Watch-and-Wait Appears Safe and Feasible for Some Patients with Rectal Cancer

Watch-and-wait in place of surgery appears to be a safe and feasible treatment approach for patients with nonmetastatic rectal cancer achieving a complete response (CR) to neoadjuvant chemoradiation (nCRT), according to a study published in the Journal of the American College of Surgeons.¹

The study, which was also presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting, suggested that careful evaluation to confirm a clinical CR after nCRT is important in selecting patients for this nonsurgical treatment option.

“Rectal cancer surgery is very good for a cure, but it does have certain potential side effects: the ability to control bowel movements, bladder accidents, sexual dysfunction, and in up to half of cases, a permanent colostomy,” senior study investigator Vikram Attaluri, MD, FACS, a colon and rectal surgeon, and assistant professor at Kaiser Permanente School of Medicine in Pasadena, California, said in a press release.² “So, someone could be living with a bag outside their body for the rest of their life, which has a huge effect on one’s quality of life. Some patients have indicated they would rather live with cancer.”

Researchers reviewed medical records from patients treated with nCRT for nonmetastatic rectal cancer at Kaiser Permanente and compared the watch-and-wait strategy to surgery in patients with a CR to nCRT. Patients with a complete endoscopic response (CER) refusing surgery were offered watch-and-wait, which included strict surveillance with digital rectal exam and endoscopy.

CER was defined as having a negative digital rectal exam and negative endoscopy at the end of neoadjuvant therapy. Moreover, a clinical CR was defined as having a CER with negative rectal MRI.

From January 2015 through February 2019, a total of 465 patients complete nCRT. Of the study cohort, 406 patients had response assessment performed, of which 95 (23%) had a CER.

Of those who had a CER, 53 patients underwent watch-and-wait and 42 patients had surgery. The median follow-up time was 35 months.

In the watch-and-wait arm, 3-year freedom from local regrowth was found to be 85%. Moreover, in the surgical and watch-and-wait groups, 3-year overall survival, rectal cancer-specific survival, and freedom from nonregrowth recurrence were 100% versus 88% (P = .03), 100% versus 95% (P = .16), and 92% versus 85% (P = .36), respectively. Importantly, of the 6 patients who underwent watch-and-wait and experienced local regrowth, 5 (83%) eventually developed distant recurrence.

“The ability to perform curative-intent salvage, or rescue, surgery at the time of regrowth was quite good, indicating this approach seemed generally safe,” lead study author Bryce W. Beard, MD, a fifth-year radiation oncology resident at Kaiser Permanente Los Angeles Medical Center, explained in the release.

Ultimately, the investigators concluded, based on the study results, that watch-and-wait appears to be safest in patients with stages I and II rectal cancer. Further, patients with stage III cancer were deemed to be less likely to be alive at 3 years unless they received intravenous chemotherapy containing oxaliplatin (Eloxatin). However, the researchers recommended performing a rectal MRI to confirm a complete treatment response.

Study co-investigator Elisabeth C. McLemore, MD, FACS, a colon-rectal surgeon at Kaiser Permanente Los Angeles Medical Center, indicated that “there are sufficient data to offer this alternative treatment to eligible patients.”

She also went on to recommend that patients who choose watch-and-wait receive monitoring every 3 months for the first 2 years, then every 6 months for years 3 to 5, and annually thereafter.

References:

1. Beard BW, Rettig RL, Ryoo JJ, Parker RA, McLemore EC, Attaluri V. Watch-and-Wait Compared to Operation for Patients with Complete Response to Neoadjuvant Therapy for Rectal Cancer. Journal of the American College of Surgeons. doi: 10.1016/j.jamcollsurg.2020.08.775

2. Some rectal cancer patients can safely avoid an aggressive operation [news release]. Chicago. Published October 26, 2020. Accessed November 5, 2020. https://www.facs.org/media/press-releases/2020/rectal-cancer-102620