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Trials Flashcards

1
Q

What are the two main studies supporting RT for DCIS?

A

NSABP B-17, EBCTCG meta-analysis

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2
Q

What studies were included in the EBCTCG meta-analysis for DCIS?

A

SweDCIS, EORTC, UK/ANZ, NSABP B-17

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3
Q

What was the IBTR with and without RT in NSABP B-17?

A

32% vs. 16%

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4
Q

What was the IBTR with and without RT in the EBCTCG meta-analysis for DCIS?

A

28% vs. 13%

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5
Q

What are the two main studies supporting observation following lumpectomy for DCIS?

A

RTOG 9804, ECOG (Hughes)

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6
Q

RTOG 9804: entry criteria and difference in IBTR

A

low or intermediate grade 3mm, IBTR 6.7% vs. 0.9%

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7
Q

ECOG (Hughes): entry criteria

A

low or intermediate grade 3mm

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8
Q

ECOG (Hughes): IBTR by grade and age

A

low/int grade: 10.5% (7yrs) high grade: 15.3% high grade age 45: 10%

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9
Q

Rate of tamoxifen use in RTOG 9804 and ECOG (Hughes)

A

RTOG 9804 - 62% ECOG (Hughes) - 40%

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10
Q

What is the main study supporting the use of tamoxifen in DCIS?

A

NSABP B-24 (50Gy + TAM 5 years vs. 50Gy alone)

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11
Q

NSABP B-24: IBRT

A

15% vs. 11%

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12
Q

What are the two main studies supporting adjuvant RT for early stage breast cancer?

A

NSABP B-06, EBCTCG meta-analysis

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13
Q

NSABP B-06: design

A

mastectomy vs. lumpectomy vs. lumpectomy + 50Gy, all underwent axillary dissection

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14
Q

NSABP B-06: IBTR, OS

A

IBTR: 39% vs 14% OS: no difference

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15
Q

What were the major trials included in the EBCTCG meta-analysis for early stage breast cancer?

A

NSABP B-06, Milan I, EORTC, Danish, NCI, Gustave-Roussy

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16
Q

EBCTCG meta-analysis for early stage breast cancer: 10 year IBTR and BCM (N0 and N+)

A

IBTR: 35% vs. 19% BCM pN0: 21% vs. 17% BCM pN+: 51% vs. 43%

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17
Q

What is the main study supporting adjuvant RT and tamoxifen for early stage breast cancer?

A

NSABP B-21

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18
Q

NSABP B-21: design

A

TAM vs. TAM + 50Gy vs. placebo + 50Gy

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19
Q

NSABP B-21: IBTR

A

TAM alone: 17% RT alone: 9% TAM + RT: 3%

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20
Q

What are the two main studies evaluating boost for early stage breast cancer?

A

EORTC (Bartelink), Lyon

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21
Q

EORTC breast boost trial: design

A

T1-2, N0-1, s/p lumpectomy and axillary dissection, 50Gy +/- 16Gy boost

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22
Q

EORTC breast boost trial: IBTR by age

A

50yrs: 7% vs 4%

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23
Q

Canadian (Whelan) hypofrac trial: design

A

T1-2 N0 post-lumpectomy, 42.5Gy/16 vs 50Gy/25, no boost

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24
Q

START B: design

A

T1-3, N0-1 post lumpectomy, 40Gy/15 vs 50Gy/25, 61% received 10Gy boost

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25
Q

What is the main study support observation following lumpectomy for elderly patients with early stage breast cancer?

