You are here: Home: CCU 3 | 2007: J Randolph Hecht, MD

Tracks 1-13

Track 1 Recent developments in the treatment of metastatic colorectal cancer Track 2 Emerging clinical data with panitumumab Track 3 Recent clinical trials of first-line therapy in metastatic colorectal cancer Track 4 XELOX-1/NO16966: CAPOX or FOLFOX4 with or without bevacizumab as first-line therapy Track 5 Investigations of chemotherapy holidays in the treatment of metastatic disease Track 6 Doublet antibodies in the treatment of metastatic colorectal cancer Track 7 Side effects and tolerability of the anti-EGFR antibody panitumumab Track 8 Current role of panitumumab in the treatment of metastatic colorectal cancer Track 9 Predictors of response to anti-EGFR antibodies Track 10 Clinical trial strategies incorporating biologic agents in the adjuvant setting Track 11 Use of chemotherapy with biologic agents to render hepatic metastases resectable Track 12 Safety of bevacizumab and its role in the adjuvant setting Track 13 Identification of targets for biologic agents and the individualization of therapy

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Track 4

DR HECHT: Initially, that study compared CAPOX and FOLFOX, then bevacizumab was included and it became a two-by-two design. The investigators did reach their intended endpoint, demonstrating that CAPOX was not inferior to FOLFOX. In fact, the two arms were very similar.

In evaluating progression-free survival, they examined fluoropyrimidine/oxaliplatin-containing chemotherapy with or without bevacizumab, and a statistically significant improvement was observed, but it was not of the expected magnitude. In fact, in an unplanned subgroup analysis, no PFS improvement was seen with FOLFOX, but it was evident when the CAPOX and FOLFOX arms were evaluated together. The hazard ratio was approximately 0.83. A fairly small improvement in median survival was seen.

So one of the questions that has arisen is, why are these results different than when FOLFOX with bevacizumab was evaluated in the second-line setting? Did the Europeans treat their patients differently? I’m anxious to see what additional data will be presented.

DR LOVE: In the IFL/bevacizumab study, when patients experienced toxicity from the chemotherapy, the chemotherapy was stopped and bevacizumab was continued until progression (Hurwitz 2004; [4.1]). In the 66 study, however, chemotherapy and bevacizumab were discontinued when patients developed toxicity, so patients ended up receiving less bevacizumab.

DR HECHT: That has been one of the interpretations of the data. The problem is, the data are the data. The question is, why are the data the data?

Track 10

DR HECHT: Two trials are under way. One is the NSABP trial evaluating bevacizumab with a fluoropyrimidine and oxaliplatin for six months followed by six additional months of bevacizumab.

The other is the worldwide, three-arm AVANT trial (4.2), which compares FOLFOX as the standard, FOLFOX with bevacizumab or CAPOX with bevacizumab. That trial was closed for a few months because of a question regarding increased toxicity in one of the arms. However, it was felt that it was not sufficient to change the trial. Additional monitoring was incorporated, and it will be years before we receive adjuvant data. Other targeted therapies are being evaluated, such as antibodies, and I believe they will form the next wave of adjuvant trials.

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Editor:
Neil Love, MD

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Alan P Venook, MD
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Steven D Wexner, MD
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Christopher Willett, MD
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J Randolph Hecht, MD
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