Breast blight accident has decidedly increased, and it has become the best accepted blight amid women in South Africa.1 Delayed presentation affiliated to backward date at diagnosis, inconsistent access, and poorer all-embracing affection of affliction has resulted in women from low- and middle-income countries (LMICs) accepting college bloodshed ante than women in advantageous countries (HICs).2,3
To appraise the affection of breast blight histopathology advertisement amid four South African bookish breast units
The affection of advertisement is not compatible beyond bookish units and needs to be improved. A civic anatomy accord and accepted use of advertisement templates and abbreviated letters will access address abyss and affection over time.
Efforts charge be fabricated to advance affection of breast blight affliction in low- and middle-income countries. Complete and reliable advertisement of breast blight histopathology is a key basal for analytic accommodation authoritative and accommodating treatment. High-quality advertisement of accepted parameters, such as bump brand and Ki-67, are decidedly important in resource-constrained settings area multigene arrays are not available.
High-quality histopathology advertisement with bright advice of predictive and anxiety markers is analytic for analytic accommodation making. South Africa is an upper- and middle-income country with added avant-garde breast anatomy assets than best sub-Saharan African countries.4 Not all analytic tests are achievable in lower-resourced areas, and the Breast Blight Action 2.5 (BCI 2.5) stratifies analytic casework according to attainable assets into basic, limited, enhanced, and best levels. In South Africa, there is a bifold bloom affliction arrangement that fulfills belief of an added akin in the attainable area and best akin in the clandestine sector.5 Although abounding HICs accept adopted multigene assays to actuate ceremony accident and adviser therapies, these are not attainable in the attainable area in South Africa, and breast units await on grade, receptor status, lymphovascular aggression (LVI), and Ki-67 for assay decisions.
For abounding years, efforts accept been fabricated to assimilate high-quality breast blight affliction in HICs, and assorted guidelines accept been accustomed to advance the affection of breast blight anatomy reporting.6-10 To date, there is a absence of abstracts from South Africa and added LMICs on the capability of breast histopathology reporting, and there are no civic guidelines for breast histopathology reporting.
One of the broadly activated sets of affection indicators (QIs) was appear by the European Society of Breast Blight Specialists (EUSOMA).10 This abstraction aimed to administer the EUSOMA histopathology QIs to a South African accomplice to appraise bounded breast blight histopathology letters and analyze advertisement affection beyond accommodating centers.
Patients and Abstracts Collection
This is a attendant assay of patients enrolled in the South African Breast Blight and HIV Outcomes (SABCHO) study, which evaluates the appulse of HIV on the affliction and outcomes of women with breast cancer.11 The aeon of assay was July 2015 to September 2017 and included 1,850 afterwards patients from Chris Hani Baragwanath Bookish Hospital (CHBAH), Charlotte Maxeke Johannesburg Bookish Hospital (CMJAH), Inkosi Albert Luthuli Central Hospital (IALCH), and Grey’s Hospital (GH). CHBAH and CMJAH are both amid in Johannesburg in the Gauteng province, and IALCH and GH are both in the KwaZulu-Natal (KZN) province. All four are attainable area bookish breast blight units and serve socioeconomically disadvantaged patients.
The anatomy letters of 3,008 specimens, including 1,850 amount biopsies and 1,158 surgical specimens, were evaluated. Letters for specimens from Gauteng sites were generated by the hospital’s corresponding anatomy departments from the Civic Bloom Class Casework (NHLS), which serves the attainable bloom area in South Africa. The majority of samples from KZN units had been outsourced to clandestine laboratories.
This abstraction was accustomed by the animal assay belief board of the University of the Witwatersrand. All patients active accounting abreast accord at the time of acceptance into the SABCHO study.
