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Editor’s Note


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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Editor’s Note
 
Norman Wolmark, MD
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John Zalcberg, MB, BS, PhD, FRACP
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Yehuda Patt, MD
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Lawrence D Wagman, MD, FACS
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