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CNS Flashcards

1
Q

What was the patient population studied in Patchell I (NEJM 1990)?

A

Single brain mets (n=48)

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2
Q

What was the regimen studied in Patchell I?

A

→resection + WBRT 36 Gy<br></br>vs.<br></br>→biopsy + WBRT 36 Gy

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3
Q

What were the results of Patchell I?

A

Surgery added to WBRT improved survival<br></br>and LC.<div><br></br>Median OS <b>40 wks</b> vs. <i>15 wks.</i></div><div><br></br>LC <b>80%</b> vs. <i>48%</i> (crude).</div>

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4
Q

What trial demonstrated that addition of surgery to WBRT forsolitary mets results inimproved OS, reduced LR, andimproved QOL?

A

”"”Patchell I”” University ofKentuky.<div>Patchell et al,NEJM, 1990<br></br></div>”

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5
Q

What was a criticism of Patchell 1?

A

11% that were randomized were found to not havemetastatic tumors. These were not included in analysis. The original result was phrased as LR (20% vs. 52%), butis now modified to LC to make parallel to other trials andto avoid framing bias. LC of 48% with WBRT seems low.

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6
Q

What was the patient population studied in Patchell 2?

A

Single brain mets s/pcomplete resection (n=95)?

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7
Q

<div>What was the regimen studied in Patchell 2?</div>

A

s/p complete resection→<div><br></br>→WBRT 50.4 Gy/28 fx<br></br>vs.<br></br>→observation</div>

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8
Q

What were the results of Patchell 2?

A

“-WBRT after surgery reduces recurrence andneurologic death, but <b><i>no change in OS.</i></b><div><br></br>-Median OS 48 wks vs. 43 wks (NS)</div><div><br></br>-neurologic death 14% vs. 44%</div><div><br></br>-LC 90% vs. 54%</div><div><br></br>-Total brain control 82% vs. 30%</div>”

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9
Q

Which study demonstrated that WBRT for solitary mets resultsin improved LC and reducedneurologic death?

A

Patchell 2.<div>Caveat was no change in OS.</div>

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10
Q

What was the WBRT dose used in Patchell 2?

A

50.4Gy/28 fx.<div>Higher than modern dose.</div>

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11
Q

What was the patient population used in RTOG 6901 and 7361?

A

Brain mets (n=1830)

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12
Q

What was the regimen studied in RTOG 6901 & 7361?

A

WBRT dose escalation:<div><br></br>30 Gy/ 10 fx → 30/15 → 40/15 →40/20</div><div><br></br>20/5 → 30/10 → 40/15</div>

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13
Q

What were the results of RTOG 6901 & 7361?

A

-No difference in OS (18 weeks for first study, 15 weeks for 2nd)<div><br></br>-OS with 40/15 trended to better inambulatory lung, p=0.07 and p=0.02 foreach study<br></br><br></br></div><div>-Better OS with 40/15 in lung brain mets only<br></br><br></br></div><div>-No difference in symptom improvement</div>

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14
Q

Which trials demonstrated there is no difference insymptom response or OSbetween WBRT dose escalation schedules(except in some populations that showed 40/15 seemed to trend tobetter OS)?

A

RTOG 6901 & 7361

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15
Q

What was the patient population studied in NRG-CC001 trial?

A

Brain metastases (n=518)

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16
Q

What was the regimen studied in NRG-CC001?

A

→WBRT 30 Gy/10 fx<br></br>vs.<br></br>→hippocampal avoidance IMRT<br></br>WBRT 30 Gy/10 fx<div><br></br><i>Memantine in both arms</i></div>

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17
Q

What were the results of NRG-CC001?

A
  • Hippocampal sparing RT led to lessdeterioration in executive function andlearning and memory.<div><br></br></div><div>- Also improved fatigue, difficulty speaking,remembering, interference in dailyactivities, and less cognitive symptoms.</div><div><br></br></div><div>- Hippocampus D100% <9-10 Gy was bestdosimetric factor correlated with outcome.</div>
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18
Q

What trial demonstratred improved cognitive function with hippocampal avoidance RT?

A

NRG-CC001<div><br></br></div><div>Brown et al,JCO, 2020<br></br></div>

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19
Q

<div>What was the patient population studied in QUARTZ trial?<br></br></div>

A

NSCLC with brainmetastasis unsuitablefor surgery or SRS (n=538)<div><br></br></div><div><br></br>Characteristics:<br></br>≥5 mets in ~33%<br></br>4 in <10%<br></br>3 in ~10%<br></br>2 in 20%<br></br>1 in 30%</div>

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20
Q

<div>What was the regimen studied in QUARTZ?</div>

A

Noninferiority<div><br></br>→WBRT 20 Gy/5 fx<br></br>vs.<br></br>→no RT</div><div><br></br>Primary endpoint: QALYs</div><div>Supportive care and <b>DEXAMETHASONE</b> in both<br></br>arms</div>

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21
Q

<div>What were the results of QUARTZ trial?</div>

A

“-QALYs noninferior<br></br>-Median OS ~2 mos, not different<br></br>-No difference in QOL or dex use<div><br></br>-On subanalysis, those with ≥5 metastatsis did show OS benefit from WBRT.</div><div><br></br>There was some trend to OS benefit ifprimary controlled, no extracranial mets, or higher GPA.</div>”

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22
Q

<div>What trial demonstrated WBRT for palliation of brain mets is noninferior to observation in QALY outcomes in these poor prognosis patients?</div>

A

QUARTZ<div><div>Although, on subanalysis OS favors WBRT for ≥5 mets or age <60?</div></div>

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23
Q

<div>What was the patient population studied in EORTC 22952-26001trial?</div>

A

1-3 brain mets <3.5cm,<div>Controlledextracranial disease,</div><div>PS0-2</div><div><br></br></div><div>(n=359)</div>

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24
Q

<div>What was the regimen studied in EORTC 22952-26001?</div>

A

Complete surgery or SRS →<div><br></br>→obs<br></br>vs.<br></br>→WBRT 30 Gy</div>

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25
Q

<div>What were the results of EORTC 22952-26001?</div>

A

•HRQOL worse with WBRT<div><br></br>•Time to worse performance statusunchanged, 11.7 mos vs. 9.5 mos</div><div>•OS similar, ~10.8 mos mos (NS)<br></br>•Neuro death improved with WBRT: 44% vs. 28% WBRT<br></br><br></br></div>

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26
Q

What were the 2-yr LC with surgery and SRS vs WBRT?

