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Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304).

Publication ,  Journal Article
Otterson, GA; Hodgson, L; Pang, H; Vokes, EE; Cancer and Leukemia Group B,
Published in: J Thorac Oncol
October 2010

INTRODUCTION: Treatment of small cell lung cancer (SCLC) is initially gratifying with most patients responding to platinum-based chemotherapy. Treatment of relapsed disease gives much lower response rates of short duration. We undertook this study of the protein deacetylase inhibitor Romidepsin in chemosensitive recurrent SCLC based on preclinical data that suggested this to be an active target. METHODS: Patients had recurrent chemosensitive SCLC (relapse ≥90 days since completion of platinum-based chemotherapy). Treatment was administered as weekly infusions of Romidepsin at 13 mg/m(2) for 3 of 4 weeks. We designed a two-stage phase II study targeting a response rate of 30% (<10% response would be uninteresting and ≥30% worthy of further study). RESULTS: Sixteen patients (10 male, 6 female) were accrued to the first stage of this study. Most (11 patients, 69%) presented with extensive-stage SCLC, and all had received prior chemotherapy, with 11 having received prior radiation. Eastern Cooperative Oncology Group performance status was excellent with 0 in 6 patients (38%) and 1 in 10 patients. No objective responses were seen, and stable disease was the best response seen in 3 patients (19%). Toxicity was modest with 3 patients suffering grade 3 toxicity (lymphopenia, insomnia, nausea, vomiting, and hyponatremia) and one patient with grade 4 thrombocytopenia. Median progression-free survival was 1.8 months, and median overall survival was 6 months. CONCLUSION: Romidepsin given on a weekly schedule in patients with chemosensitive, recurrent SCLC was inactive and will not be pursued further in this setting.

Duke Scholars

Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

October 2010

Volume

5

Issue

10

Start / End Page

1644 / 1648

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Small Cell Lung Carcinoma
  • Salvage Therapy
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lung Neoplasms
 

Citation

APA
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MLA
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Otterson, G. A., Hodgson, L., Pang, H., Vokes, E. E., & Cancer and Leukemia Group B, . (2010). Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304). J Thorac Oncol, 5(10), 1644–1648. https://doi.org/10.1097/JTO.0b013e3181ec1713
Otterson, Gregory A., Lydia Hodgson, Herbert Pang, Everett E. Vokes, and Everett E. Cancer and Leukemia Group B. “Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304).J Thorac Oncol 5, no. 10 (October 2010): 1644–48. https://doi.org/10.1097/JTO.0b013e3181ec1713.
Otterson GA, Hodgson L, Pang H, Vokes EE, Cancer and Leukemia Group B. Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304). J Thorac Oncol. 2010 Oct;5(10):1644–8.
Otterson, Gregory A., et al. “Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304).J Thorac Oncol, vol. 5, no. 10, Oct. 2010, pp. 1644–48. Pubmed, doi:10.1097/JTO.0b013e3181ec1713.
Otterson GA, Hodgson L, Pang H, Vokes EE, Cancer and Leukemia Group B. Phase II study of the histone deacetylase inhibitor Romidepsin in relapsed small cell lung cancer (Cancer and Leukemia Group B 30304). J Thorac Oncol. 2010 Oct;5(10):1644–1648.
Journal cover image

Published In

J Thorac Oncol

DOI

EISSN

1556-1380

Publication Date

October 2010

Volume

5

Issue

10

Start / End Page

1644 / 1648

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Small Cell Lung Carcinoma
  • Salvage Therapy
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lung Neoplasms