A phase II clinical trial in Japan showed improved survival time for TAS-102 when compared to a placebo in patients whose cancer had progressed on standard treatments.
Median survival was 9 months for patients who received oral TAS-102 compared to 6.6 months on placebo.
Taiho Pharmaceutical says that they are proceeding with a larger Phase III trial.
In a randomized, double-blinded clinical trial 172 patients received either TAS-102 (114 patients) or a placebo (58 patients.) All had previously had at least two other regimens that included a fluoropyrimidine, irinotecan, and oxaliplatin.
The trial was conducted in 20 medical institutions in Japan between August 2009 and April 2010.
Results were reported as an abstract at the 9th Annual Meeting of the Japanese Society of Medical Oncology held in Yokohama on July 21, 2011.
Grade 3 or higher side effects reported in more than 10 percent of patients were limited to neutropenia.
A Phase I trial of TAS-102 in was presented as a poster at ASCO in 2006.
SOURCE
News release from Taiho Pharmaceutical, July 22, 2011.
What This Means for Patients
While early results from a Phase II trial in Japan show promise for a new treatment with a drug called TAS-102, it is too soon to make any conclusions about its value.
The trial was done in patients with refractory colorectal cancer. They had already had at least two different treatment regimens including 5-FU or Xeloda, oxaliplatin, and irinotecan. There is no information about whether they had received Avastin, Erbitux, or Vectibix.
Compared to no chemotherapy at all, a placebo, there was an improvement of about two and a half months in survival time. There was also serious neutropenia or low white cell counts. Some patients, less than 1 in 10, also had serious nausea, diarrhea, and fatigue.
It is important to wait for the results of a randomized Phase III clinical trial including more specific information about survival time and side effects before evaluating the drug.
Information about the trial results came from a company news release . . . not from a peer-reviewed medical journal.
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