A Prospective Evaluation of Outcomes of Radiosurgical Treatment for Early Stage Non-Small Cell Lung Cancer (NSCLC)

James Luketich, M.D., Chief of Thoracic and Foregut Surgery University of Pittsburgh Medical Center, Pittsburgh, PA

1. To assess clinical response rate, local control, progression-free survival and overall survival following CyberKnife® Stereotactic Radiosurgery (SRS) for patients with early stage NSCLC with 5 year follow-up

1. To characterize and compare quality of life before and after SRS treatment
2. To assess quality of life in this population following treatment
3. To assess procedure-related outcomes after SRS of lung tumors– in particular, morbidity and mortality, and requirements for chest tube drainage

Medically inoperable patients with early stage NSCLC

STAGE I: T1 N0 M0 T2 N0 M0 (Size < 5 cm)   STAGE II: T3 N0 M0 (Chest wall invasion only, Size < 5 cm)

Primary treatment of solitary lung tumors by CyberKnife radiosurgery : Peripheral Lesions: 20 Gy x 3 fractions Central Lesions: 12 Gy x 4 fractions

M. D. Anderson Cancer Center to Lead Study of Surgery vs. CyberKnife® Radiosurgery for Operable Lung Cancer Patients 

SUNNYVALE, Calif, October 26, 2007– Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that the company is partnering with The University of Texas M. D. Anderson Cancer Center in Houston, Texas to launch a prospective clinical study to compare treatment outcomes in early-stage operable lung cancer. Patients in the study will be randomly assigned to traditional surgery or CyberKnife® Robotic Radiosurgery for their treatment.  

In the past several years evidence has grown showing excellent outcomes in the treatment of lung tumors with high-dose radiation delivered in three or four treatments.  Study results on operable patients treated by these short courses have demonstrated survival rates and local control rates similar to those of traditional surgery.  As the medical community moves toward adoption of more minimally invasive alternatives to treatment, data that compare outcomes of surgery to less invasive treatment options, such as radiosurgery, become extremely important.

”We feel the time is right to explore less invasive alternatives for early stage lung cancer patients,” said Jack Roth, M.D., professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic & Cardiovascular Surgery at M. D. Anderson and the study’s principal investigator. “The results achieved with radiosurgery appear to be comparable to those achieved with traditional surgery for early stage lung cancer patients and a randomized clinical trial is required to accurately compare results from the two. To do so, we must use a uniform platform to assure the highest possibility of cure for these patients, which is why we are partnering with Accuray to use the CyberKnife System.  The results of this study may change the way lung cancer patients are treated.”  

Additionally, Ritsuko Komaki, M.D., professor of Radiation Oncology and program director, Thoracic Radiation Oncology and Joe Y. Chang, M.D., Ph.D., assistant professor of Radiation Oncology and Clinical Service Chief, Thoracic Radiation Oncology, are co-principal investigators on the study. 

Sites from around the world will participate in this 1,200-patient study, with coordination and oversight by the M. D. Anderson team. The goal of the study is to compare treatment outcomes between surgery and CyberKnife radiosurgery across a broad range of geographic healthcare markets.  Patient accrual is expected to begin in early 2008.   

A major factor in the success of this study is selecting the most accurate method of treatment that will maximize radiation to the tumor and minimize damage to surrounding healthy tissue. Accuray’s CyberKnife System combined with the company’s Synchrony® Respiratory Tracking System and Xsight® Lung Tumor Tracking System allow patients to receive a completely non-invasive treatment in three to four days through the precise delivery of high-dose radiation. While the patient lies comfortably and breathes normally, the CyberKnife System continually tracks the tumor to maximize targeting accuracy and minimize damage to surrounding healthy tissue.  Treatments are performed in an outpatient setting, without the expected complications of an invasive surgical procedure. 

“Over the past five years clinicians have obtained excellent outcomes treating lung cancer with CyberKnife Radiosurgery,” said Omar Dawood, M.D., MPH, vice president of Clinical Development of Accuray Incorporated. “We believe the CyberKnife System’s unique ability to track tumor motion and deliver radiation accurately and non-invasively make it the ideal platform for this clinical study. We are excited about this partnership with M. D. Anderson, a leader in cancer treatment, and the huge benefits this study’s outcomes could have for patients with lung cancer.”