 | ||
| ≥4 | 5904 | — | — |
OR, odds ratio. Number of observations in the original data set = 638,772. Number of observations used = 515,342. Backward selection with an α level of removal of 0.1 was used. No variables were removed from the model.
Factors That Influence Type of Reconstruction
Of the 268,721 patients who received immediate breast reconstruction, factors that were associated with certain types of reconstruction were likely statistically significant (P < 0.001) due to the large sample size on UVA (Table 4). On MVA (Table 5), variables that predicted implant-based reconstruction vs tissue-based and combined reconstruction were White race (OR, 1.33), patients <40 years old (OR, 1.12), patients residing in neighborhoods with higher high-school completion (<7% did not complete OR, 1.22; 7%-12.9% did not complete OR, 1.16; and 13%-20.9% did not complete OR, 1.14). Predictors of tissue-based reconstruction on MVA vs implant-based and combined reconstruction (Table 6) were residence in zip codes with higher median income (≥$63,000 OR, 1.10) and metro area of residence (OR, 1.19) compared to rural. Variables that negatively predicted tissue-based reconstruction vs implant-based and combined reconstruction were Medicare insurance (OR, 0.89) when compared to private insurance.
Table 4.
Univariate Association With Type of Immediate Breast Reconstruction
| Type of immediate breast reconstruction | ||||||
|---|---|---|---|---|---|---|
| Covariate | Statistics | Level | Tissue (N = 76,550) | Implant (N = 96,651) | Combined tissue + implant (N = 29,484) | Parametric P valuea |
| Race | N (col %) | White | 62,931 (82.2) | 83,203 (86.1) | 25,396 (86.1) | <0.001 |
| N (col %) | Black | 8952 (11.7) | 7859 (8.1) | 2668 (9) | ||
| N (col %) | Others/unknown | 4667 (6.1) | 5589 (5.8) | 1420 (4.8) | ||
| Age at diagnosis (years) | N (col %) | <40 | 8295 (10.8) | 11,497 (11.9) | 3122 (10.6) | <0.001 |
| N (col %) | 40-60 | 51,514 (67.3) | 63,078 (65.3) | 19,296 (65.4) | ||
| N (col %) | >60 | 16,741 (21.9) | 22,076 (22.8) | 7066 (24) | ||
| Primary payer | N (col %) | Not insured | 901 (1.2) | 1120 (1.2) | 266 (0.9) | <0.001 |
| N (col %) | Private insurance | 60,119 (78.5) | 74,962 (77.6) | 22,773 (77.2) | ||
| N (col %) | Medicaid | 4062 (5.3) | 5182 (5.4) | 1563 (5.3) | ||
| N (col %) | Medicare | 9743 (12.7) | 13,521 (14) | 4328 (14.7) | ||
| N (col %) | Other government | 972 (1.3) | 1184 (1.2) | 320 (1.1) | ||
| N (col %) | Insurance status unknown | 753 (1) | 682 (0.7) | 234 (0.8) | ||
| Census median income quartiles 2008-2012 | N (col %) | <$38,000 | 7276 (10.7) | 7873 (9.2) | 2457 (9.8) | <0.001 |
| N (col %) | $38,000-$47,999 | 11,409 (16.8) | 13,980 (16.3) | 4133 (16.5) | ||
| N (col %) | $48,000-$62,999 | 16,532 (24.3) | 21,663 (25.3) | 6473 (25.8) | ||
| N (col %) | ≥$63,000 | 32,875 (48.3) | 42,244 (49.3) | 11,997 (47.9) | ||
