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

Pilewskie, Melissa; Stempel, Michelle; Rosenfeld, Hope; Eaton, Anne; Zee, Kimberly J. Van; Morrow, Monica

doi:10.1245/s10434-016-5268-2

Cited by 69 publications

(42 citation statements)

References 26 publications

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“…7 Such non-operative management should not be attempted outside of a clinical trial, as recent work by Pilewskie showed that among women with DCIS who met LORIS eligibility requirements on core biopsy, 20% had invasive cancer found in the surgical excision specimen that was heterogeneous in grade, size, and receptor status. 22 Further, among women with DCIS who continued to meet LORIS criteria even after examination of the complete surgical excision specimen, the 10-year IBE rate was a substantial 12.1%. 23 Our current data show that in our entire population of women with very low-volume DCIS, and in the subsets of those age ≥50 years and those with low-grade DCIS, risk of IBE was clinically significant at 10-years: 12.3% (entire population), 12.6% (age ≥50 years), and 14.6% (low grade, including cases borderline between ADH and DCIS), respectively.…”

Section: Discussionmentioning

confidence: 95%

Outcomes for Women with Minimal-Volume Ductal Carcinoma In Situ Completely Excised at Core Biopsy

et al. 2017

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Introduction Overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) are concerns, especially in women with low-volume screen-detected DCIS. We sought to evaluate outcomes in such patients. Methods Women with minimal-volume DCIS (mDCIS, defined as diagnosed with DCIS by core biopsy but no residual disease on surgical excision) treated with breast-conserving surgery from 1990–2011 were identified. Ipsilateral and contralateral breast events (IBE and CBE) were compared by competing-risk (CR) analysis. Kaplan-Meier (KM) estimates and log-rank tests were used to evaluate covariates. Results 290 cases of mDCIS were identified; median age was 53yrs. 27.6% received radiation (RT); 16.2% received endocrine therapy. Median follow-up was 6.8 yrs. Overall, 5- and 10-yr IBE rates were 4.3% and 12.3%. Among women not receiving RT, 5- and 10-yr IBE rates (5.4% and 14.5%) were higher than CBE rates (1.8% and 2.7%); among those receiving RT, IBE rates (1.5% and 6.0%) were lower than CBE rates (4.1% and 15.6%). Women receiving RT trended toward significantly lower IBE rates (p=0.07); age, grade and endocrine therapy were not significantly associated with IBE risk. Conclusions Among patients with mDCIS not receiving RT, IBE risk was substantially higher than CBE risk, demonstrating that even DCIS of very low volume is associated with clinically relevant disease. The finding that IBE risk is greater than CBE risk supports current strategies that treat DCIS as a precursor rather than a risk marker. Women with mDCIS are not at negligible risk of IBE in the absence of adjuvant therapy.

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Section: Discussionmentioning

confidence: 95%

Outcomes for Women with Minimal-Volume Ductal Carcinoma In Situ Completely Excised at Core Biopsy

et al. 2017

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“…A recent study by Pilewskie et al evaluated 296 LORIS-eligible patients diagnosed with DCIS by core needle biopsy between 2009 and 2012; of these, 20% had invasive carcinoma at surgical excision that was heterogeneous in grade, size, and receptor status (51). Therefore, until further risk stratification can identify patients who may be at low risk for upgrade to invasive carcinoma, patients with core biopsy-proven DCIS should not be considered for observation outside of a clinical trial.…”

Section: Prospective Studies Of Observation In Low-risk Dcismentioning

confidence: 99%

Controversies in the Treatment of Ductal Carcinoma in Situ

Barrio

Zee

2017

Annu. Rev. Med.

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Ductal carcinoma in situ (DCIS) accounts for 20% of all newly diagnosed breast cancers. Mastectomy was once the gold standard for the treatment of DCIS; however, breast-conserving surgery (BCS) has been adopted as the treatment of choice for patients with small, screen-detected lesions. Both adjuvant radiation and hormonal therapy following BCS have been demonstrated in randomized trials to reduce the risk of invasive recurrence, but neither affects survival. With the variety of surgical and adjuvant treatment options available, there has been great interest in tailoring the treatment to the individual, with the goal of optimizing the balance of risks and benefits according to the values and priorities of the woman herself. Prospective studies of women with “low-risk” DCIS have successfully identified women at lower than average risk, but have not achieved the goal of identifying a subset of women with DCIS at minimal risk of recurrence after surgical excision alone.

