Concordance between vacuum assisted biopsy and postoperative histology: Implications for the proposed Low Risk DCIS Trial (LORIS)

Soumian, Soni; Verghese, Eldo T.; Booth, Mary E.; Sharma, Nisha; Chaudhri, S.; Bradley, Stephen H; Umranikar, Salil; Millican-Slater, Rebecca; Hanby, Andrew M.; Francis, Adele

doi:10.1016/j.ejso.2013.09.028

Cited by 49 publications

(27 citation statements)

References 14 publications

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“…While one study by Soumian et al reported zero upgrades to invasive cancer among a small cohort of 19 patients with low-grade DCIS on core biopsy who met LORIS criteria 7 , our reported upgrade rate is nearly identical to that found by Brennan et al 6 in a meta-analysis reporting on 1736 patients diagnosed with DCIS by core needle biopsy. The overall reported upgrade was 26% (range 23%–30%) among all patients; with a 21% (range 15%–28%) upgrade to invasive carcinoma seen specifically among patients selected only for the presence of non-high–grade DCIS on core needle biopsy.…”

Section: Discussionsupporting

confidence: 82%

Do LORIS Trial Eligibility Criteria Identify a Ductal Carcinoma In Situ Patient Population at Low Risk of Upgrade to Invasive Carcinoma?

et al. 2016

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Background The Surgery versus Active Monitoring for Low-Risk DCIS (LORIS) trial is studying the safety of monitoring core-biopsy diagnosed low-risk ductal carcinoma in situ (DCIS) without excision. We sought to determine the incidence and characteristics of synchronous invasive carcinoma found in LORIS-eligible women who underwent excision, as this knowledge is essential in assessing the safety of observation alone. Methods Women meeting LORIS eligibility criteria (age ≥ 46 years, screen-detected calcifications, non-high–grade DCIS diagnosed by core-biopsy, absence of nipple discharge, or strong family history of breast cancer) who underwent surgical excision from 2009–2012 were identified. Histologic findings of excision specimens were reviewed. Results 296 LORIS-eligible cases were identified; 58 (20%) had invasive carcinoma on final pathology (90% invasive ductal, 78% >1 mm size, 21% high grade, 3% triple negative, 9% HER2 amplified). Of these, 18 (31%) were pT1b or larger and 3 (5%) were pN1. Among eligible upgraded cases, 90% received radiation, 89% received endocrine therapy, and 18% were recommended chemotherapy. Women upgraded to invasive carcinoma were more likely to have intermediate-grade DCIS on core biopsy and to have undergone mastectomy. Conclusions Among LORIS-eligible women, 20% had invasive carcinoma at surgical excision that was heterogeneous in grade, size, and receptor status. Information gained from surgical excision influenced receipt of adjuvant radiation and endocrine therapy in most, and indicated benefit from chemotherapy in 18%. Surgical excision is warranted until additional risk stratification is available to identify a cohort of DCIS patients at lower risk for clinically significant synchronous invasive carcinoma.

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Section: Discussionsupporting

confidence: 82%

Do LORIS Trial Eligibility Criteria Identify a Ductal Carcinoma In Situ Patient Population at Low Risk of Upgrade to Invasive Carcinoma?

et al. 2016

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“…In addition, some DCIS cases developed early recurrences (within 4 months), questioning if these were not missed invasive cancers. As we know that the rate of missed invasive disease at DCIS diagnosis is 11% to 25%, it is unlikely that this will be a major percentage of the recurrences reported (71)(72)(73)(74).…”

Section: Discussionmentioning

confidence: 99%

Predictors of an Invasive Breast Cancer Recurrence after DCIS: A Systematic Review and Meta-analyses

