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International Journal of Clinical Oncology

, Volume 24, Issue 12, pp 1574–1581 | Cite as

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

  • Rikiya Hasegawa
  • Kosuke OkuwakiEmail author
  • Mitsuhiro Kida
  • Hiroshi Yamauchi
  • Yusuke Kawaguchi
  • Takaaki Matsumoto
  • Toru Kaneko
  • Eiji Miyata
  • Kazuho Uehara
  • Tomohisa Iwai
  • Masafumi Watanabe
  • Takahiro Kurosu
  • Hiroshi Imaizumi
  • Takashi Ohno
  • Wasaburo Koizumi
Original Article
  • 291 Downloads

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.

Keywords

Nab-paclitaxel Gemcitabine Pancreatic cancer Chemotherapy Elderly patients Clinical trial 

Notes

Author 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.

Funding

This study was not supported by any external funding sources.

Compliance with ethical standards

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.

References

  1. 1.
    Siegel RL, Miller KD, Jemal A (2016) Cancer statistics, 2016. CA Cancer J Clin 66:7–30CrossRefGoogle Scholar
  2. 2.
    Center for Cancer Control and Information Services, National Cancer Center (2016) Monitoring of cancer incidence in Japan—survival 2006–2008 report. https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei17/index.html. Accessed 27 Apr 2019.
  3. 3.
    Hori M, Matsuda T, Shibata A et al (2015) Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. Jpn J Clin Oncol 45:884–891CrossRefGoogle Scholar
  4. 4.
    Von Hoff DD, Ervin T, Arena FP et al (2013) Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 369:1691–1703CrossRefGoogle Scholar
  5. 5.
    Ueno H, Ikeda M, Ueno M et al (2016) Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol 77:595–603CrossRefGoogle Scholar
  6. 6.
    Scheithauer W, Ramanathan RK, Moore M et al (2016) Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol 7:469–478CrossRefGoogle Scholar
  7. 7.
    Blomstrand H, Scheibling U, Bratthäll C et al (2019) Real world evidence on gemcitabine and nab-paclitaxel combination chemotherapy in advanced pancreatic cancer. BMC Cancer 19:40CrossRefGoogle Scholar
  8. 8.
    Imaoka H, Kou T, Tanaka M et al (2016) Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer 54:96–103CrossRefGoogle Scholar
  9. 9.
    Hamaguchi Y, Kaido T, Okumura S et al (2016) Proposal for new diagnostic criteria for low skeletal muscle mass based on computed tomography imaging in Asian adults. Nutrition 32:1200–1205CrossRefGoogle Scholar
  10. 10.
    Ogawa Y, Suzuki E, Mikata R et al (2018) Five cases of interstitial pneumonitis due to gemcitabine and nab-paclitaxel combination treatment in pancreatic cancer patients. Pancreas 47:e42–e43CrossRefGoogle Scholar
  11. 11.
    Ueno H, Ioka T, Ikeda M et al (2013) Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol 31:1640–1648CrossRefGoogle Scholar
  12. 12.
    Macarulla T, Pazo-Cid R, Guillén-Ponce C et al (2019) Phase I/II trial to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with pancreatic cancer and an ECOG performance status of 2. J Clin Oncol 37:230–238CrossRefGoogle Scholar
  13. 13.
    Pallis AG, Fortpied C, Wedding U et al (2010) EORTC elderly task force position paper: approach to the older cancer patient. Eur J Cancer 46:1502–1513CrossRefGoogle Scholar
  14. 14.
    Betge J, Chi-Kern J, Schulte N et al (2018) A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/− nab-paclitaxel in elderly pancreatic cancer patients (GrantPax). BMC Cancer 18:747CrossRefGoogle Scholar
  15. 15.
    Jin J, Teng C, Li T (2018) Combination therapy versus gemcitabine monotherapy in the treatment of elderly pancreatic cancer: a meta-analysis of randomized controlled trials. Drug Des Dev Ther 12:475–480CrossRefGoogle Scholar

Copyright information

© Japan Society of Clinical Oncology 2019

Authors and Affiliations

  • Rikiya Hasegawa
    • 1
  • Kosuke Okuwaki
    • 1
    Email author
  • Mitsuhiro Kida
    • 1
  • Hiroshi Yamauchi
    • 1
  • Yusuke Kawaguchi
    • 2
  • Takaaki Matsumoto
    • 3
  • Toru Kaneko
    • 1
  • Eiji Miyata
    • 1
  • Kazuho Uehara
    • 2
  • Tomohisa Iwai
    • 1
  • Masafumi Watanabe
    • 1
  • Takahiro Kurosu
    • 1
  • Hiroshi Imaizumi
    • 1
  • Takashi Ohno
    • 3
  • Wasaburo Koizumi
    • 1
  1. 1.Department of GastroenterologyKitasato University School of MedicineSagamiharaJapan
  2. 2.Department of GastroenterologyKitasato University Medical CenterKitamotoJapan
  3. 3.Department of GastroenterologyIsehara Kyodo HospitalIseharaJapan

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