TOPLINE:
Updated data from the OPRA trial show that nearly half of patients with stage II/III rectal cancer treated with total neoadjuvant therapy (TNT) preserved their rectum over 5 years, with local tumor regrowth occurring mostly within the first 2 years.
METHODOLOGY:
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Many patients with locally advanced rectal cancer treated with TNT in the OPRA trial achieved a complete or near-complete tumor response and were initially offered a watch-and-wait (WW) strategy.
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However, nearly one third of patients receiving WW developed local tumor regrowth and ultimately required total mesorectal excision (TME).
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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).
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Among the 304 patients restaged a median of 7.8 weeks after finishing TNT, investigators recommended TME in 26% and WW in 74% (n=225).
TAKEAWAY:
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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.
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Among the patients who received WW, 36% (n=81) experienced tumor regrowth; 94% occurred within 2 years and 99% occurred within 3 years.
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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.
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Among the patients who received WW, salvage TME following tumor regrowth appeared to offer disease-free survival (64% of patients) similar to immediate TME after incomplete response to TNT (also 64%).
IN PRACTICE:
TNT 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, how to buy cialis dapoxetine mastercard overnight with first author Floris S. Verheij, BSc, Memorial Sloan Kettering Cancer Center, New York City, was published online on October 26, 2023, in Journal of the 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 Inc., Merck, and Intuitive Surgical (full list available here).
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