Randomized Phase II Study of Bortezomib Alone and Bortezomib in Combination With Docetaxel in Previously Treated Advanced Non–Small-Cell Lung Cancer
- 1 November 2006
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 24 (31) , 5025-5033
- https://doi.org/10.1200/jco.2006.06.1853
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/m2plus 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.Keywords
This publication has 39 references indexed in Scilit:
- Erlotinib in Previously Treated Non–Small-Cell Lung CancerNew England Journal of Medicine, 2005
- Bortezomib or High-Dose Dexamethasone for Relapsed Multiple MyelomaNew England Journal of Medicine, 2005
- Proteasome Inhibition Sensitizes Non–Small-Cell Lung Cancer to Gemcitabine-Induced ApoptosisThe Annals of Thoracic Surgery, 2004
- A phase 2 study of two doses of bortezomib in relapsed or refractory myelomaBritish Journal of Haematology, 2004
- Proteasome inhibition sensitizes non–small cell lung cancer to histone deacetylase inhibitor–induced apoptosis through the generation of reactive oxygen speciesThe Journal of Thoracic and Cardiovascular Surgery, 2004
- Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung CancerJournal of Clinical Oncology, 2004
- Combined proteasome and histone deacetylase inhibition in non–small cell lung cancerThe Journal of Thoracic and Cardiovascular Surgery, 2004
- Development of docetaxel inadvanced non-small-cell lung cancerLung Cancer, 2004
- Randomized, Multinational, Phase III Study of Docetaxel Plus Platinum Combinations Versus Vinorelbine Plus Cisplatin for Advanced Non–Small-Cell Lung Cancer: The TAX 326 Study GroupJournal of Clinical Oncology, 2003
- Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung CancerJournal of Clinical Oncology, 2003