ANCO Best of ASCO 2011GI Oncology Abstracts

Katie Kelley, M.D.

Assistant Clinical Professor

University of California, San Francisco

27 August 2011

GI Oncology Abstracts

• Colorectal:– Abstract 3503: NSABP R-04– Abstract 3510: PRIME– Abstract 3511: KRAS G13D

• Gastric:– Abstract 4003: CALGB 80101– Abstract LBA 4002: CLASSIC

• GIST: – Abstract LBA1: SSGXVIII/AIO

The Impact of Capecitabine and Oxaliplatin in the Preoperative

Multimodality Treatment of Patients with Carcinoma of the Rectum:

NSABP R-04MS Roh, GA Yothers, MJ O'Connell, RW Beart, HC Pitot, AF

Shields, DS Parda, S Sharif, CJ Allegra, NJ Petrelli, JC Landry, DP Ryan, A Arora, TL Evans, GS Soori,

L Chu, RV Landes, M Mohiuddin, S Lopa, N Wolmark

ASCO June 4, 2011

1 pmAbstract #3503

Group 4Capecitabine 825 mg/m2 PO BID + Oxaliplatin 50 mg/m2/week X 5+4600cGy + 540-1080cGy

Adenocarcinoma of rectum amenable to surgical resection located < 12 cm from anal verge

STRATIFICATIONGenderClinical Tumor Stage II or IIIIntent for Type of Surgery (sphincter saving; non-sphincter saving)

RANDOMIZATION

Group 3Capecitabine 825 mg/m2 PO BID +4600cGy + 540-1080cGy

Group 25FU (CVI 225mg/m2 5d/week) + Oxaliplatin 50 mg/m2/week X 5 +4600cGy + 540-1080cGy

Group 15FU (CVI 225mg/m2 5d/week)+4600cGy + 540-1080cGy

SURGERYSURGERY

Abstract #3503

Gastrointestinal Toxicity5-Fu or CAPE vs addition of Oxaliplatin

GI Toxicity** No Oxali Oxali Total

< Grade 3 diarrhea 581 534 1115

Grade 3/4 diarrhea 41 97 138

Total Patients 622 631 1253

Incidence (%) 6.6 15.4P-value0.0001

Oxali

No Oxali

0.04 0.08 0.12 0.16 0.2

**CTCAE Version 3.0

Abstract #3503

Surgical Downstaging (SD) by Treatment5-FU vs Capecitabine

SD Status 5-FU Cape Total

without SD 149 144 293

with SD 39 43 82

Total Patients* 188 187 375

SD Rate (%)95% CI

20.715.2-27.2

23.017.2-29.7

P-value.62

*Restricted to patients without pre-trial intent for SSS

5-FU

Cape

0.15 0.2 0.25 0.3

Abstract #3503

Sphincter Saving Surgery by Treatment

Oxaliplatin vs NoneSSS Status No Oxali Oxali Total

without SSS 212 231 443

with SSS 370 353 723

Total Patients 582 584 1166

SSS Rate (%)95% CI

63.659.5-67.5

60.456.3-64.4

P-value.28

No Oxali

Oxali

0.56 0.58 0.6 0.62 0.64 0.66 0.68

Abstract #3503

Pathologic Complete Response by Treatment

Oxaliplatin vs NonepCR Status No Oxali Oxali Total

without pCR 469 457 926

with pCR 111 121 232

Total Patients 580 578 1158

pCR Rate (%)95% CI

19.116.0-22.6

20.917.7-24.5

P-value0.46

No Oxali

Oxali

0.16 0.18 0.2 0.22 0.24 0.26

Abstract #3503

NSABP R-04Conclusions

• Administration of capecitabine with preoperative RT achieved rates similar to CVI 5-FU for– Surgical downstaging– Sphincter saving surgery– Pathologic complete response

• Addition of oxaliplatin did not improve outcomes and added significant toxicity

• Longer follow up will be needed to assess local-regional tumor relapse, DFS and OS

Abstract #3503

ASCO 2011

Final Results From PRIME: Randomized Phase 3 Final Results From PRIME: Randomized Phase 3 Study of Panitumumab (pmab) With FOLFOX4 for Study of Panitumumab (pmab) With FOLFOX4 for

1st‑line Metastatic Colorectal Cancer (mCRC) 1st‑line Metastatic Colorectal Cancer (mCRC)

Jean Yves Douillard,Jean Yves Douillard,11 Salvatore Siena, Salvatore Siena,22 James Cassidy, James Cassidy,33 Josep Tabernero,Josep Tabernero,44 Ronald Burkes, Ronald Burkes,55 Mario E. Barugel, Mario E. Barugel,66 Yves Yves Humblet,Humblet,77 David Cunningham, David Cunningham,88 Feng Xu, Feng Xu,99 Kartik Krishnan Kartik Krishnan99

