"The findings were really surprising," Dr. Angelo Restivo of the University of Cagliari in Italy told Reuters Health by email. "In recent years, there has been a consistent trend toward increasing the waiting period after neoadjuvant therapy for rectal cancer before proceeding to surgical resection. This has been driven by the increasing rates of pathological complete responses that are known to be time-dependent."
"The more we wait, the more complete responses we see," he said. "Although this might seem like a good thing, we never really checked on the overall oncological results of expanding this strategy to almost every patient."
"We didn't expect this clear negative correlation with survival, and especially the magnitude of the effect of time," he noted. "It is clear that we went toward a routine practice that was not completely sustained by available scientific data. Our findings are a warning that we should always check for collateral damage before changing clinical practice. If we have a poor responder, we should recognize him/her early and proceed as soon as possible to surgical resection whenever feasible."
As reported in JAMA Surgery, Dr. Restivo and colleagues analyzed data from 1,064 patients with rectal cancer (median age, 64; 62% men) treated in 12 Italian referral centers. Patients with a minor or null tumor response (ypT stage of 2 to 3 or ypN positive) to neoadjuvant CRT were divided into two groups according to the wait time between neoadjuvant therapy end and surgery.
The primary outcomes were overall and disease-free survival between the groups.
Overall, 54.4% of patients had a shorter wait time (8 weeks or less) and the rest had a longer wait time (greater than 8 weeks).
A longer waiting time before surgery was associated with worse 5- and 10-year overall survival rates: 67.6% versus 80.3% at 5 years; 40.1% versus 57.8% at 10 years. Delayed surgery also was associated with worse 5- and 10-year disease-free survival: 59.6% versus 72.0% at 5 years; 36.2% versus 53.9% at 10 years.
In multivariate analyses, a longer waiting time was associated with a higher risk of death (hazard ratio, 1.84) and death/recurrence (HR, 1.69). Other factors independently associated with overall and disease-free survival were age, ypN stages, and postoperative complications.
Further, adjuvant chemotherapy was also independently associated with better survival. Compared with the 63.3% of patients who proceeded to postoperative chemotherapy, those who did not have adjuvant treatment were older (median age, 65 vs. 63); had mostly a final pathologic stage less than III (91.5% vs. 47.5%; odds ratio, 0.08); had a higher rate of postoperative complications (21.0% vs. 14.7%; OR, 0.64); and a higher rate of anastomotic leakage (11.0% vs. 6.5%; OR, 0.56).
Dr. Sandy Fang of Oregon Health Sciences University in Portland, coauthor of a related editorial, commented in an email to Reuters Health, "Determining the best course of therapy and timing of surgery is an evolving landscape in the management of rectal cancer."
The current study, she said, "supports the notion that oncologic prognosis is heavily dependent upon tumor biology, and the future of rectal cancer treatment will be tailored according to the nuances of molecular biomarkers within each individual cancer."
SOURCE: https://bit.ly/3Dip7VE and https://bit.ly/3FkkJYo JAMA Surgery, online September 29, 2021.
By Marilynn Larkin
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