Reports were advised complete if they included the afterward ambit for amount biopsy10: histologic type, bump grade, estrogen receptor (ER) status, progesterone receptor (PR) status, and animal epidermal advance agency receptor 2 (HER2) cachet with a acknowledging in situ admixture assay for ambiguous after-effects (usually fluorescence in situ admixture [FISH] in our setting). During the abstraction period, HER2 2 (equivocal) cachet was about authentic as circumferential film staining that is anemic to abstinent in > 10% of beef or complete and circumferential film staining that is acute aural < 10% of bump cells. HER2 3 cachet was advised complete and did not crave acknowledging testing. A Ki-67 account is recommended but not appropriate in the EUSOMA guidelines. Because Ki-67 is frequently advised for analytic decisions in our units, it was added as an alternative constant with a blow of 20% to ascertain immunohistochemical (IHC) surrogates for atomic subtypes.12 In accession to these parameters, the afterward were appropriate for surgical specimens10: pathologic stage, admeasurement in millimeters for the invasive component, peritumoral LVI, and ambit to abutting invasive margin; receptors did not crave echo because we accepted them frequently on amount biopsy. The EUSOMA guidelines set a minimum accepted of ≥ 95% complete letters with an ideal ambition of ≥ 98%. Address turnaround time (TAT) was abstinent as a locally accordant parameter, authentic as the cardinal of canicule amid the class accepting the case to final address release, and included IHC area performed.
The admeasurement of complete letters in anniversary centermost was recorded as abundance with allotment and compared amid centers by Pearson’s χ2 assay or Fisher’s exact assay for dispersed data. Assay was agitated out appliance Stata 14 statistical software (StataCorp, College Station, TX).
Demographic characteristics of the cohort, bump grade, and IHC subtype distributions are listed in Table 1. Unknown IHC receptor subtyping was 8.4% overall, alignment from 5.2%, 5.4%, and 5.7% at the CMJAH, IALCH, and CHBAH sites, respectively, to 20.8% at the GH site. The majority of patients had hormone receptor–positive ache (76.1%), and 16.8% had luminal B HER2-positive disease; alone 8.0% were HER2 enriched, and 15.8% had triple-negative breast cancer. Luminal B HER2 abrogating was the best accepted subtype for the accomplice (38.3%), except at IALCH area luminal A was added accepted at 35.9%.
TABLE 1 Demographics and Bump Characteristics on Amount Biopsy Report
The admeasurement of complete amount biopsy reports, back not because Ki-67, was 75% overall, with ante of 90.2%, 91.6%, 43.0%, and 63.5% at CHBAH, CMJAH, IALCH, and GH, appropriately (Table 2). With admittance of Ki-67, this alone to 69.7% overall, with ante of 89.0%, 90.5%, 34.5%, and 49.4% at CHBAH, CMJAH, IALCH, and GH, respectively. Abyss of IHC advertisement was aerial all-embracing throughout all sites (ER, 98%; PR, 97.9%; HER2, 97.8%). The best accepted affidavit for abridged amount biopsy letters were missing bump grade; no FISH testing for ambiguous HER2 results; and, back included, missing Ki-67 (Table 2). Ki-67 was appear in complete allotment ethics at all sites except for IALCH, area it was appear as ≤ 14% or > 14%. Cogent cross-center differences were begin for all-embracing address completeness, grade, acknowledging HER2 testing, and Ki-67 (all P ≤ .001).
TABLE 2 Amount Biopsy Reporting
The abyss of surgical case advertisement was 74.3% all-embracing (CHBAH, 89.66%; CMJAH, 86.78%; IALCH, 37.96%; GH, 70.76%; Table 3). Failure to address on abutting invasive margin, LVI, and bump brand were the best frequently missing parameters. Abutting invasive allowance advertisement was 78.1% overall, alignment from 88.5%, 86.0%, and 81.8% at CHBAH, CMJAH, and GH, respectively, to 48.2% at IALCH (P ≤ .001). LVI was included in 84.8% of cases overall, with 92.4%, 89.7%, 72.2%, and 78.8% advertisement at CHBAH, CMJAH, IALCH, and GH, appropriately (P ≤ .001). Bump brand was appear in 92.1%, alignment from 97.5% at CHBAH to 90.7% at GH (P ≤ .001). Histopathological blazon and pathologic staging were appear in 98.8% and 94.7%, respectively, but still showed cogent cross-center differences (P ≤ .001). Average all-embracing TAT was 11.9 ± 10.8 canicule for amount biopsies and 16.1 ± 11.3 canicule for surgical specimens, afresh with cogent cross-center differences (Table 4).
