"Wait And See"

"Wait and See" Instead of Surgery an Option in Rectal Cancer

November 9, 2011 — Surgery is usually the preferred option for rectal cancer, but it can have a hugely detrimental effect on quality of life. Now there are data to suggest that for some patients with rectal cancer, a "wait-and-see" policy after chemoradiotherapy appears to be feasible and safe. A study published online November 7 in the Journal of Clinical Oncology shows that patients who achieve a clinical complete response after neoadjuvant chemoradiotherapy had outcomes similar to those who underwent surgery.

Of the 21 patients treated with neoadjuvant chemoradiotherapy, 20 remain alive, without disease, after a mean follow-up of 25 ± 19 months. One patient developed a small local recurrence without nodal recurrence after 22 months of follow-up. 

The control group consisted of 20 patients who achieved a pathologic complete response after chemoradiotherapy and a total mesorectal excision. Mean follow-up was 35 ± 23 months. In this group, 2 patients died — one from metastatic disease and the other from surgical complications associated with colostomy closure. None of the patients experienced a local recurrence. 

"A wait-and-see policy for clinical complete responses after chemoradiotherapy for rectal cancer with strict selection criteria and follow-up with up-to-date imaging techniques is feasible and safe," write the authors, led by Geerard L. Beets, MD, PhD, from Maastricht University Medical Center, the Netherlands. "Outcome is at least comparable with that of patients with a pathologic complete response after surgery." 

Impressive Results 

In an accompanying editorial, Joel E. Tepper, MD, and Bert H. O'Neil, MD, from the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, note that although the follow-up in this study is short, "the results have been impressive, with only 1 local failure to date."

The wait-and-see patients did as well as those who underwent neoadjuvant therapy and who had a pathologic complete response after surgery, they note. "Importantly, this result was achieved with less toxicity and better short-term bowel function in the observed patients, compared with those who underwent surgical resection."

These early results support and enhance previous research, and "raise the possibility that this approach could be generalized to a larger portion of the patient population," the editorialists write. 

They caution that the wait-and-see approach is not one that can be easily evaluated in a randomized controlled trial; it is unlikely that sufficient numbers of patients would consent to being randomized to either surgery or no surgery. 

Well-designed prospective phase 2 studies might be the best way to advance this field, note Drs. Tepper and O'Neil. "This should not be considered a one-size-fits-all approach." 

Similar Survival Outcomes 

Previous research involving a wait-and-see policy demonstrated that patients with low rectal cancer who achieved a clinical complete response after chemoradiotherapy and did not have surgery had impressive results. Five-year overall survival was 93% and disease-free survival was 85% (Ann Surg. 2004;240:711-717; J Gastrointest Surg. 2006;10:1319-1328). 

However, the Dr. Beets and colleagues note that even though the previous results were encouraging, they were viewed with caution by physicians, because of the lack of a sufficiently accurate technique to identify patients with a clinical complete response. In addition, no other study replicated the findings. 

In their trial, Dr. Beets and colleagues hypothesized that for patients without residual tumor on imaging and endoscopy — a clinical complete response — a wait-and-see policy might be considered instead of surgery. 

Of the 21 patients in the wait-and-see cohort, 14 (67%) were male; mean age at diagnosis was 65 years. The authors note that patients who experienced a clinical complete response had a strong preference for the wait-and-see policy over resection, primarily because it offered the possibility of avoiding major surgery or a permanent colostomy. 

In the control group, 9 patients required a definitive colostomy and 11 required a temporary colostomy. Half of the patients experienced no complications after surgery, but 7 patients had major complications, including anastomotic leakage, intraabdominal abscess, and respiratory failure. 

In the wait-and-see group, the cumulative probability for 2-year disease-free survival was 89% (95% confidence interval [CI], 43% to 98%), and the cumulative probability for 2-year overall survival was 100%.

In the control group, the cumulative probability for 2-year disease-free survival was 93% (95% CI, 59% to 99%) and for overall survival was 91% (95% CI, 59% to 99%). The differences were not significantly different between the 2 study groups. 

The authors note that there are several limitations to the study, including the fact that the sample size is small and follow-up short. 

The authors and editorialists have disclosed no relevant financial relationships. 

Source : 

J Clin Oncol. Published online November 7, 2011.

http://www.medscape.com/viewarticle/753204