A

CALGB (Hughes)

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26
Q

CALGB (Hughes): design

A

>70yrs, T1N0, ER+, TAM + RT (45Gy + 14Gy boost) vs TAM alone

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27
Q

CALGB (Hughes): IBTR 10yrs

A

IBTR: 10% vs 2%

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28
Q

NSABP B-04: design

A

cN0: radical mastectomy vs. total mastectomy vs. total mastectomy + axillary RT cN+: radical mastectomy vs. total mastectomy + axillary RT

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29
Q

NSABP 32: design

A

SLNBx (with ALND if positive) vs. upfront ALND

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30
Q

Z11: design

A

SLNBx positive: ALND + RT vs. RT alone

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31
Q

AMAROS: design

A

SLNBx positive: ALND vs. RT

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32
Q

DBCG 82b/c: high risk criteria

A

T3-4 or N+

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33
Q

DBCG 82b: design

A

premenopausal patients: CMF + RT vs. CMF alone (cyclophosphamide, methotrexate, 5-FU)

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34
Q

DBCG 82c: design

A

postmenopausal patients

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35
Q

EBCTCG meta-analysis PMRT: BCM by nodes (20yrs)

A

N0: no OS difference N1: BCM 42% vs. 50% N2+: BCM 70% vs. 80%

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36
Q

Patchell I: design

A

surgery + WBRT vs. biopsy + WBRT

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37
Q

Patchell I: median OS

A

3mo vs. 9mo

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38
Q

Patchell I: what percentage of patients were found to not have metastases?

A

11%

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39
Q

Patchell II: design

A

surgery +/- WBRT (50.4Gy!)

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40
Q

Patchell II: brain recurrence

A

70% vs. 18%

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41
Q

RTOG 9508: design

A

1-3 brain mets, WBRT + SRS boost vs. WBRT alone

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42
Q

RTOG 9508: results

A

SRS boost improved median survival by 1-2 months for patients with single met

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43
Q

RTOG 9402: design

A

WHO grade III glioma, PCV + RT vs. RT alone (procarbazine, CCNU (lomustine), vincristine)

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44
Q

RTOG 9402: results

A

No difference in OS with RT, patients with 1p-19q codeletion MS 14.7 yrs vs. 7.3 yrs for patients without codeletion

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45
Q

RTOG 9802: design

A

WHO grade II glioma, observation for low risk (age

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46
Q

RTOG 9802: results

A

MS 13.3yrs vs. 7.8yrs - addition of PCV to radiation improves survival in high risk WHO grade II glioma

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47
Q

EORTC “believers trial”: design

A

WHO grade I-II, adjuvant RT 45Gy vs. 59.4Gy

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48
Q

EORTC “believers trial”: results

A

no difference in overall survival or progression free survival with dose escalation

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49
Q

EORTC “nonbelievers trial”: design

A

WHO grade I-II, adjuvant RT 54Gy vs. observation

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50
Q

EORTC “nonbelievers trial”: results

A

5yr PFS 55% vs. 35%, no difference in OS

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51
Q

EORTC, anal cancer (Bartelink): design

A

RT with concurrent 5FU/mitomycin vs. RT alone

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52
Q

EORTC, anal cancer (Bartelink): results

A

5yr LC 68% vs. 50% colostomy free survival 72% vs. 40% no difference in OS

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53
Q

UKCCCR ACT I: design

A

RT with concurrent 5FU/mitomycin vs. RT alone

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54
Q

UKCCCR ACT I: results

A

chemo improved LC and CFS but no improvement in OS

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55
Q

What are the two main studies supporting the addition of chemotherapy to RT for anal cancer?

A

EORTC (Bartelink), UKCCCR ACT I

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56
Q

What are the two main studies evaluating mitomycin vs cisplatin for anal cancer?

A

ACT II, RTOG 9811

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57
Q

ACT II: results

A

similar toxicity, no difference in LC, CFS, or OS

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58
Q

RTOG 9811: results

A

mitomycin improved 5yr OS (78% vs 71%) and CFS (725 vs 65%)

59
Q

What was the clinical question/answer with RTOG 0529?

