Clinical Study | Published:

Pazopanib maintenance after first-line etoposide and platinum chemotherapy in patients with extensive disease small-cell lung cancer: a multicentre, randomised, placebo-controlled Phase II study (KCSG-LU12-07)

British Journal of Cancer volume 118, pages 648653 (06 March 2018) | Download Citation

Abstract

Background:

We investigated whether pazopanib maintenance following first-line chemotherapy would improve survival in patients with extensive disease small-cell lung cancer (ED-SCLC).

Methods:

This study is a randomised, placebo-controlled, phase II study that enroled ED-SCLC patients who had not progressed after four cycles of etoposide plus platinum therapy. Eligible patients were randomly assigned (1 : 1 ratio) to either placebo or pazopanib 800 mg per day until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS).

Results:

97 patients were enroled and randomly assigned; 2 patients did not receive study drugs. In total, 95 patients received maintenance therapy (pazopanib, n=48; placebo, n=47) and were included in the analyses. Grade 3 toxicities for pazopanib maintenance were thrombocytopenia (10.4%, including one case with grade 4 toxicity), liver enzyme elevation (10.4%), fatigue (6.3%), and hypertension (6.3%). Median PFS was 3.7 months for pazopanib maintenance and 1.8 months for placebo (hazard ratio 0.44, 95% confidence interval: 0.29–0.69, P<0.0001).

Conclusions:

Pazopanib maintenance significantly prolonged PFS in patients with ED-SCLC. Given the toxicity profiles, however, relevant biomarkers to select patients for benefit from pazopanib should be further investigated.

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Change history

  • Corrected online 06 March 2018

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Acknowledgements

We thank the patients who participated in the trial and the investigators who enroled patients for the study. The abstract of this study will be submitted to WCLC 2017 (Yokohama, Japan). This study was supported in part by Novartis. This study was supported by the Korea Health Technology R&D Project through the Korea Heal Industry Development Institute, funded by the Ministry of Health & Welfare, Republic of Korea (HI16C1984).

Author information

Affiliations

  1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea

    • Jong-Mu Sun
    • , Se-Hoon Lee
    • , Jin Seok Ahn
    • , Keunchil Park
    •  & Myung-Ju Ahn
  2. Division of Medical Oncology, Department of Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju 28644, Korea

    • Ki Hyeong Lee
  3. Division of Hemato-Oncology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul 05368, Korea

    • Bong-Seog Kim
  4. Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University College of Medicine and Gyeongsang National University Changwon Hospital, Changwon 51472, Korea

    • Hoon-Gu Kim
  5. Division of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan 44033, Korea

    • Young Joo Min
  6. Division of Hematology-Oncology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang 10380, Korea

    • Seong Yoon Yi
  7. Division of Hematology-Oncology, Department of Medicine, Chungnam National University Hospital, Daejeon 35015, Korea

    • Hwan Jung Yun
  8. Department of Biostatistics and Bioinformatics, Duke University, Durham, NC 27710, USA

    • Sin-Ho Jung

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Competing interests

The authors declare no conflict of interest.

Corresponding author

Correspondence to Myung-Ju Ahn.

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DOI

https://doi.org/10.1038/bjc.2017.465

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