TABLE 3 Surgical Case Reporting
None of the sites accomplished the EUSOMA minimum claim of 95% complete histopathology reports. Amid the all-embracing cohort, there was complete advertisement for 75.0% of amount biopsies and 74.3% of absolute surgical specimens. There were arresting differences amid the abstraction sites, with decidedly college abyss ante for both amount and surgical specimens amid Gauteng sites compared with KZN sites.
The assay of amount biopsy specimens showed austere under-reporting of brand and HER2 ambiguous FISH reporting. For surgical case reporting, the Gauteng sites approached EUSOMA advertisement standards, admitting the KZN sites were amiss in advertisement of LVI and abutting invasive margin, which compromises the appraisal of capability of anaplasty as able-bodied as the charge for reoperations or accessory therapies.
Tumor brand is an accustomed anxiety marker, and believability in amount specimens is about high. The ability against brand 2 advertisement at IALCH is decidedly noteworthy: At 72.2%, this is abundant college than appear in the literature.13 While allocation may not be attainable in actual few cases on amount biopsy, IALCH did not address brand in 54.3% of amount biopsies and 17.6% of surgical specimens, and the all-embracing believability of brand advertisement accordingly seems questionable. The acutely aerial cardinal of missing brand was the capital contributor to the all-embracing actual low complete amount biopsy advertisement of 43% at IALCH.
HER2-targeted assay was not attainable in the attainable area during best of the abstraction aeon but has now become attainable for called patients. Nevertheless, alike in the absence of targeted treatment, HER2 should consistently be activated because it is a predictive brand for the account of chemotherapy. The BCI 2.5 allocation suggests HER2 cachet as the action metric for affection ascendancy for settings of an added level, such as the South African attainable sector.5 HER2 IHC was activated in the majority of biopsy specimens beyond all abstraction sites (97.8%). Two hundred thirty-five specimens were HER2 2 and admired as equivocal. However, 50.6% of these ambiguous HER2 after-effects lacked added FISH testing (75.6%, 68.4%, 43.3%, and 15.6% at CHBAH, CMJAH, IALCH, and GH, respectively). Differences in circuitous class processes and outsourcing of FISH testing may explain armpit differences, and argent in situ admixture testing aural the laboratories may abetment to affected logistical hurdles.
EUSOMA does not allocate Ki-67 advertisement as binding but has recommended its accepted use.12 In South African attainable area units, area multigene assays are not affordable, Ki-67 cachet is frequently acclimated for decisions about chemotherapy, abnormally in hormone receptor–positive breast cancers. Accepted advertisement of Ki-67 at the Gauteng NHLS laboratories was 96.3% and 95.5% at CHBAH and CMJAH. In contrast, alone 85.3% of amount biopsies appear Ki-67 at IALCH and 74.6% at GH. The admittance of Ki-67 decreased all-embracing complete letters from 75% to 69.7%, a bead that was about alone acclaimed aural KZN units. Although Ki-67 has acquired abounding controversies with interobserver, interlaboratory, and intraobserver variations, best of these accept been addressed by all-embracing alive groups, and there are bright guidelines for pre-analytical, analytical, and abstracts handling.14 Ki-67 is acclimated in assorted predictive models, some of which appraisal Oncotype DX (Genomic Health, Redwood City, CA) ceremony scores, which adds analytic utility, abnormally in settings area multigene assays are unavailable.15,16 Ki-67 estimation can be decidedly bigger through appliance of agenda angel assay technology, removing a abstract basal to interpretation.17 Strict affection control, civic standardization, and class accreditation will added aftereffect in added constant and able-bodied Ki-67 results.
The cogent differences in bump brand and IHC subtype administering amid the sites charge added investigation. The majority of patients had luminal B tumors beyond all sites, with the barring of IALCH that had added luminal A tumors. Exploratory analyses, including alone Black patients to abolish abashing about ethnicity and adjusting the Ki-67 blow to ≤ 14%, fabricated no aberration (Appendix Tables A1 and A2). It is apparent that these differences are due to interlaboratory variations in Ki-67 scoring and not due to authentic differences in bump biology. This illustrates, however, that allocations to subtypes are flawed: Allocation and Ki-67 appraisal do not assume to be analogously reproducible amid our sites. In the absence of multigene assays, it is important that these after-effects are bigger to abetment clinicians with assay decisions.
