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Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer.

Publication ,  Journal Article
Fanucchi, MP; Fossella, FV; Belt, R; Natale, R; Fidias, P; Carbone, DP; Govindan, R; Raez, LE; Robert, F; Ribeiro, M; Akerley, W; Kelly, K ...
Published in: J Clin Oncol
November 1, 2006

PURPOSE: To evaluate the efficacy and toxicity of bortezomib +/- docetaxel as second-line therapy in patients with relapsed or refractory advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were randomly assigned to bortezomib 1.5 mg/m2 (arm A) or bortezomib 1.3 mg/m2 plus docetaxel 75 mg/m2 (arm B). A treatment cycle of 21 days comprised four bortezomib doses on days 1, 4, 8, and 11, plus, in arm B, docetaxel on day 1. Patients could receive unlimited cycles. The primary end point was response rate. RESULTS: A total of 155 patients were treated, 75 in arm A and 80 in arm B. Baseline characteristics were comparable. Investigator-assessed response rates were 8% in arm A and 9% in arm B. Disease control rates were 29% in arm A and 54% in arm B. Median time to progression was 1.5 months in arm A and 4.0 months in arm B. One-year survival was 39% and 33%, and median survival was 7.4 and 7.8 months in arms A and B, respectively. Adverse effect profiles were as expected in both arms, with no significant additivity. The most common grade > or = 3 adverse events were neutropenia, fatigue, and dyspnea (4% and 53%, 19% and 26%, and 17% and 14% of patients in arms A and B, respectively). CONCLUSION: Bortezomib has modest single-agent activity in patients with relapsed or refractory advanced NSCLC using this schedule, with minor enhancement in combination with docetaxel. Additional investigation of bortezomib in NSCLC is warranted in combination with other drugs known to be active, or using different schedules.

Duke Scholars

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

November 1, 2006

Volume

24

Issue

31

Start / End Page

5025 / 5033

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Taxoids
  • Pyrazines
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Fanucchi, M. P., Fossella, F. V., Belt, R., Natale, R., Fidias, P., Carbone, D. P., … Schiller, J. H. (2006). Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol, 24(31), 5025–5033. https://doi.org/10.1200/JCO.2006.06.1853
Fanucchi, Michael P., Frank V. Fossella, Robert Belt, Ronald Natale, Panos Fidias, David P. Carbone, Ramaswamy Govindan, et al. “Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer.J Clin Oncol 24, no. 31 (November 1, 2006): 5025–33. https://doi.org/10.1200/JCO.2006.06.1853.
Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, et al. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025–33.
Fanucchi, Michael P., et al. “Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer.J Clin Oncol, vol. 24, no. 31, Nov. 2006, pp. 5025–33. Pubmed, doi:10.1200/JCO.2006.06.1853.
Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers H-J, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025–5033.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

November 1, 2006

Volume

24

Issue

31

Start / End Page

5025 / 5033

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Taxoids
  • Pyrazines
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Humans