| Percentage with no high-school degree 2008-2012 | N (col %) | ≥21% | 8425 (12.4) | 8504 (9.9) | 2483 (9.9) | <0.001 |
| N (col %) | 13.0%-20.9% | 14,029 (20.6) | 16,773 (19.6) | 4683 (18.7) | ||
| N (col %) | 7.0%-12.9% | 21,858 (32.1) | 28,201 (32.9) | 8487 (33.9) | ||
| N (col %) | <7.0% | 23,798 (34.9) | 32,302 (37.7) | 9415 (37.6) | ||
| County of residence 2013 | N (col %) | Metro | 67,819 (91.1) | 84,153 (90.1) | 25,909 (90.3) | <0.001 |
| N (col %) | Urban | 5940 (8) | 8317 (8.9) | 2553 (8.9) | ||
| N (col %) | Rural | 646 (0.9) | 977 (1) | 234 (0.8) | ||
| Charlson-Deyo score | N (col %) | 0/1 | 75,348 (98.4) | 95,115 (98.4) | 28,986 (98.3) | 0.372 |
| N (col %) | 2+ | 1202 (1.6) | 1536 (1.6) | 498 (1.7) | ||
| Behavior | N (col %) | Carcinoma in situ | 16,499 (21.6) | 20,065 (20.8) | 233 (21.1) | <0.001 |
| N (col %) | Invasive | 60,051 (78.4) | 76,586 (79.2) | 23,251 (78.9) | ||
| Grade | N (col %) | Differentiated | 68,612 (89.6) | 87,711 (90.8) | 26,793 (90.9) | <0.001 |
| N (col %) | Undifferentiated | 499 (0.7) | 662 (0.7) | 178 (0.6) | ||
| N (col %) | Cell type not determined | 7439 (9.7) | 8278 (8.6) | 2513 (8.5) | ||
| Tumor staging | N (col %) | T0 | 17,088 (23.3) | 21,149 (22.9) | 6569 (23.3) | 0.008 |
| N (col %) | T1 | 31,347 (42.8) | 40,330 (43.6) | 12,334 (43.7) | ||
| N (col %) | T2 | 23,268 (31.8) | 29,166 (31.6) | 8754 (31) | ||
| N (col %) | T3 | 1489 (2) | 1783 (1.9) | 560 (2) | ||
| Number of regional lymph nodes positive | N (col %) | None | 56,669 (76.4) | 71,852 (76.2) | 22,014 (76.7) | 0.007 |
| N (col %) | <4 | 16,591 (22.4) | 21,121 (22.4) | 6314 (22) | ||
| N (col %) | ≥4 | 886 (1.2) | 1307 (1.4) | 367 (1.3) | ||
| Facility type | N (col %) | Community cancer program | 30,481 (39.8) | 39,056 (40.4) | 10,950 (37.1) | <0.001 |
| N (col %) | Academic/research program | 37,774 (49.3) | 46,098 (47.7) | 15,412 (52.3) | ||
| N (col %) | Unknown (age, <40 years) | 8295 (10.8) | 11,497 (11.9) | 3122 (10.6) | ||
| Facility location | N (col %) | New England | 3640 (4.8) | 4976 (5.1) | 1530 (5.2) | <0.001 |
| N (col %) | Atlantic | 31,261 (40.8) | 32,060 (33.2) | 9622 (32.6) | ||
| N (col %) | East Central | 14,192 (18.5) | 19,909 (20.6) | 7703 (26.1) | ||
| N (col %) | West central | 10,419 (13.6) | 13,531 (14) | 3899 (13.2) | ||
| N (col %) | Mountain Pacific | 8743 (11.4) | 14,678 (15.2) | 3608 (12.2) | ||
| N (col %) | Unknown (age, <40 years) | 8295 (10.8) | 11,497 (11.9) | 3122 (10.6) | ||
| Great circle distance | N | 68,143 | 85,817 | 25,081 | 0.001 | |
| Mean | 26.3 | 27.3 | 24.6 | |||
| Median | 10.6 | 10.7 | 10.5 | |||
| Minimum | 0 | 0 | 0 | |||
| Q1 | 5.3 | 5.2 | 5.2 | |||
| Q3 | 21.3 | 22 | 21.4 | |||
| Maximum | 5064.1 | 4958.8 | 3345.2 | |||
| Standard deviation | 102.8 | 107.6 | 83.6 |
aThe parametric P value is calculated by analysis of variance for numerical covariates and chi-square test for categoric covariates.
