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Survival Improvement with Adjuvant Gemcitabine in Patients with Pancreatic Cancer

Summary and Comment |
January 16, 2007

Survival Improvement with Adjuvant Gemcitabine in Patients with Pancreatic Cancer

  1. David H. Ilson, MD, PhD

A landmark trial establishes gemcitabine as a standard of care.

  1. David H. Ilson, MD, PhD

Pancreatic cancer is common and nearly always fatal. Surgery, the only curative option, yields poor long-term survival rates, and adjuvant therapy after surgery is controversial. Use of postoperative 5-fluorouracil (5-FU) combined with radiation is common practice in the U.S., whereas use of postoperative 5-FU without radiation has been supported by results from the recent European ESPAC-1 trial (N Engl J Med 2004; 350:1200).

Although gemcitabine is more active than 5-FU for treating advanced pancreatic cancer, gemcitabine has not been evaluated thoroughly in the adjuvant setting. In a pivotal randomized phase III trial, CONKO-001, conducted at 88 centers in Germany and Austria, 368 patients who underwent surgical resection of pancreatic adenocarcinoma were assigned to either postoperative observation or 6 months of weekly gemcitabine. Patients were stratified based on negative (R0) or positive (R1) surgical margins, T stage, and nodal status. More than 80% of patients had R0 resections, more than 80% had T3 or T4 tumors, and 70% were node-positive.

At a median follow-up of 53 months, patients who received gemcitabine had significantly longer median disease-free survival than did patients who received surgery only (13.4 vs. 6.9 months; P<0.001). Three- and 5-year disease-free survival rates in gemcitabine patients (23.5% and 16.5%, respectively) also exceeded rates in surgery-alone patients (7.5% and 5.5%, respectively). An overall survival advantage favoring gemcitabine treatment did not quite reach statistical significance (median survival rates, 22.1 vs. 20.2 months; P=0.06). Adjuvant therapy significantly lengthened disease-free survival in patients with either R0 or R1 resection, and in patients with or without nodal involvement. Therapy was relatively well tolerated: Half of the gemcitabine patients completed all 6 months of therapy.

Comment

Results from CONKO-001, a landmark trial in pancreatic cancer, establish postoperative gemcitabine as a standard of care in surgical management of this disease. Patients achieved a survival benefit regardless of resection margin or nodal status. The positive results of this trial are supported by preliminary results from the RTOG 9704 trial (J Pancreas 2006; 7:337). RTOG 9704 also demonstrated a survival benefit for adjuvant gemcitabine, compared with adjuvant 5-FU, in patients who had adenocarcinomas of the pancreas head and who received postoperative radiotherapy. Whether addition of radiation therapy to adjuvant gemcitabine chemotherapy increases beneficial effects remains an unanswered question and is the subject of the ongoing EORTC trial 40013.

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