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Dose escalation study of docetaxel and nedaplatin in patients with relapsed or refractory squamous cell carcinoma of the esophagus pretreated using cisplatin, 5-fluorouracil, and radiation

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Abstract

Background

Definitive chemoradiation with cisplatin (CDDP) and 5-fluorouracil (5FU) has been playing an important role in the treatment of esophageal cancer, but some patients are not curable or have recurrent lesions. However, few chemotherapeutic regimens are available for such patients. Docetaxel and nedaplatin are active for esophageal cancer. We conducted a dose-escalation study of docetaxel and nedaplatin as second line-chemotherapy after definitive chemoradiation in patients with relapsed or refractory squamous cell carcinoma of the esophagus after chemoradiation.

Methods

Nedaplatin was administered on day 1 and docetaxel was administered on days 1 and 15, every 4 weeks. Dose escalation was based on the dose-limiting toxicity (DLT) observed during the first cycle.

Results

Twelve patients were enrolled. At a docetaxel dose of 30 mg/m2 and a nedaplatin dose of 80 mg/m2, one grade 4 neutropenia occurred and caused one treatment break longer than 2 weeks, but there were few DLTs. At doses of 35 and 80 mg/m2, respectively, two grade 4 neutropenias and one grade 2 thrombopenia occurred and caused three treatment breaks longer than 2 weeks. Therefore, the maximum tolerated dose was established at this dose level. Two grade 3 anorexias and one grade 3 nausea occurred, but other non-hematological toxicities were generally mild. Responses were seen in one-fourth of the 12 patients, including one complete remission.

Conclusion

The recommended doses of docetaxel and nedaplatin were 30 and 80 mg/m2, respectively. This combination could be a potential second-line treatment for this target population.

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Authors and Affiliations

  1. Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University, 4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan

    Takashi Yoshioka, Masato Sakayori, Shunsuke Kato, Natsuko Chiba, Hiroyuki Shibata, Hideki Shimodaira, Kazunori Ohtsuka, Yuichi Kakudo & Chikashi Ishioka

  2. Division of Advanced Surgery and Technology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Shukichi Miyazaki

  3. Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan

    Kenji Nemoto

  4. Misawa City Hospital, Misawa, Japan

    Yuh Sakata

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  1. Takashi Yoshioka
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  2. Masato Sakayori
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  3. Shunsuke Kato
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Correspondence to Takashi Yoshioka.

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Yoshioka, T., Sakayori, M., Kato, S. et al. Dose escalation study of docetaxel and nedaplatin in patients with relapsed or refractory squamous cell carcinoma of the esophagus pretreated using cisplatin, 5-fluorouracil, and radiation. Int J Clin Oncol 11, 454–460 (2006). https://doi.org/10.1007/s10147-006-0610-5

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  • DOI: https://doi.org/10.1007/s10147-006-0610-5

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