The beggarly TATs for amount biopsies and surgical specimens were 11.9 and 16.1 days, respectively, and charge to be improved. In comparison, TATs for breast biopsies in Botswana were appear at 8 canicule and 57 canicule for surgical specimens, which the authors accepted to be due to pre-analytical delays with a appear ambition TAT of < 7 canicule for all specimens in the future.18 In HICs, appear beggarly TATs for surgical anatomy specimens and mastectomies are 2.7 and 3.8 days, respectively.19,20 There is no all-embracing advocacy on TATs for histopathology letters and absolutely no civic consensus. CHBAH aims to action apprehensible surgical specimens aural 5 alive days, but abatement breast specimens are generally circuitous and may crave a added assay of the arresting case for added sections to be taken and added analyses. Furthermore, TATs for teaching units in the attainable area cannot be accepted to according those of clandestine laboratories because trainees charge administering at anniversary date of the work-up afore letters are authorized. This may adjournment TATs but is analytic for teaching and to access bounded anatomy accommodation over the best term.
The EUSOMA QIs were called because they are best cogitating of bounded practice, and all binding ambit are included as capital anatomy ambit in the Breast Blight Ascendancy Action appear by the South African Civic Department of Bloom in 2017.21 It needs to be accustomed that histopathologists are deficient and generally overburdened in South Africa, a bearings that has already led to the outsourcing of government accommodating specimens to the clandestine area in some provinces. Although South Africa has the added accomplished cardinal of pathologists in sub-Saharan Africa, with one pathologist/224.897 population, this is still in abrupt adverse to one pathologist/15-20.000 citizenry estimated for HICs.4 Best anatomy departments abridgement specialists in breast pathology, and while we do accept pathologists with appropriate interests, the bound cardinal of pathologists in South Africa, decidedly in the attainable sector, agency that it is apparently not achievable to accept pathologists who are absolutely breast pathologists.
Although EUSOMA standards were not met in this cohort, the after-effects charge be apparent in ambience with added audits in the literature. They are far above compared with added countries in sub-Saharan Africa. A abstraction from Ethiopia showed that alone 61% of specimens included basic-level advertisement of T and N staging, bump grading, and histologic blazon and alone 1% included ER status, margins, and LVI.22 Two studies from West Africa appear allocation in alone 12% of patients, and alone 26% had hormone receptors tested.23,24 Compared with aboriginal audits in HICs, alone 64.7% had complete letters according to the College of American Pathologists guidelines in an assay from 2010,25 and alone 28% accomplished all recommendations in an assay from Australia in 1995.26 Address abyss improves over time, and with advancing audits, added contempo European studies accept apparent > 94% complete letters according to EUSOMA standards.27,28
In this audit, the aberration in address affection amid sites is added awkward than the all-embracing after-effects and point against differences in bigoted bloom affliction administering and assets and interlaboratory differences amid bookish NHLS laboratories and the clandestine laboratories that action the outsourced accompaniment accommodating specimens. Although Gauteng units did not accommodated EUSOMA standards, they consistently appear on best parameters, including brand and Ki-67. Both units had about all their specimens appear by the corresponding NHLS laboratories, admitting the majority of letters in KZN were from private, nonacademic laboratories. One of the best pertinent differences is the use of connected abbreviated letters at both CMJAH and CHBAH NHLS laboratories, admitting the advertisement in KZN was predominantly chargeless argument at the time of the study. Templates and abbreviated advertisement access address completeness, they ensure a clearer advice of amount abstracts to the alleviative multidisciplinary team, they access achievement amid all aggregation members, and they may additionally access acquaintance of QIs amid pathologists.29,30 In our study, the best adverse aftereffect of chargeless argument advertisement was empiric at IALCH, area bright affidavit of bump grade, a analytic oncology constant for analytic accommodation making, was missing in an acutely aerial cardinal of cases.
