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A couple sits on a sofa, smiling and holding a tablet.A multi-institutional study designed to compare two treatment options for locally advanced rectal cancer while collecting patient-reported treatment side-effects has generated insights patients can use to make more informed quality-of-life treatment choices in consultation with their doctors. The findings were published June 4 in the Journal of Clinical Oncology.

Led by researchers at the University of North Carolina Lineberger Comprehensive Cancer Center, the quality-of-life study is a component of the PROSPECT study, a large national, phase III clinical trial to evaluate whether patients receiving treatment for localized rectal cancer can receive chemotherapy alone instead of the current standard approach of radiation therapy with some chemotherapy prior to surgery.

The results of the PROSPECT study, which will be presented in a plenary session during the 2023 American Society of Clinical Oncology Annual Meeting in Chicago on June 4, showed similar survival benefit for each treatment arm.

The patient-reported quality-of-life outcomes provide essential information for patients to weigh between these treatment options. Specifically, during treatment with chemotherapy alone before surgery patients noted significantly lower rates of diarrhea, whereas during radiation with chemotherapy patients reported significantly lower rates of anxiety, appetite loss, depression, fatigue, nausea, nerve pain, and other symptoms. In contrast, 12 months after their surgeries, patients treated only with chemotherapy had significantly less fatigue, sexual dysfunction, and nerve pain than those who received radiotherapy. Since the survival outcomes in the trial were the same, that means that quality-of-life choices could be a top-of-mind factors in deciding which treatment patients might pursue.

Headshot of Ethan Basch
UNC Lineberger’s Ethan Basch, MD, MSc.

“During the treatment itself, multiple symptoms were worse with chemotherapy, but a year after treatment ended, those symptoms resolved and the pattern flipped so that patients who received radiation exhibited lingering symptoms,” said lead author Ethan Basch, MD, MSc, the Richard M. Goldberg Distinguished Professor of Medicine, chief of medical oncology, and director of the Cancer Outcomes Research Program at UNC Lineberger. “Patients ideally will understand the potential impact of treatments on how they feel and function when making choices, so as oncologists we need to talk with our patients about their options and the consequences of those options.”

Patients and clinicians sometimes use decision-making tools to aid choices, such as interactive videos or surveys showing the tradeoffs between treatments, but Basch said these tools can only be effective if they have reliable data in them. “This study is about empowering patients and clinicians with the information they need to make informed decisions about treatment.”

Patient-reported outcomes that assess quality of life started to formally be incorporated into cancer trials in the 1980s, but this is the first trial in which patient-reported adverse events were collected with a novel, highly detailed tool: the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Basch said this rigorous tool is now used in hundreds of trials, but “this is a landmark study because it is the first large clinical trial to embed PRO-CTCAE and therefore is an exemplar for future global clinical trials.”

Authors and disclosures

In addition to Basch, the article’s other authors include Amylou C. Dueck, PhD, Brenda Ginos, MS, and Gina L. Mazza, PhD, Mayo Clinic, Scottsdale, AZ; Sandra A. Mitchell, PhD, Lori Minasian, MD, and Andrea Denicoff, MS, RN, National Cancer Institute, Bethesda, MD; Harvey Mamon, MD, PhD, Brigham and Women’s Hospital, Boston; Martin Weiser, MD, Leonard Saltz, MD, Marc Gollub, MD, Lauren Rogak, Eileen O’Reilly, MD, and Deborah Schrag, MD, MPH, Memorial Sloan Kettering Cancer Center, New York; Brian Colgrove, Gita Thanarajasingam, PhD, and Qian Shi, PhD, Mayo Clinic, Rochester, MN; George Chang, MD, MS, MD Anderson Cancer Center, Houston; Benjamin Musher, MD, The Southwest Oncology Group, Baylor College of Medicine, Houston; Thomas George, MD, University of Florida Health Cancer Center, Gainesville, FL; Alan Venook, MD, University of California, San Francisco; Jeffrey Farma, MD, Fox Chase Cancer Center, Philadelphia; and Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute, Boston.

Basch serves on the Board of Directors for ASCO, receives research funding from the National Cancer Institute and the Patient-Centered Outcomes Research Institute and is a scientific advisor to Sivan, CareVive, AstraZeneca and Navigating Cancer, Inc.

The study was funded in part by the National Cancer Institute (HHSN261200800063C, U01CA233046, UG1CA189823, U10CA180821, U10CA180882, U10CA180863 U10CA180820, U10CA180868, and U10CA180888).