CR Thomas Jr., Y Chen, J Garcia-Aguilar,, K Avila, RM Krieg, EK Bergsland, AH Ko, P Chu, DD Smith, DA Rothenberger, JM Hwang OHSU Knight Cancer Institute (Portland, OR), Memorial Sloan- Kettering Cancer Center (New York, NY), UCSF Helen Diller Family Comprehensive Cancer Center (San Francisco, CA), City of Hope (Duarte, CA), University of Minnesota (Minneapolis, MN) Phase II Timing of Rectal Cancer Response to Chemoradiation: Analysis of Radiotherapy (RT)
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Phase II Timing of Rectal Cancer Response to ... II Timing of Rectal Cancer Response to Chemoradiation: Analysis of Radiotherapy (RT) Acknowledgement •Supported, in part, by NIH,
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CR Thomas Jr., Y Chen, J Garcia-Aguilar,, K Avila, RM Krieg, EK Bergsland, AH Ko, P Chu, DD Smith,
DA Rothenberger, JM Hwang
OHSU Knight Cancer Institute (Portland, OR), Memorial Sloan-Kettering Cancer Center (New York, NY), UCSF Helen Diller
Family Comprehensive Cancer Center (San Francisco, CA), City of Hope (Duarte, CA), University of Minnesota (Minneapolis, MN)
Phase II Timing of Rectal Cancer
Response to Chemoradiation:
Analysis of Radiotherapy (RT)
Acknowledgement
• Supported, in part, by NIH, NCI R01 CA 090559 to J Garcia-Aguilar
Disclosure
• The authors have no conflicts of interest to disclose.
6 – 8 Weeks
Rectal Cancer Treatment Algorithm
uT1 (+/- uT2) well/mod diff., no LVI < 40% circumference < 6 ( ?8) cm from verge Mobile / non-fixed
uT2, N0
Non- fixed High risk uT1
uT3 or T4, N0 or uTany, N1
Metastatic disease
Consider local excision +/- postop radiation
Above anorectal ring, continent patient
Below anorectal ring, incontinent patient
Prep CMT (5FU/XRT)
Operate if potentially resectable liver metastases, otherwise for palliation only
Randomized Phase II trial testing the efficacy of 2 neoadjuvant chemotherapy schedules in maximizing the proportion of pts with distal LARC who are cured without standard radical surgery.
Randomized Phase II trial testing the efficacy of 2 neoadjuvant chemotherapy schedules in maximizing the proportion of pts with distal LARC who are cured without standard radical surgery.
SPECIFIC AIMS
• To evaluate 3-yr RFS for in pts receiving induction neoadjuvant or consolidative neoadjuvant chemotherapy, chemoradiotherapy, & selective non-operative mgt, vs standard historical controls managed with chemoradiotherapy, TME, & adjuvant chemotherapy
• To compare outcomes between pts in both study arms, with respect to organ preservation rates, compliance with treatment & adverse events
• To measure PRO (functional) & QoL in pts with distal LARC treated with neoadjuvant chemotherapy, chemoradiotherapy, & non-operative mgt, compare to pts treated with TME
• To investigate the diagnostic performance of conventional & DW-MRI in identifying pts with distal LARC treated with neoadjuvant chemotherapy & chemoradiotherapy, who may benefit from non-operative mgt.
New Directions/Successor Trial
Conclusions
A multi-institutional phase II trial in pts with locally advanced rectal cancer
who receive neoadjuvant CRT followed by consolidation chemotherapy (TNT)
& increasing interval of delayed surgery is feasible.
Pathologic response is not associated with total dose per inter- or intra-
Group
comparison.
Pathologic response is not associated with IMRT per inter- or intra-Group
comparison.
Elapsed Days (total) as a continuous variable, it is not significantly associated
with pathologic response per inter- or intra-Group comparison.
A successor trial will evaluate 3-yr RFS comparing induction vs
consolidation
systemic therapy, prospectively evaluate organ preservation non-operative
dx management, measure pt-related functional outcomes, and investigate the
predictive utility of DW-MRI for resectable rectal cancer
Supported, in part, by NIH, NCI R01 CA090559 to Julio Garcia-Aguilar
Thank you for your attention
EXAMPLE OF PARTIAL RESPONSE WITHOUT
DOWNSTAGING
The response rate is calculated based on a combination of bulk and depth.
For example, let's say the tumor is stage II at baseline (T3N0). Patients are
considered to have a pPR if the tumor has shrunk at least 30% in one
dimension. However, the bulk of the tumor may respond in the rectal wall,
but there may be residual tumor cells left at depth (e.g. cells found in
muscularis propria). In this case, the tumor would still classified as stage II
compared to baseline.
In another case, if the tumor was staged at T3N1 at baseline (nodes positive
on imaging), and upon final path review residual tumor cells are found in
the muscularis propria but all nodes are negative, then the tumor would be
considered down-staged in this case.
RESULTS: Enrollment Summary for Group 2 Total No. enrolled xx