Dr Cecchini on the Results of the PROSPECT Trial in Rectal Cancer

Michael Cecchini, MD, assistant professor, medicine, Medical Oncology, co-director, Colorectal Program, the Center for Gastrointestinal (GI) Cancers, Yale School of Medicine, medical oncologist, Yale Medicine, discusses the phase 3 PROSPECT trial (NCT01515787) of neoadjuvant chemoradiation vs neoadjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy with selective use of chemoradiation, followed by total mesorectal excision in patients with locally advanced rectal cancer, and how this regimen may fit into the current treatment landscape for rectal cancer.

Data from the randomized trial were presented at the 2023 ASCO Annual Meeting, showing that neoadjuvant FOLFOX with the selective use of chemoradiation is safe and effective in the treatment of patients with T2 node-positive, T3 node-negative, or T3 node-positive rectal cancer. The PROSPECT trial was presented during the plenary session at the meeting and was a non-inferiority study conducted by the Alliance for Clinical Trials in Oncology with 1128 patients treated, Cecchini begins.

The main goal of the study was to compare outcomes of completing induction chemotherapy vs chemoradiotherapy in rectal cancer, he expands. The induction chemotherapy group underwent an evaluation to understand whether chemoradiation, the typical standard of care for this patient population, could be omitted, he says. Investigators evaluated the possibility of de-escalating current therapies for patients with low-risk, mid-to-high rectal cancer. This long effort focused on quality of life for this patient group, Cecchini emphasizes. Upon asking whetheroncologists can give less intensive treatment for these patients, PROSPECT showed no compromise in efficacy with the omission of radiation therapy in this population, Cecchini explains.

Although Cecchini shares that this is an exciting finding, he stresses that the treatment of rectal cancer has changed dramatically over the past 10 years. Now, oncologists are using total neoadjuvant therapy in the majority of patients, and for some patients, a‘watch-and-wait’ approach is more beneficial. Therefore, these updated data may be challenging to incorporate into clinical practice, Cecchini continues. However, they show that for patients with locally advanced rectal cancer, radiation can safely be omitted, Cecchini concludes.