A

<div>2-yr LC surgery: 41% obs vs. 72% WBRT<br></br></div>

<div><br></br></div>

2-yr LC SRS: 69% obs vs. 81% WBRT<div><br></br><div>Intracranial progression 44% vs. 28%<br></br>Subanalysis shows that surgery and SRS are similar in outcomes.</div></div>

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27
Q

<div>What trial demonstrated WBRT after surgery or SRS in limited mets reduces LR but does not improve QOL or OS?</div>

A

EORTC 22952-26001

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28
Q

<div>What was the patient population studied in JSROG trial?</div>

A

1-4 brain mets <3cm<div><br></br></div><div>n=132</div>

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29
Q

<div>What was the regimen studied in JSROG?</div>

A

→SRS<br></br>vs.<br></br>→SRS+WBRT 30 Gy/10 fx<div><br></br>SRS dose 18-25 Gy for SRS alone.<br></br>Dose reduced 30% if with WBRT</div><div><br></br>MMSE used to measure cognitive<br></br>function</div>

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30
Q

<div>What were the results of JSROG trial?</div>

A

•WBRT decreased recurrence but noimprovement in OS or neuro death.<br></br>•Median OS 8.0 mos vs. 7.5 WBRT+SRS (NS)<div><br></br>•1-yr OS 28% vs. 39% (NS)<br></br>•No diff in toxicity, neuro function<br></br><br></br></div>

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31
Q

<div>What trial demonstrated SRS alone without WBRT in limited mets resulted in increased brain tumor recurrence but no change in OS or neurologic death?</div>

A

JSROG (Aoyama et al, JAMA 2006 and 2015)

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32
Q

<div>What was the patient population studied in MDACC (Chang et al, Lancet Oncol, 2009) trial?</div>

A

1-3 brain mets<div>n=58</div>

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33
Q

What was the regimen studied in MDACC (Chang et al, Lancet Oncol, 2009)?

A

→SRS<br></br>vs.<br></br>→SRS+WBRT 30 Gy/12 fx<div><br></br>Primary endpoint: neuro functionper HVLT-R</div>

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34
Q

What were the results of MDACC (Chang et al, Lancet Oncol,2009) trial?

A

•Terminated early: SRS+WBRT showed worse neuro decline at 4 months. LC improved with WBRT, but not OS<br></br><br></br><div>•Neuro decline: SRS alone 24% vs. 52%SRS+WBRT</div><div><br></br></div><div>•OS worse with WBRT, 15 mos vs. 6 mos</div>

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35
Q

What trial demonstratedworse neurodecline and worse OS with the addition of WBRT to SRS in limitedmets?

A

MDACC (Chang et al,Lancet Oncol,2009)

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36
Q

<div>What was the patient population studied in Alliance N0574 trial?</div>

A

1-3 brain mets<div>(n=213)</div>

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37
Q

What was the regimen studied in Alliance N0574?

A

→SRS <br></br>vs. <br></br>→SRS+WBRT 30 Gy/12 fx<br></br><br></br>SRS dose 18-22 Gy in SRS+WBRT<br></br>and SRS dose 20-24 Gy for SRS alone

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38
Q

<div>What were the results of Alliance N0574?</div>

A

-Median OS: 10.4 mos vs. 7.4 mos (p=.92)<div><br></br>-12-mo LC 73% vs. 90% with WBRT<br></br>-12-mo total brain control 51% vs. 85%<br></br>-Time to recurrence shorter with SRS<br></br><br></br>No effect of DS-GPA on OS<br></br><br></br></div>

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39
Q

What trial demonstrated SRS without WBRT in limited mets results in less neuro decline?

A

<div>Alliance N0574.</div>

Tumor reccurence is increased somewhat without WBRT but without change in OS.

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40
Q

<div>What was the patient population studied in RTOG 9508 trial?</div>

A

1-3 mets<div><br></br></div><div>(n=333)</div>

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41
Q

<div>What was the regimen studied in RTOG 9508?</div>

A

“<span>→WBRT 37.5 Gy <br></br></span>vs. <br></br>→SRS+WBRT<span><br></br><br></br>SRS dose per RTOG 9005:<br></br>24 Gy size ≤2.0 cm<br></br>18 Gy size >2 to ≤3cm<br></br>15 Gy size >3 cm</span>”

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42
Q

<div>What were the results of RTOG 9508?</div>

A

“<span>Addition of SRS to WBRT improved LC and KPS but no change in OS</span><br></br>1-yr LC 71% WBRT vs. 82% SRS+WBRT<br></br><br></br><div><br></br>•On MVA of all patients in both arms, RPA 1 and NSCLC histology had better OS (regardless of treatment arm)<br></br>•Median OS 5.7 mos SRS vs. 6.5 mos (NS)</div>”

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43
Q

What trial demonstrated adding an SRS boost to WBRT in limited mets improves LC?

A

RTOG 9508

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44
Q

<div>What was the patient population studied in RTOG 9005 trial?</div>

A

Recurrent primary or recurrent brain tumors s/p prior WBRT<div><br></br></div><div>(n=156)</div>

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45
Q

<div>What was the regimen studied in RTOG 9005?</div>

A

“Phase I Dose escalation in 3 Gy increments, beginning at:<br></br>18 Gy for ≤2 cm<br></br>15 Gy for 2-3 cm<br></br>12 Gy for 3-4 cm<br></br>Grade 3-5 toxicity defined as limiting.<br></br><br></br><span>All had previous WBRT (range 30-60 Gy).</span> LINAC and GammaKnife allowed. Dose to 50-90% isodose line.”

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46
Q

<div>What were the results of RTOG 9005?</div>

A

Max tolerated doses: 18 Gy for 21-30 mm and 15 Gy for 31-40 mm. 24 Gy for ≤20 mm was the highest evaluable dose but may not be MTD; Investigators declined to escalate to 27 Gy in ≤2 cm.<br></br><br></br>Diameter associated with neurotoxicity.

