Voort van 2 years 97% 62% Zyp NC 2010 Vahdat S 42 60 Gy in 3 f 20 Stage IA 43 months 2 year 95% 90% – 2010 Brown WT 60-67.5 Gy in 31 27.5 (24- 4.5 85.5% 83.5% 2009 3-5 f peripheral 53) years Stage I Van der 60 Gy in 3 f 70 15 months 1 & 2 96% Voort van peripheral years Zyp NC stage 2009 T1 & T2 Ahn SH 36-54 Gy in 3 f 8 Stage I 2 years 87.5% 2009 Collins BT 42-60 in 3 f 20 25 months 2 trial 100% 87% 2009 Peripheral Stage I Coon D 60 Gy in 3 f 26 stage I 12 months 1 year 85% 81% 2008 Collins BT 45-60 Gy in 3 24 1 12 months 1 year 100% 87% 2007 Brown WT 15 to 67.5 Gy in 59 1 to 33 85% 2007 1-5 f months Brown WT 15 to 67.5 Gy in 95 1 to 36 82% 2007 1-5 f months Brown WT 24 to 60 Gy in 3 f 19 Stage 1-25 86% 2007 1A months Nuyttens 30 to 60 Gy in 3 f 20 4 months 100% JJ 2006 * Comparison with resection ** Comparison with 3D-CRT 3DCRT 14 papers were considered by the applicant as This usability was determined by the ‘usable’. reporting of outcomes, especially overall survival, making it possible to compare the outcomes in these papers with those in the papers reporting on CyberKnife. Table B3: Conformal Radiotherapy Relevant Papers Paper Dose Patients Follow-up Kaplan- Local Overall - median Meier control survival Price A 55 Gy in 20 f 105 Stage T1-2 2 years A 56% 2012 A w/o B 52% B w chemo 5 years A 20% B 33% Bradley JD 74 Gy 53 Stage I-III 19.3 1 year 75.5% 2010 months (13.1- 57.9-72) Wurstbauer 88.2 GY 30 I 19 2 I 57% K 69.3 Gy 8 Stage II months 5 years 20% 2010 56.7 Gy 39 Stage IIIA Stage II 47 Stage IIIB 75% 13%
Voort van Zyp NC 2010 2 years 97% 62% Vahdat S 2010 42 – 60 Gy in 3 f 20 Stage IA 43 months 2 year 95% 90% Brown WT 2009 60-67.5 Gy in 3-5 f 31 peripheral Stage I 27.5 (24- 53) 4.5 years 85.5% 83.5% Van der Voort van Zyp NC 2009 60 Gy in 3 f 70 peripheral stage T1 & T2 15 months 1 & 2 years 96% Ahn SH 2009 36-54 Gy in 3 f 8 Stage I 2 years 87.5% Collins BT 2009 42-60 in 3 f 20 Peripheral Stage I 25 months 2 100% 87% Coon D 2008 60 Gy in 3 f 26 stage I 12 months 1 year 85% 81% Collins BT 2007 45-60 Gy in 3 24 1 12 months 1 year 100% 87% Brown WT 2007 15 to 67.5 Gy in 1-5 f 59 1 to 33 months 85% Brown WT 2007 15 to 67.5 Gy in 1-5 f 95 1 to 36 months 82% Brown WT 2007 24 to 60 Gy in 3 f 19 Stage 1A 1-25 months 86% Nuyttens JJ 2006 30 to 60 Gy in 3 f 20 4 months 100% * Comparison with resection ** Comparison with 3D-CRT 3DCRT 14 papers were considered by the applicant as ‘usable’. This usability was determined by the reporting of outcomes, especially overall survival, making it possible to compare the outcomes in these papers with those in the papers reporting on CyberKnife. Table B3: Conformal Radiotherapy Relevant Papers Paper Dose Patients Follow-up - median Kaplan- Meier Local control Overall survival Price A 2012 55 Gy in 20 f 105 Stage T1-2 A w/o B w chemo 2 years 5 years A 56% B 52% A 20% B 33% Bradley JD 2010 74 Gy 53 Stage I-III 19.3 months (13.1- 57.9-72) 1 year 75.5% Wurstbauer K 2010 88.2 GY 69.3 Gy 56.7 Gy 30 I 8 Stage II 39 Stage IIIA 47 Stage IIIB 19 months 2 5 years I 57% 20% Stage II 75% 13% trial
1158-PSD-Roboticimage-guidedsterotacticprecisebeamradiosurgeryandradiotherapy-Accessible%20(D13-1620678)%20(D13-1647459).docx