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A phase II trial of weekly fractionated irinotecan and cisplatin for advanced gastric cancer

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Abstract

Purpose

This study was to evaluate the activity and the safety of a combination chemotherapy regimen of weekly fractionated irinotecan and cisplatin in advanced gastric cancer patients.

Methods

Patients with advanced gastric adenocarcinoma with either chemotherapy-naive or only one prior chemotherapy regimen received irinotecan 50 mg/m2 followed by cisplatin 30 mg/m2. Both drugs were administered weekly for 3 consecutive weeks, followed by 1-week rest. Treatment was repeated until disease progression occurred. Response evaluation was performed according to the RECIST criteria.

Results

Forty-seven patients (13 chemo-naive, 34 prior chemotherapy) were enrolled. Of 46 evaluable patients, overall response rate was 25.5% (95% CI, 12.9–39.3%) and disease control rate was 63.8% (95% CI, 50.9–79.5%) by intent-to-treat analysis. The time to progression and overall survival duration were 21 and 44 weeks, respectively. One-year survival rate was 41.6%. The most frequent grade 4 toxicity was neutropenia, which was the major cause of treatment delay. Non-hematological toxicities of grade 3–4 were rare with occurrence rate of 14.9% for anorexia and emesis.

Conclusions

Fractionated irinotecan combined with cisplatin with 3-week-on and 1-week-off schedule produced favorable clinical results for advanced gastric cancer. Because of the feasible efficacy and low non-hematologic toxicity, this treatment could be a promising salvage regimen in patients who have failed to taxanes.

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Acknowledgment

This study was supported by the Korea Science and Engineering Foundation through the Cancer Metastasis Research Center at Yonsei University. We thank Won-Joo Roh for her sincere help in the documentation of the study data and the secretarial assistance.

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Authors and Affiliations

  1. Cancer Metastasis Research Center, Yonsei Cancer Center, Yonsei University College of Medicine, 134, Shinchon-Dong, Seodaemun-Ku, CPO Box #8044, Seoul, 120-752, South Korea

    Hei-Cheul Jeung, Sun Young Rha, Jae Kyung Roh & Hyun Cheol Chung

  2. Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea

    Sung Hoon Noh

  3. BK21 Project for Medical Science, Yonsei University College of Medicine, Seoul, South Korea

    Sun Young Rha, Sung Hoon Noh, Jae Kyung Roh & Hyun Cheol Chung

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  1. Hei-Cheul Jeung
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  2. Sun Young Rha
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Correspondence to Hyun Cheol Chung.

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Authors’ Disclosure of Potential Conflicts of Interest: the authors indicated no potential conflicts of interest.

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Jeung, HC., Rha, S.Y., Noh, S.H. et al. A phase II trial of weekly fractionated irinotecan and cisplatin for advanced gastric cancer. Cancer Chemother Pharmacol 59, 313–320 (2007). https://doi.org/10.1007/s00280-006-0272-z

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  • DOI: https://doi.org/10.1007/s00280-006-0272-z

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