Patient-reported outcomes from the PROSPECT trial: treatment for locally advanced rectal cancer

A recent analysis from the PROSPECT trial examined trends in patient-reported outcomes among those who received neoadjuvant FOLFOX (fluorouracil, leucovorin, oxaliplatin) or pelvic chemoradiation with fluorouracil (5-FU) for locally advanced rectal cancer.

Patient-reported outcomes: a patient’s description of their symptoms, their satisfaction with care, and how the treatment affects their physical, mental, emotional, spiritual and social well-being (National Cancer Institute)

Neoadjuvant therapy: treatment that is given as the first step to shrink a tumour before the main treatment, which is typically surgery, is given (National Cancer Institute)

Fluorouracil (5-FU): one of the most commonly used chemotherapy drugs to treat cancer.

The study

The PROSPECT trial included 1,194 patients with locally advanced rectal cancer – rectal cancer that involves tumours that have grown into or close to the mesorectal fascia, a layer of connective tissue that surrounds the rectum. The participants were randomly assigned to receive neoadjuvant FOLFOX or chemoradiation + 5-FU to determine how neoadjuvant chemotherapy (FOLFOX) alone compares to the standard treatment of chemoradiation.

Key findings

Patients in the neoadjuvant chemotherapy (FOLFOX) group reported significantly lower rates of diarrhea and better overall bowel functioning compared to the chemoradiation group. Patients who received chemoradiation reported lower rates of anxiety, appetite loss, constipation, depression, dysphagia (difficulty swallowing), shortness of breath, edema (swelling), fatigue, mucositis (inflammation of the inside of the mouth and the lining of the entire digestive tract), nausea, neuropathy, and vomiting.

At 1 year after surgery, patients who received FOLFOX chemotherapy alone reported significantly lower rates of fatigue and neuropathy and better sexual functioning compared to patients who received chemoradiation.

Bladder function and health-related quality of life did not show any significant differences between the two treatment groups.

Conclusion

For patients with locally advanced rectal cancer, the distinct patient-reported outcome profiles should be used to inform treatment selection and share decision-making between the patient and the healthcare team.