The recurrence rate following surgical resection of pancreatic cancer is extremely high, resulting in a 5-year survival rate of no more than 20%. Because of these disappointing results, the development of non-surgical treatments, including adjuvant therapy, has been investigated, with the aim of improving the prognosis of such patients. However, the optimal treatment modality remains controversial. Gemcitabine has become the standard therapy for unresectable pancreatic cancer and this has led investigators to evaluate its use in the adjuvant setting for patients with resected pancreatic cancer.

This current study was conducted at 10 centres in Japan and its primary end point was overall survival. Secondary end points were disease free survival (DFS) and gemcitabine safety. The study involved 119 patients with macroscopically curative resection of invasive ductal carcinoma of the pancreas and no prior radiation or chemotherapy. They were randomised to the surgery-only group or to receive gemcitabine 1000mg/m2 on days 1, 8 and 15, every 4 weeks for 3 cycles.

The following findings were reported for the 118 eligible and analysable patients (58 gemcitabine and 60 surgery only group):

• Overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 vs. 18.4 months; hazard ratio=0.77; 95% CI, 0.51 to 1.14; p = 0.19).

• Patients in the gemcitabine group showed longer DFS than those in the surgery-only group (median DFS, 11.4 vs. 5.0 months; 0.60, 0.40 to 0.89; p = 0.01)

• Haematological toxicity was frequently observed in the gemcitabine group, with 70% of patients experiencing grade 3 or 4 neutropenia.

The researchers conclude that their study failed to show a statistically significant improvement in overall survival with the use of adjuvant gemcitabine in patients undergoing macroscopically curative resection of pancreatic cancer. These results they note, were similar to those of the previously reported phase III trial of adjuvant gemcitabine. However adjuvant gemcitabine did contribute to prolonged DFS.