The four drug-combination of carboplatin and paclitaxel, with the targeted therapies bevacizumab (Avastin) and cetuximab (Erbitux), is safe and may improve survival for patients with advanced lung cancer, according to a cooperative group study led by The University of Texas M. D. Anderson Cancer Center.
Presented today on the press program of the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology, sponsored by ASTRO, ASCO, IASLC and the University of Chicago, the study is the first to investigate in lung cancer a four-drug regimen of two standard chemotherapies and targeted therapies.
The Southwest Oncology Group (SWOG) Phase II study was led by Edward S. Kim, M.D., assistant professor in M. D. Anderson's Department of Thoracic Head and Neck Medical Oncology. Until now, the SWOG standard regimen for lung cancer has been carboplatin, paclitaxel and Erbitux, explained Kim; with the addition of Avastin, this study looked to increase efficacy without compromising safety.
"We could not conduct a study with four chemotherapeutic agents in patients due to toxicity concerns," said Kim, the study's principal investigator. "The rationale behind the study was the finding that Avastin enhances the efficacy of existing therapy, thereby possibly improving the carboplatin-paclitaxel-Erbitux regimen."
Data in lung cancer has also suggested there's a "synergistic effect" of pairing the epidermal growth factor (EGFR) inhibitor compounds with the vascular endothelial growth factor (VEGF) inhibitor, explained Kim.
Interestingly, explained Kim, the SWOG's study came at a crossroads for lung cancer - soon after a study was presented showing the benefits of adding Avastin to standard chemotherapy, and prior to a study showing a modest survival benefit when Erbitux is combined with chemotherapy.
Between August 2006 and September 2007, the large Phase II study enrolled 110 Stage IIIB or IV non-small cell lung cancer patients, 99 of whom were able to be evaluated. Patients received six cycles of the four-drug regimen, and as maintenance, continued receiving both Avastin and Erbitux. It's unique for a trial to feature a two-drug maintenance biologic therapy combination, explained Kim.
The study met its primary endpoint, safety, defined by frequency of pulmonary hemorrhage, or bleeding, a concern related to Avastin. There were four treatment-related deaths and two due to bleeding, which is consistent with prior Avastin studies, explained Kim. Adverse events such as low blood counts and neuropathy were reported in 40 patients, also consistent with standard chemotherapy.
Secondary endpoints included response rate, progression-free survival and overall survival. Of patients enrolled, 53 percent had shrinkage of their tumors and 24 percent had stable disease. The median progression-free survival rate was seven months and overall survival was 14 months. In contrast, previous SWOG studies showed an average progression-free survival rate of five-and-a-half months and overall survival of 12 months.
"These findings were certainly compelling, and are the best results ever for a SWOG-based study for advanced lung cancer. While early, this four-drug combination seems to show promising, yet modest improvement in efficacy without compromising patients' safety," said Kim. "Our next priority will be to analyze the tissue from this to study to help find appropriate biomarkers for the disease to best understand who might benefit from this drug regimen."
A biomarker analysis of this study is ongoing and a randomized Phase III study is planned, with the trial scheduled to open in 2009.
Laura Sussman | EurekAlert!
Rutgers-led innovation could spur faster, cheaper, nano-based manufacturing
14.02.2018 | Rutgers University
New study from the University of Halle: How climate change alters plant growth
12.01.2018 | Martin-Luther-Universität Halle-Wittenberg
A newly developed laser technology has enabled physicists in the Laboratory for Attosecond Physics (jointly run by LMU Munich and the Max Planck Institute of Quantum Optics) to generate attosecond bursts of high-energy photons of unprecedented intensity. This has made it possible to observe the interaction of multiple photons in a single such pulse with electrons in the inner orbital shell of an atom.
In order to observe the ultrafast electron motion in the inner shells of atoms with short light pulses, the pulses must not only be ultrashort, but very...
A group of researchers led by Andrea Cavalleri at the Max Planck Institute for Structure and Dynamics of Matter (MPSD) in Hamburg has demonstrated a new method enabling precise measurements of the interatomic forces that hold crystalline solids together. The paper Probing the Interatomic Potential of Solids by Strong-Field Nonlinear Phononics, published online in Nature, explains how a terahertz-frequency laser pulse can drive very large deformations of the crystal.
By measuring the highly unusual atomic trajectories under extreme electromagnetic transients, the MPSD group could reconstruct how rigid the atomic bonds are...
Quantum computers may one day solve algorithmic problems which even the biggest supercomputers today can’t manage. But how do you test a quantum computer to...
For the first time, a team of researchers at the Max-Planck Institute (MPI) for Polymer Research in Mainz, Germany, has succeeded in making an integrated circuit (IC) from just a monolayer of a semiconducting polymer via a bottom-up, self-assembly approach.
In the self-assembly process, the semiconducting polymer arranges itself into an ordered monolayer in a transistor. The transistors are binary switches used...
Breakthrough provides a new concept of the design of molecular motors, sensors and electricity generators at nanoscale
Researchers from the Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague), Institute of Physics of the CAS (IP CAS) and Palacký University...
15.02.2018 | Event News
13.02.2018 | Event News
12.02.2018 | Event News
23.02.2018 | Physics and Astronomy
23.02.2018 | Health and Medicine
23.02.2018 | Physics and Astronomy