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Title: Adding Bevacizumab to Standard Chemotherapy Improves Survival in Advanced Lung Cancer: Presented at ASCO

"Adding Bevacizumab to Standard Chemotherapy Improves Survival in Advanced Lung Cancer: Presented at ASCO"

By Charlene Laino ORLANDO, FL -- May 16, 2005 --- Addition of the antiangiogenesis agent bevacizumab to standard chemotherapy increases survival by more than 2 months in people with advanced lung cancer, according to results of Eastern Cooperative Oncology Group (ECOG) Trial E4599. Alan B. Sandler, MD, associate professor of medicine, Vanderbilt University Medical Centre, Nashville, Tennessee, reported the findings of the randomized phase 2/3 trial here on May 14[^th at the American Society of Clinical Oncology Annual Meeting (ASCO).

The study followed a phase 2 trial that suggested standard chemotherapy with paclitaxel and carboplatin plus bevacizumab was more effective than standard chemotherapy alone (Johnson, DH et al., JCO 2004), Dr. Sandler said.

From July 2001 to April 2004, Dr. Sandler and colleagues enrolled 878 patients with stage IIIb-IV nonsquamous, non-small-cell lung cancers (NSCLC). Eligibility criteria included an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate hematological, renal, and hepatic function. The study excluded patients with brain metastases or histology of hemoptysis.

Patients were randomized to receive either standard chemotherapy with paclitaxel plus carboplatin (PC) every 3 weeks or the same chemotherapy regimen plus 15 mg/kg of bevacizumab every 3 weeks. All patients received 6 cycles of therapy.

The 444 patients who received bevacizumab lived a median of 12.5 months, compared to 10.2 months for the 434 patients on the standard chemotherapy, Dr. Sandler reported.

At 1 year, 51.9% of those who took bevacizumab were alive compared to 43.7% of those on standard chemotherapy. By 2 years, 22.1% and 16.9% were alive, respectively.

"The overall survival rates were highly significant," with a P value of .007, Dr. Sandler said.

Progression-free survival rates were a median of 6.4 months and 4.5 months, respectively. "This corresponded to a hazards ratio of 0.62, with a P value of less than .0001," Dr. Sandler said. "The curves separated early and remained separate."

"Toxicity was well within acceptable limits," Dr. Sandler said. "The number of deaths attributable to the drug was less than 1%."

The incidence of grade 4/5 neutropenia was 16.4% in the PC arm and 24% in the bevacizumab arm, he said. Also, 4.1% and 1.0% of patients, respectively, suffered hemorrhage.

Based on these results, ECOG now recommends that bevacizumab plus paclitaxel and carboplatin become the standard of care for patients with stage III-IV nonsquamous, non-small-cell lung cancers who do not have brain metastases, Dr. Sandler said.

[Presentation title: Randomized phase II/III Trial of Paclitaxel (P) Plus Carboplatin (C) With or Without Bevacizumab (NSC # 704865) in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial - E4599. Abstract LBA4]

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