Patients with rectal cancer who achieve a clinical complete response to treatment may be able to follow a watch-and-wait approach rather than undergo surgery, according to results of a multicenter, observational study scheduled for presentation at the Gastrointestinal Cancers Symposium.
Individuals who received “watch-and-wait” care achieved a 3-year OS rate comparable to historical data from those who underwent surgery.
“As little as 5 years ago, to think about not treating patients with rectal cancer with surgery would be heresy,” Nancy Baxter, MD, FRCSC, FACS, PhD, an ASCO gastrointestinal cancer expert who was not involved with the study, said during a press conference. “There’s a lot of reservation about using watch-and-wait simply because we do have effective therapy for rectal cancer. But I’d say, over the past 2 or 3 years, clinicians have become more receptive to it.”
Although rectal cancer treatment strategies vary widely within and across countries, surgery is a standard component of care. However, surgery carries the risk for complications, such as colostomy, incontinence and impotence.
Maxime van der Valk, MD, of Leiden University Medical Center in the Netherlands, and colleagues reviewed data from the International Watch and Wait Database Consortium, established in 2014. The consortium — which includes 35 institutions in 11 countries — is designed to compile data about the benefits, risks and safety of organ-preserving strategies in rectal cancer.
The analysis included 679 patients (66% men) who underwent chemotherapy or radiation, and subsequently showed no signs of residual cancer on physical exam, endoscopy, MRI or CT scans.
All patients received wait-and-watch care, which included intensive monitoring for cancer recurrence. All patients underwent endoscopies, MRI scans and physical exams every 3 months for 2 years.
After median follow-up of 2.6 years, 25% of patients underwent delayed surgery because they were diagnosed with cancer regrowth, and 7% of patients had developed distant metastases.
Researchers reported 3-year OS rates of 91% among all patients who received watch-and-wait care, and 87% among those who developed local cancer recurrence. These outcomes were consistent with historical data from patients who underwent surgery, researchers wrote.
“We don’t think watch-and-wait can replace rectal cancer surgery,” van der Valk said. “This is only for a selection of patients — the 20% to 25% who have a complete response after chemotherapy. We do see more and more patients are being treated with watch-and-wait, and that’s a good thing.”
It is too soon to say whether watch-and-wait care should be offered routinely to patients with rectal cancer who achieve a complete response to initial therapy, van der Valk said. The decision about whether to undergo surgery is a personal one for each patient, she added.
There are no guidelines in the United States regarding active surveillance for rectal cancer, and the protocol “is still evolving,” Baxter said.
However, Karyn A. Goodman, MD, radiation oncologist at University of Colorado School of Medicine, said the study by van der Valk and colleagues serves as a model for similar studies being conducted in the United States.
“Many of the patients we’re doing this approach with are on a multi-institutional study led by Memorial Sloan Kettering Cancer Center,” Goodman said. “This is something we’re studying because we need to understand how to select these patients.” – by Chuck Gormley
van der Valk M, et al. Abstract 521. Scheduled for presentation at: Gastrointestinal Cancers Symposium; Jan. 19-21, 2017; San Francisco.
The study was supported by grants from the European Registration of Cancer Care (EURECCA) and the Champalimaud Foundation. Van der Valk reports no relevant financial disclosures. Please see the abstract for a list of all other researchers’ relevant financial disclosures.