NcXHF

ENG ET AL
colorectal cancer. Indeed there are plans to open an NCIsponsored
ASSIGN trial to test targeted agents in molecular
subsets as second-line therapy of metastatic colon cancer. Although
critically important to fınding and validating new targeted
agents for colorectal cancer, the diffıculty in getting
such a trial activated is daunting and would still leave the
many other GI sites lacking this level of trial access.
Although studies have shown that the cost of care for patients
in cancer clinical trials is not substantially greater than
the costs of routine care, insurance 16 companies have not
universally embraced clinical trials as a component of standard
care for patients with cancer. Legislative efforts such as
SB37 in California have mandated that insurers pay for the
routine care costs for patients to participate in a clinical trial
and cannot deny access to a trial. However, loopholes exist.
Nearly 30% of California adults are uninsured, which makes
us hopeful that ACA will provide coverage for and access to
clinical trials for those who were previously uninsured.
In the 2014 ASCO Educational Book, the use of social media
to improve clinical trial accrual was discussed. 17 Another creative
use of the Internet is crowd sourcing for feedback on
how to improve the design and accrual of a particular clinical
trial. Leiter et al 18 used a Web-based platform that allowed
participants to comment on the design of a clinical trial using
metformin in prostate cancer. Hyperlinks were posted to social
networking sites. The platform was available for 6 weeks,
and this crowd-sourcing exercise resulted in 9 changes to the
protocol, 4 of which were major changes. Certainly the potential
of the Internet and social media to improve awareness
of and accrual to trials remains relatively untapped.
Patient advocacy groups may positively influence clinical trial
accrual. The Pancreatic Cancer Action Network (PANCAN)
has reported that although only 3% of patients with pancreatic
cancer in the United States enroll in trials, 16% of those
patients have called a help line to participate in clinical trials.
Although an obvious selection bias favors patients and families
who want more information, we would contend that the
effect is real and that PANCANs advocacy for trials has an
effect, even if not fıve-fold in magnitude. Sadly there are relatively
few support groups for other GI sites and none of the
size and fınancial power of those for breast and prostate cancer.
However, if there could be a coalition of GI-minded advocacy
groups to make clinical trial accrual a priority, we
might hope that a similar improvement in accrual might
occur.
Trials such as BATTLE, ISPY, and, hopefully, ASSIGN
should be encouraged and supported. Novel design methodologies
might make such trials easier to complete with fewer
patients needed to achieve clinically relevant endpoints. The
PANGEA trial 19 for gastroesophageal cancers is one such
novel design that merits further attention.
In GI malignancies, the only molecular tests that have been
validated to affect patient outcomes would be RAS testing for
metastatic colorectal cancer, HER2/neu for metastatic gastric
cancer, and microsatellite-instability (MSI) for stage II colon
cancer. All other molecular tests should be the subject of
further study. The plethora of molecular testing for cancer
approved under the Clinical Laboratory Improvement
Amendments of 1988 regulations is not linked to any accountability.
Patients and oncologists alike, in good faith,
may order such tests to be told that a drug seems like a good
match for the genetic alteration “y” in the patient’s tumor,
but rarely are there data to support a clinical benefıt of receiving
that drug in that particular setting. We should fınd a way
to encourage/mandate that any physician who orders a molecular
profıle (outside the confınes of the examples listed
above) should also obtain consent from the patient to review
and discuss the results of the profıle, and if a treatment is administered
purely on the basis of the molecular testing, that
the response to that therapy is registered anonymously in a
database available to all researchers. The establishment of
such a database could be a source of discovery and aid in the
design of clinical trials to validate promising results. Currently,
the patient may or may not respond, but that information
is lost to a future generation of patients with cancer
who might have benefıted from that knowledge.
CONCLUSION
As academic oncologists, we know how rigorous the scientifıc
methodology must be to prove a treatment is benefıcial.
As a community of providers, patients and families, we know
all too well the emotional and physical toll a cancer diagnosis
takes. The price of neglect is too high. Together we must fınd
ways to increase access, improve design, and speed completion
of clinical trials—for the good of all.
Disclosures of Potential Conflicts of Interest
Relationships are considered self-held and compensated unless otherwise noted. Relationships marked “L” indicate leadership positions. Relationships marked “I” are those held by an immediate
family member; those marked “B” are held by the author and an immediate family member. Institutional relationships are marked “Inst.” Relationships marked “U” are uncompensated.
Employment: None. Leadership Position: None. Stock or Other Ownership Interests: George Fisher, Seattle Genetics (I). Honoraria: Cathy Eng, Sanofi,
Roche, Lilly. Consulting or Advisory Role: George Fisher, Genentech. Cathy Eng, Roche/Genentech, Bayer Schering Pharma. Nancy Roach, Genentech.
Speakers’ Bureau: None. Research Funding: George Fisher, Celgene (Inst), Novartis Pharmaceutical Group (Inst), Tercica (Inst), Bristol-Meyers Squibb
(Inst), Newlink Genetics (Inst), Medivation (Inst), Pharmaceutical Research Associates (Inst), Polaris Group (Inst), Eli Lilly (Inst), PRA International (Inst),
XBiotech (Inst), Bristol-Meyers Squibb (Inst), Tercica (Inst), Novartis, Celgene. Cathy Eng, Keryx, ArQule. Patents, Royalties, or Other Intellectual
42 2015 ASCO EDUCATIONAL BOOK | asco.org/edbook