- Key Points:
- Question:
- What is the short-term safety of an active monitoring approach vs guideline-concordant care (surgery with or without radiation therapy):
- For hormone receptor–positive, grade 1 or grade 2 breast ductal carcinoma in situ?
- For hormone receptor–positive, grade 1 or grade 2 breast ductal carcinoma in situ?
- What is the short-term safety of an active monitoring approach vs guideline-concordant care (surgery with or without radiation therapy):
- Findings:
- In this prospective randomized clinical trial of:
- 957 participants
- The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 5.9% in the guideline-concordant care group vs 4.2% in the active monitoring group:
- A difference of −1.7% (upper limit of the 95% CI, 0.95%):
- Indicating that active monitoring is not inferior to guideline concordant care
- Indicating that active monitoring is not inferior to guideline concordant care
- A difference of −1.7% (upper limit of the 95% CI, 0.95%):
- Meaning:
- These data support the short-term safety of active monitoring compared with guideline-concordant care in patients with low-risk ductal carcinoma in situ
- These data support the short-term safety of active monitoring compared with guideline-concordant care in patients with low-risk ductal carcinoma in situ
- In this prospective randomized clinical trial of:
- Question:
- Abstract:
- Importance:
- Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown
- Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown
- Objective :
- To compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care
- Design, Setting, and Participants:
- Prospective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor–positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023
- Interventions:
- Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473)
- Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473)
- Main Outcomes and Measures :
- The primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 5%
- The primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 5%
- Results:
- The median age of the 957 participants analyzed was 63.6 (95% CI, 55.5-70.5) years in the guideline-concordant care group and 63.7 (95% CI, 60.0-71.6) years in the active monitoring group
- Overall, 15.7% of participants were Black and 75.0% were White
- In this prespecified primary analysis, median follow-up was 36.9 months; 346 patients had surgery for DCIS, 264 in the guideline-concordant care group and 82 in the active monitoring group
- Forty-six women were diagnosed with invasive cancer, 19 in the active monitoring group and 27 in the guideline-concordant care group
- The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 4.2% in the active monitoring group vs 5.9% in the guideline-concordant care group, a difference of −1.7% (upper limit of the 95% CI, 0.95%):
- Indicating that active monitoring is not inferior to guideline-concordant care
- Invasive tumor characteristics did not differ significantly between groups
- Conclusions and Relevance:
- Women with low-risk DCIS randomized to active monitoring did not have a higher rate of invasive cancer in the same breast at 2 years compared with those randomized to guideline-concordant care
- Importance:
Rodrigo Arrangoiz MS, MD, FACS, FSSO 