Table 5.
Multivariate Analysis With Type of Reconstruction
| Type of immediate breast reconstruction = implant | |||||
|---|---|---|---|---|---|
| Covariate | Level | N | OR (95% CI) | OR P value | Type 3 P value |
| Race | White | 136,914 | 1.33 (1.29-1.38) | <0.001 | <0.001 |
| Others/unknown | 9344 | 1.32 (1.25-1.39) | <0.001 | ||
| Black | 15,303 | — | — | ||
| Age at diagnosis (years) | <40 | 17,599 | 1.12 (1.07-1.16) | <0.001 | <0.001 |
| 40-60 | 106,732 | 1.00 (0.97-1.03) | 0.921 | ||
| >60 | 37,230 | — | — | ||
| Primary payer | Not insured | 1805 | 1.10 (1.00-1.21) | 0.040 | <0.001 |
| Medicaid | 8765 | 1.05 (1.00-1.10) | 0.031 | ||
| Medicare | 22,386 | 1.09 (1.05-1.13) | <0.001 | ||
| Other government | 1933 | 1.02 (0.94-1.12) | 0.594 | ||
| Insurance status unknown | 1287 | 0.75 (0.67-0.84) | <0.001 | ||
| Private insurance | 125,385 | — | — | ||
| Census median income quartiles 2008-2012 | ≥$63,000 | 78,735 | 1.00 (0.96-1.05) | 0.916 | 0.006 |
| $48,000-$62,999 | 40,350 | 1.05 (1.00-1.09) | 0.031 | ||
| $38,000-$47,999 | 26,651 | 1.02 (0.98-1.06) | 0.336 | ||
| <$38,000 | 15,825 | — | — | ||
| Percentage with no high-school degree 2008-2012 | <7.0% | 59,209 | 1.22 (1.17-1.27) | <0.001 | <0.001 |
| 7.0%-12.9% | 52,767 | 1.16 (1.11-1.21) | <0.001 | ||
| 13.0%-20.9% | 32,062 | 1.14 (1.10-1.19) | <0.001 | ||
| ≥21% | 17,523 | — | — | ||
| County of residence 2013 | Metro | 146,216 | 0.81 (0.73-0.90) | <0.001 | <0.001 |
| Urban | 13,855 | 0.88 (0.79-0.98) | 0.018 | ||
| Rural | 1490 | — | — | ||
| Behavior | Carcinoma in situ | 32,904 | 0.92 (0.85-0.99) | 0.035 | 0.035 |
| Invasive | 128,657 | — | — | ||
| Grade | Differentiated | 146,912 | 1.10 (1.07-1.14) | <0.001 | <0.001 |
| Undifferentiated | 1064 | 1.13 (1.00-1.28) | 0.050 | ||
| Cell type not determined | 13,585 | — | — | ||
| Tumor staging | T0 | 35,199 | 1.17 (1.05-1.30) | 0.004 | 0.003 |
| T1 | 70,947 | 1.08 (1.00-1.16) | 0.050 | ||
| T2 | 52,194 | 1.04 (0.97-1.12) | 0.280 | ||
| T3 | 3221 | — | — | ||
| Number of regional lymph nodes positive | None | 123,567 | 0.92 (0.83-1.02) | 0.112 | 0.057 |
| <4 | 36,486 | 0.95 (0.85-1.05) | 0.311 | ||
| ≥4 | 1508 | — | — |
The following variables were removed from the model: Charlson-Deyo score. OR, odds ratio. Number of observations in the original data set = 202,685. Number of observations used = 161,561. Backward selection with an α level of removal of 0.1 was used.
Table 6.
