(a) (b)

(c) (d)

(e)

Figure A1 Dose response for the duodenal haemorrhage and stricture endpoints, as a function of duodenal dose (a) D50%, (b) D30cc, (c) D5cc, (d) D1cc and (e) D0.035cc. These models include only the 32 cases with two or more fiducials. Note that D5cc has the steepest slope and D0.035cc is the flattest.

(a) (b)

(c) (d)

(e)Figure A2 Lack of dose response for the diarrhoea and obstructive jaundice endpoints, as a function of duodenal dose (a) D50%, (b) D30cc, (c) D5cc, (d) D1cc and (e) D0.035cc. These models include only the 32 cases with two or more fiducials.

(a) (b)

(c) (d)

(e)Figure A3 Dose response for any grade 3-4 endpoints per duodenal dose (a) D50%, (b) D30cc, (c) D5cc, (d) D1cc and (e) D0.035cc. These models include only cases with ≥ 2 fiducials. The diarrhoea and obstructive jaundice endpoints average out the duodenal response, so although this model has all the complications it obscures the dose response of the duodenum, hence Fig. A1 may reflect duodenal tolerance better.

(a) (b)

(c) (d)

(e)Figure A4 Dose response for duodenal endpoints, as a function of duodenal dose (a) D50%, (b) D30cc, (c) D5cc, (d) D1cc and (e) D0.035cc. These models include only the 12 cases with one or no fiducials. When D1cc

or D0.035cc are 30 Gy, these models have approximately five times higher risk than in Fig. A1.

(a)

(b)

Figure A5 Comparison of equivalent uniform dose (EUD) model from (a) the current dataset to (b) the Murphy 2010 datasetA2. Note that the range of doses and complications and hence the shape of the curves are completely different so reliable α/β estimates cannot be extracted.

DVH Risk Map 1 of 3: Any Number of Fiducials, Any Grade 3-4 Complication

Figure A6 DVH Risk Map including any grade 3-4 complication in any of the 44 cases with any number of fiducials. The red squares show the duodenal doses corresponding to complications in all 7 of the patients. The aggregate risk for the low-risk limits and the high-risk limits are essentially the same due to the lack of dose response caused by single fiducial cases and by the diarrhoea and obstructive jaundice endpoints that did not correlate with duodenal dose. This figure is not indicative of current clinical practise because we now recommend the use of 4 to 6 fiducials. This DVH Risk Map is included for the sake of completeness but we feel the DVH Risk Map in Fig. A8 is the most useful one.

DVH Risk Map 2 of 3: Multiple Fiducials, Any Grade 3-4 Complication

Figure A7 DVH Risk Map including any grade 3-4 complication in the 32 cases with multiple fiducials. The duodenal doses corresponding to each of the four patients with complications are provided in rows 4 through 7 of Table 1 in the manuscript, and may be seen as the red squares in the five panels above, for D50%, D30cc, D5cc, D1cc and D0.035cc. Figure A2 shows that the diarrhoea and obstructive jaundice endpoints did not exhibit a dose response, so including them here essentially results in a 6% constant additional risk for most of the dose tolerance limits, as compared to the DVH Risk Map in Fig. A8. It is important to be aware that other complications such as diarrhoea and obstructive jaundice may result from pancreatic SBRT treatments, but constraining the duodenal dose might not be the most effective way to mitigate those. The DVH Risk Map in Fig. A8 is preferred because it includes only the complications that were found to be highly dependent on the duodenal dose.

DVH Risk Map 3 of 3: Multiple Fiducials, Duodenal Grade 3-4 Complications

Figure A8 DVH Risk Map of duodenal tolerance in 1 to 5 fractions. This is identical to Fig. 2 of the manuscript, reproduced here for convenience of comparison to the alternate DVH Risk Maps from this dataset. This figure contains only the 32 cases with multiple fiducials, including the two duodenal grade 3-4 complications associated with rows 6-7 of Table 1 in the manuscript. These endpoints are more comparable to those in Table 2 of the Murphy 2010 manuscriptA2 which also does not include endpoints like diarrhoea and obstructive jaundice. Since these duodenal haemorrhage and stricture endpoints responded most clearly to duodenal dose in both our dataset and in Murphy 2010A2, we feel that this is the most clinically applicable DVH Risk Map.

