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Chemotherapy delays recurrence of pancreatic cancer after surgery

Gemcitabine improved disease-free survival rate in patients who had pancreatic cancer resection.

Issue: February 1, 2007

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Gemcitabine used for chemotherapy delayed cancer recurrence after pancreatic cancer surgery, according to a report published in the Journal of the American Medical Association.

The researchers observed 368 patients who had pancreatic cancer that was resected by surgery with no prior chemotherapy or radiation. The study was conducted between July 1988 and December 2004 in Germany and Austria. It included of 179 patients assigned to chemotherapy with gemcitabine (Gemzar, Eli Lilly) and 175 patients who were not assigned chemotherapy as the control group. All patients were TNM stage T1-4N0-1M0 prior to surgery with adequate bone marrow function. Patients in the gemcitabine group received six cycles of chemotherapy every four weeks, consisting of three IV infusions of 1,000 mg/m² per week for 30 minutes.

The median age of the patients in the gemcitabine group was 62; 105 were men. The median number of days between surgery and chemotherapy was 36, and 81% of patients had a resection status of R0, 82% had a T3 tumor size and 70% had N1 nodal status.

Positive results

Three years after surgery, no cancer recurrence was seen in 23.5% of the gemcitabine group, compared with 7.5% in the control group. After five years there was no recurrence in 16.5% of the gemcitabine group and 5.5% of the control group. The average survival rate with no recurrence was 13.4 months in the gemcitabine group (95% CI, 11.4-15.3) and 6.9 months in the control group (95% CI, 6.1-7.8).

Six months of adjuvant treatment with gemcitabine improved median disease-free survival significantly in patients with completely resected pancreatic cancer by more than six months compared with observation alone, the researchers wrote.

There was no difference between the groups regarding overall survival and recurrence rates. For the gemcitabine group, average estimated survival was 22.1 months (95% CI, 18.4-25.8); 34% at three years and 22.5% at five years. The control group had an estimated survival of 20.2 months (95% CI, 17-23.4); 20.5% at three years and 11.5% at five years. Recurrent disease was observed in 74.3% of patients in the gemcitabine group and 92% of the control group. Local recurrence with or without distant metastasis occurred in 34% of patients in the gemcitabine group and 41% of the control group. The main site of recurrence was the liver; 36% in the gemcitabine group and 37% in the control group.

Adjuvant therapy with gemcitabine administered in the dose and schedule used has minimal toxicity, does not compromise quality of life and offers a good, and perhaps the best, chance for prolonged disease-free survival in patients undergoing resection for pancreatic cancer, researchers wrote. – by Pam Rothman

For more information:

• Oettle H, Post S, Neuhaus P, et al. Adjuvant chemotherapy with gemcitabine vs. observation in patients undergoing curative-intent resection of pancreatic cancer. JAMA. 2007;297:267-277.