Transcript Slide 1

Multimodality Therapy of Rectal Cancer

Robert D. Madoff, MD University of Minnesota

rectal cancer

clinical issues

• colostomy or anastomosis? • local or radical surgery?

• functional outcomes?

• neoadjuvant therapy?

rectal cancer therapy

morbidity mortality function optimal cure rate

total mesorectal excision

• the rectum and its mesentery are a single fascia-enveloped unit, anatomically separate from surrounding pelvic structures • surgical violation of this anatomic package leads to a positive circumferential margin, a known predictor of local recurrence

rectal cancer

pathologic evaluation

circumferential resection margin

% 100 50 CRM (+) CRM (-) 0 local recurrence survival Adam 1995

rectal cancer

stage dictates therapy

rectal cancer

know your enemy!

uT1

uT3 uN1

Preop Staging • Review of 83 studies including 4897 patients T Stage EUS Sensitivity Specificity 93% MRI/coil 89% 78% 79% N Stage EUS 71% MRI/coil 82% 76% 83% Kwok 2000

MRI staging

circumferential margin

Prediction of Involved CRM

Beets-Tan 2004

% 50

local recurrence

surgeon as risk factor

surgeon minimum 25 rectal cancer operations per surgeon Holm 1997

rectal cancer

know your surgeon!

circumferential resection margin

% 100 50 CRM (+) CRM (-) 0 local recurrence survival Adam 1995

% 0 25

rectal cancer surgery

impact of technique

p < 0.0001* p < 0.002* Stockholm I Stockholm II TME project 15 16 9 15 14 6 local recurrence cancer deaths * Stockholm I and II vs TME project Lehander Martling 2000

Combined postoperative chemotherapy and radiation therapy improves local control and survival in Stage II and III patients and is recommended.

NIH Consensus Statement, 1990

30 local recurrence (%) 15 rectal cancer

radiation + chemo

25 14 0 RT RT + CT Krook 1991

rectal cancer

radiation + chemo, vs. TME alone

30 local recurrence (%) 15 25 14 6 0 RT RT + CT TME Krook 1991 Heald 1998

radiation therapy

friend

or

friendly fire?

radiation therapy

disadvantages

• cost • convenience • complications • covering stomas • quality of life

postop chemoradiation

functional results

CT/RT surgery only BM / 24 hr nighttime BMs occasional incontinence frequent incontinence pad unable to defer BM 15' (%) 7 46 39 7 41 78 (%) 2 14 17 0 10 19 Kollmorgen 1994

short course rt

long-term morbidity

dvt femoral neck / pelvic fractures sbo fistulas RT (+) (%) 7.5

5.3

RT (-) (%) 3.6

2.4

13.3

4.8

8.5

1.9

p 0.01

0.03

0.02

0.01

Holm 1996

radiation therapy

controversies

• patient selection –

who needs adjuvant therapy?

• timing –

pre- or postoperative?

• technique –

short or conventional course?

% 0 27 surgery +/- rt

local recurrence

SRCT Dutch TME Trial 8 11 2 surgery/ RT surgery

100 % 50 82 surgery +/- rt

2-year survival

p=0.84

82 0 surgery surgery/ RT Dutch TME Trial

pre

• biology • downstaging – resectability – sphincter salvage – margins • sb complications • functional results rectal cancer

radiation timing

post

• staging accuracy – avoids overtreatment • anastomotic leak risk – covering stomas

German rectal cancer study 823 patients - Stage II-III 50.4 Gy RT + Chemo OR (TME) OR (TME) 50.4 Gy RT + Chemo Sauer 2003

German rectal cancer study Leak Bleed Delayed healing Stricture Acute toxicity Pre-Op 10% 2% 4% 4% 27% Post-Op 12% 3% 6% 12%* 40%* Sauer, NEJM 2005

German rectal cancer study Downstaging Sphincter Preservation Local Recurrence Survival * p<0.05