There are three interventions that accept consistently led to college affection of advertisement in the literature. First, anatomy departments that accept advertisement templates with checklists and abbreviated letters accept apparent college address completeness.25,26,29-31 Second, the action of audits has facilitated accretion abyss afterwards anniversary assay process, and third, the accomplishing of civic recommendations or a guideline generally improves address adequacy.31-34
There are several limitations to this study. First, this is a attendant review. However, abstracts were calm in a -to-be address for the SABCHO study, and missing abstracts were minimal. All letters with missing ambit were rechecked in the analytic database and with laboratories. This abstracts set alone includes two ambit and is accordingly not absolutely adumbrative of all South African provinces. In addition, the assay was of a analytic cohort, and the after-effects may not be absolutely cogitating of the laboratories’ all-embracing standards. Although the majority of specimens in KZN were appear by clandestine laboratories, there are no specific abstracts on clandestine against attainable class sites to accredit absolute comparisons. Nevertheless, there are additionally bright strengths to this study, such as the ample sample admeasurement and multicenter design. To our knowledge, this is the better breast histopathology assay from an LMIC to date.
In conclusion, the affection of histopathology advertisement of breast blight specimens in South Africa is not compatible amid bookish breast units and can be improved. Appropriate efforts should be fabricated to advance advertisement of bump brand and HER2 acknowledging tests as able-bodied as abatement margins, pathologic staging, and LVI. From a analytic point of view, we additionally acclaim accepted testing and guideline-adherent advertisement of Ki-67 for added authentic accident appraisal in the absence of multigene arrays. Advertisement standards alter beyond laboratories, and a South African anatomy accord is required, including a civic ambition for TATs. All anatomy casework should use abstracts bedding and abbreviated letters to advance abyss and advice to the clinician. Accretion anatomy assets and advancing affection audits or accreditation processes aural anatomy casework should be encouraged to always advance standards countrywide. In the absence of a accord and connected reporting, the albatross will abide with the alleviative analyst to appeal clinically able letters and ensure accommodating safety.
Presented at the 2019 Affair of the Breast Absorption Accumulation of Southern Africa, Johannesburg, South Africa, October 12, 2019, and the 2019 South African Surgical Assay Society, Pretoria, South Africa, June 27-28, 2019.
Supported by Civic Blight Institute grants R01-CA192627 and P30-CA13696 (M.J., P.R.) and by a University of Witwatersrand/South African Medical Assay Council Accepted Epithelial Blight Assay Centre admission (P.R.).
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
The afterward represents acknowledgment advice provided by authors of this manuscript. All relationships are advised compensated unless contrarily noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not chronicle to the accountable amount of this manuscript. For added advice about ASCO’s battle of absorption policy, amuse accredit to www.asco.org/rwc or ascopubs.org/go/authors/author-center.
Open Payments is a attainable database absolute advice appear by companies about payments fabricated to US-licensed physicians (Open Payments).
Research Funding: MSD (Inst), Janssen Oncology (Inst), Roche (Inst), AstraZeneca (Inst), Novartis (Inst), Pfizer (Inst)
Travel, Accommodations, Expenses: Merck Serono, MSD Oncology, Pfizer, Dr Reddy’s Laboratories, AstraZeneca, Roche
No added abeyant conflicts of absorption were reported.
Conception and design: Armand Toma, Herbert Cubasch, Paul Ruff, Sarah Nietz
Financial support: Maureen Joffe, Paul Ruff
Administrative support: Maureen Joffe
Provision of abstraction actual or patients: Sharon Čačala, Paul Ruff, Sarah Nietz
Collection and accumulation of data: Armand Toma, Daniel O’Neil, Maureen Joffe, Herbert Cubasch, Boitumelo Phakathi, Sharon Čačala, Paul Ruff, Sarah Nietz
Data assay and interpretation: Armand Toma, Daniel O’Neil, Maureen Joffe, Oluwatosin Ayeni, Carolina Nel, Eunice van den Berg, Simon Nayler, Herbert Cubasch, Ines Buccimazza, Paul Ruff, Shane Norris, Sarah Nietz
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
TABLE A1 Subanalysis of IHC-Based Subtype in Black Patients Only
TABLE A2 IHC-Based Subtype With Ki-67 Blow ≤ 14%
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