of obinutuzumab for treating follicular lymphoma was based
on the results of a phase III clinical trial, which showed that
adding obinutuzumab to bendamustine more than doubled
the median time to disease progression for patients whose
disease had progressed despite treatment that included
rituximab (Rituxan) ( 112).
New FDA-approved medical products are used alongside
those already in the physician’s armamentarium. Thus,
most patients with cancer are treated with a combination
of surgery, radiotherapy, chemotherapy (including both
cytotoxic chemotherapeutics and molecularly targeted
therapeutics), and/or immunotherapy (see Supplemental
Table 2, p. 131, and Supplemental Table 3, p. 134).
The following discussion primarily highlights recent FDA
approvals that are improving lives by having an effect
across the continuum of clinical cancer care.
Cancer Prevention and Detection
Preventing cancer from developing and, if cancer develops,
detecting it at the earliest stage possible are the most effective
ways to reduce the burden of cancer. The development
of new and better approaches to cancer prevention and
early detection has been spurred by research that led to
increasing knowledge of the causes, timing, sequence, and
frequency of the genetic, molecular, and cellular changes
that drive cancer initiation and development.
Increasing Options for Colorectal
Colorectal cancer screening has helped reduce U.S.
colorectal cancer incidence and mortality rates because
it can identify precancerous colorectal abnormalities,
which can be removed before they have a chance to develop
into cancer, as well as early-stage cancers, which are more
easily treated compared with advanced-stage cancers
(see sidebar on Consensus Among Cancer Screening
Recommendations, p. 42) ( 113). However, colorectal
cancer remains the fourth most commonly diagnosed
cancer and the second leading cause of cancer-related
deaths ( 3).
One in every three U.S. adults for whom colorectal cancer
screening is recommended is not up to date with screening
( 113). It is clear that new ways to increase participation
in colorectal cancer screening could significantly reduce
the burden of this common cancer.
Research shows that people who are able to pick the
colorectal cancer screening test they prefer are more likely
to actually get the test done ( 115).
In an effort to increase the number of colorectal cancer
screening options, and hopefully thereby increase the
number of people who are screened, researchers built
on the discovery that a specific epigenetic abnormality—
GENOMICALLY INFORMED CLINICAL TRIALS FIGURE 10
One of the major uses of genomics in clinical research is in
the design and execution of novel clinical trials. Two such
types of trials are basket and umbrella trials. In the basket trial
depicted here, one drug is being tested against a particular
genetic mutation (green dots) across liver, lung, bone, colon,
and stomach cancers. In the umbrella trial illustrated here,
three different drugs are being tested against multiple
genetic mutations (yellow, green, blue, and red dots) in
Figure adapted from Ref. ( 1)