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47
Q

<div>What trial demonstrated max tolerated doses in SRS for brain mets: 24 Gy for ≤20 mm, 18 Gy for 21-30 mm, and 15 Gy for 31-40 mm?</div>

A

RTOG 9005

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48
Q

What trial established SRS dosing following WBRT for later trials?<div>(Hint: Phase I dose escalation in 3 Gy increments)</div>

A

“RTOG 9005<div><br></br></div><div><span>Prior WBRT in all patients. </span>Established dosing for later trials. This is a phase I toxicity study and was not powered for LC. On a MVA dose was not associated with LC: lower doses may have just as effective LC. (The authors did a rudimentary LC analysis looking at GK and Linac, but arms are too imbalanced to draw conclusions.) 36% were primary tumors, 64% were mets.<br></br></div>”

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49
Q

“<div>What was the patient population studied in MDACC (<a>Li et al, ASTRO, 2020</a>)?</div>”

A

4-15 brain metastases, non-melanoma<div><br></br></div><div>(n=72)</div>

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50
Q

“What was the regimen studied in MDACC (<a>Li et al, ASTRO, 2020</a>)?”

A

→SRS<br></br>vs. <br></br>→WBRT (62% had memantine)<br></br><br></br>Neurocognitive testing

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51
Q

“What were the results MDACC (<a>Li et al, ASTRO, 2020</a>)?”

A

Cognitive function is better with SRS<br></br><br></br>Median OS 8-10 mos, p=0.45<br></br>Distant brain failure 4.2 mos vs. 18.1 mos<br></br>LC 100% vs. 95.5%

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52
Q

<div>What trial demonstratedSRS for 4-15 brain metastasis has unchanged OS compared to WBRT and superior cognitive function with SRS?</div>

A

“MDACC (<a>Li et al, ASTRO, 2020</a>)”

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53
Q

<div>What was the patient population studied inMount Sinai, NY (Lehrer et al, IJROBP, 2019)?</div>

<br></br>

A

(n=1887) brain metsSRS to large brain mets

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54
Q

<div>What was the regimen studied in Mount Sinai, NY (Lehrer et al, IJROBP, 2019) meta trial?</div>

A

“Meta-analysis of 24 studies of <span>single and multi fx SRS to brain</span> mets. Evaluates radiation necrosis and LC<br></br><br></br>Various doses and fractionation regimens used”

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55
Q

What were the results of Mount Sinai, NY (Lehrer et al, IJROBP, 2019) meta trial?

A

“<span>LC in size 4-14 cc (2-3 cm) definitive<br></br></span>•single fx 78% vs. multi 93%, p=0.18<div><br></br><span>LC in size >14 cc (>3cm) definitive<br></br></span>•single fx 78% vs. multi 79%, p=.76</div><div><br></br><span>LC in size >14 cc (>3cm), post op<br></br></span>•single fx 62% vs. multi 86%, p=0.13<br></br><br></br></div>”

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56
Q

<div>What trial demonstrateda reduction in radiation necrosis with multi fx RT in tumors size 4-14 cc, about 2-3 cm diameter?</div>

A

Mount Sinai, NY (Lehrer et al, IJROBP, 2019) meta trial

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57
Q

<div>What was the patient population studied in N107C/ CEC.3/ RTOG 1270?</div>

A

1-4 brain metastases and resection of 1 lesion. STR allowed (77%% had single met, ~10% STR)<br></br><br></br>Resection cavity <5 cm and unresected lesions ≤3.0 cm<div><br></br></div><div>(n=194)</div>

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58
Q

<div>What was the regimen studied in N107C/ CEC.3/ RTOG 1270?</div>

A

“<span>→SRS to cavity </span><br></br>vs. <br></br>→WBRT to 30 or 37.5 Gy <br></br><br></br>Unresected lesions treated with SRS in both arms<br></br>”

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59
Q

<div>What were the results of N107C/ CEC.3/ RTOG 1270?</div>

A

“<span>Worse LC in cavity with SRS<br></br>12-mo cavity LC 61% vs. 81% (supp data)</span><span><br></br></span><span>12-mo distant brain control 65% vs. 89%<br></br></span><br></br>Median OS ~12 mos, not different<br></br><span><br></br>-Better cognitive deterioration free survival with SRS</span>, median 3.7 mos vs. 3.0 mos<br></br><br></br><br></br><br></br>”

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60
Q

In N107C/ CEC.3/ RTOG 1270, how did the 30Gy regimen compare to the 37.5 Gy WBRT regimen?

A

“<span>30 Gy and 37.5 Gy compared: </span><br></br><span>-More grade ≥3 toxicity with 37.5 Gy<br></br></span>-No difference in cognitive failure (p=0.64).<div><br></br></div><div><br></br></div><div><br></br></div><div>Some trend to benefit in cavity LC (p=0.14), cranial control (p=0.09), and OS (p=0.18) with 37.5 Gy</div>”

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61
Q

<div>What trial demonstrated :</div>

<div>a) SRS alone leads to unchanged OS compared to WBRT alone</div>

<div>b) WBRT has better LC</div>

<div>b) QOL is improved with SRS?</div>

A

“N107C/ CEC.3/ RTOG 1270<div><span><a>Brown et al, Lancet Oncol, 2017<br></br>Trifiletti et al, ASTRO, 2019</a></span><br></br></div><div><br></br></div>”

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62
Q

<div>What was the patient population studied in JCOG 0504?</div>

A

“1-4 brain metastasis and <span>resection of all, GTR or STR </span>(73% had single met)<span><br></br></span><br></br>One lesion >3 cm allowed<div><br></br></div><div>(n=271)</div>”

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63
Q

What was the regimen studied in JCOG 0504?

A

“Resection of <span>all</span> brain mets →<br></br><br></br>→SRS to cavity for STRs, observe GTRs (termed ““salvage SRS””)<br></br>vs. <br></br>→WBRT 37.5 Gy<span><br></br><br></br>40% in SRS arm had STR and SRS; 60% had GTR and obs<br></br></span><br></br>SRS doses: 24 Gy for ≤4 cc, 18 Gy for >4 cc”

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64
Q

<div>What were the results of JCOG 0504?</div>

A

“-Cavity LC 51% vs. 78% (WBRT)<br></br>-Median OS 15.6 mos, not different<div><br></br><span>Grade 2-4 cognitive toxicity 7.7% vs. 16.4% (WBRT)</span></div>”

65
Q

What trial demonstrated that SRS for STR only in resected brain mets is noninferior compared to WBRT in OS although LR is increased?