11Centre René Gauducheau, Nantes, France; Centre René Gauducheau, Nantes, France; 22Ospedale Niguarda Ca’ Granda, Milan, Italy; Ospedale Niguarda Ca’ Granda, Milan, Italy; 33The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; 44Vall d'Hebrón Vall d'Hebrón

University Hospital, Barcelona, Spain; University Hospital, Barcelona, Spain; 55Mount Sinai Hospital, Toronto, Canada; Mount Sinai Hospital, Toronto, Canada; 66Hospital de Hospital de Gastroenterología, Buenos Aires, Argentina; Gastroenterología, Buenos Aires, Argentina; 77Centre du Cancer de l'Université Catholique Centre du Cancer de l'Université Catholique

de Louvainde Louvain, Brussels, Belgium; , Brussels, Belgium; 88The Royal Marsden NHS Foundation Trust, London, United The Royal Marsden NHS Foundation Trust, London, United Kingdom; Kingdom; 99Amgen Inc., Thousand Oaks, California;Amgen Inc., Thousand Oaks, California;

Abstract #3510

PFS by PFS by KRASKRAS Mutation Status Mutation StatusFinal AnalysisFinal Analysis

EventsEventsn (%) n (%)

Median Median (95% CI) (95% CI) monthsmonths

Panitumumab + Panitumumab + FOLFOX4FOLFOX4

270 / 325 270 / 325 (83)(83)

10.0 (9.3 – 11.4)10.0 (9.3 – 11.4)

FOLFOX4FOLFOX4 280 / 331 280 / 331 (85)(85)

8.6 (7.5 – 9.5)8.6 (7.5 – 9.5)

HR = 0.80 (95% CI: 0.67 – 0.95) HR = 0.80 (95% CI: 0.67 – 0.95) Log-rank p-value = 0.01Log-rank p-value = 0.01

EventsEventsn (%) n (%)

Median Median (95% CI) (95% CI) monthsmonths

Panitumumab Panitumumab + FOLFOX4+ FOLFOX4

204 / 221 204 / 221 (92)(92)

7.4 (6.9 – 8.1)7.4 (6.9 – 8.1)

FOLFOX4FOLFOX4 196 / 219 196 / 219 (89)(89)

9.2 (8.1 – 9.9)9.2 (8.1 – 9.9)

HR = 1.27 (95% CI: 1.04 – 1.55)HR = 1.27 (95% CI: 1.04 – 1.55)Log-rank p-value = 0.02Log-rank p-value = 0.02

WT WT KRASKRAS MT MT KRASKRAS

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Abstract #3510

OS by KRAS Mutation StatusFinal Analysis

EventsEventsn (%)n (%)

Median (95% CI)Median (95% CI)monthsmonths

Panitumumab+ Panitumumab+ FOLFOX4FOLFOX4

214 / 325 214 / 325 (66)(66)

23.9 (20.3 - 27.7)23.9 (20.3 - 27.7)

FOLFOX4FOLFOX4 231 / 331 231 / 331 (70)(70)

19.7 (17.6 - 22.7)19.7 (17.6 - 22.7)

HR = 0.88 (95% CI: 0.73 – 1.06) HR = 0.88 (95% CI: 0.73 – 1.06) Log-rank p-value = 0.17Log-rank p-value = 0.17

EventsEventsn (%)n (%)

Median (95% CI)Median (95% CI)monthsmonths

Panitumumab+ Panitumumab+ FOLFOX4FOLFOX4

179 / 221 179 / 221 (81)(81)

15.5 (13.1 - 17.6)15.5 (13.1 - 17.6)

FOLFOX4FOLFOX4 177 / 219 177 / 219 (81)(81)

19.2 (16.5 - 21.7)19.2 (16.5 - 21.7)

HR = 1.17 (95% CI: 0.95 – 1.45)HR = 1.17 (95% CI: 0.95 – 1.45)Log-rank p-value = 0.15Log-rank p-value = 0.15

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WT WT KRASKRAS MT MT KRASKRAS

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Abstract #3510

Objective Response by KRAS Status (Central Review)

WT WT KRASKRAS MT MT KRASKRAS

Panitumumab Panitumumab + FOLFOX4+ FOLFOX4(n = 317)(n = 317)aa

FOLFOX4FOLFOX4(n = 324)(n = 324)aa

Panitumumab Panitumumab + FOLFOX4+ FOLFOX4(n = 215)(n = 215)aa

FOLFOX4FOLFOX4(n = 211)(n = 211)aa

Objective response rate, Objective response rate, % (95% CI)% (95% CI)

