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Preliminary clinical report of proton therapy at hyogo ion beam medical center (HIBMC)
Proceedings of the 44th Annual ASTRO Meeting
2229
Preliminary Clinical Report of Proton Therapy at Hyogo Ion Beam Medical Center (HIBMC)
M. Murakami1,2, K. Kagawa1, Y. Hishikawa1,2, M. Abe1, S. Kamidono3, N. Tsubota4, N. Nakao5, K. Yoshino6 1 Department of Radiology, Hyogo Ion Beam Medical Center, Japan, 2Medical Imaging & Ion Beam Therapy, Kobe University, Japan, 3Department of Urology, Kobe University, Japan, 4Department of Thoracic Surgery, Hyogo Medical Center for Adults, Japan, 5Department of Radiology, Hyogo College of Medicine, Japan, 6Department of Otolaryngology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan Purpose/Objective: To confirm the acute toxicity, tumor response and stability of the machine which provides proton beams in the newly constructed Hyogo Ion Beam Medical Center (HIBMC). Materials/Methods: The HIBMC has predominant features of (1) generating two ion beams including proton (70-230MeV/u) and carbon (70-320MeV/u), (2) delivering beams in 5 treatment units (2 gantry, 1 horizontal & vertical, 1 horizontal and 1 oblique fixed beam port), and (3) having a hospital (4,500m2) as an annex to a accelerator facility (12,000m2). The hospital opened in April 2001 and we started proton radiotherapy as a clinical study based on the Good Clinical Practices regulated by the Minister for Health, Labour and Welfare in Japan. Beforehand, the relative biological effectiveness of proton beams was estimated as 1.1 by preclinical investigations. Thirty patients with histological proven cancer originated in head & neck in 4, lung in 5, liver in 5, or prostate cancer in 16 were treated. Eligibility criteria of the UICC TNM clinical staging system were T1T2N0M0 in both lung and prostate cancer. However, in H & N and liver cancer, it did not care about TN factors instead of a requirement about tumor size within 12 cm in diameter. There were 26 males and 4 females. All patients had an ECOG performance status of grade 2 or less. Eight patients (27%) had a past history of various anticancer treatments without irradiation. Eighteen patients (60%) were inoperable because of locally advanced in 5, elder in 6, or combined disease in 7, while 12 patients (40%) who were regarded as medically operable refused their proposal of surgery. The beam delivery system consists of a pair of wobbler magnets, beam scatterers, ridge filters, dose-monitering devices, multi-leaf collimator and bolus-collimator unit. The ridge filter was designed to produce biologically equal effects along the spread-out Bragg Peak. We can choose various treatment fields with maximum 15 cm in diameter. Treatment planning was performed using a 3-D radiation treatment planning system (FOCUS-M: Mitsubishi co.) and a software of image fusion. When dealing with moving target under breathing such as lung or liver cancers, respiratory gating system was used. Prescribed dose was 65 gray equivalent (GyE) to the 4MVX rays /26Fr/7wks in H & N cancer, 80GyE/20Fr/5wks in lung cancer, 76GyE/ 20Fr/5wks in liver cancer, and 74GyE/37Fr/8wks in prostate cancer. The acute toxicity was assessed according to the criteria of the NCI-CTC Version 2.0 up to 90 days after starting proton irradiation. Objective tumor response was evaluated at the four to six weeks after completion of the treatment using the WHO criteria. In the case of prostate cancer, serum prostate specific antigen (PSA) level was also used as a response evaluation. Complete response was defined as a decrease in PSA to baseline levels (4 ng/ml). Partial response was defined as a decrease in PSA of greater than or equal to 50%. No change was defined as a decrease in PSA of less than 50% or as an increase in PSA of less than 25%. Results: Full courses of proton therapy consisted of 896 portals in the 30 patients were given exactly as scheduled without any trouble of the accelerator or treatment system. No patients experienced severe acute local reactions more than grade 3. Two patients with H & N cancer developed skin & mucosa reaction of grade 3 and one with liver cancer liver dysfunction of grade 3. However, these reactions were improved spontaneously one month later. In measurable 23 cases, two patients were CR, 12 PR, and 9 NC. The response rate (CR⫹PR) was calculated 60.9%. When the PSA level was used as an objective response in prostate cancer, 26 patients resulted CR in 7, PR in 10, and NC in 9 and the response rate was calculated 65.4%. Conclusions: These results indicate that our treatment units and systems are safe and reliable enough for proton irradiation to be used for several malignant tumors localized in the body.
