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A phase II study of paclitaxel by weekly 1-h infusion for advanced or recurrent esophageal cancer in patients who had previously received platinum-based chemotherapy

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Abstract

Purpose

To evaluate the efficacy and safety of weekly paclitaxel (Taxol®) in patients with advanced or recurrent esophageal cancer.

Methods

Fifty-three patients with recurrent or advanced esophageal cancer who had previously received platinum-based chemotherapy were treated with paclitaxel 100 mg/m2 once weekly by 1-h infusion on days 1, 8, 15, 22, 29, and 36 of a 49-day cycle. Fifty-two patients were evaluable for efficacy and 53 for safety. Forty-one (77%) patients had recurrent, and 12 (23%) had advanced disease. Most patients (52/53) had squamous cell carcinoma, and one had adenocarcinoma.

Results

A median of 2 cycles was delivered (range 1–8). The overall response rate was 44.2% (23/52; 95% confidence interval (CI) 30.5, 58.7%), with 4 patients (7.7%) achieving complete response. The median duration of response was 4.8 months, and median overall survival was 10.4 months. The most common Grade 3 or 4 adverse events were neutropenia (52.8%), leukopenia (45.3%), anorexia (9.4%), and fatigue (9.4%). Adverse events resulted in treatment discontinuation in 34.0% of patients and dose reductions in 43.4%. There were no treatment-related deaths.

Conclusions

Weekly paclitaxel demonstrated efficacy and manageable toxicity in patients with advanced or recurrent esophageal cancer and may be a treatment option for this population.

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Acknowledgments

The Paclitaxel Esophageal Cancer Study Group comprises the following institutions: National Cancer Center Hospital, Tokyo; National Cancer Center Hospital East, Chiba; Shizuoka Cancer Center, Shizuoka; Aichi Cancer Center Central Hospital, Aichi; Osaka Medical College, Osaka; Tochigi Cancer Center, Tochigi; Kinki University School of Medicine, Osaka; The Cancer Institute Hospital of JFCR, Tokyo; Kitasato University East Hospital, Kanagawa; Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Saitama Cancer Center, Saitama; and Graduate School of Medicine, Osaka University, Osaka, Japan. This study was supported by a grant from Bristol-Myers K.K.

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Authors and Affiliations

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

    Ken Kato

  2. Department of Gastrointestinal Medicine, National Cancer Center Hospital East, Kashiwanoha 6-5-1, Kashiwa, Chiba, 277-8577, Japan

    Makoto Tahara

  3. Gastrointestinal Oncology Division, Shizuoka Cancer Center, 1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka, 411-8777, Japan

    Shuichi Hironaka

  4. Department of Clinical Oncology, Aichi Cancer Center Central Hospital, 1-1 Kanakoden, Chikusa-ku Nagoya, Aichi, 464-8681, Japan

    Kei Muro

  5. Department of Gastrointestinal Medicine, Osaka Medical College, Daigaku-cho 2-7, Takatsuki, Osaka, 569-8686, Japan

    Hiroya Takiuchi

  6. Division of Clinical Oncology, Tochigi Cancer Center, Yonan 4-9-13, Utsunomiya, Tochigi, 320-0834, Japan

    Yasuo Hamamoto

  7. Department of Surgery, Kinki University, Onohigashi 377-1, Osakasayama, Osaka, 589-8511, Japan

    Haruhiko Imamoto

  8. Research and Development, Bristol-Myers K.K, Nishishinjuku 6-5-1, Shinjuku-ku, Tokyo, 163-1328, Japan

    Norihito Amano & Taku Seriu

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  1. Ken Kato
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  2. Makoto Tahara
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  3. Shuichi Hironaka
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  6. Yasuo Hamamoto
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  7. Haruhiko Imamoto
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  9. Taku Seriu
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Corresponding author

Correspondence to Ken Kato.

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Kato, K., Tahara, M., Hironaka, S. et al. A phase II study of paclitaxel by weekly 1-h infusion for advanced or recurrent esophageal cancer in patients who had previously received platinum-based chemotherapy. Cancer Chemother Pharmacol 67, 1265–1272 (2011). https://doi.org/10.1007/s00280-010-1422-x

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  • DOI: https://doi.org/10.1007/s00280-010-1422-x

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