膵臓がんに対する有効な化学療法（Abstract #: LBA4504）

ゲムシタビンは早期膵臓がん患者の全生存率を改善する

Gemcitabine improves overall survival for patients with early-stage pancreatic cancer

早期膵臓がん患者に対し、ゲムシタビンは全生存率を改善し利益をもたらした初めての化学療法薬であるとAmerican Society of Clinical Oncology学会で発表された。CONKO-001トライアルでは外科的切除術（すなわち肉眼的腫瘍摘出術）の成功した患者368人をゲムシタビン投与群または特別な抗がん療法を施行せず経過観察する群に無作為に割り付けた。過去に公表されたデータではゲムシタビンは無病生存率を改善した。最終のデータを用いた今回の解析では、3年後および5年後の無病生存率はゲムシタビンでそれぞれ23.5%および16.5%であり、経過観察ではそれぞれ7.5%および5.5%であった。3年後および5年後の全生存率はゲムシタビンでそれぞれ36.5%および21％であり、経過観察ではそれぞれ19.5%および9.0%であった。現在進行中のスタディでは、ゲムシタビンと分子標的薬erlotinibまたはsorafenibの併用を評価している。

Gemcitabine improves overall survival for patients with early-stage pancreatic cancer, the first chemotherapeutic drug to provide a benefit for these patients, according to a presentation at the annual meeting of the American Society of Clinical Oncology.

The large, multicenter study showed that gemcitabine more than doubled overall survival in patients who have undergone surgery for pancreatic cancer. Gemcitabine is the standard treatment for pancreatic cancer that is too advanced for surgery.

The CONKO-001 study examined whether gemcitabine is beneficial earlier in the course of the disease. Previous results from this study, presented at in 2005, showed that adjuvant gemcitabine improved disease-free survival; investigators continued to follow these patients in order to determine whether the drug also improves overall survival.

"The ultimate goal of adjuvant therapy is improving the cure rate, and we have shown that this treatment more than doubles the overall survival five years after treatment," said Hanno Riess, MD, PhD, a professor at Charite University Medical School in Berlin and the leader of the CONKO study group.

"Based on the earlier results of this study, this regimen is already more widely used in both Europe and the United States. These findings can reassure physicians that the drug is also extending lives."

The trial randomized 368 patients to postoperative gemcitabine or observation with no specific anticancer treatment. All patients had already undergone complete surgical resection of their tumor. Only about 15 to 20 percent of patients are diagnosed at an earlier stage that makes surgery possible.

Estimated disease-free survival at three and five years, respectively, was 23.5 percent and 16.5 percent for gemcitabine versus 7.5 percent and 5.5 percent for the observation group. Overall survival at three and five years was 36.5 percent and 21.0 percent for gemcitabine versus 19.5 percent and 9.0 percent for observation.

Gemcitabine was well-tolerated among patients and there were no differences in toxicity between groups except for white blood cell and platelet counts, which were lower in the gemcitabine group.

Additional studies are already underway comparing treatment with gemcitabine alone to treatment with gemcitabine plus the targeted therapies erlotinib or sorafenib in patients who have undergone successful surgical resection.