A

anal cancer, when compared to results from RTOG 9811, IMRT results in reduced skin, GI, and heme toxicity

60
Q

CROSS trial: design

A

surgery alone vs. surgery with neoadjuvant CRT (41.4Gy, carboplatin/paclitaxel)

61
Q

CROSS trial: 5yr OS results

A

5yr OS 47% vs 34%

62
Q

CROSS trial: pCR rate(s)

A

pCR 29% (23% for adeno, 49% for SCCa)

63
Q

RTOG 8501: design

A

esophageal cancer definitive treatment, 64Gy vs. 50Gy + cisplatin/5FU

64
Q

RTOG 8501: 5yr OS

A

26% vs. 0%

65
Q

RTOG 9405 (Minsky): design

A

50.4Gy + 5FU/cisplatin vs. 64.8Gy + 5FU/cisplatin

66
Q

RTOG 9405 (Minsky): results

A

closed early, excess early deaths in dose escalation arm

67
Q

MAGIC trial: design

A

gastric cancer, surgery alone vs. surgery + pre and post-op ECF chemotherapy (epirubicin, cisplatin, 5FU)

68
Q

What chemo was used in the MAGIC trial?

A

ECF (epirubicin, cisplatin, 5FU)

69
Q

MAGIC trial: 5yr OS results

A

5yr OS 36% vs. 23%

70
Q

Intergroup / SWOG gastric cancer study: design

A

post-op observation vs. 45Gy + 5FU/leucovorin

71
Q

Intergroup / SWOG gastric cancer study: 5yr OS and criticisms

A

5yr OS 44% vs. 26%, D1 resection in 50%, D2 resection in 10%

72
Q

ARTIST trial: design

A

gastric cancer s/p surgery with D2 resection, adjuvant capecitabine/cisplatin vs. sequential chemo/RT/chemo

73
Q

ARTIST trial: results

A

no difference in OS, possibly due to extensive surgical resection (D2)

74
Q

CONKO: design

A

pancreas s/p resection, observation vs. gemcitabine

75
Q

CONKO: MS results

A

MS 22mo vs 20mo

76
Q

GITSG resectable pancreas: design

A

surgery alone vs. surgery + adjuvant RT + 5FU (40Gy split course)

77
Q

GITSG resectable pancreas: MS results

A

MS 20mo vs. 11mo

78
Q

EORTC resectable pancreas: design

A

adjuvant observation vs. CRT (40Gy split course, 5FU)

79
Q

EORTC resectable pancreas: results

A

no difference in PFS or OS with adjuvant CRT, per Bill Regine there is a benefit if a one-sided t-test is used

80
Q

ESPAC-1: design

A

2x2 factorial design, RT 40Gy, 5FU chemotherapy

81
Q

ESPAC-1: results and criticisms

A

reduced survival with patients receiving RT, not really randomized, no RT quality assurance, wide range of RT doses used

82
Q

RTOG 9704: design

A

adjuvant 5FU vs gemcitabine (5FU vs gem -> 50.4Gy with 5FU -> 5FU vs gem)

83
Q

RTOG 9704: results

A

nonsignificant trend toward improved survival with gemcitabine

84
Q

NEJM FOLFIRINOX vs. gemcitabine for metastatic pancreatic cancer: results

A

MS 11mo vs 7mo (leucovorin, 5FU, irinotecan, oxaliplatin)

85
Q

Dutch rectal cancer study: design and results

A

design: preop RT (25Gy/5) + TME vs. TME alone, results: 10yr LR 5% vs 11%

86
Q

Swedish rectal cancer study: design and results

A

design: preop RT (25Gy/5) + surgery vs. surgery alone (TME not used) results: 13yr OS 38% vs. 30%, LR 9% vs 27%

87
Q

German rectal cancer study: design

A

preop CRT (50.4Gy, 5FU) vs postop CRT (50.4Gy, 5.4Gy boost, 5FU)

88
Q

German rectal cancer study: results

A

5yr LR 6% vs. 13% favoring preop

89
Q

Rectal cancer: what was the pCR rate on the German rectal cancer study and NSABP R-04?

