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ANKI- GI > Colorectal > Flashcards

Colorectal Flashcards

1
Q

What is the clinical relevance of the Dutch rectal cancer study?

A

This trial showed improved outcomes for resectable rectal cancer when combining pre-op short course RT with TME.

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2
Q

What is the clinical relevance of the Dutch rectal cancer study?

A

This trial showed improved outcomes for resectable rectal cancer when combining pre-op short course RT with TME.

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3
Q

What was the population studied in th Dutch rectal cancer study?

A

1861 patients; resectable rectal cancer (included 31% Stage I patients)

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4
Q

What was the regimen studied in the Dutch rectal cancer study?

A

TME +/- Pre-op short-course RT (25Gy/5fx) without chemotherapy

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5
Q

What were the results of the Dutch rectal cancer study?

A

Reduced 10 yr LR: 11% VS 5%

No change in OS for allcomers

Subgroup analysis showed OS benefit for Stage III with negative circumferential margins

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6
Q

What is the relevance of the Swedish rectal cancer study?

A

This was the first trial to show a benefit to pre-op short course RT (25Gy/5fx). It was also the only study to show an OS benefit.

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7
Q

What was the population studied in the Swedish rectal cancer study?

A

1168 patients; resectable rectal cancer

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8
Q

What was the regimen studied in the Swedish rectal cancer study?

A

Blunt dissection +/- short-course neoadjuvant RT (25Gy/5fx). No chemotherapy.

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9
Q

What were the results of the Swedish rectal cancer study?

A

Improved OS, CSS, and LR

13 yr OS 30% vs 38%

13 yr LR 9% vs 27%

13 yr CSS 62% vs 72%

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10
Q

What is the clinical relevance of the German rectal cancer study?

A

This was the key study to compare pre-op and post-op chemoRT for rectal cancer.

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11
Q

What was the patient population studied in the German rectal cancer study?

A

823 patients; cT3-4 or N+

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12
Q

What was the regimen studied in the German rectal cancer study?

A

Neoadjuvant chemoRT (50.4Gy with 5-FU) vs adjuvant chemoRT (50.4Gy+5.4Gy with 5-FU). All patient s got TME and adjuvant chemotherapy.

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13
Q

What were the results of the German rectal cancer study?

A

Improved LC, acute and late toxicities, and sphincter sparing rates with neoadjuvant chemoRT.

10 yr LR: 7% vs 10%

Acute Grade 3-4: 27% vs 40%

Late Grade 3-4: 14% vs 24%

Among patients initially thought to require APR, neoadjuvant chemoRT allowed more patients to undergo sphincter-sparing surgery (19% vs 39%).

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14
Q

What was the clinical relevance of NSABP R-03?

A

This study supports the findings of the German rectal cancer study (i.e. neoadjuvant chemoRT preferred over adjuvant chemoRT).

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15
Q

What was the population studied in NSABP R-03?

A

267 pts; cT3-4 or N+ rectal cancer

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16
Q

What was the regimen studied in NSABP R-03?

A

Pre-op chemoRT vs post-op chemoRT

50.4Gy/28fx with 5FU + Leucovorin

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17
Q

What were the results of NSABP R-03?

A

Improved DFS but no significant benefit in LC or OS (UNDERPOWERED STUDY)

DFS: 53% vs 65%

15% pCR rate

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18
Q

In 2001, the Colorectal Cancer Collaborative Group performed a meta-analysis of trials including surgery +/- RT for rectal cancer. What were their key findings?

A
  1. There was a trend to OS benefit for patients receiving RT.
  2. LR was improved with RT. The biggest benefit came from neoadjuvant RT (46% decrease) compared to adjuvant (37% decrease).
  3. RT reduced risk of death due to rectal cancer (50% with no RT vs 45% with RT).
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19
Q

What studies established neoadjuvant chemoradiation as the standard of care for locally advanced rectal cancer?

A

German Rectal Study and NSABP R-03

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20
Q

What is the clinical relevance of MRC CR07?

A

This trial showed better outcomes for neoadjuvant short-course RT compared to adjuvant chemoradiation for patients with rectal cancer.

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21
Q

What was the population studied in MRC CR07?

A

1350 pts with operable rectal adenocarcinoma

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22
Q

What was the regimen studied in MRC CR07?