Table A1 Duodenal logistic model parameters  Mult. Num. Dose          

Endpoint Fid. Cases Descriptor TD50 (68% CI) g50 (68% CI) TD5 TD10 TD25Duodenal G3-4 No 12 D50% 1316.16 (10.70-Inf) 0.2758 (0.1166-0.5931) - - 5.6Duodenal G3-4 No 12 D10% 36.63 (17.36-128.38) 0.4135 (0.1373-0.8802) - - 12.3Duodenal G3-4 No 12 D30cc 20.30 (12.18-71.36) 0.4763 (0.1773-0.8498) - - 8.6Duodenal G3-4 No 12 D5cc 30.61 (19.65-107.09) 0.5370 (0.1778-1.0063) - - 15.0Duodenal G3-4 No 12 D1cc 32.45 (23.38-114.13) 0.6615 (0.2103-1.2544) - 5.5 19.0Duodenal G3-4 No 12 D0.035cc 34.78 (26.64-121.57) 0.7798 (0.2564-1.4396) 1.9 10.3 22.5"Non-Duodenal" G3-4 Yes 32 D50% No Response No Response - - -"Non-Duodenal" G3-4 Yes 32 D10% No Response No Response - - -"Non-Duodenal" G3-4 Yes 32 D30cc No Response No Response - - -"Non-Duodenal" G3-4 Yes 32 D5cc No Response No Response - - -"Non-Duodenal" G3-4 Yes 32 D1cc No Response No Response - - -"Non-Duodenal" G3-4 Yes 32 D0.035cc No Response No Response - - -Duodenal G3-4 Yes 32 D50% 23.80 (16.29-84.87) 1.1638 (0.6248-1.9662) 8.7 12.6 18.2Duodenal G3-4 Yes 32 D10% 27.34 (24.79-43.83) 3.0251 (1.2385-5.6029) 20.7 22.4 24.9Duodenal G3-4 Yes 32 D30cc 48.74 (25.24-170.90) 0.9617 (0.5706-1.7579) 11.4 20.9 34.8Duodenal G3-4 Yes 32 D5cc 33.07 (28.70-119.74) 2.7495 (0.7678-6.0722) 24.2 26.5 29.8Duodenal G3-4 Yes 32 D1cc 47.62 (34.06-169.85) 1.6136 (0.6374-4.0934) 25.9 31.4 39.5Duodenal G3-4 Yes 32 D0.035cc 89.66 (42.10-318.94) 1.0194 (0.5695-2.5751) 24.9 41.3 -Any G3-4 Yes 32 D50% 33.32 (17.22-119.89) 0.6773 (0.4033-1.1448) - 6.3 19.8Any G3-4 Yes 32 D10% 47.79 (28.42-170.47) 0.8230 (0.4209-1.6603) 5.0 15.9 31.8Any G3-4 Yes 32 D30cc 90.57 (27.26-325.73) 0.5749 (0.3794-1.0572) - 4.0 47.3Any G3-4 Yes 32 D5cc 125.18 (36.34-440.38) 0.5980 (0.3828-1.4315) - 10.2 -Any G3-4 Yes 32 D1cc 105.20 (38.82-368.55) 0.6529 (0.3917-1.6604) - 16.7 -Any G3-4 Yes 32 D0.035cc 100.39 (42.50-362.13) 0.6927 (0.3963-1.7164) - 20.8 -

Table A1 Duodenal logistic model parameters, cont’d  Mult. Num. Dose          

Endpoint Fid. Cases Descriptor TD50 (68% CI) g50 (68% CI) TD5 TD10 TD25Duodenal G3-4 Yes 32 EUD, n=1.000 18.52 (15.19-51.14) 1.6706 (0.8227-2.7990) 10.4 12.4 15.5Duodenal G3-4 Yes 32 EUD, n=0.562 19.77 (16.38-70.17) 1.8219 (0.7922-3.1982) 11.8 13.8 16.8Duodenal G3-4 Yes 32 EUD, n=0.316 20.94 (17.88-76.66) 2.2206 (0.8102-4.1766) 14.0 15.8 18.4Duodenal G3-4 Yes 32 EUD, n=0.178 22.35 (19.88-67.47) 3.0554 (0.8853-6.4266) 17.0 18.3 20.3Duodenal G3-4 Yes 32 EUD, n=0.120 24.91 (21.85-91.34) 3.0880 (0.7814-7.4649) 19.0 20.5 22.7Duodenal G3-4 Yes 32 EUD, n=0.100 26.93 (23.06-98.43) 2.7533 (0.7378-6.8196) 19.7 21.5 24.2Duodenal G3-4 Yes 32 EUD, n=0.056 36.77 (27.80-128.38) 1.7820 (0.6555-4.2545) 21.6 25.4 31.1Duodenal G3-4 Yes 32 EUD, n=0.032 53.44 (33.01-191.19) 1.2687 (0.6001-3.0402) 22.4 30.3 41.9Duodenal G3-4 Yes 32 EUD, n=0.018 83.19 (38.05-298.21) 0.9981 (0.5662-2.4668) 21.8 37.4 -Duodenal G3-4 Yes 32 EUD, n=0.010 126.18 (41.85-453.87) 0.8721 (0.5475-2.2333) 19.7 46.7 -

Notes:1) The logistic model is as defined in reference A1.2) The EUD formulation is as defined in reference A2.3) All doses are in 3-fraction equivalents, using linear quadratic with α/β=3 Gy.