A

German: pCR 8% (concurrent 5FU) NSABP R-04: pCR 21% (concurrent capecitabine)

90
Q

BC2001: design

A

two randomizations: 1. concurrent 5FU/mitomycin vs. no chemo 2. standard volume RT vs. reduced high dose volume RT

91
Q

BC2001: results

A

nonsignificant trend toward improved OS with chemotherapy (48% vs 35%)

92
Q

RTOG meta-analysis for bladder preservation: pCR, 5yr intact bladder, 5yr OS

A

pCR 69% 5yr intact bladder 80% 5yr OS 57%

93
Q

seminoma, MRC 18: design and results

A

PA field, adjuvant 30Gy vs 20Gy, no difference in local control

94
Q

seminoma, MRC 10: design and results

A

30Gy, dogleg vs. para-aortic field, less toxicity with PA field but slightly increased risk of pelvic relapse

95
Q

Bill-Axelson / Scandinavian study: entry criteria and design

A

age 10yrs, operable T1-2, PSA

96
Q

Bill-Axelson / Scandinavian study: results

A

improved survival in men

97
Q

What are the eight dose escalation studies in prostate cancer?

A
  1. MDACC (Pollack) 2. Brazil meta-analysis 3. GETUG 4. Dutch 5. MGH PROG 6. MRC RT01 7. Ontario 8. Fox Chase
98
Q

MDACC prostate dose escalation: design and results

A

70Gy vs. 78Gy, failure free survival significantly improved with dose escalation

99
Q

EORTC high risk prostate (Bolla): design

A

RT 70Gy +/- concurrent and adjuvant ADT (36mos)

100
Q

EORTC high risk prostate (Bolla): 10yr OS results

A

10yr OS 58% vs 40%

101
Q

RTOG 9202: design

A

mostly high risk patients, RT 65-70Gy and 4mos NCADT +/- 24mos adjuvant ADT

102
Q

RTOG 9202: results

A

long term ADT improved LR and CSS; OS improvement in GS 8+ patients

103
Q

GOG 122: population and design

A

stage III or IV endometrial cancer s/p resection, adjuvant chemo (doxorubicin/cisplatin) vs. WART (30Gy + 15Gy boost)

104
Q

GOG 122: 5yr OS

A

5yr OS 53% vs 42%

105
Q

GOG 37 (Homesley): population and design

A

vulvar cancer with positive groin nodes after vulvectomy and lymphadenectomy; pelvic node dissection vs. RT to bilateral pelvic and inguinal nodes

106
Q

GOG 37 (Homesley): 6yr OS

A

6yr OS 41% vs. 51%

107
Q

GOG 88: population and design

A

vulvar cancer, clinically N0; vulvectomy + groin dissection vs. vulvectomy + adjuvant inguinal RT (50Gy)

108
Q

GOG 88: results and criticism

A

LR 19% vs. 0%; 20% received groin dissection and RT, OS 88% vs 63%, RT was prescribed to 3cm and often underdosed

109
Q

GOG 92 (Sedlis): population and design

A

stage IB, two of 3 criteria (>1/3 stromal invasion, LVSI, >4cm tumor), all had radical hysterectomy and pelvic lymphadenectomy, randomized to adjuvant RT vs. observation

110
Q

GOG 92 (Sedlis): 10yr LR and OS

A

10yr LR 21% vs 14% 10yr OS 80% vs 71% (NS)

111
Q

GOG 109 (Peters): population and design

A

stage IA2-IIA s/p radical hysterectomy with positive nodes, positive nodes, OR parametrial invasion; RT +/- chemo (cisplatin, 5FU)

112
Q

GOG 109 (Peters): 4yr OS

A

4yr OS 71% vs 81%

113
Q

GOG 123 (Keys): population and design

A

IB2 cervical cancer, RT -> hyst vs. CRT -> hyst

114
Q

GOG 123 (Keys): 3yr OS

A

3yr OS 74% vs 83%

115
Q

GOG 120: population and design

A

cervical cancer stage IIB-IVA, definitive CRT with cisplatin vs hydroxyurea vs both

116
Q

GOG 120: results

A

OS better with weekly cisplatin; less toxicity with cisplatin vs. cisplatin + hydroxyurea

117
Q

RTOG 9001: population and design

A

cervical cancer stage IIB-IVA, RT vs CRT (cisplatin, 5FU)

118
Q

RTOG 9001: 8yr OS

A

8yr OS 41% vs 67%

119
Q

RTOG 7920: population, design, results

A

cervical cancer IB-IIB, WPRT vs EFRT, improved OS with EFRT

120
Q

GOG 33 (Creasman): population and design

A

stage I endometrial cancer s/p TAH/BSO, analyzed risk factors for nodal involvement, risk of nodal mets found to be related to grade and depth of invasion

