The results of an international, multicenter study, presented at the American Society of Clinical Oncology, reports no difference in survival between the adjuvant chemotherapy regimens gemcitabine (Gemzar) and 5-fluorouracil/folinic acid (5-FU/FA) when given after surgery for pancreatic cancer, though gemcitabine was associated with fewer side effects.
5-FU/FA is the current standard adjuvant treatment for pancreatic cancer in parts of Europe, whereas gemcitabine alone or in combination with radiation therapy is more commonly used in the United States. It has not been clear until now whether one was superior. Gemcitabine is also considered the standard treatment in patients with metastatic and locally advanced, inoperable pancreatic cancer. This is the first study to directly compare the two treatments in the adjuvant setting.
In this phase III trial, 1,088 patients were randomised to receive one of the two treatments after surgery. All patients had histologically confirmed disease, 72 per cent with metastases to lymph nodes and 35 percent with microscopically involved resected tumour margins. After a median follow up of 34 months, the investigators found that the median overall survival of patients treated with 5-FU/FA was 23 months, compared with 23.6 months in patients treated with gemcitabine. However, patients who received 5-FU/FA reported more toxicities, compared to those treated with gemcitabine, including: grade 3/4 toxicity stomatitis, or inflammation in the mouth (10 per cent in the 5-FU/FA group; none in the gemcitabine group); diarrhea (13 per cent and 2 per cent of patients, respectively); and treatment-related hospitalizations (10 per cent and 3.5 per cent, respectively).
"This study is important because it shows no difference between these treatments in prolonging survival," said Dr. John P. Neoptolemos, Head of the Division of Surgery and Oncology at the University of Liverpool and the lead author of the study, known as ESPAC-3. "On the basis of the safety profile, however, this trial shows that gemcitabine is likely to be the preferred adjuvant therapy. We are now also looking at combining the two treatments to see if we get a better response, because the drugs have different mechanisms of action."
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