KTS Flashcards
What are the two main studies supporting RT for DCIS?
NSABP B-17, EBCTCG meta-analysis
What studies were included in the EBCTCG meta-analysis for DCIS?
SweDCIS, EORTC, UK/ANZ, NSABP B-17
What was the IBTR with and without RT in NSABP B-17?
32% vs. 16%
What was the IBTR with and without RT in the EBCTCG meta-analysis for DCIS?
28% vs. 13%
What are the two main studies supporting observation following lumpectomy for DCIS?
RTOG 9804, ECOG (Hughes)
RTOG 9804: entry criteria and difference in IBTR
low or intermediate grade 3mm, IBTR 6.7% vs. 0.9%
ECOG (Hughes): entry criteria
low or intermediate grade 3mm
ECOG (Hughes): IBTR by grade and age
low/int grade: 10.5% (7yrs) high grade: 15.3% high grade age 45: 10%
Rate of tamoxifen use in RTOG 9804 and ECOG (Hughes)
RTOG 9804 - 62% ECOG (Hughes) - 40%
What is the main study supporting the use of tamoxifen in DCIS?
NSABP B-24 (50Gy + TAM 5 years vs. 50Gy alone)
NSABP B-24: IBRT
15% vs. 11%
What are the two main studies supporting adjuvant RT for early stage breast cancer?
NSABP B-06, EBCTCG meta-analysis
NSABP B-06: design
mastectomy vs. lumpectomy vs. lumpectomy + 50Gy, all underwent axillary dissection
NSABP B-06: IBTR, OS
IBTR: 39% vs 14% OS: no difference
What were the major trials included in the EBCTCG meta-analysis for early stage breast cancer?
NSABP B-06, Milan I, EORTC, Danish, NCI, Gustave-Roussy
EBCTCG meta-analysis for early stage breast cancer: 10 year IBTR and BCM (N0 and N+)
IBTR: 35% vs. 19% BCM pN0: 21% vs. 17% BCM pN+: 51% vs. 43%
What is the main study supporting adjuvant RT and tamoxifen for early stage breast cancer?
NSABP B-21
NSABP B-21: design
TAM vs. TAM + 50Gy vs. placebo + 50Gy
NSABP B-21: IBTR
TAM alone: 17% RT alone: 9% TAM + RT: 3%
What are the two main studies evaluating boost for early stage breast cancer?
EORTC (Bartelink), Lyon
EORTC breast boost trial: design
T1-2, N0-1, s/p lumpectomy and axillary dissection, 50Gy +/- 16Gy boost
EORTC breast boost trial: IBTR by age
50yrs: 7% vs 4%
Canadian (Whelan) hypofrac trial: design
T1-2 N0 post-lumpectomy, 42.5Gy/16 vs 50Gy/25, no boost
START B: design
T1-3, N0-1 post lumpectomy, 40Gy/15 vs 50Gy/25, 61% received 10Gy boost
What is the main study support observation following lumpectomy for elderly patients with early stage breast cancer?
CALGB (Hughes)
CALGB (Hughes): design
>70yrs, T1N0, ER+, TAM + RT (45Gy + 14Gy boost) vs TAM alone
CALGB (Hughes): IBTR 10yrs
IBTR: 10% vs 2%
NSABP B-04: design
cN0: radical mastectomy vs. total mastectomy vs. total mastectomy + axillary RT cN+: radical mastectomy vs. total mastectomy + axillary RT
NSABP 32: design
SLNBx (with ALND if positive) vs. upfront ALND
Z11: design
SLNBx positive: ALND + RT vs. RT alone
AMAROS: design
SLNBx positive: ALND vs. RT
DBCG 82b/c: high risk criteria
T3-4 or N+
DBCG 82b: design
premenopausal patients: CMF + RT vs. CMF alone (cyclophosphamide, methotrexate, 5-FU)
DBCG 82c: design
postmenopausal patients
EBCTCG meta-analysis PMRT: BCM by nodes (20yrs)
N0: no OS difference N1: BCM 42% vs. 50% N2+: BCM 70% vs. 80%
Patchell I: design
surgery + WBRT vs. biopsy + WBRT
Patchell I: median OS
3mo vs. 9mo
Patchell I: what percentage of patients were found to not have metastases?
11%
Patchell II: design
surgery +/- WBRT (50.4Gy!)
