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Editor’s Note |
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Visit to the Magic Kingdom |
Florida residents, like myself, usually find that after about a dozen trips,
Disney
World becomes a tiresome experience. However, my June 2003 sojourn to the
Contemporary Hotel in Orlando included a thrill-a-minute ride on what might
be called, “Dr Norm’s wild ride into the future.” Specifically,
the NSABP meeting —
just weeks after a breathtaking series of colorectal cancer research presentations
at
ASCO in Chicago — featured discussions of a number of new visionary
trials that
are about to be launched in this disease.
At the helm of this adventure was, of course, NSABP chairman, Dr Norman
Wolmark. A past guest on our breast cancer series, Dr Wolmark is passionate
about clinical research, and his enthusiasm for the new wave of bold Phase
III
colorectal trials was obvious. He implored me to carry the message of protocol
accrual to practicing oncologists.
An interesting feature to many of these new studies is the central role of
colorectal
surgeons. To that end, this issue includes an interview with surgical oncologist
Dr Lawrence Wagman, who presented to the NSABP membership a proposed
new trial, protocol C-09, which will randomize patients with resectable or
ablatable hepatic metastases to intrahepatic FUDR or not, with all patients
receiving systemic oxaliplatin and capecitabine.
While the NSABP patiently waits for its C-07 adjuvant trial to provide additional
information on the potential value of oxaliplatin in adjuvant therapy, the
new
adjuvant study, C-08, incorporates oxaliplatin into all three major initial
randomization arms. As discussed on this program by Dr John Zalcberg, a major
part of the impetus to study adjuvant oxaliplatin is the data presented at
ASCO
by Dr Aimery DeGramont on the MOSAIC trial. (Figures 1a, b). This study
demonstrated an impressive disease-free survival advantage for the FOLFOX4
regimen, and Dr Zalcberg is optimistic that this benefit will eventually
translate
into a survival advantage.
The second proposed randomization on C-08 is perhaps the most breathtaking
part of the Phase III NSABP panorama. Patients will be randomized to control
or
the anti-VEGF agent, bevacizumab, bringing the vision of Judah Folkman and
others into “prime time.” Dr Zalcberg discusses the key new database
that led to
this design, groundbreaking trial data presented by Dr Herbert Hurwitz at ASCO
demonstrating a prolongation of progression-free and overall survival in patients
receiving bevacizumab on an IFL background (Figure 2).
The other interviewee for this issue, Dr Yehuda Patt, presents and discusses
a case
history that was rare five years ago but now is becoming more common. Because
of the dramatic tumor response this patient experienced while receiving
oxaliplatin and capecitabine, Dr Patt is considering hepatic resection or ablation
of
the remaining liver disease. This situation also fits the C-09 trial discussed
by
Dr Wagman.
In his interview, Dr Wolmark cites the initial positive NSABP adjuvant trials*
in
1993 as the last major turning point in colorectal cancer research. My visit
to the
Magic Kingdom revealed that 2003 is clearly the next milestone year in the
treatment of this disease.
—Neil Love, MD
*Wolmark N et al. The benefit of leucovorin-modulated
fluorouracil as postoperative adjuvant
therapy for primary colon cancer: Results from National Surgical Adjuvant
Breast and Bowel
Project protocol C-03. J Clin Oncol 1993;11(10):1879-87. Abstract
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