LORD Trial Shows Active Surveillance May Be Safe Alternative to Surgery for Low-Risk DCIS
核心洞察
The LORD trial of 1,423 patients with low-risk ductal carcinoma in situ (搜索) (DCIS (搜索)) found that active surveillance resulted in comparable early outcomes to immediate surgery, with 6% developing invasive cancer versus 9% in the surgery group.
Researchers presented reassuring interim results at the 15th European Breast Cancer (搜索) Conference, showing that tumors detected during active surveillance were only slightly larger but not more aggressive than those found with immediate treatment.
The study contributes important evidence for reducing overtreatment in breast cancer (搜索) care, as research suggests four out of five DCIS (搜索) cases never become invasive or life-threatening.
Researchers leading the LORD trial have reported reassuring early results for active surveillance as an alternative to immediate surgery for patients with low-risk ductal carcinoma in situ (搜索) (DCIS (搜索)), presenting their findings at the 15th European Breast Cancer (搜索) Conference (EBCC15) in Barcelona.
The study, led by Professor Jelle Wesseling from The Netherlands Cancer Institute (搜索) and Leiden University Medical Center (搜索), challenges the traditional approach to DCIS (搜索) treatment by demonstrating that carefully monitored active surveillance may offer comparable outcomes to immediate surgery while avoiding potential overtreatment.
Trial Design and Patient Population
The LORD trial (ClinicalTrials.gov identifier NCT02492607) enrolled 1,423 patients with low-risk DCIS (搜索) across approximately 60 hospitals in the Netherlands. Patients had grade 1 or 2 DCIS detected through breast screening and were followed for an average of two years.
The trial began in 2017 with the first 73 patients randomly assigned to either standard treatment or active surveillance. Following feedback, the protocol was adapted to allow patient choice, with approximately three-quarters (1,025 patients) opting for active surveillance compared to 330 choosing immediate treatment.
"For decades, DCIS (搜索) was framed as 'early-stage breast cancer (搜索)'. As a result, it has almost always been treated in the same way as breast cancer," explained Professor Wesseling. "But if most DCIS will never become dangerous, an important question arises: are some women receiving more treatment than they need?"
Key Findings
The interim results showed comparable rates of invasive cancer development between the two treatment approaches. Among 363 patients who received immediate surgery, 33 (9%) were diagnosed with invasive breast cancer (搜索). This included 29 patients who had signs of invasive cancer discovered during initial tissue examination and four additional patients diagnosed during follow-up.
In the active surveillance group, 63 out of 1,060 patients (6%) developed invasive breast cancer (搜索). The study was stopped according to protocol once 60 patients in the surveillance group had been diagnosed with invasive cancer.
Importantly, while tumors detected in the active surveillance group were slightly larger on average (9mm compared to 6mm), researchers found they were not more aggressive than those in the immediate surgery group.
Clinical Implications
Professor Wesseling emphasized that active surveillance does not mean withholding treatment but rather involves close monitoring with surgery remaining available at any time. "There is currently no indication that active surveillance leads to worse early outcomes compared with immediate surgery," he stated.
The findings are particularly significant given that research suggests approximately four out of five DCIS (搜索) cases will never become invasive or life-threatening, yet current standard practice typically involves surgical intervention.
Professor Isabel Rubio, Chair of EBCC15 and Head of Breast Surgical Oncology at the Clínica Universidad de Navarra, who was not involved in the research, noted the study's importance: "The LORD trial is one of the largest prospective studies worldwide focusing specifically on patients with low-risk DCIS (搜索). With longer follow-up, these findings may help support a more de-escalated approach to care for selected patients."
Future Directions
Researchers continue to follow all trial participants to monitor long-term safety outcomes and are conducting detailed analyses to identify which patients develop invasive cancer. This work aims to better understand which women can safely avoid immediate surgery.
Professor Wesseling cautioned that longer follow-up will be crucial before making changes to existing clinical guidelines, though the early results contribute important evidence to discussions about reducing overtreatment in breast cancer (搜索) care.
The study represents a significant step toward personalized treatment approaches for DCIS (搜索), potentially offering selected patients the option to avoid unnecessary surgical intervention while maintaining safety through careful monitoring.