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A phase II study of weekly irinotecan as first-line therapy for patients with metastatic pancreatic cancer

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Abstract

Purpose

The aim of this study was to assess the efficacy and toxicity of weekly irinotecan in patients with metastatic pancreatic cancer.

Patients and methods

Patients with histologically proven pancreatic adenocarcinoma, at least one bidimensionally measurable metastatic lesion, and no prior chemotherapy were selected. Irinotecan at a dose of 100 mg/m2 was administered intravenously for 90 min on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. Pharmacokinetics was examined on day 1 of the first cycle of treatment.

Results

Thirty-seven of 40 enrolled patients were assessable for efficacy and toxicity. A partial response was obtained in 10 patients, giving an overall response rate of 27.0% (95% confidence interval 13.8–44.1%). The median overall survival was 7.3 months with a 1-year survival rate of 29.5%. Although toxicities were generally tolerated, one patient died of disseminated intravascular coagulation syndrome induced by neutropenia with watery diarrhea. Pharmacokinetic study showed that patients with biliary drainage seemed to have higher area under the concentration versus time curve for irinotecan and its metabolites compared with patients without biliary drainage.

Conclusion

Single-agent irinotecan has significant efficacy for metastatic pancreatic cancer. The toxicity with this schedule appears manageable, though it must be monitored carefully.

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Acknowledgments

This article is dedicated to the memory of Dr. Okada, a principal investigator and Mr. Sahashi, who assisted for management of this study. We are grateful to Drs T. Taguchi, T. Hayakawa, K. Nagao, Y. Ohashi and M. Kurihara for their kind advice, Drs Y. Sakata, N. Moriyama, and M. Hiraoka for extramural review, and Miss T. Tomizawa and K. Ohno for good support. We also thank Messrs T. Asano and H. Takizawa for assistance in data management. This study was supported by Yakult Honsha and Daiichi Pharmaceutical, Japan.

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Authors and Affiliations

  1. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Hideki Ueno & Takuji Okusaka

  2. Department of Gastroenterology, National Kyushu Cancer Center, Fukuoka, Japan

    Akihiro Funakoshi

  3. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital East, Chiba, Japan

    Hiroshi Ishii

  4. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan

    Kenji Yamao

  5. Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Osamu Ishikawa

  6. Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan

    Shinichi Ohkawa

  7. Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan

    Soh Saitoh

Authors
  1. Hideki Ueno
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  2. Takuji Okusaka
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  3. Akihiro Funakoshi
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  4. Hiroshi Ishii
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  5. Kenji Yamao
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  6. Osamu Ishikawa
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  7. Shinichi Ohkawa
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  8. Soh Saitoh
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Corresponding author

Correspondence to Hideki Ueno.

Additional information

Presented, in part, at the 40th meeting of the American Society of Clinical Oncology (New Orleans, LA, June 5–8, 2004)

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Ueno, H., Okusaka, T., Funakoshi, A. et al. A phase II study of weekly irinotecan as first-line therapy for patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol 59, 447–454 (2007). https://doi.org/10.1007/s00280-006-0283-9

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  • DOI: https://doi.org/10.1007/s00280-006-0283-9

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