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A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer

(2013) JOURNAL OF THORACIC ONCOLOGY. 8(3). p.329-337
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Organization
Abstract
Introduction: This study evaluated the efficacy, safety, and pharmacokinetics of conatumumab combined with paclitaxel-carboplatin (PC) as first-line treatment for advanced non-small-cell lung cancer (NSCLC). Methods: Patients (aged >18 years) with previously untreated advanced or recurrent NSCLC were randomized 1: 1: 1 (stratified by Eastern Cooperative Oncology Group performance status and disease stage) to receive up to six 3-week cycles of PC combined with conatumumab (arm 1, 3 mg/kg; arm 2, 15 mg/kg) or placebo (arm 3) every 3 weeks. The primary endpoint was progression-free survival (PFS). This study is registered with ClinicalTrials.gov (NCT00534027). Results: Between August 8, 2007 and April 9, 2009, 172 patients were randomized (arm 1, n = 57; arm 2, n = 56; arm 3, n = 59). Median PFS was 5.4 months (95% confidence interval [CI] 4.1-6.3) in arm 1 (hazard ratio [HR] 0.84 [95% CI 0.57-1.24]; p = 0.41), 4.8 months (95% CI 3.2-6.5) in arm 2 (HR 0.93 [0.64-1.35]; p = 0.57), and 5.5 months (95% CI 4.3-5.7) in arm 3. There was an interaction between tumor histology and the effect of conatumumab on PFS (squamous HR 0.47 [0.23-0.94]; nonsquamous HR 1.08 [0.74-1.57]; interaction p = 0.039). The most common grade of three or more adverse events were neutropenia, anemia, and thrombocytopenia. There was no evidence of pharmacokinetic interactions between conatumumab and PC. Of 158 patients assessable for FCGR3A polymorphisms, conatumumab treatment was associated with a trend toward longer overall survival (HR 0.72 [0.43-1.23]) among V-allele carriers (V/V or F/V; n = 54) but not among F-allele homozygotes (n = 34; HR 1.37 [0.66-2.86]). Conclusion: Although well tolerated, the addition of conatumumab to PC did not improve outcomes in unselected patients with previously untreated advanced NSCLC.
Keywords
carboplatin, non-small-cell lung cancer, paclitaxel, conatumumab, death receptor 5, AGONISTIC MONOCLONAL-ANTIBODY, APOPTOSIS-INDUCING LIGAND, C-RECEPTOR POLYMORPHISMS, ADVANCED SOLID TUMORS, COLORECTAL-CANCER, TRAIL, CHEMOTHERAPY, LEXATUMUMAB, MAPATUMUMAB, DULANERMIN

