TOPLINE:
with local tumor regrowth occurring mostly within the first 2 years.
METHODOLOGY:
- Many patients with locally advanced rectal cancer treated with total neoadjuvant therapy in the OPRA trial achieved a complete or near-complete tumor response and were initially offered a watch-and-wait strategy.
- However, nearly one-third of patients receiving watch-and-wait developed local tumor regrowth and ultimately required total mesorectal excision (TME).
- The study team reported updated organ preservation rates and oncologic outcomes in the OPRA trial of 324 patients with stage II/III rectal cancer randomized to induction chemotherapy followed by chemoradiation (n = 158) or chemoradiation followed by consolidation chemotherapy (n = 166).
- Among the 304 patients restaged a median of 7.8 weeks after finishing total neoadjuvant therapy, investigators recommended TME in 26% and watch-and-wait in 74% (n = 225).
TAKEAWAY:
- The researchers reported similar 5-year disease-free survival among patients in the induction chemotherapy group (71%) and the consolidation chemotherapy group (69%). The estimated 5-year overall survival rates were also similar in the two groups – 88% in the induction group vs. 85% in the consolidation group.
- Among the patients who received watch-and-wait, 36% (n = 81) experienced tumor regrowth; 94% occurred within 2 years and 99% occurred within 3 years.
- An estimated 39% of patients in the induction chemotherapy group and 54% in the consolidation chemotherapy group achieved organ preservation at 5 years, representing about half of patients overall.
- Among the patients who received watch-and-wait, salvage TME following tumor regrowth appeared to offer disease-free survival (64% of patients) similar to immediate TME after incomplete response to total neoadjuvant therapy (also 64%).
IN PRACTICE:
Total neoadjuvant therapy among patients with rectal cancer “resulted in long-term organ preservation in half of the patients,” the authors concluded. Although the order of therapy did not affect survival, consolidation chemotherapy “resulted in higher organ preservation at 5 years.”
“Our results support the recommendation that patients with rectal cancer offered [watch-and-wait] after neoadjuvant therapy should have very close surveillance during the first 3 years,” the authors added.
SOURCE:
The study, with first author Floris S. Verheij, BSc, Memorial Sloan Kettering Cancer Center, New York, was published online Oct. 26, 2023, in the Journal of Clinical Oncology.
LIMITATIONS:
The study, published as a clinical trials update, does not include a discussion of limitations.
DISCLOSURES:
Funding was provided by the National Cancer Institute. Several OPRA trialists disclosed relationships with a range of companies, including Sironax, Janssen Oncology, Toray Industries, Merck, and Intuitive Surgical.
A version of this article first appeared on Medscape.com.