A

“JCOG 0504<a>Kayama et al, JCO, 2017</a>”

66
Q

“What were the criticisms of JCOG 0504<a>Kayama et al, JCO, 2017</a>?”

A

This study requires resection of all brain mets. SRS was given only when resection was subtotal (40%), but not for GTR (60%), which may explain the poor LC in this study. <br></br><br></br>WBRT was 15 fractions (higher BED than 30 Gy in 10 fx).

67
Q

<div>What was the patient population studied inMDACC (Mahajan et al, Lancet Oncol, 2017)?</div>

A

1-3 brain metastases and GTR of ≥1 lesion (~62% had single met)<br></br><br></br>Resection cavity ≤4 cm and unresected lesions ≤3 cm<div><br></br></div><div>n=131</div>

68
Q

<div>What was the regimen studied in MDACC (Mahajan et al, Lancet Oncol, 2017)?</div>

A

“<span>→SRS to cavity</span><br></br>vs. <br></br>→Obs to cavity <br></br><br></br>Unresected lesions treated with SRS in both arms<br></br><br></br>SRS doses: 16 Gy for ≤10 cc, 14 Gy for >10.1-15 cc, 12 Gy for >15 cc”

69
Q

What were the results of MDACC (Mahajan et al, Lancet Oncol, 2017)?

A

“<span>LC improved with SRS over obs<br></br>12-mo cavity LC 72% vs. 43% (obs)</span><br></br>Median OS 17 mos, not different<br></br>”

70
Q

<div>What trial demonstratedpostoperative SRS is effective at the reduction of LF and may be considered as an alternative to WBRT?</div>

A

Mahajan, MDACC (Lancet Oncol 2017)

71
Q

What is theRTOG Recursive Partitioning Analysis (RPA) prognostic system?

A

“<img></img>”

72
Q

What is the revised diagnosis-specific GPA (Graded Prognostic Assessment)?

A

“Most recent multi-institutionalretrospective cohort, more modern than the RPA and less subjective<div><br></br></div><div><img></img><br></br></div>”

73
Q

“<div>What were the results of the 3 BTSG trials for malignant glioma (86% GB, n=621;<a>Walker et al, IJROBP, 1979</a>)?</div>”

A

“Median OS: <span>18 wks for no RT</span>, 28 wks for 50 Gy, 36 wks for 55 Gy, and <b>42 wks for 60 Gy.</b><br></br><br></br>KPS was biased against the ≤45 Gy, group - more died in that group before completing therapy”

74
Q

<div>What was the patient population studied in EORTC 26899 (Stupp et al, NEJM, 2005<br></br>Hegi et al, NEJM, 2005, Stupp et al, Lancet Oncol, 2009)?</div>

A

PRT of 573 pts with GBM, ages 18 to 70 with ECOG PS 0-2.<div><br></br></div><div>MGMT was methylated in 45%</div>

75
Q

<div>What was the regimen studied in Stupp EORTC 26899/NCIC?</div>

A

“<span>→60 Gy + conc TMZ & adj TMZ x6<br></br></span>vs. <br></br>→60 Gy <span><br></br><br></br></span>Later analysis evaluated effect of MGMT methylation”

76
Q

<div>What were the results of Stupp EORTC 26899/NCIC?</div>

A

Improved OS with TMZ. <br></br>Median OS 14.6 mos vs. 12.1 mos<div><br></br>2-yr OS 26.5% vs. 10.4%. <br></br>5-yr OS 10% vs. 2%<br></br><br></br></div>

77
Q

How were the outcomes of Methylated MGMT vs Unmethylated MGMT GBM patients differ in Stupp EORTC 26899/NCIC?

A

“Adding TMZ to RT results in OS benefit. Only those with a methylated MGMT promoter benefitted, though there was trend to benefit without methylation.<div><br></br><span>Methylated MGMT:</span><br></br>Median OS 22 mos TMZ vs. 15 mos<br></br>2-yr OS 46% vs. 23%<br></br>5-yr OS 14% vs. 5%<br></br><br></br><span>Unmethylated MGMT:</span><br></br><span>Median OS 12.7 vs. 11.8 mos (p=0.06)</span><br></br>2-yr OS 14% vs. 2%<br></br>5-yr OS 8% vs. 0</div>”

78
Q

<div>What was the patient population studied in CeTeG / NOA-09 (Herrlinger et al, Lancet, 2019)?</div>

A

“Glioblastoma with <span>methylated MGMT</span><div><span><br></br></span></div><div>n=141</div>”

79
Q

<div>What was the regimen studied in CeTeG / NOA-09?</div>

A

“→60 Gy + conc & adj TMZ<br></br>vs.<br></br><span>→60 Gy + TMZ + lomustine</span>”

80
Q

<div>What were the results of CeTeG / NOA-09?</div>

A

“Median OS 31<span> vs. 48 mos (ITT) (+Lomustine group)</span><br></br>Median OS 30 vs. 40 mos per protocol <br></br>”

81
Q

<div>What trial demonstrated improved OS with the addition of lomustine to TMZ and RT in GB with methylated MGMT?</div>

A

CeTeG / NOA-09<div>Herrlinger et al, Lancet, 2019</div><div><br></br></div><div>The trial may be underpowered. The modifed ITT analysis leads to patients being excluded and even lower power. Some call for a multi-institutional trial with larger numbers (Stupp 2019). It is unclear how there can be a change in OS without a change in PFS. Perhaps lomustine has a later effect, or lomustine creates more pseudoprogression that was called progression. There were some small differences in 2nd line therapies but not major.<br></br></div>

82
Q

<div>What was the patient population studied in EF-14 (Stupp et al, JAMA, 2015; Kesari et al, SNO, 2015; Stupp et al, JAMA, 2017)?</div>

A

315 newly diagnosed glioblastoma<div>Optune tumor TTF trial</div>

83
Q

<div>What was the regimen studied in EF-14 (Stupp et al, JAMA, 2015; Kesari et al, SNO, 2015; Stupp et al, JAMA, 2017)?</div>

A

“RT + conc TMZ →<br></br><br></br><span>→adjuvant TMZ + tumor treating fields (until 2nd progression or 2 years)<br></br></span>vs.<br></br>→adjuvant TMZ”

84
Q

What were the results of EF-14 (Stupp et al, JAMA, 2015; Kesari et al, SNO, 2015; Stupp et al, JAMA, 2017)?