A

Neoadjuvant RT alone (25Gy/5fx) vs Adjuvant chemoradiation (45Gy/25fx + 5-FU)

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23
Q

What were the findings of MRC CR07?

A

Improved 3 year LR (4% vs 11%) and DFS (78% vs 72%) but no change in OS.

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24
Q

What is the clinical relevance of the Polish rectal cancer study?

A

This trial compared pre-op short course RT with pre-op long course chemoRT. It showed that pre-op long course chemoRT did not improve survival, local control, or late toxicity. It did improve positive margins though.

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25
Q

What population was studied in the Polish rectal cancer study?

A

312 patients with T3-T4 resectable rectal cancer

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26
Q

What regimen was studied in the Polish rectal cancer study?

A

25Gy/5fx pre-op without chemo vs 50.4Gy/28fx with 5FU/LV

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27
Q

What were the results of the Polish rectal cancer study?

A

Long-course neoadjuvant chemoradiation resulted in a lower rate of positive margins (13% vs 4%) but higher acute toxicity (3% vs 18%).

There was no difference between short-course RT and long-course chemoradiation in LC (14% vs 9%), survival, or toxicity.

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28
Q

What is the clinical relevance of the rectal study TROG 01.04?

A

This trial compared neoadjuvant short-course RT with neoadjuvant long-course chemoradiation. It showed a trend towards better local control with long-course chemoradiation, especially for distal tumors.

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29
Q

What population was studied in the rectal study TROG 01.04?

A

326 patients with T3N0-3 rectal cancer

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30
Q

What regimens were studied in the rectal study TROG 01.04?

A

25Gy/5fx without chemotherapy vs 50.4Gy/28fx with 5FU; all patients received 5FU consolidation

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31
Q

What were the results of the rectal study TROG 01.04?

A

Trend towards better LC with long-course neoadjuvant chemoradiation (4.4% vs 7.5% NS) especially for distal tumors (<5cm from anal verge) (0% vs 12.5%).

No difference in other endpoints.

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32
Q

What is the clinical relevance of the RAPIDO trial?

A

This trial evaluated a new paradigm for treating advanced rectal tumors: short course RT, aggressive chemo, and then surgery. The comparison was traditional neoadjuvant chemoradiation (and maybe outback chemo).

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33
Q

What population was studied in the RAPIDO trial?

A

920 patients; advanced rectal tumors (cT4a-b, N2, extramural vascular invasion, involved mesorectal fascia, or enlarged lateral nodes)

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34
Q

What regimens were studied in the RAPIDO trial?

A

Experimental Arm: 25Gy/5fx –> CAPOX/FOLFOX –> TME

Standard Arm: 50.4Gy/28fx with Capecitabine –> TME –> maybe adjuvant chemo

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35
Q

What were the results of the RAPIDO trial?

A

Improved pCR rate (28% vs 14%) and disease-related failure (24% vs 30%). The disease-related failure improvement was driven by fewer distant metastases in the experimental arm.

This illustrates the importance of Oxaliplatin in management of systemic risk for rectal cancer patients.

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36
Q

What is the clinical relevance of the Stockholm III trial?

A

This trial investigated the optimal duration of time between short-course radiation (25Gy/5fx) and surgery for rectal cancer. Short-course radiation with a 4-8 week waiting period before surgery showed better pCR rates and fewer post-op complications.

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37
Q

What population was studied in Stockholm III?

A

840 patients with resectable rectal cancer [T2-4a (allowable T stage depended on location), N1-2, and no compromise of mesorectal fascia)]

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38
Q

What were the regimens studied in Stockholm III?

A
  1. Short-course RT (25Gy/5fx) –> 1 week –> surgery
  2. Short-course RT (25Gy/5fx) –> 4-8 weeks –> surgery
  3. Long-course RT (50Gy/25fx) –> 4-8 weeks –> surgery

No chemo for anyone

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39
Q

What were the results of Stockholm III?

A

Short-course RT (25Gy/5fx) –> 4-8 weeks –> surgery showed the best pCR rate (10%) and a better post-op complication rate compared to short-course RT followed by immediate surgery (38% vs 50%).

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40
Q

What were the results of the Chines meta-analysis (Zhou et al.) that compared short-course neoadjuvant RT with long-course neoadjuvant chemoRT for rectal cancer?

A

Increased pCR rate and higher acute grade 3-4 toxicity with long-course chemoRT.

