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A phase II trial of modified weekly irinotecan and cisplatin for chemotherapy-naïve patients with metastatic or recurrent squamous cell carcinoma of the esophagus

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Abstract

Purpose

This phase II study assessed the efficacy and toxicity profile of a modified weekly irinotecan and cisplatin for chemotherapy-naïve patients with metastatic/recurrent esophageal squamous cell carcinoma (SQCC).

Methods

The eligibility criteria included histologically confirmed esophageal SQCC, no prior chemotherapy, adequate organ functions and written informed consent. Patients received irinotecan 65 mg/m2 plus cisplatin 30 mg/m2 on days 1 and 8, every 3 weeks.

Results

Thirty-two patients were assessed for response and toxicity. Ten patients achieved a partial response (31.3%; 95% CI, 16.0–50.0%). With a median follow-up of 19.0 months, median progression-free and overall survival was 4.4 and 9.6 months, respectively, with a 1-year survival rate of 27.4%. Grade (G) 3/4 neutropenia was observed in 50.0% of the patients, which was the most common cause of dose reduction or therapy delay. G3 non-hematologic toxicity included seven (21.9%) asthenias, four (12.5%) diarrheas, and one (3.1%) nausea/vomiting, but no G4 non-hematologic toxicity was observed.

Conclusions

This modified weekly irinotecan and cisplatin failed to ameliorate hematologic toxicity and to improve efficacy. However, easy administration and favorable non-hematologic toxicity as well as modest anti-tumor activity against metastatic or recurrent esophageal SQCC can make this regimen a potential treatment option, given the complexity of administration and toxicity of conventional infusional 5-FU and cisplatin.

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Acknowledgment

Supported in part by NCC Grant 0510140 from National Cancer Canter. Irinotecan (Campto®) was kindly provided by CJ Corp., Seoul, Korea. Presented partly in Poster Session at the 31st European Society for Medical Oncology Congress, Istanbul, Turkey, September 29–October 3, 2006.

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Authors and Affiliations

  1. Division of Oncology, Department of Internal Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea

    Dae Ho Lee

  2. Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu-dong, Ilsandong-gu, Goyang, Gyeonggi, 411-769, South Korea

    Heung Tae Kim, Ji-Youn Han, Sung Young Lee, Sung Jin Yoon, Hyae Young Kim & Jin Soo Lee

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  1. Dae Ho Lee
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  2. Heung Tae Kim
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Correspondence to Jin Soo Lee.

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Lee, D.H., Kim, H.T., Han, JY. et al. A phase II trial of modified weekly irinotecan and cisplatin for chemotherapy-naïve patients with metastatic or recurrent squamous cell carcinoma of the esophagus. Cancer Chemother Pharmacol 61, 83–88 (2008). https://doi.org/10.1007/s00280-007-0450-7

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  • DOI: https://doi.org/10.1007/s00280-007-0450-7

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