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“…However, unlike our results, a recent study of 296 patients who met criteria for the LORIS trial identified up to 58 patients with invasive carcinoma upon excision, emphasizing that there is a risk when including patients with pure DCIS on core biopsy because of undersampled invasive carcinoma, despite strict inclusion and exclusion criteria. 32 In summary, approximately one-half the upgrades in our study were due to low-and intermediate-grades of DCIS; therefore, this diagnosis of DCIS on core biopsy should not be underassumed or underestimated as being an indolent lesion. Axillary lymph node positivity was rare but affected 3% (7 of 218) of the carcinomas smaller than 2 cm.…”

Section: Discussionmentioning

confidence: 55%

Not All Ductal Carcinomas In Situ Are Created IDLE (Indolent Lesions of Epithelial Origin)

Alexander

Beyda

Nayak

et al. 2018

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Mammographic screening has increased the incidence of ductal carcinoma in situ (DCIS), but this has not been accompanied by a decline in the incidence of invasive carcinoma (IC). Consequently, the surgical treatment of DCIS has recently been questioned, with some advocating only surveillance (with or without neoadjuvant endocrine therapy) after a core biopsy diagnosis of DCIS.Objectives.-To examine the predictive value of a core biopsy diagnosis of DCIS, particularly the upgrade rate to IC, and to identify associated factors.Design.-Using the pathology database, we identified 2943 cases of DCIS diagnosed on core biopsy from 2000 to 2015, of which 229 cases (8%) later had the stage upgraded to IC.Results.-Ages ranged from 25 to 90 years (mean, 59 years). The DCIS presented with calcifications in 151 of 229 cases (65.9%), was widespread in 26 of 151 cases (17%), had a mass or density present in 70 of 229 cases (31%), with heterogeneous echogenic features in 44 of those 70 cases (63%), and an enhancement upon magnetic resonance imaging in 8 of 229 cases (3.5%). Of the 229 cases, the DCIS grades were as follows: low in 29 cases (13%), intermediate in 79 cases (36%), and high in 121 cases (53%). Of the 229 cases, necrosis was present in 152 (66.4%) and was comedo necrosis in 99 cases (43%). Of the 229 cases of IC, the tumor stage was as follows: microIC in 36 (16%), T1a in 119 (52%), T1b in 35 (15%), T1c in 28 (12%), T2 in 8 (3%), and T3 in 3 cases (1%). Axillary lymph nodes were staged in 167 patients as follows: N0, 141 cases (84%); N0(iþ), 14 cases (8%); and N1, 12 cases (7%). The 12 N1 cases were subclassified by T stage as follows: T1a, 1 case (8%); T1b, 4 cases (33%); T1c, 2 cases (17%); T2, 4 cases (33%); and T3, 1 case (8%). The IC cases of stage upgrading were predominantly smaller than 2 cm (218 of 229; 95%), and more than twothirds were smaller than 0.5 cm (155 of 229; 95%), most of which were accompanied by extensive DCIS.Conclusions.-Approximately one-half of the upgrades were associated with high-grade DCIS, especially with comedo necrosis; nevertheless, the other one-half of the upgrades were due to low-and intermediate-grade DCIS and should not be underestimated. There were few positive results from axillary lymph node biopsies, but they occurred in 3% (7 of 218) of the carcinomas smaller than 2 cm. Our findings indicate that caution is needed when DCIS cases diagnosed by core biopsy are treated nonsurgically with surveillance (with or without neoadjuvant endocrine therapy), given the number of cases (229 of 2943; 8%) that are upgraded to IC and those with axillary lymph node metastases (12 of 167; 7%).

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

Cited by 69 publications

References 26 publications

Outcomes for Women with Minimal-Volume Ductal Carcinoma In Situ Completely Excised at Core Biopsy

Outcomes for Women with Minimal-Volume Ductal Carcinoma In Situ Completely Excised at Core Biopsy

Controversies in the Treatment of Ductal Carcinoma in Situ

Not All Ductal Carcinomas In Situ Are Created IDLE (Indolent Lesions of Epithelial Origin)

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