No difference in other outcomes (survival, sphincter preservation, late toxicity, etc.).

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41
Q

What was the clinical relevance of the Polish study analyzing short-course pre-op RT with consolidation FOLFOX compared to long-course pre-op chemoRT with FOLFOX?

A

This study showed better OS and lower toxicity with short-course RT and consolidation chemo. (Even for patients with T4 and low-lying tumors.)

42
Q

What population was studied in the Polish study comparing short-course pre-op RT with consolidation FOLFOX vs long-course pre-op chemoRT with concurrent FOLFOX?

A

541 pts; cT4 or fixed cT3 rectal tumors. Included low-lying rectal tumors.

43
Q

What were the results of the Polish study comparing short-course pre-op RT with consolidation FOLFOX vs long-course pre-op chemoRT with concurrent FOLFOX?

A

Better OS and lower acute toxicity with short-course and consolidation FOLFOX.

3 yr OS: 73% vs 65%

Any toxicity: 75% vs 83%

Side note: higher pelvic recurrences in the short-course arm (13% vs 7%)

44
Q

What is the clinical relevance of RTOG 0822?

A

It showed no benefit to the use of IMRT for rectal cancer

45
Q

What was the population studied in RTOG 0822?

A

68 pts with resectable rectal cancer

46
Q

What was the regimen studied in RTOG 0822?

A

RT (45Gy IMRT + 5.4Gy 3DCRT boost) + concurrent Capecitabine/Oxaliplatin —> surgery —–> FOLFOX

(Phase II trial comparing the above regimen to historical controls from RTOG 0247)

47
Q

What were the results of RTOG 0822?

A

No difference in toxicity when comparing IMRT to historical controls

48
Q

What is a key criticism of RTOG 0822?

A

All patients got concurrent Oxaliplatin which likely increased toxicity and may have masked the benefit of IMRT

49
Q

What is the clinical relevance of the OPRA trial?

A

This trial showed that watchful waiting may be reasonable for patients with a complete or near-complete response to TNT for rectal cancer

50
Q

What was the population studied in the OPRA trial?

A

324 pts with stage II or III rectal cancer

51
Q

What was the regimen studied in the OPRA trial?

A

All pts received long course chemoradiation (54Gy + 5FU or Capecitabine). They were randomized to FOLFOX or CAPEOX before or after chemoradiation (i.e. everyone got TNT). After TNT, they all got DRE, flex sig, and MRI. If complete response or near-complete response then watchful waiting was performed. If partial response then TME.

Each arm was compared to historical controls with 3 yr DFS of 75%

52
Q

What were the results of the OPRA trial?

A

No difference in DFS compared to historical controls when a patient underwent watchful waiting instead of TME after TNT (3 yr DFS 77-78% vs 75%).

*Underpowered analysis suggested that organ preservation rates were higher when TNT used consolidation chemo rather than neoadjuvant chemo (3 yr rate of 58% vs 43%).

53
Q

What is the clinical relevance of the TREC study?

A

This study showed that short-course RT with transanal excision might be an alternative to TME for pts with early stage rectal cancer.

54
Q

What population was studied in the TREC study?

A

55 pts with T1-2 tumors ≤3cm, N0, M0

55
Q

What regimen was studied in the TREC study?

A

Short-course RT (25Gy/5fx) followed by transanal excision vs TME with no RT

56
Q

What were the results of the TREC study?

A

Organ preservation was achieved in 70% of patients randomized to it (the other 30% were converted to TME instead of transanal excision).

30% of patients had a complete response after short-course RT.

Better QOL and toxicities with short-course RT and transanal excision compared to TME alone.

57
Q

What was the clinical relevance of the GRECCAR 2 study?

A

This study showed that transanal excision (instead of TME) could be feasible for patients with good response (i.e. <2cm residual disease) to chemoradiation for rectal cancer.

58
Q

What was the population studied in the GRECCAR 2 study?

A

186 pts with initially T2-3 disease <4cm and within 8 cm of anal verge; all patients had <2cm of residual disease after neoadjuvant chemoRT

59
Q

What was the regimen studied in GRECCAR 2?

A

TME vs transanal excision (after good response to chemoRT)

If a patient was ypT2-3 after transanal excision they were then required to undergo TME

60
Q

What were the results of GRECCAR 2?

A

No difference in outcomes between TME and transanal excision

(This was a superiority design intended to show that transanal excision would be better than TME for good responders to chemoradiation. However, a noninferiority design would be better).

