Tuesday, October 18, 2011 (Last Updated: 10/19/2011)
TUESDAY, Oct. 18 (HealthDay News) -- Addition of dulanermin to paclitaxel and carboplatin (PC) and bevacizumab (PCB) does not improve outcomes for patients with advanced squamous or nonsquamous non-small-cell lung cancer (NSCLC), according to a study published online Oct. 17 in the Journal of Clinical Oncology.
Jean-Charles Soria, M.D., from the South Paris University, and colleagues investigated the efficacy and safety of dulanermin in combination with PC and PCB in 213 patients with advanced or recurrent NSCLC. Patients with squamous histology and/or CNS metastases were randomly allocated to receive PC every three weeks alone (arm 1) or with dulanermin for five days (arm 2), and patients with nonsquamous histology received PCB alone (arm 3) or with dulanermin 8 mg/kg for five days (arm 4) or 20 mg/kg for two days (arm 5). The objective response rate (ORR) was the primary end point.
The investigators found that the ORRs in arms 1 to 5 were 39, 38, 50, 40, and 40 percent, respectively. The odds ratios for ORR were not significant for arm 1 versus arm 2, arm 3 versus arm 4, or for arm 3 versus arm 5. Neutropenia, asthenia, anemia, thrombocytopenia, and hemoptysis were the most common grade ≥3 adverse events. A trend toward increased caspase-cleaved cytokeratin-18 was observed in 161 available serum samples after dulanermin treatment in cycles 1 and 2.
"The addition of dulanermin to PC and PCB did not improve outcomes in unselected patients with previously untreated advanced or recurrent NSCLC," the authors write.
Several authors disclosed financial relationships with Amgen and Genentech, both of whom partially funded the study.
Hematology & Oncology
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