Pre-Op 8% 39% 6% 76% Post-Op 19%* 13%* 74% Sauer, NEJM 2005

short vs. long course United States: 45-54 Gy OR 6 weeks Europe: 25 Gy 1 week OR

short course radiation pro

convenience

cost

effectiveness con

• • •

unsafe if given improperly ? higher rate of late toxic effects cannot give simultaneously with chemotherapy

short course vs. conventional radiation

no data!

radiation therapy current status (USA)

• optimally stage patient (ERUS) • conventional (long course) RT plus chemotherapy for stage II (T3), stage III (N1) or stage IV cancers • • postoperative chemoradiation for positive circumferential margin

consider

postoperative chemoradiation for understaged T3 or N1 lesions

RECTAL CANCER AS BREAST CANCER: PARADIGM FOUND?

pensa globalmente… …agisci localmente

RECTAL CANCER LOCAL EXCISION

pro –low morbidity/mortality –avoids sexual/urinary/bowel dysfunction –avoids colostomy con –nodal status not pathologically assessed –involved nodes not excised –? equivalent oncologic results to radical excision

non usare un cannone per sperare ad una pulce…

…ma prima assicurati che sia proprio ad una pulce che stai sparando!

local therapy

results

25

local recurrence (%) 14 3 T1 T1: local excision T2: local excision plus chemoradiation T2 CALGB 8984

local excision vs. radical surgery 100 local recurrence (%) 50 47 18 0 0 T1 T1: local excision T2: local excision; no chemoradiation T2 6 local excision radical surgery Garcia-Aguilar 2000

“Dr. Mellgren and colleagues deserve to be congratulated for their honesty…” Steele 2000

“…remarkably bad outcome… significantly worse than any previously reported…” “the University of Minnesota experience stands alone…” Steele 2000

% local recurrence

local excision T 1 rectal cancer

25 18 15 17 UMN 2000 MSKCC 2005 CCF 2005

CALGB 8984 Steele 1999

TEM results

superior to transanal excision!

TME VS. TMN

local excision:

TOTAL MESORECTAL NEGLECT!

select tumors with a low likelihood of regional metastases

risk of nodal involvement

resected colorectal cancer

T stage T1 T2 T3 T4 positive nodes 0-18% avg 8% 12-38% 36-67% 53-88% avg 22% avg 60% avg 65%

risk stratification

within T stage

differentiation well moderate poor 9% positive nodes T1 T2 4% 12% 20% 13% 48%

submucosal invasion

Japanese classification

Kikuchi nodal metastasis

Japanese classification

Sm 1 0% Sm 2 10% Sm 3 39% Nivatvongs 2.9% 7.5% 23%

local excision is first a complete excisional biopsy

local excision

pathologic exclusion criteria

• • • •

T stage > T1 Sm3 positive or equivocal margins poor differentiation lymphovascular invasion

SALVAGE SURGERY STATUS

29 patients unresectable hepatic mets additional recurrence free of disease ( positive margin, NED 3*) 1 11 17

*follow-up 12 months Friel 2002

SALVAGE SURGERY AFTER LOCAL EXCISION

don’t count on it!

LOCAL EXCISION

primum non nocere!

It is the wise surgeon who understands that the patient takes all the risk.

local excision

rules of engagement

• selection, selection, selection!

– ERUS stage first, but reassess pathologic specimen – no “winking” at adverse histology or inadequate margins • adjuvant chemoradiation for pT2 tumors • mandate close follow up • remember that recurrent tumors are almost always more advanced than they start, and radical salvage surgery cures only 50% of patients

local excision

preoperative chemoradiation?

downstages tumor

? curative in some patients

may reduce risk of tumor implantation at excision site

rectal cancer therapy

morbidity mortality function optimal cure rate

rectal cancer

conclusions

• • • • •

numerous treatment permutations appropriate treatment depends upon tumor stage, which should be determined before surgery surgery is technically driven; optimal results require training and experience role of local therapy remains controversial oncologic cure is the primary goal, but functional results are an important outcome