Document Type

Conference Proceeding

Publication Date

5-12-2025

Abstract

Purpose/Background: Many centers now offer organ preservation for selected patients with locally advanced rectal cancer. Our group initiated three Phase II trials to assess the safety of this approach in various clinical scenarios. Nonoperative management was recommended only for patients achieving complete clinical response CCR)after total neoadjuvant therapy TNT. Total mesorectal excision TME was advised when CCR was not achieved (primary TME), following residual cancer after Limited Local Excision LLE (completion TME), or after tumor recurrence/regrowth post-LLE or watchful waiting WW (salvage TME). This study examines treatment outcomes following primary or salvage TME in these biologically unfavorable cases.

Methods/Interventions: Each trial focused on organ preservation in specific subgroups based on tumor T and N stage, size of the largest lymph node, presence of an involved lateral pelvic lymph node, and tumor distance from the anus. All trials included induction FOLFOX followed by concurrent 5-FU/capecitabine and radiotherapy. Final tumor restaging occurred 12-20 weeks after completing the TNT regimen. Variables such as the number of FOLFOX cycles (3 or 4), radiation dose (4500-5400), use of consolidation chemotherapy, observation period, and nonoperative approach (LLE or WW) were tailored to tumor presentation and response to TNT.

Results/Outcomes: A total of 35 patients were enrolled between 2016 and 2022, with a mean age of 65 years (range: 40-86). Of these, 51% were female (n=18) and 49% male (n=17). The mean tumor distance from the anal verge was 4.6 cm, and the mean tumor length was 4.3 cm. The mean follow-up was 4.4 years. One patient had completion TME, 11 underwent primary TME, and two had salvage TME. 38% (n=6) had an Abdominoperineal Resection (APR), and 54% (n=8) had Low Anterior Resection (LAR), all with a diverting loop ileostomy. Surgeries were minimally invasive, with six robotic and the rest laparoscopic. Postoperative complications occurred in 35% (n=4), with two patients requiring ICU care. Ultimate pelvic control was achieved in all, with two patients developing distant metastases (lung and liver).

Conclusion/Discussion: TME achieves high local control rates (around 95%) when used routinely after preoperative TNT, regardless of tumor response. Recent regimens have intensified with the addition of induction or consolidation multitarget chemotherapy, reserving TME for cases where TNT fails to achieve CCR or after tumor regrowth following nonoperative management. While salvage TME after WW and regrowth shows high local control, most reports come from large, experienced institutions and often exclude systemic chemotherapy. The OPRA study's 24% local recurrence rate after salvage TME raises concerns. Our community hospital experience, however, shows that salvage TME remains a safe and effective option.
CONCLUSION
Treatment outcomes after salvage TME is satisfactory and provide reassurance to pursue the policy of organ preservation strategy.

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Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons, May 10-13, 2025, San Diego, CA

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