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MLA
Paz-Ares, Luis, Beatrix Bálint, Richard H de Boer, et al. “A Randomized Phase 2 Study of Paclitaxel and Carboplatin with or Without Conatumumab for First-line Treatment of Advanced Non-small-cell Lung Cancer.” JOURNAL OF THORACIC ONCOLOGY 8.3 (2013): 329–337. Print.
APA
Paz-Ares, L., Bálint, B., de Boer, R. H., Van Meerbeeck, J., Wierzbicki, R., De Souza, P., Galimi, F., et al. (2013). A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer. JOURNAL OF THORACIC ONCOLOGY, 8(3), 329–337.
Chicago author-date
Paz-Ares, Luis, Beatrix Bálint, Richard H de Boer, Jan Van Meerbeeck, Rafal Wierzbicki, Paul De Souza, Francesco Galimi, et al. 2013. “A Randomized Phase 2 Study of Paclitaxel and Carboplatin with or Without Conatumumab for First-line Treatment of Advanced Non-small-cell Lung Cancer.” Journal of Thoracic Oncology 8 (3): 329–337.
Chicago author-date (all authors)
Paz-Ares, Luis, Beatrix Bálint, Richard H de Boer, Jan Van Meerbeeck, Rafal Wierzbicki, Paul De Souza, Francesco Galimi, Vincent Haddad, Tony Sabin, Yong-Jiang Hei, Yang Pan, Susan Cottrell, Cheng-Pang Hsu, and Rodryg RamLau. 2013. “A Randomized Phase 2 Study of Paclitaxel and Carboplatin with or Without Conatumumab for First-line Treatment of Advanced Non-small-cell Lung Cancer.” Journal of Thoracic Oncology 8 (3): 329–337.
Vancouver
1.
Paz-Ares L, Bálint B, de Boer RH, Van Meerbeeck J, Wierzbicki R, De Souza P, et al. A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer. JOURNAL OF THORACIC ONCOLOGY. 2013;8(3):329–37.
IEEE
[1]
L. Paz-Ares et al., “A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer,” JOURNAL OF THORACIC ONCOLOGY, vol. 8, no. 3, pp. 329–337, 2013.
@article{4218376,
  abstract     = {{Introduction: This study evaluated the efficacy, safety, and pharmacokinetics of conatumumab combined with paclitaxel-carboplatin (PC) as first-line treatment for advanced non-small-cell lung cancer (NSCLC). 
Methods: Patients (aged >18 years) with previously untreated advanced or recurrent NSCLC were randomized 1: 1: 1 (stratified by Eastern Cooperative Oncology Group performance status and disease stage) to receive up to six 3-week cycles of PC combined with conatumumab (arm 1, 3 mg/kg; arm 2, 15 mg/kg) or placebo (arm 3) every 3 weeks. The primary endpoint was progression-free survival (PFS). This study is registered with ClinicalTrials.gov (NCT00534027). 
Results: Between August 8, 2007 and April 9, 2009, 172 patients were randomized (arm 1, n = 57; arm 2, n = 56; arm 3, n = 59). Median PFS was 5.4 months (95% confidence interval [CI] 4.1-6.3) in arm 1 (hazard ratio [HR] 0.84 [95% CI 0.57-1.24]; p = 0.41), 4.8 months (95% CI 3.2-6.5) in arm 2 (HR 0.93 [0.64-1.35]; p = 0.57), and 5.5 months (95% CI 4.3-5.7) in arm 3. There was an interaction between tumor histology and the effect of conatumumab on PFS (squamous HR 0.47 [0.23-0.94]; nonsquamous HR 1.08 [0.74-1.57]; interaction p = 0.039). The most common grade of three or more adverse events were neutropenia, anemia, and thrombocytopenia. There was no evidence of pharmacokinetic interactions between conatumumab and PC. Of 158 patients assessable for FCGR3A polymorphisms, conatumumab treatment was associated with a trend toward longer overall survival (HR 0.72 [0.43-1.23]) among V-allele carriers (V/V or F/V; n = 54) but not among F-allele homozygotes (n = 34; HR 1.37 [0.66-2.86]). 
Conclusion: Although well tolerated, the addition of conatumumab to PC did not improve outcomes in unselected patients with previously untreated advanced NSCLC.}},
  author       = {{Paz-Ares, Luis and Bálint, Beatrix and de Boer, Richard H and Van Meerbeeck, Jan and Wierzbicki, Rafal and De Souza, Paul and Galimi, Francesco and Haddad, Vincent and Sabin, Tony and Hei, Yong-Jiang and Pan, Yang and Cottrell, Susan and Hsu, Cheng-Pang and RamLau, Rodryg}},
  issn         = {{1556-0864}},
  journal      = {{JOURNAL OF THORACIC ONCOLOGY}},
  keywords     = {{carboplatin,non-small-cell lung cancer,paclitaxel,conatumumab,death receptor 5,AGONISTIC MONOCLONAL-ANTIBODY,APOPTOSIS-INDUCING LIGAND,C-RECEPTOR POLYMORPHISMS,ADVANCED SOLID TUMORS,COLORECTAL-CANCER,TRAIL,CHEMOTHERAPY,LEXATUMUMAB,MAPATUMUMAB,DULANERMIN}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{329--337}},
  title        = {{A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer}},
  url          = {{http://dx.doi.org/10.1097/JTO.0b013e31827ce554}},
  volume       = {{8}},
  year         = {{2013}},
}

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