Multivariate Analysis With Type of Reconstruction
| Type of immediate breast reconstruction = tissue | |||||
|---|---|---|---|---|---|
| Covariate | Level | N | OR (95% CI) | OR P value | Type 3 P value |
| Race | White | 136,914 | 0.71 (0.69-0.74) | <0.001 | <0.001 |
| Others/unknown | 9344 | 0.78 (0.74-0.83) | <0.001 | ||
| Black | 15,303 | — | — | ||
| Age at diagnosis (years) | <40 | 17,599 | 0.95 (0.91-0.99) | 0.016 | <0.001 |
| 40-60 | 106,732 | 1.03 (1.00-1.07) | 0.028 | ||
| >60 | 37,230 | — | — | ||
| Primary payer | Not insured | 1805 | 1.00 (0.91-1.10) | 0.979 | <0.001 |
| Medicaid | 8765 | 0.91 (0.87-0.96) | <0.001 | ||
| Medicare | 22,386 | 0.89 (0.86-0.92) | <0.001 | ||
| Other government | 1933 | 1.00 (0.91-1.10) | 0.970 | ||
| Insurance status unknown | 1287 | 1.30 (1.17-1.46) | <0.001 | ||
| Private insurance | 125,385 | — | — | ||
| Census median income quartiles 2008-2012 | ≥$63,000 | 78,735 | 1.10 (1.05-1.15) | <0.001 | <0.001 |
| $48,000-$62,999 | 40,350 | 0.99 (0.95-1.04) | 0.805 | ||
| $38,000-$47,999 | 26,651 | 1.02 (0.98-1.06) | 0.402 | ||
| <$38,000 | 15,825 | — | — | ||
| Percentage with no high-school degree 2008-2012 | <7.0% | 59,209 | 0.71 (0.68-0.74) | <0.001 | <0.001 |
| 7.0%-12.9% | 52,767 | 0.76 (0.73-0.80) | <0.001 | ||
| 13.0%-20.9% | 32,062 | 0.84 (0.81-0.88) | <0.001 | ||
| ≥21% | 17,523 | — | — | ||
| County of residence 2013 | Metro | 146,216 | 1.19 (1.07-1.33) | 0.002 | <0.001 |
| Urban | 13,855 | 1.06 (0.95-1.19) | 0.324 | ||
| Rural | 1490 | — | — | ||
| Behavior | Carcinoma in situ | 32,904 | 1.16 (1.06-1.26) | <0.001 | <0.001 |
| Invasive | 128,657 | — | — | ||
| Grade | Differentiated | 146,912 | 0.87 (0.84-0.90) | <0.001 | <0.001 |
| Undifferentiated | 1064 | 0.89 (0.78-1.01) | 0.064 | ||
| Cell type not determined | 13,585 | — | — | ||
| Tumor staging | T0 | 35,199 | 0.79 (0.71-0.89) | <0.001 | <0.001 |
| T1 | 70,947 | 0.91 (0.84-0.99) | 0.020 | ||
| T2 | 52,194 | 0.96 (0.89-1.03) | 0.233 | ||
| T3 | 3221 | — | — | ||
| Number of regional lymph nodes positive | None | 123,567 | 1.09 (0.98-1.21) | 0.128 | 0.019 |
| <4 | 36,486 | 1.04 (0.94-1.16) | 0.431 | ||
| ≥4 | 1508 | — | — |
The following variables were removed from the model: Charlson-Deyo score. OR, odds ratio. aNumber of observations in the original data set = 202,685. Number of observations used = 161,561. bBackward selection with an α level of removal of 0.1 was used.
