NcXHF

INVITED ARTICLES
BREAST CANCER
I Will Recommend a Clinical Trial—If I Can
William M. Sikov, MD, FACP
You have completed your examination and have left the patient’s
room to let her get dressed while preparing to sit
down with her and her partner to discuss her diagnosis, stage,
prognosis, and treatment recommendations. With the patient’s
permission, a second-year medical resident will sit in on
this discussion. As you wait, you run through what you are
planning to say, especially about her standard treatment options
and about a clinical trial for which she appears to be eligible—a
randomized study that could answer important
questions about the treatment of her disease. You tell the resident
that the doctor’s role in suggesting and explaining a study
to a patient is vital, even though the research staff will do much
of the work if the patient agrees to consider the study. But you
can only succeed if you try. Albrecht et al, studying interactions
between oncologists and patients and their families at two
comprehensive cancer centers, found that clinical trials were
offered to patients only 20% of the time, but, when offered, 75%
of patients agreed to participate. 1 In a telephone survey of
1,000 adults, 32% of responders said they would be very willing
to participate in a cancer clinical trial if asked and another
38% indicated that they would be inclined to do so. 2
Unfortunately, scenes like this could well become much
less common for many medical oncologists, especially those
who work at smaller academic cancer centers, community
hospitals, and private practices, where the vast majority of
Americans receive their oncologic care. Many sites that have
been involved in clinical research for decades are fınding it
increasingly diffıcult to gain access to clinical trials that they
can offer to more than a minute fraction of their patients.
Why is this? Certainly there is no dearth of important questions
to address regarding the management of many common
cancers. In the past, many of the larger trials in which
patients participated originated with the site’s cooperative
group; the creation of the Clinical Trials Study Unit (CTSU)
offered the opportunity to enroll patients on phase II and III
studies conducted by other groups. Many institutions and
practices have supported their staff’s participation in the
groups, covering the costs of membership and travel to attend
group meetings and accepting a reduction in “productivity”
so that the site can contribute to the research effort.
You know that this part of the conversation can be disconcerting
for the patient; she was referred to you because of your
knowledge and experience, not to have such an important decision
made by a computer, by a flip of a virtual coin. Why open
this can of worms? You are already 40 minutes behind schedule,
and the study discussion is bound to add at least 30 minutes
to this visit. It is certainly not for the money; with the
exception of a few well-funded pharmaceutical company–
sponsored trials, your protocol offıce actually loses money on a
per-accrual basis. It is not for the “glory”—there is no way your
site will enroll enough patients on this large study to be given
authorship credit, and, in the academic scheme of things, clinical
research is a poor relation. You know the statistics, which
you share with the resident—how few patients are candidates
for available trials despite efforts to liberalize eligibility criteria,
how few are offered the chance to be part of a trial, how few
agree to participate (less than 5% of adult patients with cancer
enroll in clinical trials, in comparison to more than 60% of
children with cancer), and how many studies fail to meet accrual
goals or take years longer than planned to answer the
important questions they address. How many axillae were unnecessarily
dissected because it took so long to complete
ACOSOG Z0011?
The accomplishments of the U.S. cooperative groups in advancing
the understanding of and improving outcomes for
many different types of cancer should not be underestimated
(see summary by Schilsky 3 ); if you scan the lists of plenary
and oral abstract presentations at the American Society of
Clinical Oncology’s Annual Meetings, or any other major national
meeting over the past 2 decades, you will see ample
evidence of their effect, despite being level-funded since 2003
(which has the effect of reducing available funding by a few
percent every year, given inflation), and over the past few
years, many presenters have reminded us of this origin for
their practice-changing trials. Still, there is no doubt that they
could have been more productive and effıcient and that there
were costs associated with their conduct that could be re-
From the Program in Women’s Oncology, Women and Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Disclosures of potential conflicts of interest are found at the end of this article.
Corresponding author: William M. Sikov, MD, Women and Infants Hospital of Rhode Island, Breast Health Center, 101 Dudley St., Providence, RI 02905: email: wsikov@wihri.org.
© 2015 by American Society of Clinical Oncology.
44 2015 ASCO EDUCATIONAL BOOK | asco.org/edbook