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2229
Preliminary Clinical Report of Proton Therapy at Hyogo Ion Beam Medical Center (HIBMC)
M. Murakami1,2, K. Kagawa1, Y. Hishikawa1,2, M. Abe1, S. Kamidono3, N. Tsubota4, N. Nakao5, K. Yoshino6 1 Department of Radiology, Hyogo Ion Beam Medical Center, Japan, 2Medical Imaging & Ion Beam Therapy, Kobe University, Japan, 3Department of Urology, Kobe University, Japan, 4Department of Thoracic Surgery, Hyogo Medical Center for Adults, Japan, 5Department of Radiology, Hyogo College of Medicine, Japan, 6Department of Otolaryngology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan Purpose/Objective: To confirm the acute toxicity, tumor response and stability of the machine which provides proton beams in the newly constructed Hyogo Ion Beam Medical Center (HIBMC). Materials/Methods: The HIBMC has predominant features of (1) generating two ion beams including proton (70-230MeV/u) and carbon (70-320MeV/u), (2) delivering beams in 5 treatment units (2 gantry, 1 horizontal & vertical, 1 horizontal and 1 oblique fixed beam port), and (3) having a hospital (4,500m2) as an annex to a accelerator facility (12,000m2). The hospital opened in April 2001 and we started proton radiotherapy as a clinical study based on the Good Clinical Practices regulated by the Minister for Health, Labour and Welfare in Japan. Beforehand, the relative biological effectiveness of proton beams was estimated as 1.1 by preclinical investigations. Thirty patients with histological proven cancer originated in head & neck in 4, lung in 5, liver in 5, or prostate cancer in 16 were treated. Eligibility criteria of the UICC TNM clinical staging system were T1T2N0M0 in both lung and prostate cancer. However, in H & N and liver cancer, it did not care about TN factors instead of a requirement about tumor size within 12 cm in diameter. There were 26 males and 4 females. All patients had an ECOG performance status of grade 2 or less. Eight patients (27%) had a past history of various anticancer treatments without irradiation. Eighteen patients (60%) were inoperable because of locally advanced in 5, elder in 6, or combined disease in 7, while 12 patients (40%) who were regarded as medically operable refused their proposal of surgery. The beam delivery system consists of a pair of wobbler magnets, beam scatterers, ridge filters, dose-monitering devices, multi-leaf collimator and bolus-collimator unit. The ridge filter was designed to produce biologically equal effects along the spread-out Bragg Peak. We can choose various treatment fields with maximum 15 cm in diameter. Treatment planning was performed using a 3-D radiation treatment planning system (FOCUS-M: Mitsubishi co.) and a software of image fusion. When dealing with moving target under breathing such as lung or liver cancers, respiratory gating system was used. Prescribed dose was 65 gray equivalent (GyE) to the 4MVX rays /26Fr/7wks in H & N cancer, 80GyE/20Fr/5wks in lung cancer, 76GyE/ 20Fr/5wks in liver cancer, and 74GyE/37Fr/8wks in prostate cancer. The acute toxicity was assessed according to the criteria of the NCI-CTC Version 2.0 up to 90 days after starting proton irradiation. Objective tumor response was evaluated at the four to six weeks after completion of the treatment using the WHO criteria. In the case of prostate cancer, serum prostate specific antigen (PSA) level was also used as a response evaluation. Complete response was defined as a decrease in PSA to baseline levels (4 ng/ml). Partial response was defined as a decrease in PSA of greater than or equal to 50%. No change was defined as a decrease in PSA of less than 50% or as an increase in PSA of less than 25%. Results: Full courses of proton therapy consisted of 896 portals in the 30 patients were given exactly as scheduled without any trouble of the accelerator or treatment system. No patients experienced severe acute local reactions more than grade 3. Two patients with H & N cancer developed skin & mucosa reaction of grade 3 and one with liver cancer liver dysfunction of grade 3. However, these reactions were improved spontaneously one month later. In measurable 23 cases, two patients were CR, 12 PR, and 9 NC. The response rate (CR⫹PR) was calculated 60.9%. When the PSA level was used as an objective response in prostate cancer, 26 patients resulted CR in 7, PR in 10, and NC in 9 and the response rate was calculated 65.4%. Conclusions: These results indicate that our treatment units and systems are safe and reliable enough for proton irradiation to be used for several malignant tumors localized in the body.
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