Discussion
This study is the first since Morrow et al’s 2001 work which used the NCDB to look at the factors associated with breast reconstruction after mastectomy, and the only one to date that investigated the factors influencing the type of immediate breast reconstruction.26 We found that during the span of years of diagnosis from 2004 to 2017, 42.1% of women received immediate breast reconstruction after mastectomy; a clear jump from the mere 8.3% among women diagnosed in 1994 to 1995. Although the NCDB is not a population-based dataset, similar increases have been demonstrated in papers that have utilized data from the National Cancer Institute (NIH); Surveillance, Epidemiology, and End Results (SEER) Program cancer registries, showing an increase from 15.4% in 199817 to 35.7% in 2005 to 2007.27 Our data have reaffirmed trends already established in previous smaller institutional studies that women who receive immediate reconstruction tend to be White, younger, more educated, of higher socioeconomic status, and live in more metro or urban areas than their counterparts who did not receive immediate reconstruction. The cohort of women receiving immediate reconstruction also have fewer comorbidities, and earlier disease showing noninvasive cancer characteristics, Tis to T2 disease, and involvement of <4 lymph nodes.
In an effort to increase access to breast reconstruction, the Women’s Health and Cancer Rights Act was passed in 1998, mandating insurance coverage for breast reconstruction for HMO group plans and insurance companies with exceptions for Medicare/Medicaid and some religious plans.28 Although government-sponsored insurances were exempt, Medicare insurance already routinely covers reconstruction, and those women receiving Medicaid gain reconstruction coverage on a state-by-state basis.28 Reuben et al, who studied the Nationwide Inpatient Sample from 1999 to 2003, found that private insurance status is a positive predictor of reconstruction with an OR of 3.40, while Medicare (OR, 0.31) and Medicaid (OR, 0.85) negatively predicted receipt. Alderman et al found similar results when analyzing the Los Angeles and Detroit SEER Cancer Registries from 2005 to 2007; compared to having private insurance, Medicaid (OR, 0.32), Medicare (OR, 0.76), and no insurance coverage (OR, 0.36) negatively predicted immediate breast reconstruction. These results did not change when the Nationwide Inpatient Sample was resampled from 2000 to 2009.29
Our results from the NCDB also demonstrated that Medicaid (OR, 0.53), Medicare (OR, 0.41), other government insurance (OR, 0.79), uninsured (OR, 0.34), and unknown insurance (OR, 0.52), compared to private insurance, all negatively predicted receipt of immediate breast reconstruction after mastectomies. Taken together, these findings raise the question whether Medicaid and Medicare are fully able to meet the needs of women undergoing mastectomy for breast cancer. As Medicare is only available for those over 65 years, it is possible that some of the negative association found in our results occurs from older women deciding not to pursue immediate breast reconstruction, or from those who have increased comorbidities, making immediate reconstruction not feasible. Women on Medicaid are younger, which should positively predict immediate breast reconstruction; however, they might be equally restricted in pursuing reconstruction due to lower socioeconomic status leading to issues with transportation, paid time off, and childcare needs that come with a surgery requiring longer recovery times and meetings with specialist surgeons. Further studies on this topic are needed to determine impact on rates of immediate breast reconstruction when women are not covered by private insurance. In addition, prospective studies are needed to ascertain women’s views related to immediate reconstruction and the role of insurance coverage as well as other factors that determine the final decision.
Albornoz et al documented a 5% increase in implant-based reconstructions since 2002, demonstrating this method had surpassed the earlier preferred autologous tissue–based reconstructions.17 In 2019, the American Society of Plastic Surgery reported that board-certified surgeons performed 82.1% of immediate breast reconstructions with implants, whereas 17.9% involved tissue-based methods.30 Our data showed similar results, with implant-based reconstructions representing 40.0% between 2004 and 2017, and tissue-based reconstruction making up 31.6%. Although tissue-based reconstructions have a proven superior long-term satisfaction,8,32,33 there are multiple drawbacks that could discourage women from choosing it as an option. Tissue-based reconstructions require longer, more complex surgeries, along with prolonged recovery, with multiple surgeons working together, and a high comfort level with microsurgery techniques for the surgeons involved.34 On the other hand, implant-based reconstruction has faster surgery and recovery times.35 New techniques for implant-based reconstructions have also produced better and more natural results,35 and old fears of implants were addressed by the FDA in 2006.34 Lastly, Medicare reimbursement for tissue-based reconstructions has continually decreased, whereas reimbursements for implant-based reconstructions have remained stable.36
According to the NCDB, women choosing implant-based breast reconstruction vs tissue-based and combined reconstruction tended to be White, under 40 years old, and reside in zip codes with higher rates of high-school completion. The main factors that predict tissue-based reconstruction are primarily access based. These include residence in zip codes with higher median incomes and residence in a metro area. The likely explanations for this are as mentioned previously, ie, due to the increased costs of tissue-based reconstruction vs implant-based reconstruction, and the accessibility of high-acuity hospital centers, which provide access to surgeons with the skills needed to perform the lengthier and more complicated tissue-based procedures. In both reconstruction categories, however, insurance type (or lack thereof) was a significant driver of receipt of reconstruction.
