Randomized phase II study of dulanermin in combination with paclitaxel, carboplatin, and bevacizumab in advanced non-small-cell lung cancer

  • Soria J
  • Mark Z
  • Zatloukal P
 et al. 
  • 15

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Abstract

PURPOSE: To evaluate the efficacy and safety of dulanermin combined with paclitaxel and carboplatin (PC) and bevacizumab (PCB) as first-line treatment for advanced or recurrent non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with squamous NSCLC and/or CNS metastases received PC every 3 weeks alone (arm 1) or with dulanermin 8 mg/kg for 5 days (arm 2). Patients with nonsquamous NSCLC received PCB alone (arm 3) or with dulanermin 8 mg/kg for 5 days (arm 4) or 20 mg/kg for 2 days (arm 5). The primary end point was the objective response rate (ORR). RESULTS: Overall, 213 patients were randomly assigned (arm 1, n = 41; arm 2, n = 39; arm 3, n = 42; arm 4, n = 40; arm 5, n = 41). The ORR in arms 1 to 5 was 39% (95% CI, 24% to 56%), 38% (95% CI, 24% to 54%), 50% (95% CI, 35% to 65%), 40% (95% CI, 25% to 56%), and 40% (95% CI, 25% to 56%), respectively. The odds ratio for ORR was 1.04 (P = 1.000) for arm 1 versus arm 2, 1.53 (P = .391) for arm 3 and versus arm 4, and 1.53 (P = .391) for arm 3 versus arm 5. The most common grade >/= 3 adverse events were neutropenia, asthenia, anemia, thrombocytopenia, and hemoptysis. Of 161 available serum samples, a trend toward increased caspase-cleaved cytokeratin-18 was observed after dulanermin treatment in cycles 1 and 2. Among 84 patients evaluated for GalNT14 expression, there was a trend toward favorable progression-free survival and overall survival with dulanermin treatment in those with high GalNT14 expression. CONCLUSION: The addition of dulanermin to PC and PCB did not improve outcomes in unselected patients with previously untreated advanced or recurrent NSCLC.

Author-supplied keywords

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized/administration &
  • Antineoplastic Combined Chemotherapy Protocols/adv
  • Carboplatin/administration & dosage
  • Carcinoma, Non-Small-Cell Lung/ drug therapy/morta
  • Female
  • Humans
  • Keratin-18/blood
  • Lung Neoplasms/ drug therapy/mortality
  • Male
  • Middle Aged
  • N-Acetylgalactosaminyltransferases/analysis
  • Paclitaxel/administration & dosage
  • TNF-Related Apoptosis-Inducing Ligand/administrati

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Authors

  • J C Soria

  • Z Mark

  • P Zatloukal

  • B Szima

  • I Albert

  • E Juhasz

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