In an analysis from the PROSPECT trial (Alliance N1048) reported in the Journal of Clinical Oncology, Ethan Basch, MD, MSc, FASCO, and colleagues identified patient-reported outcome patterns 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 trial, 1,194 patients with clinical stage T2N1, cT3N–, or cT3N1 disease who were candidates 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 contributed data for the patient-reported outcome analysis (493 in the FOLFOX group, 447 in the 5FUCRT group).
Ethan Basch, MD, MSc, FASCO
FOLFOX was given in six cycles over 12 weeks followed by surgery; 5FUCRT was delivered in 28 fractions over 5.5 weeks followed by surgery. Adjuvant chemotherapy was 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 instruments measured bowel, bladder, sexual function, and health-related quality of life. Patient-reported outcomes were collected at baseline, during neoadjuvant treatment, and at 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, whereas patients in the 5FUCRT group reported lower rates of anxiety, appetite loss, constipation, depression, dysphagia, dyspnea, edema, fatigue, mucositis, nausea, neuropathy, and vomiting (all 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 vs 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 adjustment for multiple comparisons.
In evaluation of patient-reported severity, frequency, and activity interference for symptoms, ≥ 15% of patients in the FOLFOX group reported: high (score ≥ 3) severity for appetite loss, constipation, fatigue, mucositis, neuropathy, and pain; high frequency for anxiety, diarrhea, nausea, and pain; and high interference due to 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 due to fatigue and pain during neoadjuvant treatment. At 12 months after surgery, ≥ 15% of the 5FUCRT group reported high frequency for diarrhea.
The investigators concluded: “For patients with locally advanced rectal cancer choosing between neoadjuvant FOLFOX and 5FUCRT, the distinctive 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 article.
Disclosure: The study was supported by the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.