Patchell II: brain recurrence
70% vs. 18%
RTOG 9508: design
1-3 brain mets, WBRT + SRS boost vs. WBRT alone
RTOG 9508: results
SRS boost improved median survival by 1-2 months for patients with single met
RTOG 9402: design
WHO grade III glioma, PCV + RT vs. RT alone (procarbazine, CCNU (lomustine), vincristine)
RTOG 9402: results
No difference in OS with RT, patients with 1p-19q codeletion MS 14.7 yrs vs. 7.3 yrs for patients without codeletion
RTOG 9802: design
WHO grade II glioma, observation for low risk (age
RTOG 9802: results
MS 13.3yrs vs. 7.8yrs - addition of PCV to radiation improves survival in high risk WHO grade II glioma
EORTC “believers trial”: design
WHO grade I-II, adjuvant RT 45Gy vs. 59.4Gy
EORTC “believers trial”: results
no difference in overall survival or progression free survival with dose escalation
EORTC “nonbelievers trial”: design
WHO grade I-II, adjuvant RT 54Gy vs. observation
EORTC “nonbelievers trial”: results
5yr PFS 55% vs. 35%, no difference in OS
EORTC, anal cancer (Bartelink): design
RT with concurrent 5FU/mitomycin vs. RT alone
EORTC, anal cancer (Bartelink): results
5yr LC 68% vs. 50% colostomy free survival 72% vs. 40% no difference in OS
UKCCCR ACT I: design
RT with concurrent 5FU/mitomycin vs. RT alone
UKCCCR ACT I: results
chemo improved LC and CFS but no improvement in OS
What are the two main studies supporting the addition of chemotherapy to RT for anal cancer?
EORTC (Bartelink), UKCCCR ACT I
What are the two main studies evaluating mitomycin vs cisplatin for anal cancer?
ACT II, RTOG 9811
ACT II: results
similar toxicity, no difference in LC, CFS, or OS
RTOG 9811: results
mitomycin improved 5yr OS (78% vs 71%) and CFS (725 vs 65%)
What was the clinical question/answer with RTOG 0529?
anal cancer, when compared to results from RTOG 9811, IMRT results in reduced skin, GI, and heme toxicity
CROSS trial: design
surgery alone vs. surgery with neoadjuvant CRT (41.4Gy, carboplatin/paclitaxel)
CROSS trial: 5yr OS results
5yr OS 47% vs 34%
CROSS trial: pCR rate(s)
pCR 29% (23% for adeno, 49% for SCCa)
RTOG 8501: design
esophageal cancer definitive treatment, 64Gy vs. 50Gy + cisplatin/5FU
RTOG 8501: 5yr OS
26% vs. 0%
RTOG 9405 (Minsky): design
50.4Gy + 5FU/cisplatin vs. 64.8Gy + 5FU/cisplatin
RTOG 9405 (Minsky): results
closed early, excess early deaths in dose escalation arm
MAGIC trial: design
gastric cancer, surgery alone vs. surgery + pre and post-op ECF chemotherapy (epirubicin, cisplatin, 5FU)
What chemo was used in the MAGIC trial?