Limitations of the study come from the use of the NCDB, which, as with other retrospective, observational databases, is restricted in terms of lacking any ability to understand or interpret the decision-making process of individual patients or clinicians. We are only able to hypothesize as to why non–private insurance status negatively impacts receipt of immediate breast reconstruction and further studies, including interviews or surveys of patients’ thought processes during surgical management of their breast cancer, would be needed to clarify this. The database is not a population-based dataset. It is limited to about 1500 Commission on Cancer–approved cancer programs that participate in the collection process, representing about 75% to 80% of all breast cancer cases. Thus, any temporal trends or year-to-year analyses are limited in that participating programs may change over time. However, the data are national in scope and reflect a large proportion of cancer patients despite not being population-based. Although the large sample size is an advantage, the size of the sample can be problematic in that findings are often significant based on sheer sample size alone. In addition, the data are limited by the predetermined variables collected, focusing primarily on clinical and tumor characteristics and demographics, and coding being done by others, leading to missing data such as BRCA status and other genetic mutations linked to increased breast cancer occurrences that could impact women’s decisions on reconstruction. Although such data also have the risk of errors in coding or inaccurate data collection, the NCDB undergoes multiple layers of quality control prior to any data being added to the national dataset.
Immediate breast reconstruction has gained increasing popularity since the turn of the century, and it will likely continue to increase. This is the first study in 20 years using the NCDB database to examine patient, clinical, and facility factors that predict the receipt of immediate breast reconstruction. We have confirmed findings from smaller, single-center studies that those receiving immediate reconstruction tend to be younger, White, more educated, reside in metro areas, and have earlier disease. This is also the first ever study that has used the NCDB to also investigate the type of reconstruction received, whether implant based, tissue based, or a combination. We found that most women tended to receive implant-based reconstruction, and shared similar characteristics of being White, young, and more educated. Although the Women’s Health and Cancer Rights Act mandate has reflected our belief that immediate breast reconstruction should be available and free for every woman facing a breast cancer diagnosis, it is apparent that there is still a way to go before every woman is able to choose it as an option for themselves if they so wish.
Conclusions
This study builds a framework, accentuating areas where patient, clinical, and facility factors may positively or negatively predict immediate breast reconstruction and type of reconstruction after mastectomy. These findings confirm some earlier work, but also raise new questions that relate to the impact of third-party payer on receipt and type of reconstruction postmastectomy for breast cancer. As the United States grapples with ongoing issues related to government-sponsored healthcare, the scope and quality of such care is a subject for continued scrutiny. Future prospective studies can use these data and results as a springboard to focus further research on the specific highlighted factors and their significance in each woman’s and provider’s decisions about breast cancer care.
Disclosures
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.
Funding
Research reported in this publication was supported in part by the Biostatistics and Bioinformatics Shared Resource of Winship Cancer Institute of Emory University (Atlanta, GA) and NIH/NCI (Bethesda, MD) under award number P30CA138292. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The data used in the study are derived from a deidentified NCDB file. The American College of Surgeons and the Commission on Cancer have not verified and are not responsible for the analytic or statistical methodology employed, or the conclusions drawn from these data by the investigators.
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