番茄社区

CHICAGO -- After surgery for pancreatic cancer, two chemotherapy drugs are better than one and should become the new standard of care, a researcher said here.

In a phase III randomized trial, the combination of gemcitabine (Gemzar) and capecitabine (Xeloda) outperformed gemcitabine alone in terms of overall survival (OS), according to , of the University of Liverpool in England.

Importantly, the combination did not have a worse safety profile than either drug alone, Neoptolemos told 番茄社区 at the American Society of Clinical Oncology annual meeting.

"This will change practice around the world," Neoptolemos said.

Indeed, the finding should change practice, commented , of the Dana-Farber Cancer Institute in Boston.

The marked improvement in survival seen in the trial, combined with ease of delivery and good tolerability, means the combination "will become a standard of care for post-operative treatment" of pancreatic cancer, Mayer told 番茄社区.

"One and one can equal three," he said. "The message to our patients is that progress is being made."

Pancreatic cancer is now the third leading cause of cancer deaths in the U.S., Neoptolemos noted, and more people die of it than from breast cancer. "This is a relatively lethal cancer in the scheme of things," he told reporters.

Neoptolemos said outcomes for pancreatic cancer have been improving as a result of better surgical techniques and greater use of chemotherapy. Five-year survival was 8% with surgery alone, 11% with surgery plus chemoradiation, and between 16% and 18% with surgery followed by gemcitabine or 5FU chemotherapy.

The goal of the current was to see how the combination of gemcitabine and capecitabine -- both drugs that are active against pancreatic cancer -- fared against gemcitabine alone when delivered after surgery, he said.

The investigators enrolled 722 patients who had surgery for pancreatic ductal carcinoma and randomly assigned them to adjuvant therapy of six 4-week cycles of the combination or gemcitabine alone, Neoptolemos said.

The primary efficacy endpoint of the study was OS, and the results were sufficiently striking that the investigators were asked by the trial's independent steering committee to declare the results early.

When data was frozen in March this year, the group found that median survival for patients treated with the combination was 28 months, compared with 25.5 months for those who received gemcitabine alone.

The 5-year survival with the combination is now 29%, which is markedly higher than with previous therapies.

At the same time, the combination was as well tolerated as the single drug.

All told, 216 patients reported 384 serious adverse events, but they were evenly divided -- 181 among those taking gemcitabine and 203 among those taking the combination.

The patter was similar with treatment-related serious adverse events -- 94 gemcitabine patients reported 151 events, while 86 combination patients reported 154 events.

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