Analysis Shows Combining Sorafenib With Carboplatin/Paclitaxel Adds No Benefit In Lung Cancer

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 25 Apr 2008 - 8:00 PST

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A clinical trial evaluating the benefit of adding the drug sorafenib to the combination of carboplatin/paclitaxel chemotherapy for lung cancer patients has been stopped based on results from an interim analysis, after an independent data monitoring committee concluded that the study would not meet its primary endpoint of improved overall survival.

In a late-breaking abstract presented at the 1st European Lung Cancer Conference jointly organized by the International Association for the Study of Lung Cancer (IASLC) and the European Society for Medical Oncology (ESMO), Prof. Giorgio Scagliotti from the University of Torino, Italy presented data from the clinical trial stopped in February.

For some patients, the drug results in worse outcomes. "Based on a planned interim analysis the study showed a clear inferiority from adding sorafenib to carboplatin/paclitaxel in first-line non-small-cell lung cancer patients with squamous histology," Prof. Scagliotti said.

Sorafenib is an oral multikinase inhibitor with anti-angiogenic and antiproliferative activity. The drug, marketed as Nexavar by Bayer, is already approved for use in more than 40 countries for liver cancer and more than 70 countries for renal cell cancer.

The latest trial included 926 patients with unresectable stage IIIB/IV non-small-cell lung cancer who had received no prior systemic treatment. Patients were randomized to receive carboplatin plus paclitaxel, combined with either sorafenib 400 mg or placebo.

After a formal review of the ongoing study, the trial's data monitoring committee recommended termination. Preliminary results showed a median overall survival of 10.7 months in the sorafenib group vs 10.6 months in the placebo arm. Sorafenib-treated patients with squamous-cell non-small-cell lung cancer had a greater mortality rate than those with non-squamous histology.

"To date there is no evidence of any detrimental effect from sorafenib in additional subgroups of patients," Prof. Scagliotti said.

He noted that researchers are still studying the drug in lung cancer, including an ongoing study examining adding it to the combination of cisplatin and gemcitabine.

About the European Society for Medical Oncology (ESMO)

The European Society for Medical Oncology (ESMO) is the leading European non-profit, professional organization for medical oncology promoting multidisciplinary cancer treatment around the world.

ESMO unites medical oncologists, oncology specialists, healthcare professionals, caregivers, patients and policy makers in a global alliance committed to eradicating cancer and ensuring equal access to high quality treatment for all patients. Thanks to its state-of-the-art education and training programs, ESMO plays an instrumental role in providing the oncology community with the most up-to-date scientific research and information available. ESMO is dedicated to educating and supporting oncologists, optimizing patient care, disseminating cancer-specific information to the public, and advocating patient rights. As an authoritative voice in the fight against cancer, ESMO provides both the platform and the consultative expertise to influence national and international organizations as well as European authorities, in order to establish common standards for a multidisciplinary approach to cancer treatment. Through its flagship journal, Annals of Oncology, ESMO publishes articles on all aspects of clinical oncology.

http://www.esmo.org

About the International Association for the Study of Lung Cancer (IASLC)

Founded in 1972, the International Association for the Study of Lung Cancer (IASLC) is an international organization of 2,000 lung cancer specialists, spanning 53 countries. IASLC members work towards developing and promoting the study of etiology, epidemiology, prevention, diagnosis, treatment and all other aspects of lung cancer. IASLC's mission is to enhance the understanding and education of lung cancer to scientists, members of the medical community and the public. IASLC publishes the Journal of Thoracic Oncology, a prized resource for medical specialists and scientists who focus on the detection, prevention, diagnosis and treatment of lung cancer.

http://www.iaslc.org

Abstract No. LATE-BREAKING
Proffered papers 6 - Advanced NSCLC, Friday 25th April (16.30 - 19.00)
Sorafenib Plus Carboplatin/Paclitaxel in Chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC): Interim Analysis (IA) Results from the Phase III, Randomized, Double-Blind, Placebo-Controlled, ESCAPE (Evaluation of Sorafenib, Carboplatin, and Paclitaxel Efficacy in NSCLC) Trial
G. Scagliotti, J. von Pawel, M. Reck, L. Cupit, F. Cihon, S. DiMatteo, J. O'Leary, N. Hanna

European Society for Medical Oncology