121
Q

GOG 99 (Keys): population and design

A

stage IB-IIB endometrial cancer s/p TAH/BSO, WPRT 50.4Gy vs. observation

122
Q

GOG 99 (Keys): high intermediate risk criteria

A

grade 2-3, LVSI, outer third myometrial invasion; 3 factors if 70yrs

123
Q

GOG 99 (Keys): 2yr LR

A

cumulative 2yr LR 12% vs 3% HIR LR: 26% vs 6% non-HIR LR: 6% vs 2%

124
Q

PORTEC 1: population and design

A

stage I endometrial cancer s/p TAH/BSO, 46Gy WPRT vs. observation

125
Q

PORTEC 1: high intermediate risk criteria

A

myometrial invasion >50% AND grade 3 (or one factor if age > 60yrs)

126
Q

PORTEC 1: LR and location of recurrence

A

LR 4% vs 14% 75% of recurrences were vaginal

127
Q

PORTEC 2: population and design

A

stage I endometrial cancer s/p TAH/BSO; WPRT 46Gy vs. VBT 7Gy x 3

128
Q

PORTEC 2: 5yr LR, 5yr vaginal recurrence

A

5yr LR 2.1% vs. 5.1% 5yr vaginal recurrence 1.6% vs 1.8%

129
Q

What are the three main studies demonstrating a benefit for PORT in prostate cancer?

A

ARO/German, EORTC, SWOB

130
Q

What were the doses used in the three main prostate PORT studies?

A

ARO 60Gy EORTC 60Gy SWOG 60-64Gy

131
Q

What was the inclusion criteria for the three main prostate PORT studies?

A

ARO - pT3N0 with undetectable PSA EORTC - positive margin or pT3 (N0) SWOG - pT3 or positive margin

132
Q

What was the 10yr BPFS for the three main prostate PORT studies?

A

ARO - 56% vs 35% EORTC - 61% vs 41% SWOG - 58% vs 28%

133
Q

What was the 15yr OS for the SWOG prostate PORT study?

A

15yr OS 47% vs 37%

134
Q

What were the predictors of biochemical failure in the Stephenson prostate salvage study?

A

GS 8+, PSA >2, negative margins, PSADT

135
Q

What are the three main RT studies for node positive prostate cancer?

A

Zagars, RTOG 8531, ECOG/Messing

136
Q

Zagars: design and results

A

pN+ prostate cancer, RT + ADT vs. ADT alone, 10yr OS 67% vs 46%

137
Q

RTOG 8531 N+ subset: design and results

A

RT (ADT at relapse) vs RT with indefinite ADT, 9yr OS 38% vs 62%

138
Q

ECOG/Messing: design and results

A

N+ after prostatectomy, indefinite ADT vs observation with ADT at recurrence, MS 13.9 vs 11.3 years

139
Q

What are the three main RT dose studies for limited stage SCLC?

A

CALGB 39808, INT 0096, RTOG 0538

140
Q

What was the design of the four main RD dose studies for limited stage SCLC?

A

CALGB 39808 - 70Gy w/ concurrent paclitaxel/topotecan INT 0096 - 45Gy BID fxs vs 45Gy qday fxs RTOG 0538 - 45Gy BID vs. 70Gy qday

141
Q

INT 0096: 5yr OS and grade 3 esophagitis rates

A

5yr OS 26% vs 16% grade 3 esophagitis 27% vs 11%

142
Q

What are the two main studies confirming the benefit of RT in limited stage SCLC?

A

Pignon meta-analysis, Warde meta-analysis

143
Q

Auperin meta-analysis: 3yr OS, 3yr LR

A

3yr OS 21% vs 15% 3yr LR 33% vs 59%

144
Q

RTOG 7303: design and results

A

head and neck cancer, T2-4 N1-2, preop 50Gy vs postop 60Gy, 10yr LC 58% vs 70%

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