Use of the drug gemcitabine for chemotherapy significantly delays the recurrence of cancer, compared to no chemotherapy, for patients following pancreatic cancer surgery, according to a study in the January 17 issue of JAMA.
With an estimated 232,000 new cases per year, pancreatic cancer is among the most common malignancies worldwide. It is also one of the most lethal cancers, with a mortality incidence ratio of 98 percent, according to background information in the article. Pancreatic cancer is the fourth leading cause of death from cancer in the U.S., with 32,300 deaths estimated in 2006. Surgery is the only curative treatment option for this type of cancer, though the prognosis still often remains poor. Therefore, surgery alone is an inadequate approach to achieve long-term disease control in patients with resectable (surgically remove a part of an organ) pancreatic cancer.
Helmut Oettle, M.D., Ph.D., of Charite School of Medicine, Campus Virchow-Klinikum, Berlin, Germany, and colleagues conducted a study (CONKO-001) comparing use of the drug gemcitabine with no anticancer drug therapy in 368 patients who had undergone complete resection of pancreatic cancer. The study was conducted from July 1988 to December 2004 at 88 oncology centers in Germany and Austria. Patients received chemotherapy with gemcitabine (n = 179), or no chemotherapy (observation; [control, n = 175]).
With a median (midpoint) follow-up of about 4.5 years, recurrent cancer developed in 74.3 percent in the gemcitabine group and 92 percent in the control group. The estimated median disease-free survival was 13.4 months in the gemcitabine group compared with 6.9 months in the control group. Estimated disease-free survival at 3 and 5 years was 23.5 percent and 16.5 percent in the gemcitabine group, and 7.5 percent and 5.5 percent in the control group, respectively. There was no difference in overall survival between the gemcitabine group and the control group.
"The results of CONKO-001 indicates that adjuvant treatment with gemcitabine in the dose and schedule used has minimal toxicity, does not compromise quality of life, and offers a good, and currently perhaps the best, chance for prolonged disease-free survival in patients undergoing [certain types of] resection for pancreatic cancer," the authors conclude.
(JAMA. 2007;297:267-277. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This trial was supported in part by a grant from Lilly Deutschland, Bad Homburg, Germany. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Adjuvant Therapy for Pancreatic Cancer - One Small Step Forward
In an accompanying editorial, Al B. Benson III, M.D., of the Feinberg School of Medicine, Northwestern University, Chicago, comments on the study by Oettle and colleagues.
"Worldwide, there is a need to move away from the question of current chemotherapy agents vs. chemoradiation to a research focus based on enhancing understanding of biologic principles. Given the rapid lethality of pancreatic cancer, this is no easy task. Whether it is possible to build on the small steps taken with CONKO-001 results remains to be seen. It is unlikely, however, that these small steps alone will provide the necessary enhancement of benefit beyond the improvements in surgery to profoundly alter the course of this most challenging of cancers."
(JAMA. 2007;297:311-313. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Dr. Benson reported that he has been a consultant to Eli Lilly, but the research funding goes directly to his institution and not to him personally.
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