A

“<span>OS improved with TTF</span><br></br>Median OS 20.9 mos vs. 16.0 mos<br></br><span>2-yr OS 43% vs. 31%<br></br></span>Median PFS 6.7 vs. 4.0 mos<div><br></br><span>On subanalysis, benefit present in any MGMT status, any age</span><br></br></div>”

85
Q

What trial demonstrated NovoTTF is associated with a 5-month OS benefit when added to adjuvant TMZ as part of Stupp protocol?

A

<b>EF-14 (Stupp et al</b>, JAMA, 2015; Kesari et al, SNO, 2015; Stupp et al, JAMA, 2017)<div><br></br></div><div><br></br></div><div>Tumor treating fields (TTF) mechanism: low amplitude alternating electric fields that disrupt cell division and organelles. Required to wear ≥18 hrs in protocol.<br></br><br></br>Sharp dropoff of treatment effect if device worn <50% of time. At 75% of time (18 hours), a greater benefit occurs.<br></br></div>

86
Q

What was the patient population studied in RTOG 0825?

A

Glioblastoma<div><br></br></div><div>n=978</div>

87
Q

What was the regimen studied inRTOG 0825?

A

60 Gy + TMZ →<br></br><br></br>→bevacizumab <br></br>vs. <br></br>→placebo<br></br><br></br>Bev started at week 4 during RT and continued as maintenance<br></br><br></br>Crossover allowed if disease progression

88
Q

What were the results of RTOG 0825?

A

“<span>No change in OS</span>: 15.7 vs. 16.1 mos<br></br>PFS longer with bev: 10.7 mos vs. 7.3 mos<div><br></br>•Adverse effects higher in bev group: hypertension, thromboembolism, intenstinal perf, neutropenia, decline in QOL and cognitive function<br></br>•Those with Pro-B type (indicative of proneural) had improved PFS, but not OS. But non-Pro B type had worse OS</div>”

89
Q

What trial demonstrated bevacizumab improves only PFS without benefit in OS while increasing toxicity, including cognitive?

A

<div>RTOG 0825</div>

<div><br></br></div>

PFS may be a result of vascular changes and not tumoricidal effects.<div>Some say lack of OS benefit was due to crossover, but note that median OS without bev is nearly identical to EORTC Stupp trial outcome and a direct comparison is not possible (Stupp 2009). Bevacizumab also failed to show OS benefit in a randomized trial in recurrent GB (Wick 2017).<br></br></div>

90
Q

What was the patient population studied in EORTC 26062/TROG/CCTG?

A

“Glioblastoma <span>age ≥65</span>”

91
Q

What was the regimen studied in EORTC 26062/TROG/CCTG?

A

“<span>→40 Gy/15 fx + conc and adjuvant TMZ <br></br></span>vs. <br></br>→RT alone 40 Gy/15 fx”

92
Q

What were the results of EORTC 26062/TROG/CCTG?

A

“<span>Median OS and PFS improved with TMZ</span><br></br>Median OS 9.3 mos vs. 7.6 mos<br></br>Median PFS 5.3 mos vs. 3.9 mos<div><br></br>Methylated MGMT median OS 13.5 mos vs. 7.7 mos—->statistically significant<br></br>Un-methylated MGMT median OS 10.0 mos vs 7.9 mos—->NOT statistically significant</div>”

93
Q

What trial demonstrated an OS benefit with the addition of TMZ in elderly GM patients<br></br>receiving a hypofractionated RT?

A

EORTC 26062/TROG/CCTG?<div><br></br></div><div>Pts with MGMT methylation benefit most fromRT + TMZ with a ~6-month improvement in OS.<br></br></div>

94
Q

What trial demonstrated TMZ alone is a noninferior option compared to standard RT in elderly pts and may be preferred<br></br>over RT alone in pts with MGMT promoter methylation?

A

“<b>NOA-08 (Wick,Lancet Oncology 2012)</b><div><br></br></div><div>TMZ was noninferior to RT in elderly or poor KPS GB. TMZ is ideal for methylated MGMT and RT is ideal for unmethylated MGMT.<br></br></div><div><br></br></div><div><span>RT and TMZ noninferior: <br></br>OS 9.6 mos vs. 8 mos</span><br></br>-With MGMT methylation, longer EFS with TMZ: 8.4 vs. 4.6 mos<br></br>-With no MGMT methylation, outcomes poor but RT better: 4.6 vs. 3.3 mos<br></br></div>”

95
Q

What was the patient population studied in Malmström, Nordic Trial (Lancet 2012)?

A

High grade glioma in age ≥60<div>n=342</div>

96
Q

What was the regimen studied inMalmström, Nordic Trial (Lancet 2012)?

A

→60 Gy/30 fx <br></br>vs. <br></br>→34 Gy/10 fx <br></br>vs. <br></br>→TMZ alone

97
Q

What were the results ofMalmström, Nordic Trial (Lancet 2012)

A

MS was significantly improved for pts<br></br>receiving TMZ alone (8 mos) versus standard RT (6 mos) but not versus hypofractionated<br></br>RT (7.5 mos).

98
Q

What was the patient population studied in Roa, Canadian (JCO 2004)?

A

GBM, age ≥60 and KPS≥50<div><br></br><div>n=100</div></div>

99
Q

What was the regimen studied in Roa, Canadian (JCO 2004)?

A

→60 Gy/30 fx <br></br>vs. <br></br>→40 Gy/15 fx

100
Q

What were the results of Roa, Canadian (JCO 2004)?

A

MS was 5.1 mos for standard (60Gy/30) versus 5.6 for shorter course RT (40Gy/15) (p = NS)<div><br></br></div><div>26% pts stopped long-courseRT versus 10% in short-course arm<br></br></div>

101
Q

What trial demonstrated no difference in OS between 40 Gy/15 fx and standardfractionation in pts older than 60 who are not receivingsystemic therapy?

A

Roa, Canadian (JCO 2004)

102
Q

What was the patient population studied in Roa, IAEA (JCO 2015)?

