Patient-Reported Outcomes from the PROSPECT FOLFOX Study Neoadjuvant Versus Chemoradiotherapy for Locally Advanced Rectal Cancer

By Matteo Stenger

Posted: 06/19/2023 11:54:00

Last update: 19/06/2023 14:51:35

Be allowed

In an analysis of the PROSPECT study (Alliance N1048) reported in the Journal of Clinical Oncology, Ethan Basch, MD, MSc, FASCOand colleagues identified patient-reported patterns of outcome among those receiving neoadjuvant FOLFOX (fluorouracil, leucovorin, oxaliplatin) or pelvic chemoradiation with fluorouracil (5FUCRT) for locally advanced rectal cancer.

Study details

In the open-label study, 1,194 patients with clinical stage T2N1, cT3N, or cT3N1 disease scheduled for sphincter-sparing surgery were randomly assigned between June 2012 and December 2018 to receive neoadjuvant FOLFOX or 5FUCRT; of these, 1,128 initiated treatment and 940 provided data for analysis of patient-reported outcomes (493 in the FOLFOX group, 447 in the 5FUCRT group).

Ethan Basch, MD, MSc, FASCO

Ethan Basch, MD, MSc, FASCO

FOLFOX was administered in six cycles over 12 weeks followed by surgery; 5FUCRT was administered in 28 fractions over 5.5 weeks followed by surgery. Adjuvant chemotherapy has been suggested but not mandatory. Patient-reported outcomes included 14 symptoms from the National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Additional patient-reported outcome tools measured bowel, bladder, sexual function, and health-related quality of life. Patient-reported outcomes were collected at baseline, during neoadjuvant treatment, and 12 months after surgery.

Key Findings

During neoadjuvant treatment, patients in the FOLFOX group reported significantly lower rates of diarrhea and better overall bowel function, while patients in the 5FUCRT group reported lower rates of anxiety, loss of appetite, constipation, depression, dysphagia, dyspnoea , edema, fatigue, mucositis, nausea, neuropathy, and vomiting (all multiplicities 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 than those in the 5FUCRT group (all multiplicity adjusted P < .05).

No differences in bladder function or health-related quality of life were observed between groups at any time point after adjusting for multiple comparisons.

In assessing patient-reported severity, frequency, and activity interference for symptoms, 15% of patients in the FOLFOX group reported: high severity (score 3) for loss of appetite, constipation, fatigue, mucositis, neuropathy and pain; high frequency for anxiety, diarrhea, nausea, and pain; and high interference from fatigue, mucositis, neuropathy, and pain during neoadjuvant treatment. In the 5FUCRT group, 15% of patients reported high severity for fatigue and pain; high frequency for diarrhea and pain; and high interference from fatigue and pain during neoadjuvant treatment. At 12 months postoperatively, 15% of the 5FUCRT group reported a high frequency of diarrhea.

The researchers concluded: For patients with locally advanced rectal cancer choosing between neoadjuvant FOLFOX and 5FUCRT, the distinct patient-reported outcome profiles inform treatment selection and shared decision-making.

Dr. Basch, of the Division of Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, is the corresponding author for the Journal of Clinical Oncology item.

Disclosure: The study was supported by the National Cancer Institute. For complete information on the study authors, visit

The content of this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO) and does not necessarily reflect the views and opinions of ASCO.

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