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Italian Trial Adds Bevacizumab to Cisplatin/Etoposide in Extensive-Disease Small Cell Lung Cancer

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Key Points

  • Adding bevacizumab to cisplatin/etoposide did not significantly prolong overall survival in patients with extensive-disease small cell lung cancer.
  • A survival benefit was seen in patients in the bevacizumab group who received maintenance bevacizumab.

In an Italian phase III trial reported in the Journal of Clinical Oncology, Tiseo et al found that adding first-line bevacizumab (Avastin) to cisplatin/etoposide did not prolong overall survival in patients with extensive-disease small cell lung cancer.

Study Details

In the open-label trial, 204 treatment-naive patients from 29 sites in Italy were randomized between November 2009 and October 2015 to receive cisplatin/etoposide with (n = 101) or without bevacizumab (n = 104). Treatment consisted of cisplatin at 25 mg/m2 on days 1 to 3 and etoposide at 100 mg/m2 on days 1 to 3 every 3 weeks for a maximum of 6 cycles with or without bevacizumab at 7.5 mg/kg on day 1 every 3 weeks; patients without disease progression in the bevacizumab group continued to receive bevacizumab for a maximum of 18 cycles or until disease progression.

The primary endpoint was overall survival in the intent-to-treat population. Five patients in the bevacizumab group and one patient in the control group dropped out of the study before receiving study medication.

Overall Survival

Median follow-up was 34.9 months. Median overall survival was 9.9 months in the bevacizumab group vs 8.9 months in the control group (hazard ratio [HR] = 0.78, P = .113), with 1-year survival of 37% vs 25%. A survival benefit was observed among 41 patients in the bevacizumab group who received maintenance bevacizumab (HR = 0.60, P = .011).

Median progression-free survival was 6.7 vs 5.7 months (HR = 0.72, P = .030). Response was observed in 58.4% vs 55.3% of patients (odds ratio = 1.13, P = .657).

Adverse Events

Grade 3 or 4 hematologic toxicity in the bevacizumab and control groups included neutropenia (46% in both), leukopenia (15% vs 14%), thrombocytopenia (4% vs 11%), and anemia (3% vs 10%). Among nonhematologic grade 3 or 4 toxicities, hypertension (6% vs 1.0%) and thrombosis (5% vs 3%) were more common in the bevacizumab group and fatigue (8% vs 15%) and nausea (1% vs 5%) were more common in the control group.

The investigators concluded: “The addition of bevacizumab to cisplatin and etoposide in the first-line treatment of [extensive-disease small cell lung cancer] had an acceptable toxicity profile and led to a statistically significant improvement in progression-free survival, which, however, did not translate into a statistically significant increase in [overall survival]. Further research with novel antiangiogenic agents, particularly in the maintenance setting, is warranted.”

The study was supported by the Agenzia Italiana del Farmaco.

Marcello Tiseo, MD, of Azienda Ospedaliero-Universitaria, Parma, Italy, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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