Visser

Groen

Leeuwen

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

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We performed a systematic review with meta-analyses to summarize current knowledge on prognostic factors for invasive disease after a diagnosis of ductal carcinoma in situ (DCIS). Eligible studies assessed risk of invasive recurrence in women primarily diagnosed and treated for DCIS and included at least 10 ipsilateral-invasive breast cancer events and 1 year of follow-up. Quality in Prognosis Studies tool was used for risk of bias assessment. Meta-analyses were performed to estimate the average effect size of the prognostic factors. Of 1,781 articles reviewed, 40 articles met the inclusion criteria. Highest risk of bias was attributable to insufficient handling of confounders and poorly described study groups. Six prognostic factors were statistically signif-icant in the meta-analyses: African-American race [pooled estimate (ES), 1.43; 95% confidence interval (CI), 1.15-1.79], premenopausal status (ES, 1.59; 95% CI, 1.20-2.11), detection by palpation (ES, 1.84; 95% CI, 1.47-2.29), involved margins (ES, 1.63; 95% CI, 1.14-2.32), high histologic grade (ES, 1.36; 95% CI, 1.04-1.77), and high p16 expression (ES, 1.51; 95% CI, 1.04-2.19). Six prognostic factors associated with invasive recurrence were identified, whereas many other factors need confirmation in welldesigned studies on large patient numbers. Furthermore, we identified frequently occurring biases in studies on invasive recurrence after DCIS. Avoiding these common methodological pitfalls can improve future study designs.

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“…Although one small study by Soumian et al reported zero upgrades to invasive carcinoma among a cohort of 19 women with low-grade DCIS who met all LORIS criteria, 22 a meta-analysis of 52 studies including 7350 patients reported an overall underestimation rate of 26%. They found that among women with non-high–grade DCIS diagnosed by core biopsy, 21% were upgraded to invasive carcinoma at the time of surgical excision.…”

Section: Discussionmentioning

confidence: 98%

Women with Low-Risk DCIS Eligible for the LORIS Trial After Complete Surgical Excision: How Low Is Their Risk After Standard Therapy?

et al. 2016

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Background Identifying DCIS patients at low risk for disease progression could obviate need for standard therapy. The LORIS (surgery versus active monitoring for low-risk DCIS) trial is studying the safety of monitoring low-risk DCIS, although ipsilateral breast tumor recurrence (IBTR) rates in patients meeting enrollment criteria after complete surgical excision are unknown. Methods Women with pure DCIS treated with breast-conserving surgery (BCS) with/without radiation therapy (RT) from 1/1996–1/2011 were included from a prospectively maintained database. IBTR rates were compared between those who did and did not meet LORIS eligibility criteria (age ≥46yrs, screen-detected calcifications, nipple discharge absence, minimal family history, non-high–grade DCIS) after complete surgical excision. Results 2394 women were identified; 401 met LORIS criteria. Median follow-up was 5.9yrs; 431 had ≥10yrs follow-up. LORIS cohort median age was 61yrs (range: 46–86yrs); 207 (52%) underwent RT, 79(20%) received endocrine therapy. 24 of 401 experienced an IBTR. Overall 10-year IBTR rates were 10.3% (LORIS) versus 15.4% (non-LORIS)(p=0.08); without RT, 12.1% versus 21.4%, respectively (p=0.06). 10-year invasive-IBTR rates for women meeting LORIS criteria were: 5.3% BCS overall; 6.0% without RT. Conclusion Women meeting LORIS criteria (after complete surgical excision) are at somewhat lower risk for IBTR. Among such women undergoing excision without RT, the 10-year invasive-IBTR rate was 6%. Given approximately 20% of women with core-biopsy–proven non-high–grade DCIS have invasive cancer at excision, women managed without excision would be expected to incur higher invasive cancer rates. Additional criteria are needed to identify women not requiring intervention for DCIS.

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Concordance between vacuum assisted biopsy and postoperative histology: Implications for the proposed Low Risk DCIS Trial (LORIS)

Cited by 49 publications

References 14 publications

Do LORIS Trial Eligibility Criteria Identify a Ductal Carcinoma In Situ Patient Population at Low Risk of Upgrade to Invasive Carcinoma?

Do LORIS Trial Eligibility Criteria Identify a Ductal Carcinoma In Situ Patient Population at Low Risk of Upgrade to Invasive Carcinoma?

Predictors of an Invasive Breast Cancer Recurrence after DCIS: A Systematic Review and Meta-analyses

Women with Low-Risk DCIS Eligible for the LORIS Trial After Complete Surgical Excision: How Low Is Their Risk After Standard Therapy?

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