Most patients with rectal cancer who have a complete clinical response (cCR) and many patients who achieve a major clinical response (mCR) after neoadjuvant therapy may be appropriate candidates for rectum-sparing management, according to new research.
Prior research has supported the use of watch and wait and local excision in these patients. “But those studies were limited by factors such as small sample size, single center and the variability of methodology used in conducting the studies,” said Gaya Spolverato, MD, a surgical oncologist with the University of Padova, in Italy.
At the Society for Surgical Oncology 2020 virtual meeting, Dr. Spolverato presented the preliminary results of reSARCh (Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer), the first prospective multicenter observational trial to investigate a rectum-sparing approach after preoperative radiation therapy and/or chemotherapy.
Dr. Spolverato’s presentation reported short-term outcomes in 176 adult patients enrolled between 2016 and 2019 with adenocarcinoma within 12 cm of the anal verge who had achieved cCR or mCR. Patients who achieved cCR were offered a choice of watch and wait or local excision; those who achieved mCR were offered local excision; the 20 patients who achieved neither cCR nor mCR were referred to total mesorectal excision (TME).
Before neoadjuvant therapy, most patients had T3, node-positive disease. After neoadjuvant therapy, the majority had T0-T1, node-negative disease. Among those who achieved cCR, 57 (62%) opted for watch and wait and 34 (37%) chose local excision. In the group that achieved mCR, 63 (97%) underwent local excision and two (3%) watch and wait. Among the 107 patients who underwent local excision, the median interval between radiation therapy and surgery was 15 weeks.
“The majority of patients had no complication, and those who did have complications mostly had a grade 1 or 2 complication,” Dr. Spolverato said. TME was required in 30 (28%) patients, mainly due to grade T2 or higher disease.
At a follow-up of 15 weeks, 14 of the 66 watch-and-wait patients experienced tumor regrowth. Nearly all of these patients proceeded with TME. Overall, 28 (16%) of patients underwent TME: 16 in the local excision group and 12 in the watch-and-wait group.
Overall organ preservation at 13.5 months was 85% (83.5% in the local excision group and 88% in the watch-and-wait group). Correspondingly, the rate of definite stoma was low: 9% in the local excision group and 2% in the watch-and-wait group.
“The preliminary results of the reSARCh trial are promising. However, further studies are needed to better define long-term outcomes, and to find an effective definition of clinical response with the ability to predict pathological response,” Dr. Spolverato said.
She acknowledged the main limitation of the study is its inability to define the oncologic outcome of the rectum-sparing approaches; these will be evaluated as soon as the study achieves two years’ median follow-up.
“In the meantime, we are creating the national registry of patients undergoing rectal-sparing approaches in Italy,” Dr. Spolverato said.
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