5757(51 – 63)(51 – 63)

4848(42 – 53)(42 – 53)

40 40 (33 – 47)(33 – 47)

41 41 (34 – 48)(34 – 48)

Odds ratio (95% CI)Odds ratio (95% CI)bb 1.47 (1.07 – 2.04)1.47 (1.07 – 2.04)p = 0.02p = 0.02

0.98 (0.65 – 1.47)0.98 (0.65 – 1.47)p = 0.92p = 0.92

Complete response, %Complete response, % <1<1 <1<1 00 00

Partial response, %Partial response, % 5757 4747 4040 4141

Stable disease, %Stable disease, % 2929 3636 3737 4343

Progressive disease, %Progressive disease, % 77 1111 1313 1111

aaIncluded only patients with baseline measurable disease per central reviewIncluded only patients with baseline measurable disease per central reviewbbAdjusted for geographic region and ECOG performance status scoreAdjusted for geographic region and ECOG performance status scoreAll responses were required to be confirmed at least 28 days after the response criteria were first metAll responses were required to be confirmed at least 28 days after the response criteria were first met

Abstract #3510

PFS, OS, and Objective Response by Worst Grade Skin Toxicityin Patients With WT KRAS Tumors Receiving Panitumumab*

* Landmark analysis among patients with a PFS * Landmark analysis among patients with a PFS time time ≥ 28 days≥ 28 days

EventsEventsn (%) n (%)

Median (95% CI)Median (95% CI)monthsmonths

Grade 2-4Grade 2-4 208 / 250 (83)208 / 250 (83) 11.3 (9.9 – 13.2)11.3 (9.9 – 13.2)

Grade 0-1Grade 0-1 55 / 64 (86)55 / 64 (86) 6.1 (5.3 – 9.2)6.1 (5.3 – 9.2)

HR (Gr 2-4: 0-1) = 0.56 (95% CI: 0.41 – 0.76) HR (Gr 2-4: 0-1) = 0.56 (95% CI: 0.41 – 0.76) Log-rank p-value = 0.002Log-rank p-value = 0.002

Skin Toxicity Worst Skin Toxicity Worst Grade 0-1Grade 0-1(n = 61)(n = 61)

Skin Toxicity Worst Skin Toxicity Worst Grade 2-4Grade 2-4(n = 246)(n = 246)

Objective response rate, % (95% CI)Objective response rate, % (95% CI) 41 (29 – 54)41 (29 – 54) 63 (57 – 69)63 (57 – 69)

Odds Ratio (95% CI)Odds Ratio (95% CI) 2.55 (1.36, 4.80)2.55 (1.36, 4.80)

p-valuep-value p = 0.003p = 0.003

HR (Gr 2 - 4 : 0 - 1) = 0.53 (95% CI: 0.38 - 0.73)HR (Gr 2 - 4 : 0 - 1) = 0.53 (95% CI: 0.38 - 0.73)p-value = 0.0001p-value = 0.0001

EventsEventsn (%) n (%)

Median (95% CI)Median (95% CI) months months

Grade 2-4Grade 2-4 157 / 250 (63)157 / 250 (63) 27.7 (23.8 – 30.8)27.7 (23.8 – 30.8)

Grade 0-1Grade 0-1 50 / 64 (78)50 / 64 (78) 11.5 (9.1 – 20.2)11.5 (9.1 – 20.2)

PFSPFS OSOS

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• Median (Q1, Q3) time to worst grade 2 or greater skin toxicity was 53 (13, 118) daysMedian (Q1, Q3) time to worst grade 2 or greater skin toxicity was 53 (13, 118) days

Abstract #3510

Conclusions• In the final analysis of PRIME, panitumumab plus FOLFOX4 vs FOLFOX4 in In the final analysis of PRIME, panitumumab plus FOLFOX4 vs FOLFOX4 in

patients with WT patients with WT KRASKRAS mCRC showed: mCRC showed:

– Statistically significant improvement in PFSStatistically significant improvement in PFS

– Trend toward improved OSTrend toward improved OS

– Statistically significant improvement in response rateStatistically significant improvement in response rate

• A quarter of patients with WT A quarter of patients with WT KRASKRAS enrolled in the FOLFOX4 “alone” arm enrolled in the FOLFOX4 “alone” arm received subsequent anti-EGFR therapy after the protocol treatment phase was received subsequent anti-EGFR therapy after the protocol treatment phase was complete but before the final efficacy analyses, likely affecting OS resultscomplete but before the final efficacy analyses, likely affecting OS results

