The GO2 study found that lowering the intensity of chemotherapy may increase quality of life without significantly compromising survival among older and frail patients with advanced gastroesophageal cancers. It started out by asking patients themselves what degree of compromise they would be willing to accept.
“When you look at any study that is aiming to see whether we can reduce the intensity of treatment without compromising survival, we have to design it as a noninferiority comparison,” the study’s corresponding author, Matthew T. Seymour, MD, explained in an interview with The ASCO Post. “One of the important things we did with this study was include a forum for patients and survivors with cancer. We did not just include researchers or doctors sitting around a table and discussing noninferiority margins or degree of compromise.” Dr. Seymour is Professor of Gastrointestinal Cancer Medicine, Institute of Oncology, St. James University Hospital, University of Leeds, United Kingdom.
Among the findings, Dr. Seymour reported, is that “doctors were willing to accept only a small compromise in efficacy, where patients were a lot more interested in quality of life and rather less interested in quantity of life.”
As reported in the study, published in JAMA Oncology,1 “patients were prepared to sacrifice 6 weeks or more of progression-free survival in return for reduced treatment toxic effects. However, clinicians were more conservative, and the trial was eventually powered to exclude 34 days or greater reduction in median progression-free survival from a predicted 134 days, equivalent to a hazard ratio at or over 1.34.”
A Very Strong Patient Voice
“This trial has been a real partnership among researchers, clinicians, and patients. Having patients intimately involved in the design of the trial, in the setting of the statistical parameters, and being very much part of the research team have been important,” Dr. Seymour stressed.
“We have been able to do that because, in the United Kingdom, patients have a very strong voice, and that is part of our National Cancer Research Institute,” Dr. Seymour said. “This is using the patient’s voice in trial design, setting the questions, setting the parameters, helping to design the studies, and being really involved. I would recommend to others to use that approach.”
Who Decides What’s ‘Manageable’?
“One of the phrases you read very often in oncology reports,” Dr. Seymour added, “is the toxicity was ‘manageable,’ and you always wonder who it is who is doing the managing? The truth is that toxicity might be described as manageable by the oncologist, but for the patient experiencing that toxicity, it might not feel manageable at all. We need to start communicating better with patients and hear their views on what is acceptable, or manageable, and what isn’t. Also, we need patients to rank the different goals of treatment, both in terms of quantity and quality of life.”
Among the surprising findings in the trial was that, during the recruitment interviews, there were more patients who said they wanted the lowest dose of chemotherapy, rather than patients who said they wanted to have the high dose of chemotherapy. For some patients, “chemotherapy does engender real fear that it could potentially make their condition worse, make them sick, or cause other side effects,” Dr. Seymour said.
“It was interesting to learn there were more people who wanted the lower-dose treatment,” Dr. Seymour commented. “It challenges this assumption in oncology that we should always push the dose to the highest we can get away with.”
DISCLOSURE: Dr. Seymour received grants from Cancer Research UK during the conduct of the study and institutional research funding from Amgen and AstraZeneca.
REFERENCE
1. Hall PS, Swinson D, Cairns DA, et al: Efficacy of reduced-intensity chemotherapy with oxaliplatin and capecitabine on quality of life and cancer control among older and frail patients with advanced gastroesophageal cancer: The GO2 phase 3 randomized clinical trial. JAMA Oncol 7:869-877, 2021.