A

GBM + age ≥50, KPS 50-70, or age ≥65 KPS 50-100<div>n=98</div>

103
Q

What was the regimen studied inRoa, IAEA (JCO 2015)?

A

→25 Gy/5 fx <br></br>vs. <br></br>→40 Gy/15 fx

104
Q

What were the results ofRoa, IAEA (JCO 2015)?

A

Pts receiving 25 Gy/5 fx had noninferior OS compared to those receiving 40 Gy/15fx, and no difference in PFS or QOL.<div><br></br></div><div>Conclusion: Short-course RT delivered in 1 week (25Gy/5 fx) is a treatment option for elderly and/or frail pts with newly diagnosed GBM.</div>

105
Q

What trial demonstrated improves OS with RT over best supportive care in elderly GBM pts with good KPS?

A

Keime-Guibert, France (NEJM 2007)<div><br></br></div><div>Median OS 7.3 mos RT (50 Gy/28 fx) vs. 4.3 mos<br></br>No diff in QOL or cognition<br></br></div>

106
Q

What trial established 11 Gy x 3 fx as the maximum tolerated dose for single site small size recurrent GBM treated with RT?

A

MSKCC Clarke et al, IJROBP, 2017<div><br></br><div>Recurrent glioblastoma or anaplastic astrocytoma, size ≤40cc; Phase 1 with 15pts<br></br><br></br></div><div>SRT delivered to GTV plus 2-5 mm PTV margin<br></br></div></div>

107
Q

What phase III trial demonstrated no OS benefit but improvement in PFS with addition of bevazicumab to lomustine?

A

EORTC 26101(Wick et al, NEJM, 2017)<div><br></br></div><div>→lomustine plus bevacizumab <br></br>vs. <br></br>→lomustine alone<br></br></div><div><br></br></div><div>in first progression of GBM</div>

108
Q

What was the patient population studied inRTOG 9402 Cairncross et al (JCO, 2006 and JCO, 2013, and JCO, 2014)?

A

Anaplastic Oligoastrocytoma (AOA), and Anaplastic Oligodendroglioma (AO) s/p surgery<div><br></br></div><div>n=289</div>

109
Q

What was the regimen studied in RTOG 9402 Cairncross et al (JCO, 2006 and JCO, 2013, and JCO, 2014)?

A

“<b>→</b><i>neoadj </i><i>dose escalated PCV x4</i> (procarbaine, CCNU, vincristine) → RT 59.4 Gy<br></br>vs. <br></br>→RT 59.4 Gy”

110
Q

What were the results of RTOG 9402 Cairncross et al (JCO, 2006 and JCO, 2013, and JCO, 2014)?

A

“<img></img>”

111
Q

What was the patient population studied in van den Bent, EORTC 26951 (JCO 2006)

A

Anaplastic Oligoastrocytoma (AOA), and Anaplastic Oligodendroglioma (AO) s/p surgery<div><br></br></div><div>n=368</div>

112
Q

What was the regimen studied in van den Bent, EORTC 26951 (JCO 2006)?

A

“→RT 59.4 Gy → <i>adj</i> <span>PCV</span> x6 <br></br>vs. <br></br>→RT alone (PCV allowed at progression)”

113
Q

What were the results of van den Bent, EORTC 26951 (JCO 2006)?

A

“<img></img><div><img></img><br></br><div><br></br></div></div>”

114
Q

What trial demonstrated improvement in PFS but not OS in AO with <i><b>adjuvant </b></i>PCV?

A

EORTC 26951 van den Bent et al, JCO, 2006 and JCO, 2013<div><br></br></div><div><i>RTOG 9402 was neoadjuvant PCV</i></div>

115
Q

What was the patient population studied in NOA-04 Wick et al (JCO, 2009;Neuro Oncol 2016)?

A

“AA (some AO, AOA), KPS≥70<div><br></br></div><div>n=274<br></br><br></br>["”AOA”” diagnosis is now strongly discouraged in WHO 2016]</div>”

116
Q

What was the regimen studied in NOA-04 Wick et al (JCO, 2009;Neuro Oncol 2016)?

A

→60 Gy (Arm A) <br></br>vs. <br></br>→PCV/TMZ (Arm B1/B2)<br></br><br></br>Crossover at toxicity or progression: <br></br>•Arm A→PCV or tem<br></br>•Arm B→RT<br></br><br></br>Primary endpoint: TTF

117
Q

What were the results of NOA-04 Wick et al (JCO, 2009;Neuro Oncol 2016)?

A

“•Median TTF, PFS, and OS were similar for arms A and B1/2<div><br></br><span>•IDH1 mutation is strongest prognostic factor, even more than 1p19q codel</span><br></br>•methylated-MGMT and oligo histology also associated with better PFS (methylated-MGMT gave same prognosis with chemo and RT)</div>”

118
Q

What trial demonstrated no change in outcomes in AA and AO sequencing order of RT and chemo?

A

NOA-04 Wick et al (JCO, 2009;Neuro Oncol 2016)<div><br></br></div><div>Molecular diagnosis is superior to histology to convey prognosis.<br></br></div><div><br></br>No differential activity of chemo vs. RT in any subgroup.<br></br></div>

119
Q

What was the patient polutation studied inCATNON (van den Bent et al, ASCO, 2019)?

A

“<span>anaplastic glioma</span> <span>without</span> 1p19q co-deletion”

120
Q

What was the regimen studied in CATNON (van den Bent et al, ASCO, 2019)?

A

“→RT alone 59.4 Gy<br></br>vs. <br></br>→RT with conc TMZ <br></br>vs. <br></br><span>→RT with adj TMZ</span> <br></br>vs. <br></br>→RT with conc & adj TMZ”

121
Q

What were the results of CATNON (van den Bent et al, ASCO, 2019)?

A

○ Interim results for arms ± adjuvant TMZ: 5y OS 44→ 56%, MPFS 19→ 43 mo. IDHmt benefit from adjuvant TMZ.<div><br></br>○ ASCO results for ± concurrent TMZ: HR 0.97. 5y OS ~50%. Trend to benefit with concurrent TMZ for IDHmt.</div>

122
Q

What trial demonstrated the following:<div>-OS benefit with adj TMZ in IDH mutant tumors but not IDH wt. <br></br>-No benefit to conc TMZ, but there is a trend to benefit with the addition of conc to adj in IDH mutant?<br></br></div>

A

CATNON (van den Bent et al, ASCO, 2019)

123
Q

What is the patient population and regimen in the ongoingCODEL (Jaeckle et al, Neuro Oncol. 2020)?