Table A2 Duodenal dose tolerance limits from the literature. Fx: Fractions, AE: Adverse Event, Pts: Patients, Rx: Received.

     cc or

% Max # # Pts # Pts    Num Vol. Vol. Limit Limit AE Rx this inFx cc % Gy Gy ≥G3 Dose Study References Notes

1 5.00% 22.5 3,4,5,6,7,8 After 4-10 months, G3-4 ulceration encountered1 5.00% 22.5 6 77 71 21.6 1 67 9 Highest sm intestine/stomach Dmax among 67 cases1 15.1 1 33 67 9 Median sm intestine/stomach Dmax over 67 cases1 16 101 16 10 73 2 1yr risk G2-4: 46% above this limit, 15% below1 10 9 11,12 TG1011 5 11.2 0 33 11,12,13,14 RTOG 0631, TG1011 0.03 16 0 33 13,14 RTOG 06311 5 8.8 101 50.00% 14.5 2 16 3,4,5,6 After 4-10 months, G3-4 ulceration encountered1 50.00% 12.5 4,7,15 G3-4 ulceration, 50% isodose line should not reach distal lumen wall1 50.00% 12.5 6 77 71 16 10 17 37 73 2 1yr risk G2-4: 46% above this limit, 15% below1 9.1 15 19 36 73 2 1yr risk G2-4: 52% above this limit, 11% below1 3.3 20 19 36 73 2 1yr risk G2-4: 52% above this limit, 11% below1 0.21 25 16 36 73 2 1yr risk G2-4: 45% above this limit, 12% below1 1 23 18 36 73 2 1yr risk G2-4: 49% above this limit, 12% below1 12.4 11,12 TG1013 58 1 1 40 163 54 2 2 40 163 47 1 1 35 17 G5 duodenal ulcer 5 months after tx3 42 3 3 40 163 37 0 12 183 5 30 0 12 183 15 24 0 12 18

Table A2 Duodenal dose tolerance limits from the literature, cont’d

     cc or

% Max # # Pts # Pts    Num Vol. Vol. Limit Limit AE Rx this inFx cc % Gy Gy ≥G3 Dose Study References Notes

3 30 15 0 12 183 1 37.4 10 26 19,20 Mean D1cc of the 10 cases with G2+ AE, p=0.033 1 25.3 0 26 19,20 Mean D1cc of the 16 cases without G2+ AE, p=0.033 7.00% 30 6 11 26 19 Median V30Gy; G2+ risk 55% above this volume, 27% below3 9.00% 27 6 12 26 19 Median V27Gy; G2+ risk 50% above this volume, 29% below3 9.00% 24 7 13 26 19 Median V24Gy; G2+ risk 54% above this volume, 23% below3 12.00% 21 7 14 26 19 Median V21Gy; G2+ risk 50% above this volume, 25% below3 30 21,22,23,243 30 4 36 21 2 late GI bleeding, 2 acute cramping, vomiting, dehydration3 30 3 39 22 3 late GI bleeding3 30 2 22 23 Mucositis (n=2) or ulceration (n=2) of the stomach or duodenum3 30 6 2 61 24,25 2 G3 duodenal ulceration, 2 G3 nausea, 2 G3 diarrhea3 5 21 26,27,28,29,30,313 5 21 0 25 273 5 21 0 44 28,29,30,323 1.00% 21 0 61 333 1 21 0 40 343 10 11.4 11 TG1013 5 16.5 11 TG1013 5 15 10,35,363 5 15 1 25 36 D5cc exceeded 15Gy for the case with G3 ulceration3 24 6,10,35,36,373 24 0 10 373 24 1 25 363 22.2 11 TG1013 21 0 31 38

Table A2 Duodenal dose tolerance limits from the literature, cont’d

     cc or

% Max # # Pts # Pts    Num Vol. Vol. Limit Limit AE Rx this inFx cc % Gy Gy ≥G3 Dose Study References Notes

5 42 1 37 18 1 G5 duodenal perforation, local tumor invasion5 5 38 1 37 18 1 G5 duodenal perforation, local tumor invasion5 15 32.5 1 37 18 1 G5 duodenal perforation, local tumor invasion5 30 20 1 37 18 1 G5 duodenal perforation, local tumor invasion5 39.4 1 1 37 18 1 G5 duodenal perforation, 50.4 Gy 2 y prior to SBRT5 5 21.5 1 1 37 18 1 G5 duodenal perforation, 50.4 Gy 2 y prior to SBRT5 15 16.4 1 1 37 18 1 G5 duodenal perforation, 50.4 Gy 2 y prior to SBRT5 30 1.6 1 1 37 18 1 G5 duodenal perforation, 50.4 Gy 2 y prior to SBRT5 35 3 73 39 At least half of the cases met this Dmax limit5 1 35 3 73 395 5.2 30 3 36 73 39 Median V30Gy over 73 cases5 5 30 3 73 39 Stated V30Gy limit5 1 33 1 40 40 1 G4 ulcer5 3 20 1 40 40 1 G4 ulcer5 9 15 1 40 40 1 G4 ulcer5 32 10,11,41 TG1015 32 0 18 415 10 12.5 11 TG1015 5 18.3 355 5 18 10,11,41 TG1015 5 18 0 18 415 27.5 356 0.5 30 0 41 42

10 10 40 0 18 43 Stated limit10 10 38.5 0 1 18 43 Highest D10cc used in 18 cases10 10 5.5 0 9 18 43 Median D10cc among 18 cases

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