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

Michael P. Fanucchi, Frank V. Fossella, Robert Belt, Ronald Natale, Panos Fidias, David P. Carbone, Ramaswamy Govindan, Luis E. Raez, Francisco Robert, Maria Ribeiro, Wallace Akerley, Karen Kelly, Steven A. Limentani, Jeffrey Crawford, Hans Joachim Reimers, Rita Axelrod, Oscar Kashala, Shihong Sheng, Joan H. Schiller

Research output: Contribution to journalArticle

131 Citations (Scopus)

Abstract

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 ≥ 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.

Original languageEnglish (US)
Pages (from-to)5025-5033
Number of pages9
JournalJournal of Clinical Oncology
Volume24
Issue number31
DOIs
StatePublished - Nov 1 2006

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docetaxel
Non-Small Cell Lung Carcinoma
Appointments and Schedules
Survival
Bortezomib
Neutropenia
Dyspnea
Fatigue

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Fanucchi, Michael P.; Fossella, Frank V.; Belt, Robert; Natale, Ronald; Fidias, Panos; Carbone, David P.; Govindan, Ramaswamy; Raez, Luis E.; Robert, Francisco; Ribeiro, Maria; Akerley, Wallace; Kelly, Karen; Limentani, Steven A.; Crawford, Jeffrey; Reimers, Hans Joachim; Axelrod, Rita; Kashala, Oscar; Sheng, Shihong; Schiller, Joan H.

In: Journal of Clinical Oncology, Vol. 24, No. 31, 01.11.2006, p. 5025-5033.

Research output: Contribution to journalArticle

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, HJ, Axelrod, R, Kashala, O, Sheng, S & Schiller, JH 2006, 'Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer', Journal of Clinical Oncology, vol. 24, no. 31, pp. 5025-5033. https://doi.org/10.1200/JCO.2006.06.1853
Fanucchi, Michael P. ; Fossella, Frank V. ; Belt, Robert ; Natale, Ronald ; Fidias, Panos ; Carbone, David P. ; Govindan, Ramaswamy ; Raez, Luis E. ; Robert, Francisco ; Ribeiro, Maria ; Akerley, Wallace ; Kelly, Karen ; Limentani, Steven A. ; Crawford, Jeffrey ; Reimers, Hans Joachim ; Axelrod, Rita ; Kashala, Oscar ; Sheng, Shihong ; Schiller, Joan H. / Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 31. pp. 5025-5033.
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abstract = "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 ≥ 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.",
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T1 - Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer

AU - Fanucchi, Michael P.

AU - Fossella, Frank V.

AU - Belt, Robert

AU - Natale, Ronald

AU - Fidias, Panos

AU - Carbone, David P.

AU - Govindan, Ramaswamy

AU - Raez, Luis E.

AU - Robert, Francisco

AU - Ribeiro, Maria

AU - Akerley, Wallace

AU - Kelly, Karen

AU - Limentani, Steven A.

AU - Crawford, Jeffrey

AU - Reimers, Hans Joachim

AU - Axelrod, Rita

AU - Kashala, Oscar

AU - Sheng, Shihong

AU - Schiller, Joan H.

PY - 2006/11/1

Y1 - 2006/11/1

N2 - 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 ≥ 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.

AB - 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 ≥ 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.

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