SOURCE: TomoTherapy

TomoTherapy

March 23, 2010 09:00 ET

Study Reveals TomoTherapy® Technology Plays Key Role in Enabling Concurrent Chemo-Radiation Treatments for Lung Cancer

Clinical Trial From Brussels University Hospital in Belgium

MADISON, WI--(Marketwire - March 23, 2010) - TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for cancer care, today cited the first published results on the concurrent use of hypofractionated TomoTherapySM radiation treatments and chemotherapy for unresectable locally-advanced non-small cell lung cancer (NSCLC). The clinical trial was carried out by the Department of Radiation Oncology at the Universitaire Ziekenhuis (UZ) Brussel in Brussels, Belgium, and published in the journal Cancer (Volume 116, Issue 1, Pages 241-250, Jan 2010). Previous studies have shown an increase in the rate of tumor control via either escalating biologically effective radiation dose, or the addition of chemotherapy concurrent with the course of radiation. This trial tests the feasibility of dose escalation along with concurrent chemotherapy, taking advantage of the accuracy and dose conformity of helical TomoTherapy treatments in minimizing radiation damage to normal tissues.

The paper, "Toxicity Report of a Phase 1/2 Dose-Escalation Study in Patients With Inoperable, Locally Advanced Non-small Cell Lung Cancer With Helical TomoTherapy and Concurrent Chemotherapy," concludes that a TomoTherapy schedule of 67.2 Gy in 30 fractions, concurrent with cisplatin/docetaxel, is feasible and has acceptable toxicity with a promising tumor response rate.

The UZ Brussel authors state that all radiation plans in the study met the given dose constraints to healthy organs such as the lung, esophagus, heart and spinal cord, while maintaining sufficient coverage of the planning target volume. This result is encouraging given the advanced stage IIIB disease harbored by most patients in the study and the usual high toxicity associated with combining chemotherapy and high radiation doses. Previous hypofractionated dose-escalation studies for advanced disease, using three-dimensional conformal radiotherapy, have shown an inability to reach an appropriate dose due to high toxicity rates.

"We are very encouraged by the results of this study that demonstrate the value of TomoTherapy imaging and dosimetric capabilities," said Prof. Guy Storme, M.D., Ph.D., director of the Oncologic Center at UZ Brussel. "We are hopeful that this work -- and the growing body of published TomoTherapy-focused work from UZ Brussel -- will result in positive outcomes for patients with locally advanced NSCLC."

Dose-per-fraction escalation, starting at 2.0 Gy and increasing by 6 percent per dose cohort, was employed in the UZ Brussel study to determine maximum tolerated dose. A total of 34 patients were included over five dose groups receiving total doses from 60 to 74.4 Gy. Early and late toxicity to esophagus, lungs and heart were monitored and scored using Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) criteria. Results led the authors to nominate 2.24 Gy per fraction as the maximum tolerated dose. For patients receiving doses up to this level, the incidence of late lung toxicity designated as RTOG grade 3 or above was only 14 percent, comparing favorably with previous studies using concurrent chemo-radiation for advanced NSCLC.

Complete metabolic tumor response on FDG-PET scans was seen in 55 percent of patients. With a median follow-up of 17 months, median survival was calculated using Kaplan-Meier analysis to be 17.9 months. A full phase 2 study has been initiated to further investigate toxicity and treatment efficacy with a helical TomoTherapy dose of 67.2 Gy in 30 fractions and concurrent chemotherapy.

A previous study by the same authors showed the use of TomoTherapy megavoltage computed tomography (MVCT) imaging in monitoring patients and evaluating them for acute toxicity in addition to volumetric changes. The study, "Volumetric Response Analysis During Chemo-radiation as Predictive Tool for Optimizing Treatment Strategy in Locally Advanced Unresectable NSCLC" (Radiotherapy and Oncology, Volume 91, Issue 3, Pages 438-442, June 2009), allowed authors to determine volumetric changes and correlate these variations to prognosis and prediction of local response in patients treated with chemo-radiation for locally advanced NSCLC.

Further work from UZ Brussel in the paper "Toxicity and Outcome Results of a Class Solution with Moderately Hypofractionated Radiotherapy in Inoperable Stage III Non-Small Cell Lung Cancer Using Helical TomoTherapy" (Int J Radiat Oncol Biol Phys., Jan 2010; Epub ahead of print) discusses outcome and toxicity results in Stage III NSCLC and shows encouraging results in local progression free survival and toxicity results in line with other studies.

"It is very rewarding to once again see TomoTherapy technology playing a key role in advancing the management of this disease for which survival rates have traditionally been so dismal," said TomoTherapy CEO Fred Robertson. "We appreciate that radiation therapy often must go hand-in-hand with drugs. In this case, the TomoTherapy platform plays its part by safely enabling innovative and aggressive combination treatments."

About TomoTherapy Incorporated
TomoTherapy Incorporated develops, markets and sells advanced radiation therapy solutions that can be used to treat a wide variety of cancers, from the most common to the most complex. The ring gantry-based TomoTherapy® platform combines integrated CT imaging with conformal radiation therapy to deliver sophisticated radiation treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue. TomoTherapy's suite of solutions include its flagship Hi·Art® treatment system, which has been used to deliver more than three million CT-guided, helical intensity-modulated radiation therapy (IMRT) treatment fractions; the TomoHD™ treatment system, designed to enable cancer centers to treat a broader patient population with a single device; and the TomoMobile™ relocatable radiation therapy solution, designed to improve access and availability of state-of-the-art cancer care. TomoTherapy's stock is traded on the NASDAQ Global Select Market under the symbol TOMO. To learn more about TomoTherapy, please visit TomoTherapy.com.

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