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Can preoperative chemotherapy set the stage for organ-sparing surgery in early rectal cancer?

Three months of induction chemotherapy resulted in successful downstaging for certain patients with early-stage rectal cancer, allowing them to undergo organ-sparing therapy, according to a phase II trial.

In 33 of 58 patients, induction with modified folinic acid, fluorouracil, oxaliplatin 6 (FOLFOX6), or capecitabine-oxaliplatin (CAPOX), followed by transanal excision surgery, resulted in downstaging to ypT0/1N0/X tumors, reported Hagen F. Kennecke, MD, MHA, of the Providence Cancer Institute in Portland, Oregon, and colleagues.

The protocol-specific organ preservation rate was 57% (90% CI: 45-68). Additionally, this rate was similar across T-stage subgroups at 63% in the cT1 group (n=8), 54% in the T2 group (n=37), and 62% in the T3ab group (n=13). declared in the Journal of Clinical Oncology.

Of the remaining 23 patients recommended for total mesorectal excision (TME) surgery based on protocol requirements, 13 refused surgery and proceeded to observation. This resulted in a total of 46 patients, or 79%, who achieved organ preservation (90% CI 69-88), defined as the proportion of patients with ypT0/T1goodN0 tumor and who avoided radical surgery.

Kennecke and colleagues noted that this Canadian Cancer Trials Group NEO CO.28 study was conducted at cancer centers specializing in transanal rectal cancer diagnosis, therapy, and surgery, and that the concentration of rectal cancer surgeries in high volume centers it has been associated with superior results of organ preservation therapy.

Still, they stressed that, to the best of their knowledge, “this is the first published study describing the organ preservation outcomes of patients with stage I and early stage II rectal cancer treated with induction chemotherapy and transanal surgical excision.” offers a highly desired organ preservation option and warrants further investigation.”

The researchers explained that the current standard therapy for patients with histologically high-risk cT1 and cT2N0 rectal tumors is TME resection combined with preoperative chemoradiation for patients with T3 or N1 tumors.

“Although locoregional relapse rates with modern neoadjuvant therapy are low and survival is excellent, TME causes problems with bowel function, incontinence, and sexual function,” they said. Therefore, the idea behind organ-sparing therapy, such as excisional neoadjuvant chemotherapy for early stage I/IIA rectal cancer, aims to avoid the adverse effects associated with TME.

Among the 13 patients who refused the recommended TME, 85% had ypT2N0 tumors and one patient developed a locoregional recurrence during the follow-up period that was successfully resected with TME. Among the 10 patients who underwent the recommended TME surgery, only two had pathologically N1 tumors.

The 1-year locoregional relapse-free survival rate was 98% (95% CI 86-100) and the 2-year locoregional relapse-free survival rate was 90% (95% CI 58-98), respectively. There were no distant recurrences or deaths.

The authors also investigated rectal function and quality of life outcomes and found that there was little change in these scores from baseline.

The trial was conducted at seven centers in Canada and the US. All patients (median age 67 years, 71% male, 83% white) had lower or mid rectal tumors, clinical T1-T3abN0 adenocarcinoma in the lower or middle rectum diagnosed by proctoscopy. . The study surgeon deemed them suitable for endoscopic resection. All patients required pelvic magnetic resonance imaging and computed tomography of the chest, abdomen, and pelvis.

Patients were required to have a pretreatment ECOG performance score of 0 or 1 and adequate hematologic and organ function, while exclusion criteria included a history of pelvic external-beam radiation, prior therapy for rectal cancer, or metastatic disease.

Patients received six cycles of modified FOLFOX6 or four cycles of CAPOX, based on the investigator’s discretion. Pelvic MRI and proctoscopy were performed 2 to 3 weeks after the last dose of chemotherapy, and patients who had tumors with evidence of protocol-defined response proceeded to transanal excision surgery. Those with progression or no response to chemotherapy were referred for TME and preoperative pelvic radiation if MRI revealed cT3ab, cN+, or compromised or threatened circumferential radial margin.

The researchers noted that in 2014, the American College of Surgeons released the National Accreditation Program for Rectal Cancerthat allowed “patients to benefit from novel approaches like NEO.”

  • Mike Bassett is a staff writer specializing in oncology and hematology. He is based out of Massachusetts.

Disclosures

Kennecke disclosed support and/or relationships with Natera, TerSera Therapeutics, Novartis, and Taiho Pharmaceutical, as well as institutional support from Novartis and Exelixis.

The co-authors disclosed multiple industry relationships.

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