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Adding the antiangiogenic agent bevacizumab to standard first-line chemotherapy improves progression-free survival in extensive small-cell lung cancer, according to a report published online Jan. 30.
In what they described as the first prospective randomized, controlled phase III trial comparing these two approaches, researchers studied 204 adults who had extensive SCLC, including brain and bone metastases, at 29 medical centers in Italy. These participants (mean age, 64 years) were randomly assigned to receive a combination of standard cisplatin, etoposide, and bevacizumab every 3 weeks or cisplatin and etoposide chemotherapy every 3 weeks. Patients who developed cisplatin contraindications or toxicity related to the drug could substitute carboplatin. In the experimental arm of the study, patients could opt to continue bevacizumab alone as maintenance therapy for a maximum of 18 cycles. Forty-one patients (42%) did so, said Marcello Tiseo, MD, PhD, of Azienda Ospedaliero Universitaria, Parma, Italy, and his associates.
After a median follow-up of 35 months, the median progression-free survival was 5.7 months with standard therapy and 6.7 months with add-on bevacizumab (hazard ratio, 0.72; 95% confidence interval, 0.54 to 0.97; P = .030). However, adding bevacizumab did not significantly improve overall survival, which was the primary endpoint of the trial. A subgroup analysis showed that bevacizumab significantly extended overall survival among men (HR, 0.55) but not among women (HR, 1.55), an association that has been reported in previous studies, Dr. Tiseo and his associates said (J Clin Oncol. 2017 Jan 30. doi:10.1200/JCO.2016.69.4844).
These findings, together with those of other investigators assessing the same class of agents, justify “further studies with novel and better antiangiogenic agents in extensive SCLC, particularly in the maintenance setting,” they added.
This trial was supported by the Agenzia Italiana del Farmaco. Dr. Tiseo reported serving as a consultant for AstraZeneca, Eli Lilly, Boehringer Ingelheim, Novartis, Bristol-Myers Squibb, Pierre Fabre, and Otsuka; his associates reported ties to numerous industry sources.
Adding the antiangiogenic agent bevacizumab to standard first-line chemotherapy improves progression-free survival in extensive small-cell lung cancer, according to a report published online Jan. 30.
In what they described as the first prospective randomized, controlled phase III trial comparing these two approaches, researchers studied 204 adults who had extensive SCLC, including brain and bone metastases, at 29 medical centers in Italy. These participants (mean age, 64 years) were randomly assigned to receive a combination of standard cisplatin, etoposide, and bevacizumab every 3 weeks or cisplatin and etoposide chemotherapy every 3 weeks. Patients who developed cisplatin contraindications or toxicity related to the drug could substitute carboplatin. In the experimental arm of the study, patients could opt to continue bevacizumab alone as maintenance therapy for a maximum of 18 cycles. Forty-one patients (42%) did so, said Marcello Tiseo, MD, PhD, of Azienda Ospedaliero Universitaria, Parma, Italy, and his associates.
After a median follow-up of 35 months, the median progression-free survival was 5.7 months with standard therapy and 6.7 months with add-on bevacizumab (hazard ratio, 0.72; 95% confidence interval, 0.54 to 0.97; P = .030). However, adding bevacizumab did not significantly improve overall survival, which was the primary endpoint of the trial. A subgroup analysis showed that bevacizumab significantly extended overall survival among men (HR, 0.55) but not among women (HR, 1.55), an association that has been reported in previous studies, Dr. Tiseo and his associates said (J Clin Oncol. 2017 Jan 30. doi:10.1200/JCO.2016.69.4844).
These findings, together with those of other investigators assessing the same class of agents, justify “further studies with novel and better antiangiogenic agents in extensive SCLC, particularly in the maintenance setting,” they added.
This trial was supported by the Agenzia Italiana del Farmaco. Dr. Tiseo reported serving as a consultant for AstraZeneca, Eli Lilly, Boehringer Ingelheim, Novartis, Bristol-Myers Squibb, Pierre Fabre, and Otsuka; his associates reported ties to numerous industry sources.
Adding the antiangiogenic agent bevacizumab to standard first-line chemotherapy improves progression-free survival in extensive small-cell lung cancer, according to a report published online Jan. 30.
In what they described as the first prospective randomized, controlled phase III trial comparing these two approaches, researchers studied 204 adults who had extensive SCLC, including brain and bone metastases, at 29 medical centers in Italy. These participants (mean age, 64 years) were randomly assigned to receive a combination of standard cisplatin, etoposide, and bevacizumab every 3 weeks or cisplatin and etoposide chemotherapy every 3 weeks. Patients who developed cisplatin contraindications or toxicity related to the drug could substitute carboplatin. In the experimental arm of the study, patients could opt to continue bevacizumab alone as maintenance therapy for a maximum of 18 cycles. Forty-one patients (42%) did so, said Marcello Tiseo, MD, PhD, of Azienda Ospedaliero Universitaria, Parma, Italy, and his associates.
After a median follow-up of 35 months, the median progression-free survival was 5.7 months with standard therapy and 6.7 months with add-on bevacizumab (hazard ratio, 0.72; 95% confidence interval, 0.54 to 0.97; P = .030). However, adding bevacizumab did not significantly improve overall survival, which was the primary endpoint of the trial. A subgroup analysis showed that bevacizumab significantly extended overall survival among men (HR, 0.55) but not among women (HR, 1.55), an association that has been reported in previous studies, Dr. Tiseo and his associates said (J Clin Oncol. 2017 Jan 30. doi:10.1200/JCO.2016.69.4844).
These findings, together with those of other investigators assessing the same class of agents, justify “further studies with novel and better antiangiogenic agents in extensive SCLC, particularly in the maintenance setting,” they added.
This trial was supported by the Agenzia Italiana del Farmaco. Dr. Tiseo reported serving as a consultant for AstraZeneca, Eli Lilly, Boehringer Ingelheim, Novartis, Bristol-Myers Squibb, Pierre Fabre, and Otsuka; his associates reported ties to numerous industry sources.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Adding bevacizumab to standard first-line chemotherapy improves progression-free survival in extensive small-cell lung cancer.
Major finding: After a median follow-up of 35 months, the median progression-free survival was 5.7 months with standard therapy and 6.7 months with add-on bevacizumab (hazard ratio, 0.72; 95% confidence interval, 0.54 to 0.97; P = .030).
Data source: A multicenter open-label randomized, controlled phase III trial involving 204 adults in Italy.
Disclosures: This trial was supported by the Agenzia Italiana del Farmaco. Dr. Tiseo reported serving as a consultant for AstraZeneca, Eli Lilly, Boehringer Ingelheim, Novartis, Bristol-Myers Squibb, Pierre Fabre, and Otsuka; his associates reported ties to numerous industry sources.