Stereotactic Body Radiation Therapy Shows Advances for Inoperable, Non-Small Cell Lung Cancer Patients

Shorter Treatment Window and Low Toxicity Reported

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| Source: American Society for Radiation Oncology

BOSTON, Oct. 29, 2012 (GLOBE NEWSWIRE) -- Stereotactic body radiation therapy (SBRT) yielded higher overall survival rates and low toxicity for patients with inoperable, non-small cell lung cancer (NSCLC) in comparison to conventional radiation therapy, according to research presented today at the American Society for Radiation Oncology's (ASTRO's) 54th Annual Meeting. The study follows a 2010 report1 on operable patients with NSCLC.
    
The study evaluated the safety and efficacy of SBRT in 100 patients with medically inoperable NSCLC from June* 2004 to November 2008 (*updated data), from 15 institutions throughout Japan with a median follow-up of 37 months. Patients' overall survival rate was 59.9 percent after three years and only mild toxicity was shown. At the three-year follow-up, progression-free survival was 49.8 percent, local progression-free survival was 52.8 percent and event-free survival was 46.8 percent. Of the grade 3 adverse events (AEs), 10* percent of patients (*updated data) experienced dyspnea, eight percent experienced hypoxia, seven percent experienced pneumonitis, two percent experienced chest pain and one percent experienced cough. Only two percent of patients experienced grade 4 AEs of dyspnea and hypoxia. No grade 5 AEs were observed.
     
At the start of the study, 104 patients were included, 77 male and 27 female, with a median age of 78 (range 59-90). Patients were treated with 48 Gy at the isocenter in four fractions for four to eight days. Patients had a median tumor size of 21 mm (range 9 to 30 mm), with 50 patients exhibiting adenocarcinomas, 40 patients exhibiting squamous cell carcinomas and 14 with other types of lung cancer. All patients completed the protocol treatment. Four patients were eliminated from the study results after completion because three patients were diagnosed with another cancer within five years after registration and one patient was unexpectedly treated with SBRT in combination with chemotherapy.
     
"Our study found that SBRT for inoperable lung cancer patients was highly effective and showed mild toxicity," said Yasushi Nagata, MD, lead author of the study and a radiation oncologist at the Department of Radiation Oncology at Hiroshima University in Hiroshima, Japan. "This treatment should be the new standard replacing conventional radiotherapy for this population of patients."
     
The abstract, "Stereotactic Body Radiation Therapy For T1N0M0 Non-small Cell Lung Cancer: First Report For Inoperable Population Of A Phase II Trial By Japan Clinical Oncology Group," will be presented in detail during a scientific session at ASTRO's Annual Meeting at 11:00 a.m., Eastern time on Monday, October 29, 2012. To speak with Dr. Nagata, call Michelle Kirkwood on October 28 – 31, 2012, in the ASTRO Press Office at the Boston Convention and Exhibition Center at 617-954-3461 or 617-954-3462, or email michellek@astro.org.
     
ASTRO's 54th Annual Meeting, held in Boston, October 28 – 31, 2012, is the premier scientific meeting in radiation oncology and brings together more than 11,000 attendees including oncologists from all disciplines, medical physicists, dosimetrists, radiation therapists, radiation oncology nurses and nurse practitioners, biologists, physician assistants, practice administrators, industry representatives and other health care professionals from around the world. The theme of the 2012 Annual Meeting is "Advancing Patient Care through Innovation" and examines how innovation in technology and patient care delivery can lead to improved patient outcomes. The four-day scientific meeting includes six plenary papers and 410 oral presentations in 63 oral scientific sessions, and 1,724 posters and 130 digital posters in 18 tracks/topic areas.
     
ABOUT ASTRO

ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. For more information on radiation therapy, visit www.rtanswers.org. To learn more about ASTRO, visit www.astro.org.