ECF (epirubicin, cisplatin, 5FU)
MAGIC trial: 5yr OS results
5yr OS 36% vs. 23%
Intergroup / SWOG gastric cancer study: design
post-op observation vs. 45Gy + 5FU/leucovorin
Intergroup / SWOG gastric cancer study: 5yr OS and criticisms
5yr OS 44% vs. 26%, D1 resection in 50%, D2 resection in 10%
ARTIST trial: design
gastric cancer s/p surgery with D2 resection, adjuvant capecitabine/cisplatin vs. sequential chemo/RT/chemo
ARTIST trial: results
no difference in OS, possibly due to extensive surgical resection (D2)
CONKO: design
pancreas s/p resection, observation vs. gemcitabine
CONKO: MS results
MS 22mo vs 20mo
GITSG resectable pancreas: design
surgery alone vs. surgery + adjuvant RT + 5FU (40Gy split course)
GITSG resectable pancreas: MS results
MS 20mo vs. 11mo
EORTC resectable pancreas: design
adjuvant observation vs. CRT (40Gy split course, 5FU)
EORTC resectable pancreas: results
no difference in PFS or OS with adjuvant CRT, per Bill Regine there is a benefit if a one-sided t-test is used
ESPAC-1: design
2x2 factorial design, RT 40Gy, 5FU chemotherapy
ESPAC-1: results and criticisms
reduced survival with patients receiving RT, not really randomized, no RT quality assurance, wide range of RT doses used
RTOG 9704: design
adjuvant 5FU vs gemcitabine (5FU vs gem -> 50.4Gy with 5FU -> 5FU vs gem)
RTOG 9704: results
nonsignificant trend toward improved survival with gemcitabine
NEJM FOLFIRINOX vs. gemcitabine for metastatic pancreatic cancer: results
MS 11mo vs 7mo (leucovorin, 5FU, irinotecan, oxaliplatin)
Dutch rectal cancer study: design and results
design: preop RT (25Gy/5) + TME vs. TME alone, results: 10yr LR 5% vs 11%
Swedish rectal cancer study: design and results
design: preop RT (25Gy/5) + surgery vs. surgery alone (TME not used) results: 13yr OS 38% vs. 30%, LR 9% vs 27%
German rectal cancer study: design
preop CRT (50.4Gy, 5FU) vs postop CRT (50.4Gy, 5.4Gy boost, 5FU)
German rectal cancer study: results
5yr LR 6% vs. 13% favoring preop
Rectal cancer: what was the pCR rate on the German rectal cancer study and NSABP R-04?
German: pCR 8% (concurrent 5FU) NSABP R-04: pCR 21% (concurrent capecitabine)
BC2001: design
two randomizations: 1. concurrent 5FU/mitomycin vs. no chemo 2. standard volume RT vs. reduced high dose volume RT
BC2001: results
nonsignificant trend toward improved OS with chemotherapy (48% vs 35%)
RTOG meta-analysis for bladder preservation: pCR, 5yr intact bladder, 5yr OS
pCR 69% 5yr intact bladder 80% 5yr OS 57%
seminoma, MRC 18: design and results
PA field, adjuvant 30Gy vs 20Gy, no difference in local control
seminoma, MRC 10: design and results
30Gy, dogleg vs. para-aortic field, less toxicity with PA field but slightly increased risk of pelvic relapse
Bill-Axelson / Scandinavian study: entry criteria and design
age 10yrs, operable T1-2, PSA
Bill-Axelson / Scandinavian study: results
improved survival in men
What are the eight dose escalation studies in prostate cancer?
- MDACC (Pollack) 2. Brazil meta-analysis 3. GETUG 4. Dutch 5. MGH PROG 6. MRC RT01 7. Ontario 8. Fox Chase
MDACC prostate dose escalation: design and results
70Gy vs. 78Gy, failure free survival significantly improved with dose escalation
EORTC high risk prostate (Bolla): design
RT 70Gy +/- concurrent and adjuvant ADT (36mos)
EORTC high risk prostate (Bolla): 10yr OS results
10yr OS 58% vs 40%
RTOG 9202: design
mostly high risk patients, RT 65-70Gy and 4mos NCADT +/- 24mos adjuvant ADT
RTOG 9202: results
long term ADT improved LR and CSS; OS improvement in GS 8+ patients
GOG 122: population and design
stage III or IV endometrial cancer s/p resection, adjuvant chemo (doxorubicin/cisplatin) vs. WART (30Gy + 15Gy boost)
GOG 122: 5yr OS
5yr OS 53% vs 42%
GOG 37 (Homesley): population and design
vulvar cancer with positive groin nodes after vulvectomy and lymphadenectomy; pelvic node dissection vs. RT to bilateral pelvic and inguinal nodes
GOG 37 (Homesley): 6yr OS
6yr OS 41% vs. 51%
GOG 88: population and design