A

grade IIIwith 1p19qcodel glioma and grade II oligo with age≥40 or subtotal resection<div><br></br></div><div><br></br>→TMZ alone<br></br></div><div>vs.<br></br>→RT 59.4 Gy then PCV<br></br>vs.<br></br>→RT + conc and adj TMZ</div>

124
Q

<div>What was the patient population studied in RTOG 9802 Shaw et al (JCO, 2012, Buckner et al, NEJM, 2016</div>

Bell et al, JCO, 2020)?

A

WHO Grade II astrocytoma, oligoastrocytoma, or oligodendroglioma<div><br></br></div><div>n=365</div>

125
Q

What was the regimen studied in RTOG 9802 Shaw et al (JCO, 2012, Buckner et al, NEJM, 2016<br></br>Bell et al, JCO, 2020)?

A

“High risk (age ≥40 or STR):<br></br> <br></br>→<span>54 Gy RT → PCV x6</span><br></br>vs. <br></br><span>→</span>54 Gy RT <br></br><br></br>Low risk: obs<span><br></br></span><br></br>PCV= procarbazine/CCNU/vincristine”

126
Q

What were the results of RTOG 9802 Shaw et al (JCO, 2012, Buckner et al, NEJM, 2016<br></br>Bell et al, JCO, 2020)?

A

“PFS and OS improved with PCV<br></br><span>Median OS 13.3 yrs vs. 7.8 <br></br>Median PFS 10.4 yrs vs. 4.0</span><div><br></br>•On subanalysis, benefit only in IDH-mutant (non-codeleted or codeleted). There is no benefit to chemo in IDH-wt</div>”

127
Q

What trial demonstrated an improvement in OS and PFS in high risk low grade glioma with the addition of PCV to radiation?<br></br>

A

RTOG 9802 Shaw et al (JCO, 2012, Buckner et al, NEJM, 2016, Bell et al, JCO, 2020)<div><br></br>On subanalysis, benefit only in IDH-mutant (non-codeleted or codeleted). There is no benefit to chemo in IDH-wt</div>

128
Q

What was the patient population in INT/NCCTG 86-72-51(Shaw et al, JCO, 2002<br></br>Breen et al, Neuro Oncol, 2020)?

A

WHO I-II disease s/p surgery<div><br></br></div><div>n=203</div>

129
Q

What was the regimen studied in INT/NCCTG 86-72-51(Shaw et al, JCO, 2002, Breen et al, Neuro Oncol, 2020)?

A

“<span>→50.4 Gy</span> <br></br>vs. <br></br>→64.8 Gy”

130
Q

What were the results of INT/NCCTG 86-72-51(Shaw et al, JCO, 2002,Breen et al, Neuro Oncol, 2020)?

A

No difference in OS or PFS <br></br>5-yr OS 72% low dose vs. 64% <br></br><br></br>•More Grade 3-5 toxicity with high dose. <br></br>•Favorable prognostic factors: age <40, oligo histo

131
Q

<div>What trial demonstrated no OS benefit to dose escalation (50.4 vs 64.8 Gy) in low grade glioma (necrosis is increased) ?</div>

A

INT/NCCTG 86-72-51(Shaw et al, JCO, 2002,Breen et al, Neuro Oncol, 2020)

132
Q

What was the patient population studied in Believers trial EORTC 22844?

A

WHO I-II disease s/p surgery<div><br></br></div><div>n=343</div>

133
Q

What was the regimen studied in Believers trial EORTC 22844?

A

<div>→45 Gy <br></br>vs. <br></br>→59.4 Gy<br></br></div>

<div><br></br></div>

<div><br></br></div>

low-grade astrocytomas, oligodendrogliomas, and mixed oligoastrocyatoma,<br></br>ages 16 to 65, KPS ≥60, randomized to 45 Gy/25 fx versus 59.4 Gy/33 fx after<br></br>surgery (any degree of resection).

134
Q

What were the results of Believers trial EORTC 22844?

A

“No difference in 5-yr OS (59% vs. 58%) or PFS (50% vs. 47%) with dose escalation (45Gy vs 59.4)<div><br></br></div><div><br></br><span>Prognostic variables: size ≥6 cm, age ≥40, tumor crossing midline, astrocytoma, neuro deficits [mnemonic: ““SATAN”” criteria]<br></br>3-5 factors is high risk</span></div>”

135
Q

What trial demonstrated no role for dose escalation (45Gy vs 59.4Gy) in WHO GII (although molecular information is not available on this trial)?

A

Believers trial EORTC 22844<div><br></br>Pignatti risk factors (SATAN) : preop S ize ≥ 6 cm, A ge ≥ 40y, bihemispherical T umor, A A, or a pre op N euro fxn status >1.</div>

136
Q

What was the patient population studied in Nonbelievers trial EORTC 22845?

A

WHO I-II s/p surgery (any kind)<div><br></br></div><div>n=311</div>

137
Q

What was the regimen studied Nonbelievers trial EORTC 22845?

A

“<span>→54 Gy</span>/ 30 fx<br></br>vs. <br></br>→obs (RT allowed at recurrence)”

138
Q

What were the results of Nonbelievers trialEORTC 22845?

A

“5-yr PFS improved RT 55% vs. 35%<br></br>5-yr OS unchanged at 66-68%<div><br></br><span>•Rate of malignant transformation 72% vs. 66% (NS)</span><br></br>•No changes in cognitive deficits after treatment<br></br>•RT helped to control seizures</div>”

139
Q

What trial demonstated immediate(vs. delayed) RT improved PFS and decreased seizure rate, but did not improve OS?

A

Nonbelievers trialEORTC 22845<div><br></br></div><div>Note that 65% of pts in observation arm eventually received RT salvage contributing to higher than expected surival.</div>

140
Q

What was the patient population studied in Baumert, EORTC 22033-26033 (Lancet Oncol 2016)?

A

<div>LGG with≥1 high-risk feature (Age ≥40, progressive mass, new or worsening neuro symptoms, intractable seizures)</div>

<div><br></br></div>

<div>n=477</div>

141
Q

What was the regimen studied inBaumert, EORTC 22033-26033 (Lancet Oncol 2016)?