2012 American Society for Radiation Oncology (ASTRO) 54th Annual Meeting
News Briefing, Wednesday, October 31, 2012, 7:00 a.m. – 7:45 a.m. Eastern time

Scientific Session: Monday, October 29, 2012, 11:00 a.m. – 12:30 p.m. ET, Boston Convention & Exhibition Center

115  Stereotactic Body Radiation Therapy For T1N0M0 Non-small Cell Lung Cancer: First Report For Inoperable Population Of A Phase II Trial By Japan Clinical Oncology Group

Y. Nagata1, M. Hiraoka2, T. Shibata3, H. Onishi4, M. Kokubo5, K. Karasawa6, Y. Shioyama7, R. Onimaru8, T. Kozuka9, S. Ishikura10, 1Radiation Oncology, Hiroshima University, Hiroshima, Japan, 2Therapeutic Radiology and Image-applied therapy, Kyoto University, Kyoto, Japan, 3JCOG Data Center, National Cancer Center, Tokyo, Japan, 4Radiation Oncology, University of Yamanashi, Yamanashi, Japan, 5Image-based Medicine, Institute of Biomedical research and innovation, Kobe, Japan, 6Radiation Oncology, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan, 7Clinical Radiology, Kyushu University, Fukuoka, Japan, 8Radiology, Hokkaido University, Sapporo, Japan, 9Radiation Oncology, The Cancer Institute Hospital, Tokyo, Japan, 10Radiology, Nagoya City University, Nagoya, Japan

Background: The purpose of JCOG0403 was to evaluate the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with both operable and medically inoperable T1N0M0 non-small cell lung cancer (NSCLC) (UICC 6th ed., 2002). The first report for operable population was reported in 2010, and this is the report analyzed for inoperable population.

Materials and Methods: The eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0, inoperable patients assessed by thoracic surgeons, PS 0-2, > 20 years old, PaO2 > 60 torr, FEV1.0 > 700 ml, and written informed consent. The prescription was 48 Gy at the isocenter in 4 fractions over 4-8 days. 4-10 MV X rays were allowed. Heterogeneity corrected doses by pencil beam algorithms were used. The GTV included the primary tumor only, CTV margin was not considered, and ITV margin and 5 mm setup margin were added. As a quality assurance program, credentialing of institutions and an individual case review using the Image-guided Therapy Center (ITC) remote review tool were performed. The primary endpoint was the three-year overall survival (OS). The secondary endpoints included OS, progression-free survival (PFS), local-progression free survival (LPFS), event-free survival (EFS), toxicity. The required sample size was 91 to provide at least 90% power under the hypothesis of the expected value of the primary endpoint of 50% and the threshold value of 35% with a one-sided alpha of 0.05. Taking into account ineligible patients and a precision of estimate, sample size was determined as 100.

Results: Between July 2004 and November 2008, 104 inoperable patients were registered in this study from 15 institutions. The patients characteristics were: male 77, female 27; median age 78 (range 59-90); median tumor size 21 mm (range 9-30 mm); adenocarcinomas 50, squamous cell carcinomas 40, others 14; and PS 0/1/2, 49/46/9. All patients completed the protocol treatment. At the last follow-up in December 2011, median follow-up of censored cases was 46.8 months. Of the eligible 100 patients, the 3-year overall survival was 59.9% (the lower limit of 90%CI, 51.4%, exceeded a threshold of 35%, 95% CI: 49.6% - 68.8%), and the 3-year PFS, LPFS, and EFS were 49.8% (95% CI: 39.7% - 59.2%), 52.8 % (95% CI: 42.6 % -62.1 %), 46.8 % (95% CI: 36.7 % - 56.2 %), respectively. Grade 3 adverse event (AE) was observed in dyspnea 9 (9%), hypoxia 8 (8%), pneumonitis 7 (7%), chest pain 2 (2%), and cough 1(1%). Grade 4 AE was observed in dyspnea 1 (1%) and hypoxia 1 (1%). No grade 5 AE was observed.

Conclusions: SBRT for inoperable stage I NSCLC is highly effective with mild toxicity. This treatment should be the new standard treatment replacing conventional radiotherapy.

Author Disclosure Block:
Y. Nagata: None. M. Hiraoka: None. T. Shibata: None. H. Onishi: None. M. Kokubo: None. K. Karasawa: None. Y. Shioyama: None. R. Onimaru: None. T. Kozuka: None. S. Ishikura: None.

1 "A Phase II Trial of Stereotactic Body Radiation Therapy for Operable T1N0M0 Non-Small Cell Lung Cancer," Yasushi Nagata, MD; Japan Clinical Oncology Group; presented at the 2010 ASTRO Annual Meeting.

Michelle Kirkwood
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