The following is a summary of “Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048),” published in the July 2023 issue of Oncology by Basch, et al.
For a multicenter, randomized trial, researchers sought to compare patient-reported outcomes (PROs) between neoadjuvant pelvic chemoradiation with fluorouracil (5FUCRT) and neoadjuvant chemotherapy with fluorouracil and oxaliplatin (FOLFOX) in patients with locally advanced rectal cancer. They aimed to understand the relative patient experiences with these treatment options to inform treatment decisions better.
The PROSPECT trial enrolled adults with rectal cancer clinically staged as T2N+, cT3N-, or cT3N+ eligible for sphincter-sparing surgery. The participants were randomly assigned to receive either neoadjuvant FOLFOX, consisting of six cycles over 12 weeks, followed by surgery, or neoadjuvant 5FUCRT, delivered in 28 fractions over 5.5 weeks, followed by surgery. Adjuvant chemotherapy was suggested but not mandated for both groups. Patients were asked to provide PROs at baseline, during neoadjuvant treatment, and 12 months after surgery. The PROs included 14 symptoms from the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Additional PRO instruments measured bowel, bladder, sexual function, and health-related quality of life (HRQL).
Between June 2012 and December 2018, 1,194 patients were randomly assigned, 1,128 initiated treatment, and 940 provided PRO-CTCAE data (493 in the FOLFOX group; 447 in the 5FUCRT group). During neoadjuvant treatment, patients in the FOLFOX group reported significantly lower rates of diarrhea and better overall bowel function, while anxiety, appetite loss, constipation, depression, dysphagia, dyspnea, edema, fatigue, mucositis, nausea, neuropathy, and vomiting were lower in the 5FUCRT group (all with multiplicity adjusted P < .05). At 12 months after surgery, patients in the FOLFOX group reported significantly lower rates of fatigue and neuropathy and better sexual function compared to the 5FUCRT group (all with multiplicity adjusted P < .05). Bladder function and HRQL did not differ between the groups at any time point.
The study’s findings suggested that the distinctive PRO profiles of neoadjuvant FOLFOX and 5FUCRT in patients with locally advanced rectal cancer can help inform treatment selection and shared decision-making between patients and healthcare providers.