For patients able to have surgery for pancreatic cancer, the adjuvant use of gemcitabine plus capecitabine, instead of gemcitabine alone, leads to a significant improvement in 5-year survival, according to results of the ESPAC-4 trial. The finding will likely change the standard of care for these patients.

For patients able to have surgery for pancreatic cancer, the adjuvant use of gemcitabine plus capecitabine, instead of gemcitabine alone, leads to a significant improvement in 5-year survival, according to results of the ESPAC-4 trial, which were presented at the annual meeting of the American Society of Clinical Oncology (ASCO), June 3–7, in Chicago, IL. That finding, experts said, means that the chemotherapy combination is the new standard of care for these patients.

Although the likelihood of living for a year following a diagnosis of pancreatic cancer has always been low, survival rates have increased. Based on data from Cancer Research UK, 1-year survival has more than doubled over the past 30 years—from 10% to 21%, largely due to the greater use of adjuvant chemotherapy, said John Neoptolemos, MD, PhD, of the University of Liverpool, United Kingdom, who presented the new findings. He noted that trials conducted by the European Study Group for Pancreatic Cancer (ESPAC) in the 2000s found that 5-year survival for patients undergoing surgery and receiving chemotherapy was at least 16%, compared with 8% for surgery alone.

“Some progress is being made,” said Neoptolemos. “We're beginning to see some clear water now between the number of cases being diagnosed and the actual number of deaths.” Even so, the prognosis for patients remains bleak, he said, so the study group launched ESPAC-4 to determine whether a combination of gemcitabine and capecitabine would be more effective in patients with resected pancreatic ductal adenocarcinoma than gemcitabine only.

The phase III randomized controlled trial enrolled 722 patients who had had pancreatic surgery to one of the two chemotherapy regimens for 6 months. Patients in the single-agent group had a 5-year survival rate of 16%. However, that rate was 29% among the patients who received the gemcitabine–capecitabine combination. The number of patients who experienced serious treatment-related side effects was similar—26% and 24%, respectively.

Given the significant improvement in survival with adjuvant gemcitabine plus capecitabine, “this is now the standard of care for resected pancreatic cancer,” said Neoptolemos.

Agreeing that the trial results will likely change clinical practice, Eileen Mary O'Reilly, MD, of Memorial Sloan Kettering Cancer Center in New York, NY, said that combining other chemotherapies may further advance survival. “We'll need to see where other multi-agent cytotoxic combinations fall out with the comparison of toxicity and benefit, which may be more significant.”

O'Reilly also said that the findings prompt questions about whether neoadjuvant therapy might be valuable for patients, adding that this “is an important direction in which the field is moving.” –Suzanne Rose

©2016 American Association for Cancer Research.
2016
American Association for Cancer Research.