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 The comparison of side effects reported by patients and their
physicians in three separate cancer drug trials found that doctors
under-reported by up to 75 percent how many patients had six of the
most common chemotherapy side effects.
Lacking accurate estimates of side effects makes it difficult for
doctors to discuss the benefits versus risks of new cancer drugs
with their patients, the study authors say.
“Our findings are consistent with previous research data and confirm
that patient reported outcomes have to be integrated into cancer
clinical trials because they are very important in defining
tolerability of new treatments from the patients’ perspective,”
senior study author Dr. Francesco Perrone told Reuters Health in an
email.
“Patients should be empowered to directly report subjective side
effects and be active in defining the tolerability of anticancer
drugs,” said Perrone, director of the Clinical Trials Unit at the
National Cancer Institute of Naples, Italy.
For their study in the Journal of Clinical Oncology, Perrone and
colleagues reviewed the side effects reported by a total of 1,090
patients from three separate cancer drug trials. One trial was of a
secondary treatment for elderly patients with breast cancer and two
trials involved new first-line treatments for lung cancer.
Almost 2,500 treatment cycles were included in the analysis. Trial
physicians reported and graded their perceptions of patients’ side
effects afterwards, and the patients filled out questionnaires
following each cycle that assessed the presence and severity of
appetite loss, nausea, vomiting, constipation, diarrhea and hair
loss.
When the researchers compared reports from doctors and patients,
they found physicians had under-reported loss of appetite by about
75 percent, nausea by about 40 percent, vomiting by about 47
percent, constipation by about 70 percent, diarrhea by about 51
percent and hair loss by about 65 percent.
When the study team focused just on severe side effects that
patients reported experiencing “very much,” they found physicians
under-reported appetite loss by about 50 percent, nausea by about 26
percent, vomiting by about 13 percent, constipation by about 44
percent, diarrhea by about 24 percent and hair loss by about 43
percent.
Perrone said the findings show that physicians should be cautious
when reading and interpreting the results of clinical trials,
particularly if patient reports of subjective side effects are not
included.
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The results should also push physicians toward spending more time
listening to the patient’s experience of symptoms, he said.
“When I tell somebody what to expect from the side effects
standpoint, I really rely on the previously published studies, which
are largely based on other clinical investigators reporting out the
percentage of things like nausea, pain, hair loss, fatigue and
knowing that these side effects may be under-reported, I think is
important,” said Dr. Sam Lubner, an oncologist with the University
of Wisconsin School of Medicine and Public Health in Madison.
Lubner, who was not involved in the study, said physicians have
criteria for assessing subjective complaints like nausea, pain, and
anxiety, but it’s often difficult for patients to describe their
levels of discomfort.
Lubner said patients should ask for a written list of the possible
side effects before they begin treatment.
In addition, patients should keep a diary of their symptoms so they
can bring that information to office visits, he said.
“One thing I tell patients, is these are the expected side effects -
if you experience these with regularity, write them down and make
sure that we talk about them every time and see if they’re getting
better or worse,” he said.
Lubner added that it’s important to tell doctors about side effects
because they can often be managed and that sometimes just talking
about them and knowing what is expected can help.
SOURCE: http://bit.ly/1EB4gfc Journal of Clinical Oncology, online
January 26, 2015.
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