Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer

  • Authors:
    • Hidehiro Tajima
    • Tetsuo Ohta
    • Hiroyuki Shinbashi
    • Atsushi Hirose
    • Mitsuyoshi Okazaki
    • Takahisa Yamaguchi
    • Yoshinao Ohbatake
    • Koichi Okamoto
    • Shinichi Nakanuma
    • Seisho Sakai
    • Jun Kinoshita
    • Isamu Makino
    • Keishi Nakamura
    • Hironori Hayashi
    • Katsunobu Oyama
    • Masafumi Inokuchi
    • Tomoharu Miyashita
    • Hiroyuki Takamura
    • Itasu Ninomiya
    • Sachio Fushida
    • Hiroyuki Nakamura
  • View Affiliations

  • Published online on: March 30, 2017     https://doi.org/10.3892/mco.2017.1206
  • Pages: 753-757
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Abstract

The prognosis of patients with unresectable and recurrent biliary tract cancer (BTC) is very poor. Although gemcitabine (GEM) plus cisplatin therapy is useful for unresectable cases, the median overall survival (OS) of the patients is <1 year, and third‑line chemotherapy following failure of 5‑fluorouracil (5‑FU) and GEM plus cisplatin is currently unavailable. The clinical efficacy and basic effects of low‑dose paclitaxel (PTX) therapy for patients with BTC was previously reported. We herein present the results of a phase I clinical trial of weekly low‑dose PTX as third‑line palliative chemotherapy. PTX was administered on days 1, 8, 15 and 22 of each cycle and repeated twice as follows: Level 1, 40 mg/m2; level 2, 50 mg/m2 (n=3). During the two cycles, grade 1 or 2 adverse events were observed in 3 patients, whereas dose-limiting adverse events (grade 3 or 4) were not observed. The disease control rate was 83.3% (partial response, n=3; stable disease, n=2). The OS and median survival were 15.4 and 9.0 months, respectively. In conclusion, palliative chemotherapy with low‑dose PTX following failure of GEM and 5‑FU was well‑tolerated, safe and effective for patients with unresectable or recurrent BTCs, and the optimal dose was 50 mg/m2.
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May-2017
Volume 6 Issue 5

Print ISSN: 2049-9450
Online ISSN:2049-9469

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Spandidos Publications style
Tajima H, Ohta T, Shinbashi H, Hirose A, Okazaki M, Yamaguchi T, Ohbatake Y, Okamoto K, Nakanuma S, Sakai S, Sakai S, et al: Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer. Mol Clin Oncol 6: 753-757, 2017
APA
Tajima, H., Ohta, T., Shinbashi, H., Hirose, A., Okazaki, M., Yamaguchi, T. ... Nakamura, H. (2017). Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer. Molecular and Clinical Oncology, 6, 753-757. https://doi.org/10.3892/mco.2017.1206
MLA
Tajima, H., Ohta, T., Shinbashi, H., Hirose, A., Okazaki, M., Yamaguchi, T., Ohbatake, Y., Okamoto, K., Nakanuma, S., Sakai, S., Kinoshita, J., Makino, I., Nakamura, K., Hayashi, H., Oyama, K., Inokuchi, M., Miyashita, T., Takamura, H., Ninomiya, I., Fushida, S., Nakamura, H."Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer". Molecular and Clinical Oncology 6.5 (2017): 753-757.
Chicago
Tajima, H., Ohta, T., Shinbashi, H., Hirose, A., Okazaki, M., Yamaguchi, T., Ohbatake, Y., Okamoto, K., Nakanuma, S., Sakai, S., Kinoshita, J., Makino, I., Nakamura, K., Hayashi, H., Oyama, K., Inokuchi, M., Miyashita, T., Takamura, H., Ninomiya, I., Fushida, S., Nakamura, H."Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer". Molecular and Clinical Oncology 6, no. 5 (2017): 753-757. https://doi.org/10.3892/mco.2017.1206