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Oral agent improved OS in Japanese patients with pancreatic cancer

Adjuvant treatment with the chemotherapy drug S-1 increased OS among Japanese patients with pancreatic cancer, according to results of a phase 3 trial presented at the Gastrointestinal Cancers Symposium.

Pancreatic cancer is the fourth leading cause of cancer-related death. Because the disease is typically discovered after it spreads beyond the pancreas, only 20% to 30% of patients are candidates for surgery.

Patients typically receive gemcitabine (Gemzar, Eli Lilly) following surgery. Previous studies have suggested that treatment with the oral fluoropyrimidine S-1 is associated with similar outcomes as gemcitabine among patients with inoperable cancer, according to background information provided by researchers.

Katsuhiko Uesaka, MD, medical deputy director at the Shizuoka Cancer Center Hospital in Shizuoka Prefecture, Japan, and colleagues compared the efficacy of S-1 as an adjuvant, single-agent chemotherapy with gemcitabine in Japanese patients with stage I-III pancreatic cancer.

The researchers randomly assigned 385 patients from 33 hospitals in Japan to postoperative treatment with gemcitabine (n=193) or S-1 (n=192) from April 2007 to June 2010.

An interim analysis of the study results showed patients assigned to S-1 had a 44% lower risk of death than patients assigned to gemcitabine.

Patients who received S-1 had higher rates of 2-year OS (70% vs. 53%) and 2-year relapse-free survival (49% vs. 29%) than patients who received gemcitabine.

“S-1 may be considered as the new standard treatment for Japanese pancreatic cancer patients,” Uesaka said during a press conference prior to the symposium. “Our survival data were much stronger than expected.”

S-1 currently is available in several Asian countries and most of Europe. It is not yet available in the United States. Gastrointestinal side effects — such as diarrhea — are most severe among white patients, and they must receive lower doses of the drug.

Consequently, findings in this study are not applicable to non-Asian populations, Uesaka and colleagues said.

For more information:

Uesaka K. Abstract #145. Presented at: Gastrointestinal Cancers Symposium; Jan. 24-26, 2013; San Francisco.

Disclosure: The researchers report honoraria and research funding from Eli Lilly and Taiho Pharmaceutical.

Adjuvant treatment with the chemotherapy drug S-1 increased OS among Japanese patients with pancreatic cancer, according to results of a phase 3 trial presented at the Gastrointestinal Cancers Symposium.

Pancreatic cancer is the fourth leading cause of cancer-related death. Because the disease is typically discovered after it spreads beyond the pancreas, only 20% to 30% of patients are candidates for surgery.

Patients typically receive gemcitabine (Gemzar, Eli Lilly) following surgery. Previous studies have suggested that treatment with the oral fluoropyrimidine S-1 is associated with similar outcomes as gemcitabine among patients with inoperable cancer, according to background information provided by researchers.

Katsuhiko Uesaka, MD, medical deputy director at the Shizuoka Cancer Center Hospital in Shizuoka Prefecture, Japan, and colleagues compared the efficacy of S-1 as an adjuvant, single-agent chemotherapy with gemcitabine in Japanese patients with stage I-III pancreatic cancer.

The researchers randomly assigned 385 patients from 33 hospitals in Japan to postoperative treatment with gemcitabine (n=193) or S-1 (n=192) from April 2007 to June 2010.

An interim analysis of the study results showed patients assigned to S-1 had a 44% lower risk of death than patients assigned to gemcitabine.

Patients who received S-1 had higher rates of 2-year OS (70% vs. 53%) and 2-year relapse-free survival (49% vs. 29%) than patients who received gemcitabine.

“S-1 may be considered as the new standard treatment for Japanese pancreatic cancer patients,” Uesaka said during a press conference prior to the symposium. “Our survival data were much stronger than expected.”

S-1 currently is available in several Asian countries and most of Europe. It is not yet available in the United States. Gastrointestinal side effects — such as diarrhea — are most severe among white patients, and they must receive lower doses of the drug.

Consequently, findings in this study are not applicable to non-Asian populations, Uesaka and colleagues said.

For more information:

Uesaka K. Abstract #145. Presented at: Gastrointestinal Cancers Symposium; Jan. 24-26, 2013; San Francisco.

Disclosure: The researchers report honoraria and research funding from Eli Lilly and Taiho Pharmaceutical.

    Perspective

    This phase 3 trial absolutely changes the standard of care for the adjuvant treatment of pancreatic cancer… in Japan. If and when S-1 does become available in the United States, the question is whether this agent will, and should, supplant gemcitabine (the current Western standard) for this same indication. This reflects our lack of certainty as to whether biologic differences that result in different chemosensitivities exist between pancreatic adenocarcinomas arising in Asian vs. Western patients.

    Analyzing intratumoral expression levels and genetic polymorphisms of metabolizing enzymes and transporter proteins of these drugs may ultimately help a treating physician decide how best to treat any given patient in this setting. Hopefully, results from such analyses will be forthcoming from the Japanese study. Looking ahead, adjuvant trials of more intensive chemotherapy regimens — such as FOLFIRINOX and gemcitabine/nab-paclitaxel — will help elucidate whether these combinations used for advanced pancreatic cancer also may confer a significant RFS and OS benefit when given for earlier stages of the disease.

    • Andrew H. Ko, MD
    • HemOnc Today Editorial Board member

    Disclosures: Ko reports no relevant financial disclosures.

    Perspective

    Pancreas cancer remains a highly lethal disease. Yet, about a third of patients who present with pancreas cancer can undergo surgery with potentially curative intent. Among these patients, we’ve viewed gemcitabine as the standard therapy to improve survival over surgery alone. For the first time, we now have another option that appears superior to gemcitabine in this setting.

    • Neal J. Meropol, MD
    • Chief of hematology and oncology Case Western Reserve University School of Medicine and University Hospitals

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