vulvar cancer, clinically N0; vulvectomy + groin dissection vs. vulvectomy + adjuvant inguinal RT (50Gy)
GOG 88: results and criticism
LR 19% vs. 0%; 20% received groin dissection and RT, OS 88% vs 63%, RT was prescribed to 3cm and often underdosed
GOG 92 (Sedlis): population and design
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
GOG 92 (Sedlis): 10yr LR and OS
10yr LR 21% vs 14% 10yr OS 80% vs 71% (NS)
GOG 109 (Peters): population and design
stage IA2-IIA s/p radical hysterectomy with positive nodes, positive nodes, OR parametrial invasion; RT +/- chemo (cisplatin, 5FU)
GOG 109 (Peters): 4yr OS
4yr OS 71% vs 81%
GOG 123 (Keys): population and design
IB2 cervical cancer, RT -> hyst vs. CRT -> hyst
GOG 123 (Keys): 3yr OS
3yr OS 74% vs 83%
GOG 120: population and design
cervical cancer stage IIB-IVA, definitive CRT with cisplatin vs hydroxyurea vs both
GOG 120: results
OS better with weekly cisplatin; less toxicity with cisplatin vs. cisplatin + hydroxyurea
RTOG 9001: population and design
cervical cancer stage IIB-IVA, RT vs CRT (cisplatin, 5FU)
RTOG 9001: 8yr OS
8yr OS 41% vs 67%
RTOG 7920: population, design, results
cervical cancer IB-IIB, WPRT vs EFRT, improved OS with EFRT
GOG 33 (Creasman): population and design
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
GOG 99 (Keys): population and design
stage IB-IIB endometrial cancer s/p TAH/BSO, WPRT 50.4Gy vs. observation
GOG 99 (Keys): high intermediate risk criteria
grade 2-3, LVSI, outer third myometrial invasion; 3 factors if 70yrs
GOG 99 (Keys): 2yr LR
cumulative 2yr LR 12% vs 3% HIR LR: 26% vs 6% non-HIR LR: 6% vs 2%
PORTEC 1: population and design
stage I endometrial cancer s/p TAH/BSO, 46Gy WPRT vs. observation
PORTEC 1: high intermediate risk criteria
myometrial invasion >50% AND grade 3 (or one factor if age > 60yrs)
PORTEC 1: LR and location of recurrence
LR 4% vs 14% 75% of recurrences were vaginal
PORTEC 2: population and design
stage I endometrial cancer s/p TAH/BSO; WPRT 46Gy vs. VBT 7Gy x 3
PORTEC 2: 5yr LR, 5yr vaginal recurrence
5yr LR 2.1% vs. 5.1% 5yr vaginal recurrence 1.6% vs 1.8%
What are the three main studies demonstrating a benefit for PORT in prostate cancer?
ARO/German, EORTC, SWOB
What were the doses used in the three main prostate PORT studies?
ARO 60Gy EORTC 60Gy SWOG 60-64Gy
What was the inclusion criteria for the three main prostate PORT studies?
ARO - pT3N0 with undetectable PSA EORTC - positive margin or pT3 (N0) SWOG - pT3 or positive margin
What was the 10yr BPFS for the three main prostate PORT studies?
ARO - 56% vs 35% EORTC - 61% vs 41% SWOG - 58% vs 28%
What was the 15yr OS for the SWOG prostate PORT study?
15yr OS 47% vs 37%
What were the predictors of biochemical failure in the Stephenson prostate salvage study?
GS 8+, PSA >2, negative margins, PSADT
What are the three main RT studies for node positive prostate cancer?
Zagars, RTOG 8531, ECOG/Messing
Zagars: design and results
pN+ prostate cancer, RT + ADT vs. ADT alone, 10yr OS 67% vs 46%
RTOG 8531 N+ subset: design and results
RT (ADT at relapse) vs RT with indefinite ADT, 9yr OS 38% vs 62%
ECOG/Messing: design and results
N+ after prostatectomy, indefinite ADT vs observation with ADT at recurrence, MS 13.9 vs 11.3 years
What are the three main RT dose studies for limited stage SCLC?
CALGB 39808, INT 0096, RTOG 0538
What was the design of the four main RD dose studies for limited stage SCLC?
CALGB 39808 - 70Gy w/ concurrent paclitaxel/topotecan INT 0096 - 45Gy BID fxs vs 45Gy qday fxs RTOG 0538 - 45Gy BID vs. 70Gy qday
INT 0096: 5yr OS and grade 3 esophagitis rates
5yr OS 26% vs 16% grade 3 esophagitis 27% vs 11%
What are the two main studies confirming the benefit of RT in limited stage SCLC?
Pignon meta-analysis, Warde meta-analysis
Auperin meta-analysis: 3yr OS, 3yr LR
3yr OS 21% vs 15% 3yr LR 33% vs 59%
RTOG 7303: design and results
head and neck cancer, T2-4 N1-2, preop 50Gy vs postop 60Gy, 10yr LC 58% vs 70%