A

→50.4 Gy <br></br>vs. <br></br>→dose dense TMZ (75 mg/m2 days 1–21 of a 28-day cycle, max 12 cycles)

142
Q

What were the results of Baumert, EORTC 22033-26033 (Lancet Oncol 2016)?

A

PFS 46 mos with RT vs. 39 mos TMZ, p=0.22<div><br></br>•If IDHmt/non-codel, RT had longer PFS. No different in PFS with IDHmt/codel and IDHwt tumors<br></br>•Median OS not reached<br></br>•No differences in HRQOL or global cognitive function between groups</div>

143
Q

What trial demonstrated no significant difference in PFS for LGG treated withRT alone versus TMZ alone?

A

Baumert, EORTC 22033-26033 (Lancet Oncol 2016)<div><br></br></div><div>Criteria used in this study are similar to the so called SATAN criteria from the EORTC Believers’ study but modified (Karim 1996).<br></br></div>

144
Q

What was the patient population studied in Fisher, RTOG 0424 (IJROBP 2015)?

A

Low grade glioma (high risk) with ≥3 risk factors (age ≥40, astrocytoma, crosses midline, size 6 cm, pre-op neuro function status >1)<div><br></br></div><div>n=129</div>

145
Q

What was the regimen studied in Fisher, RTOG 0424 (IJROBP 2015)?

A

Phase II<br></br>54 Gy + conc and adj TMZ

146
Q

What were the results of Fisher, RTOG 0424 (IJROBP 2015)?

A

“<span>3-yr OS 74% [improved from historical control 54%]</span><br></br><br></br>Median OS 8.2 yrs<br></br>Median PFS 4.5 yrs <br></br>MGMT associated with improved OS<br></br><br></br>”

147
Q

What trial demonstrated improved OS in high risk LGG compared to historical controls treated with RT + TMZ?

A

Fisher, RTOG 0424 (IJROBP 2015)

148
Q

What was the patient population studied in RTOG 0539?

A

Meningioma<div>Low risk: Grade I GTR and STR<br></br>Int risk: Grade I recurrent or grade II GTR<br></br>High risk: Grade II recurrent or STR, or grade III any<br></br></div><div><br></br></div><div>n= 244</div>

149
Q

<div>What was the regimen studied in RTOG 0539?<br></br></div>

A

“Phase II<br></br>•<span>Low risk (</span>G1, GTR/STR): obs<br></br>•<span>Int risk (</span>G1 recur, G2 GTR): 54 Gy (with CTV 1.0 cm, 0.5 cm CTV at barriers)<br></br>•<span>High risk (</span>G2 recur/STR, G3 STR): 54 Gy (2.0 cm CTV) and 60 Gy (1.0 cm CTV)<br></br><br></br>Edema and dural tail are not included in volumes”

150
Q

What were the results of RTOG 0539?

A

“<img></img><br></br><br></br>”

151
Q

What trial supports observation for low-risk pts with meningioma and 54 Gy for intermediate risk pts WHOgrade I pts s/p STR may warrant adjuvant RT (crude failure rate 40%)?

A

RTO 0539

152
Q

What trial randomized unruptured AVMs to medical management +/- intervention (SRS, embolization, neurosurgery or combination)?

A

ARUBA (2020)<div>Unruptured AVM<br></br><br></br>(Characteristics: Spetzler-Martin grade I-III in ~30% each, and grade IV in ~10%)<br></br></div>

153
Q

What were the results of the ARUBA trial randomizing unruptured AVMs to medical management +/- intervention (SRS, embolization, neurosurgery or combination)?

A

-Mean f/u of 50 mos<br></br>-Death or stroke 3.39 (medical mngmt) vs. 12.32 per 100 pt-years<br></br>-Adverse events 59% vs. 79%<br></br>

154
Q

What trial demonstrated less death, stroke, and adverse effects with medical management alone compared to interventional therapy (SRS, surgery, or embolization) in unruptured AVM?

A

ARUBA

155
Q

Which systematic review outlined outcomes of SRS for trigeminal neuralgia?

A

“International Stereotactic Radiosurgery Society<div><span><a>Tuleasca et al, J Neurosurg, 2020</a></span></div><div>65 studies, 6461 patients<i><u><br></br></u></i><div><br></br></div></div>”

156
Q

What were the results of the International Stereotactic Radiosurgery Society Trigeminal Neuralgia Systematic Review?

A

-Mean freedom from pain 80-87%<br></br>-(no difference in GK, LINAC, or CK)<br></br>-Mean time to relief 15-81 days<br></br>-Hypoesthesia ranges 0-17%<br></br>-Mean recurrence 25-32%<br></br>-(For recurrence, LINAC was better than GK. No difference between GK and CK)<br></br>7-yr pain relief 22-60%<br></br>10-yr pain relief 30-45%

157
Q

What were the results of the Acoustic Neuroma prospective review out of Timone Hospital Marseille (France) comparing surgery vs GKS?

A

“n=207<div>surgery vs. GKS<br></br>•CN VII disturbance: 37% vs. 0%<br></br>•V disturbancs: 29% vs. 4%<br></br><span>•Hearing preserved: 37.5% vs. 70%</span><br></br>•Hospital stay: 23 days vs. 3 days<br></br></div>”

158
Q

“What were the results of the results Acoustic Neuroma retrospective reviewout of Thomas Jefferson (<span><a>Andrews et al, IJROBP, 2001</a>)</span><span></span>comparing SRS (12Gy) vs FSRT (50 Gy/ 25fx)?”

A

SRS v FSRT<div>•Tumor control 98% SRS vs. 97% FSRT<br></br>•CNV preservation 95% vs. 93%<br></br>•CNVII preservation 98% vs. 98%<br></br>•Hearing preservation 33% vs. 81%<br></br></div>

159
Q

What were the results of the COMS (2006) uveal melanoma trial comparing outcome between plaque brachytherapy and enucleation?

A

“n=1317<div>Uveal melanoma, selected T2 tumors (<span>medium</span>)<br></br></div><div><br></br></div><div>•12-yr all-cause mortality 41-43%, not different<br></br>•LF <10%<br></br>•But, 3-yr blindness 43%<br></br></div>”

ANKI- CNS (1 decks)

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