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A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer

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Abstract

Background

The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus gemcitabine (GEM) in elderly Japanese patients with pancreatic cancer remain unclear. Therefore, we prospectively investigated the tolerability and efficacy of nab-PTX + GEM in Japanese patients aged ≥ 75 years with non-curatively resectable pancreatic cancer.

Methods

We treated eligible patients (n = 27) with nab-PTX + GEM until disease progression, appearance of adverse events, or withdrawal of consent. The primary endpoints included adverse events as well as dosing- and survival-related parameters.

Results

The rates of 2-cycle completion were 48.1% for nab-PTX and 55.6% for GEM; the relative dose intensities for the 7th (median) treatment cycle were 65.1% and 74.1%, respectively, whereas the dose-reduction rates were 81.5% and 48.1%, respectively. Grade 3 or higher hemotoxicity was observed in 14 of 27 subjects (51.9%); moreover, 22% experienced grade ≥ 3 peripheral nerve disorder and 1 patient (3.7%) died owing to chemotherapy-related interstitial pneumonia. The disease control rate was 92.6% (25/27), while the median progression-free and overall survival times were 7 and 10.3 months, respectively.

Conclusion

The nab-PTX + GEM regimen is as efficacious in elderly patients who meet certain criteria as it is in previously reported non-elderly patients. The regimen is feasible with appropriate dose adjustments and attention to adverse events.

Trial registration

Clinical trial registration number: UMIN000018907.

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Funding

This study was not supported by any external funding sources.

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Authors and Affiliations

  1. Department of Gastroenterology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami, Sagamihara, 252-0375, Kanagawa, Japan

    Rikiya Hasegawa, Kosuke Okuwaki, Mitsuhiro Kida, Hiroshi Yamauchi, Toru Kaneko, Eiji Miyata, Tomohisa Iwai, Masafumi Watanabe, Takahiro Kurosu, Hiroshi Imaizumi & Wasaburo Koizumi

  2. Department of Gastroenterology, Kitasato University Medical Center, 6-100 Arai, Kitamoto, 364-8501, Saitama, Japan

    Yusuke Kawaguchi & Kazuho Uehara

  3. Department of Gastroenterology, Isehara Kyodo Hospital, 345 Tanaka, Isehara, 259-1187, Kanagawa, Japan

    Takaaki Matsumoto & Takashi Ohno

Authors
  1. Rikiya Hasegawa
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  2. Kosuke Okuwaki
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  3. Mitsuhiro Kida
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  4. Hiroshi Yamauchi
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  5. Yusuke Kawaguchi
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  6. Takaaki Matsumoto
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  7. Toru Kaneko
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  8. Eiji Miyata
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  9. Kazuho Uehara
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  10. Tomohisa Iwai
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  11. Masafumi Watanabe
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  12. Takahiro Kurosu
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  13. Hiroshi Imaizumi
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  14. Takashi Ohno
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  15. Wasaburo Koizumi
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Contributions

KO designed the study. RH and KO were major contributors in writing the manuscript. MK, HY, TI, and HI contributed to analysis and interpretation of data and assisted in the preparation of the manuscript. All other authors have contributed to data collection and interpretation, and critically reviewed the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Kosuke Okuwaki.

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Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Hasegawa, R., Okuwaki, K., Kida, M. et al. A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. Int J Clin Oncol 24, 1574–1581 (2019). https://doi.org/10.1007/s10147-019-01511-0

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  • DOI: https://doi.org/10.1007/s10147-019-01511-0

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