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Investigational New Drugs

, Volume 35, Issue 2, pp 227–234 | Cite as

A phase II study of carboplatin plus weekly paclitaxel with bevacizumab for elderly patients with non-squamous non-small-cell lung cancer (NEJ016)

  • Satoru MiuraEmail author
  • Makoto Maemondo
  • Akira Iwashima
  • Toshiyuki Harada
  • Shunichi Sugawara
  • Kunihiko Kobayashi
  • Akira Inoue
  • Taku Nakagawa
  • Yuichi Takiguchi
  • Hiroshi Watanabe
  • Takashi Ishida
  • Masaki Terada
  • Hiroshi Kagamu
  • Akihiko Gemma
  • Hirohisa Yoshizawa
PHASE II STUDIES

Summary

Background The efficacy and safety of bevacizumab in elderly patients with non-small cell lung cancer remain controversial. This study focused on both selecting fit elderly patients and overcoming interpatient variability with respect to pharmacodynamics. Methods Elderly (age: ≥70 years) patients with advanced non-squamous non-small cell lung cancer were enrolled. Patients with uncontrolled congestive heart failure and uncontrolled diabetes were excluded. The treatment regimen comprised carboplatin at an area under the curve of 5 mg/ml/min on day 1, paclitaxel at 90 mg/m2 on days 1 and 8, and bevacizumab at 15 mg/kg on day 1 every 21 days for up to 4 cycles, followed by maintenance bevacizumab. Dose reduction due to side effects was performed, with a wide range of doses of paclitaxel from 23 mg/m2/week to 60 mg/m2/week. Results Of the 36 patients entered, 38.9% required a dose reduction or cancellation of paclitaxel administration on day 8, and 75% patients were able to complete 4 cycles of triplet therapy. The response rate, primary endpoint, was 69.4% (95% confidence interval [CI]: 51.9–83.7). The median progression free survival and overall survival were 8.4 months and 29.2 months, respectively. The most common adverse events included neutropenia, hypertension, anemia, and infection. Although Grade ≥ 3 adverse events were observed in 24 patients (66.7%), there were no deaths due to toxicity. Conclusion Carboplatin plus weekly paclitaxel with bevacizumab is a feasible, effective first-line regimen for elderly non-small cell lung cancer patients. (UMIN00006622).

Keywords

Non-small cell lung cancer Non-squamous histology Bevacizumab Elderly patients Patient selection 

Notes

Acknowledgements

We thank the patients and their families for their support and participation in this study. We thank the data management staff of The Tokyo Cooperative Oncology Group (TCOG) data center, especially Hiromi Odagiri, and the data analysis staff of the Medical TOUKEI Corporation. The authors also thank Dr. Keiichi Nagao, Dr. Yushi Nakai, and Dr. Hiroshi Tanaka for their assistance as the Safety Monitoring Committee.

Compliance with ethical standards

Conflict of interest

Satoru Miura, Shunichi Sugawara, Kunihiko Kobayashi, Yuichi Takiguchi and Akihiko Gemma has received lecture fees from Chugai Pharmaceutical Co. Makoto Maemondo, Akira Inoue Yuichi Takiguchi has received lecture fees from Chugai and Bristol-Myers Squibb. All other authors declare that they have no conflict of interest.

Financial support

This study was supported by the North East Japan Study Group (NEJSG).

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. This study was approved by the institutional review boards of all participating sites.

Informed consent

All study participants provided written informed consent prior to enrollment.

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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • Satoru Miura
    • 1
    • 2
    Email author
  • Makoto Maemondo
    • 3
  • Akira Iwashima
    • 4
  • Toshiyuki Harada
    • 5
  • Shunichi Sugawara
    • 6
  • Kunihiko Kobayashi
    • 7
  • Akira Inoue
    • 8
  • Taku Nakagawa
    • 9
  • Yuichi Takiguchi
    • 10
  • Hiroshi Watanabe
    • 11
  • Takashi Ishida
    • 12
  • Masaki Terada
    • 13
  • Hiroshi Kagamu
    • 2
    • 7
  • Akihiko Gemma
    • 14
  • Hirohisa Yoshizawa
    • 2
    • 15
  1. 1.Department of Internal MedicineNiigata Cancer Center HospitalNiigataJapan
  2. 2.Department of Respiratory Medicine and Infectious DiseaseNiigata University Medical and Dental HospitalNiigataJapan
  3. 3.Department of Respiratory MedicineMiyagi Cancer CenterNatoriJapan
  4. 4.Department of Respiratory MedicineNagaoka Chuo General HospitalNagaokaJapan
  5. 5.Center for Respiratory DiseasesJapan Community Health Care Organization Hokkaido HospitalSapporoJapan
  6. 6.Department of Pulmonary MedicineSendai Kousei HospitalSendaiJapan
  7. 7.Department of Respiratory MedicineSaitama Medical University International Medical CenterHidakaJapan
  8. 8.Department of Palliative MedicineTohoku University School of MedicineSendaiJapan
  9. 9.Department of Thoracic SurgeryOmagari Kosei Medical CenterAkitaJapan
  10. 10.Department of Medical Oncology, Graduate School of MedicineChiba UniversityChibaJapan
  11. 11.Department of Respiratory MedicineSaka General HospitalShiogamaJapan
  12. 12.Department of Internal MedicineNiigata Prefectural Central HospitalJoetsuJapan
  13. 13.Department of Respiratory MedicineSaiseikai Niigata Daini HospitalNiigataJapan
  14. 14.Department of Pulmonary Medicine and Oncology, Nippon Medical SchoolGraduate School of MedicineTokyoJapan
  15. 15.Department of Respiratory MedicineNiigata Medical Center HospitalNiigataJapan

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