It’s extremely difficult to conduct studies comparing an active therapy like chemotherapy treatment vs. a supportive care approach, because patients and their physicians tend to have biases that make random assignment particularly difficult to accept. That said, there are important questions in oncology for which a supportive care arm is appropriate, both because treatments often have side effects, and there’s concern for worsening of quality of life, and there are situations where treatment is commonly given, but there may not be the level of evidence you’d like to see, like we have in front-line therapy.
This very important study shows two things: One, that second-line therapy in patients with esophagus and gastric cancers is of benefit in prolonging survival. In addition, there’s a quality of life benefit – so there’s not detriment to patients from the side effects of this treatment.
It’s really important to note that supportive care isn’t no-therapy. Supportive care means that there is an agreement that the goals of therapy are different than the goals of curative chemotherapy. But it’s still treatment, it’s still aggressive treatment, and it has specific goals.
There’s a lot of concern amongst the oncology community and beyond about how we approach the care of patients at the extremes, at the very end of life. There is significant evidence that a lot of treatment is given to patients within weeks of their death. Because treatment is toxic, we’re very cognizant of the question of whether patients are being harmed by this type of aggressive therapy.
This study is a critical type of study for providing an evidence base to help guide our treatment decisions at points in times when the goals are palliative and not curative, and where we’re talking about modest prolongations in survival. This is really a model for a type of study that we’d like to see more of, both from a clinical outcomes point of view and, of course, when evaluating health care costs.
Oncology, as a field, is one of the most clearly evidence-based fields of medicine. Most of what we do is based on high levels of evidence. Treatment towards the end of life is an area where perhaps we’ve fallen a little short and need to pay additional attention.
Dr. Neal J. Meropol is chief of hematology and oncology at Case Western Reserve University, Cleveland. He gave these comments as moderator of the press briefing. He has been a consultant or adviser to Precision Therapeutics.
