Carlo Aschele

La Spezia

Rectum and anus cancer

Highlights

AIOM post ASCO GI review, Roma 5-6 Febbraio 2016

• PREOP CRT POTENTIATION

• MAINTENANCE / CONSOLIDATION CHEMO

• INCIDENCE OF RT-INDUCED SECOND PELVIC

TUMORS

• RT schedule

• Role of chemo

• Optimal imaging / staging

TOPICS

Slide 4

Presented By Claus Roedel at TBD

Disease Free Survival (ITT analysis) : 5 year follow-up

Presented By Eric Francois at TBD

Overall Survival (ITT analysis) : 5 year follow-up

Presented By Eric Francois at TBD

Causes of death

Presented By Eric Francois at TBD

Cumulative local recurrence (5 year follow-up)

Presented By Eric Francois at TBD

Prognostic factors for DFS<br />(multivariate Cox proportional-hazards model)

Presented By Eric Francois at TBD

Conclusions

Presented By Eric Francois at TBD

PHASE III trials : neoadjuvant RCT with oxaliplatin

Presented By Eric Francois at TBD

Slide 14

Presented By Claus Roedel at TBD

• Negative also for 2ries endpoints (1ry ep=pCR)

… but effect on DFS seen and similar to other studies

• Apparent difference in deaths unrelated to rectal K

… could this balance the increased acute toxicity?

• Pay attention to LR

• pN stage strongly prognostic

ACCORD 12 (& co)

THM

WEEKLY OXA + FP-based CRT

PRO

4-5% DFS

early mts

Less late mortality

CONTRA

No impact on pCR

Increased acute toxicity

WEEKLY OXA + FP-based CRT

US rejected

FRANCE rejected

GERMANY RETAINED

ITALY ………

Slide 16

Presented By Claus Roedel at TBD

Inclusion criteria

Presented By Krzysztof Bujko at TBD

Slide 4

Presented By Krzysztof Bujko at TBD

5% ineligible!!!

Acute toxicity

Presented By Krzysztof Bujko at TBD

???

Postoperative complications

Presented By Krzysztof Bujko at TBD

Late toxicity

Presented By Krzysztof Bujko at TBD

Pathology

Presented By Krzysztof Bujko at TBD

Primary endpoint – R0 resections

Presented By Krzysztof Bujko at TBD

Cumulative incidence of local failure

Presented By Krzysztof Bujko at TBD

Cumulative incidence of distant metastases

Presented By Krzysztof Bujko at TBD

Disease-free survival

Presented By Krzysztof Bujko at TBD

Overall survival

Presented By Krzysztof Bujko at TBD

• Confirms the interest for consolidation chemo

• Major study limitations:

• heterogenous pop (loc adv + recurr)

• unusual endpoint

• staging

• unconventional control arm (with OXA)

• unusual OXA regimen (monotherapy)

• Roughly similar outcome and toxicity

• Implications for other studies of consolidation chemo?

POLISH II

Slide 19

Presented By Claus Roedel at TBD

Will this become an OXA vs non-OXA study?

The Incidence of Secondary Pelvic Tumors after Previous Radiation for Rectal Cancer<br />

Presented By Anouk Rombouts at TBD

Results

Presented By Anouk Rombouts at TBD

Standardized incidence ratios (SIR)

Presented By Anouk Rombouts at TBD

Cumulative incidence risk of second pelvic tumors

Presented By Anouk Rombouts at TBD

Cumulative incidence risk of second tumors - Prostate

Presented By Anouk Rombouts at TBD

Cumulative incidence risk of second tumors - Rectosigmoid

Presented By Anouk Rombouts at TBD

Cumulative incidence risk of second tumors - other locations

Presented By Anouk Rombouts at TBD

Results

Presented By Anouk Rombouts at TBD

Conclusion

Presented By Anouk Rombouts at TBD

Slide 23

Presented By Claus Roedel at TBD

Slide 24

Presented By Claus Roedel at TBD

THM

Modest DFS > with OXA (stat sig in 1 of 3 studies

so far reported)

No evident benefit for SCRT with maintenance

FOLFOX compared to OXA-based pre-op CRT

(major study limitations)

Protective effect of RT against 2nd pelvic tumors

(prov: will the same apply to oxa?)

GRAZIE

TME RT

FP FP

EORTC

CNR

PROCTOR/SCRIPT

Chronicle

CAO-ARO-AIO 04

PETACC

ADORE

CT vs obs

FP +/- OXA

2014

CNR EORTC Chronicle Proctor/Script

Random preop preop postop postop

Compliance 55% 43% 48% 73%

Accrual

duration 9-y 10-y 4-y 13-y

completed yes yes 113/780 437/840

Included in analysis 245/634 473/1011 75/113 403/437

ONLY yp stage II and III included

Slide 1

Presented By Claus Roedel at TBD

Slide 2

Presented By Claus Roedel at TBD

Slide 13

Presented By Claus Roedel at TBD

Slide 19

Presented By Claus Roedel at TBD

Will this become an OXA vs non-OXA study?

Slide 20

Presented By Claus Roedel at TBD

Slide 23

Presented By Claus Roedel at TBD

Slide 24

Presented By Claus Roedel at TBD

CRT TME CT

CRT/RT TME CT

(CRT) TME CT

Chemotherapy for Rectal Cancer: When Is It Needed? <br />

Presented By Bengt Glimelius at TBD

Conclusions <br />(adding chemotherapy to radiation preoperatively)

Presented By Bengt Glimelius at TBD

Slide 16

Presented By Bengt Glimelius at TBD

Adjuvant chemotherapy in rectal cancer

Presented By Bengt Glimelius at TBD

Adjuvant chemotherapy in rectal cancer<br />- pragmatic conclusions

Presented By Bengt Glimelius at TBD

TME RT

FP FP

EORTC

CNR

PROCTOR/SCRIPT

Chronicle

CAO-ARO-AIO 04

PETACC

ADORE

CT vs obs

FP +/- OXA

2014

CNR EORTC Chronicle Proctor/Script

Random preop preop postop postop

Compliance 55% 43% 48% 73%

Accrual

duration 9-y 10-y 4-y 13-y

completed yes yes 113/780 437/840

Included in analysis 245/634 473/1011 75/113 403/437

ONLY yp stage II and III included

Endoscopic Ultrasonography vs MRI for Staging and Response Evaluation

Presented By Gina Brown at TBD

Randomised trial evidence unimportance of nodal status

Presented By Gina Brown at TBD

mrEMVI is associated with pelvic sidewall tumour deposits

Presented By Gina Brown at TBD

MRI as a gold standard – why we need to go beyond TNM

Presented By Gina Brown at TBD

MDT choices and making best use of high resolution MRI

Presented By Gina Brown at TBD

Reporting Minimum Standards

Presented By Gina Brown at TBD