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台北榮民總醫院血液腫瘤科
Supervisor: VS 鄧豪偉Presenter: R4 王浩元
Deborah Schrag, Martin R. Weiser, Karyn A. Goodman, Mithat Gon¨en, Ellen
Hollywood, Andrea Cercek, Diane L. Reidy-Lagunes, Marc J. Gollub, Jinru Shia,
Jose G. Guillem, Larissa K.F. Temple, Philip B. Paty, Leonard B. Saltz
《Journal of Clinical Oncology 2014; 32: 513》
Memorial Sloan-Kettering Cancer Center, New York, NY
Neoadjuvant Chemotherapy Without
Routine Use of Radiation Therapy for
Locally Advanced Rectal Cancer:
A Pilot Trial
ESMO for stage I/II/III rectal cancer
Combine-modality therapy for stage II/III
resectable non-metastatic rectal cancer:
Surgery (OP)
Radiation therapy (RT)
Chemotherapy (CT)
CRT TME Adjuvant CT
Pre-OP vs Post-OP
Which regimen
CCRT vs scRT
Combine-modality therapy for stage II/III
resectable non-metastatic rectal cancer:
Surgery (OP)
Radiation therapy (RT)
Chemotherapy (CT)
CRT TME Adjuvant CT
>25% distant mets0 3M
Rare local recurrence Pre-OP vs Post-OP
Which regimen
CCRT vs scRT
II & III
Arm- A Arm- B
Response to neoadjuvant treatment correlates
with long-term outcomes in rectal cancer
MERCURY prospective cohort trial (111 P’t):
MRI-assessed tumor regression grade
significantly associated with OS & DFS
J Clin Oncol 2011;29:3753-3760
Poor tumor
regression
Good tumor
regression
P
5-year OS 27% 72% 0.001
DFS 31% 64% 0.007
A retrospective review of 725 patients with
rectal cancer found similar results
Pathological response to neoadjuvant treatment
correlated with long-term outcomes.
Distant metastases and local recurrences also
correlated with the level of response.
J Clin Oncol 2012;30:1770-1776.
Response to neoadjuvant treatment correlates
with long-term outcomes in rectal cancer
Pathological response Good Intermediate poor
5Y recurrence-free
survival rate90.5% 78.7% 58.5%
Combine-modality therapy for stage II/III
resectable non-metastatic rectal cancer:
Surgery (OP)
Radiation therapy (RT)
Chemotherapy (CT)
CRT TME Adjuvant CT
>25% distant mets0 3M
Rare local recurrence
Combine-modality therapy for stage II/III
resectable non-metastatic rectal cancer:
Surgery (OP)
Radiation therapy (RT)
Chemotherapy (CT)
CRT TME Adjuvant CT
>25% distant mets0M
Rare local recurrence
Neoadjuvant
Combine-modality therapy for stage II/III
resectable non-metastatic rectal cancer:
Surgery (OP)
Radiation therapy (RT)
Chemotherapy (CT)
TME Adjuvant CT
>25% distant mets0M
Rare local recurrence
Neoadjuvant
Methods
Inclusion: Rectal adenocarcinoma
No previous treament
No metastatic disease
Amenable to sphincter-preserving TME
Distal edge of tumor: 5-12cm
Exclusion: T4
Clinical obstruction
≥ 4 pelvic LNs (>2cm) on MRI/ERUS
Tx for another primary cancer within 5 years
Thrombotic episode within 6 months
Work-up:• Rigid proctoscopy
• ERUS & Pelvis MRI (for LN)
• Chest/Abdomen/Pelvis CT (for M1)
• ECOG: 0-2
• ANC > 1500/uL,
• PLT > 100K/uL
• CCr > 30 mL/min
• T-bil < 2X UNL
• ALT/ALP < 3X UNL
cT3N(+), cT3N(-): N(-): NO perirectal LN > 5mm
N(+): ≥ 1 perirectal LN > 5mm
Intolerance
Progression (PD)
No response (SD) Clinical response
3–6 wk
3–6 wk
Primary endpoint: R0 resection rate
(no evidence of tumor within 1mm of tumor margin)
Secondary endpoint: Disease-free survival (DFS)
Proportion of trial participants receiving
preoperative or postoperative radiation
Results
Enrollement: 32 patients (2007/03 - 2009/10)
Median follow-up time: 54 months (26-81m)
Median age: 52y (26-81y)
Women: 53% (17 of 32)
LN(+): 72% (23 of 32)
Results
T3N(+) 63% (20 of 32)
T2N(+) 9% (3 of 32)
T3N(--) 28% (9 of 32)
pCR
pCR
pCR
pCR
pCR
pCR
pCR
pCR
Pre-OP
Pre-OP
Post-OP
Lung
Lung
Lung
Lung
Discussion
Highlights
CRT OP Adjuvant CT
Rare local recurrence
>25% distant mets0 3M
Neoadjuvant OP Adjuvant CT
Rare local recurrence
16% distant metsCRT
94%
6 %
Could low recurrence rate be
attributed to other factors ?
Rectal tumor: 5-12cm from AV
Bevacizumab: negative results in adjuvant setting
LNs: 72% of participants had nodal involvement
Limitationsmall number of participants
single center
ConclusionFor selected clinical stages II to III rectal
cancer, neoadjuvant chemotherapy
(without routine use of radiation) does
NOT compromise outcomes.
Thanks for your attention