61
Q

What is the clinical relevance of the International Watch and Wait Database?

A

Allows for large scale analysis of outcomes for watch and wait strategy in rectal cancer

62
Q

What is the patient population studied in the International Watch and Wait Database?

A

>1000 pts; all pts underwent neoadjuvant chemoRT and then watch and wait instead of TME

(each certain submitting data decided on their own why a given patient did not get TME)

63
Q

What was the regimen studied in the International Watch and Wait Database?

A

ChemoRT and then surveillance instead of TME

64
Q

What are the results of the International Watch and Wait Database?

A

For patients with a complete response to chemoRT electing for watch and wait strategy:

2 yr local regrowth rate of 25%

2 yr distant mets rate of 8%

88% of recurrences occured within 2 years

If a complete response is sustained for 3 years, the likelihood of local or distant failure is <5%.

65
Q

How does the local regrowth rate compare for patients in the International Watch and Wait Database compared to other watch and wait studies?

A

It is higher (25% at 2 yrs). This is probably because the database includes a wide variety of patients with no common criteria for eligbility.

66
Q

What was the clinical significance of the RECTAL-BOOST study?

A

This study showed no benefit to the addition of a radiation boost upfront prior to standard chemoRT for rectal cancer.

67
Q

What was the population and regimen studied in the RECTAL-BOOST study?

A

128 pts with locally advanced rectal cancer

Standard chemoRT +/- 15Gy/3fx upfront boost

68
Q

What were the results of the RECTAL-BOOST study?

A

No difference in outcomes. No benefit to boost.

69
Q

What is the clinical relevance of the Garcia-Aguilar study analyzing addition of mFOLFOX to neoadjuvant chemoRT for rectal cancer?

A

This trial showed that pCR rates were improved when mFOLFOX was given after neoadjuvant chemoRT for rectal cancer.

70
Q

What population was studied in the Garcia-Aguilar mFOLFOX study?

A

381 pts with Stage II-III rectal cancer

71
Q

What were the regimens studied in the Garcia-Aguilar mFOLFOX study?

A

Standard chemoRT (5FU + 50.4Gy) vs addition of mFOLFOX (2 vs 4 vs 6 cycles)

72
Q

What were the results of the Garcia-Aguilar mFOLFOX study?

A

Improved pCR rate with addition of mFOLFOX: 18% (none) vs 25% (2 cycles) vs 30% (4 cycles) vs 38% (6 cycles)

More toxicity and surgical complications in FOLFOX arms

73
Q

What is the clinical relevance of the PRODIGE study?

A

This trial showed that neoadjuvant mFOLFIRINOX is potentially better than adjuvant mFOLFOX for rectal cancer.

74
Q

What population was studied in the PRODIGE 23 study?

A

460 pts with T3/4 N0-1 rectal cancer

75
Q

What regimens were studied in the PRODIGE 23 study?

A

Neoadjuvant FOLFIRINOX —> chemoRT —> TME —> adjuvant FOLFOX (3)

VS

chemoRT —> TME —> adjuvant FOLFOX (6)

76
Q

What were the results of the PRODIGE 23 study?

A

Improved pCR (28% vs 12%) and PFS

No improvement in OS (3 YR 88 vs 91%)

77
Q

The PROSPECT trial for rectal cancer is ongoing. What regimens are being studied?

A

Standard: pre-op chemoRT then TME and FOLFOX x8

vs.

Selective arm: FOLFOX x6 →
if response ≥20%, TME and FOLFOX x6
if response <20%, chemoRT then TME and FOLFOX x2

78
Q

What is the clinical relevance of EORTC 22921 (rectal cancer study)?

A

This trial showed no survival benefit to the addition of adjuvant 5FU to pre-op chemoRT for rectal cancer

79
Q

What was the population studied in EORTC 22921 (rectal cancer)?

A

1011 pts with T3/T4 rectal cancer

80
Q

What was the regimen studied in EORTC 22921 (rectal cancer study)?

A

Pre-op chemoRT vs. chemoRT with adjuvant 5-FU/LV

81
Q

What were the results of EORTC 22921 (rectal cancer study)?

A

Improvement in LC addition of adjuvant 5FU to neoadjuvant chemoRT.

No difference in DFS or OS.

82
Q

What is the clinical relevance of NSABP R-04?

