Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer

Raghunadharao Digumarti, P. P. Bapsy, Attili V. Suresh, G. S. Bhattacharyya, Lokanatha Dasappa, Joseph S. Shan, David E. Gerber

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Objective: Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating and tumor-specific vascular targeting properties. Preclinical studies have shown activity against numerous solid tumors and at least an additive effect in combination with chemotherapy. This study evaluated bavituximab in combination with paclitaxel and carboplatin in patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC). Patients and methods: This phase II, open-label study (NCT00687817) was conducted in 49 patients with stage IIIB/IV NSCLC utilizing a Simon two-stage design. Patients were treated with up to six cycles of carboplatin area under the concentration-time curve (AUC) 5 plus paclitaxel 175mg/m2 every 21 days with weekly bavituximab 3mg/kg followed by bavituximab monotherapy until progression or unacceptable toxicity. Results: The primary efficacy endpoint of overall response rate (ORR) was 40.8% (complete response [CR] 2.0%, partial response [PR] was 38.8%). Median progression-free survival (PFS) and overall survival (OS) were 6.0 and 12.4 months, respectively. Treatment-related adverse events (AEs) occurred in 40.8% of patients. The most common treatment-related AEs were anemia (10.2%), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1% each). One patient with a central, cavitating squamous tumor developed fatal hemoptysis and aspiration. Conclusion: Bavituximab in combination with paclitaxel-carboplatin as first-line therapy demonstrated a tolerable safety profile and potential efficacy in this single-arm phase II trial in patients with advanced local or metastatic NSCLC. Randomized trials with this regimen are in progress. ClinicalTrials.gov identifier: NCT00687817.

Original languageEnglish (US)
Pages (from-to)231-236
Number of pages6
JournalLung Cancer
Volume86
Issue number2
DOIs
StatePublished - Nov 1 2014

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Therapeutics
Asthenia
Neoplasms
Hemoptysis
Paresthesia
Phosphatidylserines
Anorexia
bavituximab
Combination Drug Therapy
Disease-Free Survival
Vomiting
Fatigue
Blood Vessels
Anemia
Monoclonal Antibodies
Safety
Survival

Keywords

  • Bavituximab
  • Carboplatin
  • Immune modulation
  • Monoclonal antibody
  • Non-small-cell lung cancer
  • Paclitaxel
  • Phosphatidylserine

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Digumarti, R., Bapsy, P. P., Suresh, A. V., Bhattacharyya, G. S., Dasappa, L., Shan, J. S., & Gerber, D. E. (2014). Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. Lung Cancer, 86(2), 231-236. https://doi.org/10.1016/j.lungcan.2014.08.010

Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. / Digumarti, Raghunadharao; Bapsy, P. P.; Suresh, Attili V.; Bhattacharyya, G. S.; Dasappa, Lokanatha; Shan, Joseph S.; Gerber, David E.

In: Lung Cancer, Vol. 86, No. 2, 01.11.2014, p. 231-236.

Research output: Contribution to journalArticle

Digumarti, R, Bapsy, PP, Suresh, AV, Bhattacharyya, GS, Dasappa, L, Shan, JS & Gerber, DE 2014, 'Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer', Lung Cancer, vol. 86, no. 2, pp. 231-236. https://doi.org/10.1016/j.lungcan.2014.08.010
Digumarti R, Bapsy PP, Suresh AV, Bhattacharyya GS, Dasappa L, Shan JS et al. Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. Lung Cancer. 2014 Nov 1;86(2):231-236. https://doi.org/10.1016/j.lungcan.2014.08.010
Digumarti, Raghunadharao ; Bapsy, P. P. ; Suresh, Attili V. ; Bhattacharyya, G. S. ; Dasappa, Lokanatha ; Shan, Joseph S. ; Gerber, David E. / Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer. In: Lung Cancer. 2014 ; Vol. 86, No. 2. pp. 231-236.
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abstract = "Objective: Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with immune-modulating and tumor-specific vascular targeting properties. Preclinical studies have shown activity against numerous solid tumors and at least an additive effect in combination with chemotherapy. This study evaluated bavituximab in combination with paclitaxel and carboplatin in patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC). Patients and methods: This phase II, open-label study (NCT00687817) was conducted in 49 patients with stage IIIB/IV NSCLC utilizing a Simon two-stage design. Patients were treated with up to six cycles of carboplatin area under the concentration-time curve (AUC) 5 plus paclitaxel 175mg/m2 every 21 days with weekly bavituximab 3mg/kg followed by bavituximab monotherapy until progression or unacceptable toxicity. Results: The primary efficacy endpoint of overall response rate (ORR) was 40.8{\%} (complete response [CR] 2.0{\%}, partial response [PR] was 38.8{\%}). Median progression-free survival (PFS) and overall survival (OS) were 6.0 and 12.4 months, respectively. Treatment-related adverse events (AEs) occurred in 40.8{\%} of patients. The most common treatment-related AEs were anemia (10.2{\%}), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1{\%} each). One patient with a central, cavitating squamous tumor developed fatal hemoptysis and aspiration. Conclusion: Bavituximab in combination with paclitaxel-carboplatin as first-line therapy demonstrated a tolerable safety profile and potential efficacy in this single-arm phase II trial in patients with advanced local or metastatic NSCLC. Randomized trials with this regimen are in progress. ClinicalTrials.gov identifier: NCT00687817.",
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AU - Suresh, Attili V.

AU - Bhattacharyya, G. S.

AU - Dasappa, Lokanatha

AU - Shan, Joseph S.

AU - Gerber, David E.

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