Clinical

Combination therapy with sorafenib more effective in advanced liver cancer

Last Updated: 2009-10-30 16:11:03 -0400 (Reuters Health)

By Sue Mulley

HONG KONG (Reuters) - In patients with advanced hepatocellular carcinoma (HCC), disease-free survival was twice as long with sorafenib plus capecitabine and oxaliplatin (SECOX) than with sorafenib alone, according to researchers here at a press briefing.

Hong Kong University's Dr. Ronnie Ting-ping Poon and his colleagues compared interim findings from a single-arm, multi-center phase II efficacy and tolerability study of SECOX with results from their earlier study of sorafenib monotherapy.

The phase II SECOX study involved 51 patients with locally advanced or metastatic HCC recruited between October 2007 and March 2009.

"Almost 50% of the SECOX patients are still alive, and we have a patient who has survived now for two years," said co-investigator Dr. Thomas Chung-cheung Yau in an interview with Reuters Health.

As of the end of August 2009, the overall disease control rate was 75% for patients receiving SECOX, Dr. Yau said, noting there was a significant decrease in tumor size in 14% of patients, and tumor growth was contained in 61%.

In the earlier study of sorafenib monotherapy, also involving 51 patients, the disease control rate was 34%, including 8% of patients who had a partial response and 26% whose condition stabilized.

The median overall survival for patients receiving SECOX is 10.2 months and the median progression-free survival is 7.1 months.

In contrast, median overall survival with sorafenib monotherapy was only 5 months, and median progression-free survival was 3 months.

"None of the patients receiving SECOX suffered any life-threatening complications," Dr. Poon said, noting that tolerability was "good." But, hand-and-foot skin reactions and thrombocytopenia were more common in patients receiving SECOX than sorafenib monotherapy (31% versus 16% and 20% versus 10%, respectively).

The SECOX treatment regimen involved four 14-day cycles. Sorafenib was administered continuously throughout each cycle, capecitabine for the first seven days and oxaliplatin IV on the first day.

Of 38 patients who had stable disease or a partial response after four cycles of treatment, 37 completed another four cycles.

Only patients who had HCC not amenable to resection or loco-regional therapy and who had not received any prior systemic therapy were admitted to the study. The median age was 58 years, and 84% of subjects were men. Eighty percent had distant metastases, most commonly to the lungs (47%).

Hong Kong University is slated to lead an international, randomized controlled trial comparing SECOX and sorafenib alone in the treatment of liver cancer. Patients will be recruited at centers in China, Taiwan, Korea, Singapore and Thailand, Dr. Poon told Reuters Health.

"In clinical practice, we have used the regimen for less severe disease. Of course, the survival rate is better if less severe disease is treated," Dr. Poon said.

The cost of two cycles of SECOX is about HK$60,000 (or about US$7,692), according to Dr. Poon. "The Hong Kong government won't cover the costs under their present healthcare system," he added.