Section 4
Randomized Trial of Docetaxel-Capecitabine versus Docetaxel

RESULTS

The study was conducted in 16 countries at 25 different sites,and a crossover was not built into it, because not all of the institutions and countries had access to capecitabine. So it was not designed as a crossover trial. The question being addressed was combination therapy versus full-dose docetaxel monotherapy.

It turned out that 15% of women receiving single-agent docetaxel crossed over to receive capecitabine. Two-thirds of the patients went on to receive further cytotoxic chemotherapy — 25% of them received additional vinorelbine, for example. So, women were treated appropriately with what sounds like good standard therapy afterwards,and there were no imbalances there. What was seen in this trial was that the combination led to a superior, statistically significant, objective response rate and a 33% improvement in median time to progression. Most significantly, a 25% relative improvement in median overall survival was observed. Importantly, the survival curves pulled apart very early — so it became very clear earlier in the study that more women were living with the combination compared to the single agent.

After giving this a lot of thought, I have concluded that there is at least a reasonable possibility that the biochemical synergism between these agents was largely responsible for the survival advantage. This was not front-line therapy for metastatic breast cancer; it was fairly late-line therapy,and it was a very heavily tumor-burdened population of women. And the time to progression and survival curves separated early.

I am just not sure that you would have captured the same degree of survival advantage in this late-line therapy situation by giving the drugs sequentially. That’s my personal opinion, but we simply don’t know.

—Joyce O’Shaughnessy, MD

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