A

This study examined preop chemoRT for rectal cancer. In particular, 5FU vs Capecitabine and is there any benefit to Oxaliplatin?

83
Q

What was the population studied in NSABP R-04?

A

1608 pts with Stage II or III rectal cancer

84
Q

What were the regimens studied in NSABP R-04?

A

Pre-op chemoRT (50.4 Gy with different concurrent chemotherapies):

5-FU vs. cape/ox vs. 5-FU/ox

85
Q

What were the results of NSABP R-04?

A

No difference in outcomes among the arms (i.e. Capecitabine can be used instead of 5FU and there was no benefit to adding Oxaliplatin).

Worse toxicity with addition of Oxaliplatin.

86
Q

What is the clinical relevance of the ADORE trial?

A

This trial compared adjuvant 5FU to adjuvant FOLOFX after chemoRT and TME for rectal cancer.

87
Q

What was the population studied in the ADORE trial?

A

321 pts with ypT3-4N0 or any ypN1-2 after 5FU chemoRT and TME

88
Q

What were the regimens studied in the ADORE trial?

A

5FU chemo RT and TME → randomized to:

→5FU+LV
vs.
→FOLFOX

Primary endpoint: DFS

89
Q

What were the results of the ADORE trial?

A

Oxaliplatin showed better DFS than 5FU. 6 yr DFS 68% vs 57%.

No benefit in OS.

90
Q

What was the clinical relevance of the Intergroup 0130 trial analyzing adjuvant RT for resected colon cancer?

A

This trial showed that adjuvant RT does not benefit OS or DFS in advanced colon cancer. However the trial had low power and was terminated early.

91
Q

What population was studied in the Intergroup 0130 trial analyzing adjuvant RT for resected colon cancer?

A

222 pts with resected colon cancer T4 at any location or T3N1/T3N2 in ascending or descending colon

92
Q

What regimen was studied in the Intergroup 0130 trial analyzing adjuvant RT for resected colon cancer?

A

→5FU and levamisole alone
vs.
→with radiation therapy

93
Q

What were the results of the Intergroup 0130 trial analyzing adjuvant RT for resected colon cancer?

A

Underpowered, terminated early, no change in OS or DFS, worse toxicity with RT

5-yr OS 62% vs. 58% (NS)
5-yr DFS 51% in both (NS)
Grade ≥3 toxicity 42% vs. 54% (p=0.04)

94
Q

What are some concerns about the Intergroup 0130 trial analyzing adjuvant RT for resected colon cancer?

A

Trial was terminated due to poor accrual (222 out of planned 700 patients). Therefore power was insufficient. LC not assessed. RT was delivered to PA lymph nodes. T3N1 may be too low risk. Chemotherapy used is no longer current. No pre-op imaging or clips required to locate tumor. Margins often not assessed on pathology.

Is there a benefit with radiation therapy with modern technique? One obstacle is that small bowel is often adjacent or adherent to site.

95
Q

What was the clinical relevance of the MOSAIC trial for colon cancer?

A

Showed that adding oxaliplatin to 5FU-LV improves OS in resected colon cancer.

96
Q

What population was studied in the MOSAIC trial for colon cancer?

A

2246 pts with Stage II or III colon cancer

97
Q

What regimen was studied in the MOSAIC trial for colon cancer?

A

Curative resection →

F5U-L vs. FOLFOX

98
Q

What were the results of the MOSAIC trial for colon cancer?

A

Improved OS with FOLFOX over 5FU alone.

10-yr OS 67% vs. 72%
Stage III OS 59% vs. 67%
No benefit in Stage II (OS ~80%)

99
Q

What was the clinical relevance of the EORTC 40983 trial for colorectal cancer?

A

Showed a trend to OS benefit with perioperative FOLFOX for colorectal cancer with hepatic metastases.

100
Q

What population was studied in the EORTC 40983 trial for colorectal cancer?

A

364 pts with resectable liver metastases from colorectal cancer

101
Q

What regimen was studied in the EORTC 40983 trial for colorectal cancer?

A

→perioperative FOLFOX
vs.
→surgery alone

102
Q

What were the results of the EORTC 40983 trial for colorectal cancer?

A

PFS benefit seen on initial publication, but lost on update. Median OS 54 mos vs. 51 mos, trend toward benefit with peri-op

ANKI- GI (8 decks)

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