• In patients with MT In patients with MT KRASKRAS tumors, outcomes were inferior for panitumumab + tumors, outcomes were inferior for panitumumab + FOLFOX4 vs FOLFOX4 aloneFOLFOX4 vs FOLFOX4 alone

• Adverse event rates were consistent with the primary analysis and as expected Adverse event rates were consistent with the primary analysis and as expected for an EGFR inhibitorfor an EGFR inhibitor

• In patients receiving panitumumab with WT In patients receiving panitumumab with WT KRASKRAS mCRC who develop grade 2– mCRC who develop grade 2–4 skin toxicity, PFS, OS, and objective response are improved vs patients with 4 skin toxicity, PFS, OS, and objective response are improved vs patients with skin toxicity grade 0–1skin toxicity grade 0–1

Abstract #3510

Influence of KRAS G13D mutations on outcome in patients with

metastatic colorectal cancer (mCRC) treated with first-line chemotherapy

with or without cetuximab

S. Tejpar*,

C. Bokemeyer, I. Celik, M. Schlichting,

U. Sartorius, E. Van Cutsem

*University Hospital Gasthuisberg, Leuven, Belgium

Abstract #3511

Objectives

• To investigate the influence of KRAS G13D mutations on clinical outcome in mCRC patients treated in the first-line setting– A pooled exploratory analysis of the CRYSTAL and OPUS

studies• KRAS G13D vs KRAS wt• KRAS G13D vs other KRAS mutations

• To explore the impact of KRAS G12V mutations

– A marker of poor prognosis ? (RASCAL study)1

wt, wild-type1Andreyev H, et al. Br J Cancer 2001;85:692-6

Abstract #3511

• KRAS codon 13 mutations are more frequent in CRC than other tumor types (lung and pancreas)1

• KRAS codon 13 mutations exhibit weaker in vitro transforming activity than codon 12 mutations2

• Isogenic cell lines showed3

– KRAS G12V mutated CRC cells were insensitive to cetuximab– KRAS G13D mutated CRC cells were sensitive to cetuximab

1Welcome Trust Sanger Institute; http://www.sanger.ac.uk/genetics/CGP/cosmic/2Guerro S, et al. Cancer Res 2000;60:6750-6756

3De Roock W, et al. JAMA 2010;304:1812-1820

Are all KRAS mutations equal?

Abstract #3511

Chemotherapy arm: KRAS mutation status and outcome in the pooled analysis

Months

0.0

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120 4 8 16 20

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of P

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OS

MonthsMonths

wt mt G13D mt G12V mt Other

(n=447) (n=41) (n=53) (n=148)

Median OS 19.5 14.7 17.8 17.7

[95% CI] [17.8-21.1] [12.4-19.4] [15.5-21.7] [15.3-20.5]

wt mt G13D mt G12V mt Other

(n=447) (n=41) (n=53) (n=148)

Median PFS 7.6 6.0 8.8 8.1

[95% CI] [7.4-8.4] [5.4-7.8] [7.2-9.5] [7.2-9.4]

mt, mutant; wt, wild-type

KRAS G13D vs other mut: HR 1.39, p=0.0988KRAS G13D vs other mut: HR 1.54, p=0.0847

PFS OS

Abstract #3511

KRAS mutation status and treatment effect: PFS

mt, mutant; wt, wild-type

Study Population Median (months)chemotherapy + cetuximab vs. chemotherapy

HR [95% CI]

Pooled Analysis KRAS wt (n=845) 9.6 vs 7.6 0.66 [0.55-0.80]

KRAS mt-G13D (n=83) 7.4 vs. 6.0 0.60 [0.32-1.12]

KRAS mt-G12V (n=125) 5.6 vs. 8.8 1.55 [0.94-2.56]

KRAS mt-other (n=325) 6.7 vs. 8.1 1.37 [1.02-1.84]

CRYSTAL KRAS wt (n=666) 9.9 vs. 8.4 0.69 [0.56-0.86]

KRAS mt-G13D (n=60) 7.5 vs. 7.4 0.72 [0.33-1.57]

KRAS mt-G12V (n=91) 6.7 vs. 8.2 1.43 [0.79-2.59]

KRAS mt-other (n=246) 7.1 vs. 7.7 1.19 [0.84-1.68]

OPUS KRAS wt (n=179) 8.3 vs. 7.2 0.57 [0.37-0.88]

KRAS mt-G13D (n=23) 5.7 vs. 5.6 0.40 [0.13-1.21]

KRAS mt-G12V (n=34) 4.4 vs. 9.4 1.89 [0.73-4.86]

KRAS mt-other (n=79) 5.5 vs. 8.6 2.06 [1.12-3.76]

Benefit under chemotherapy + cetuximab Benefit under chemotherapy alone

0.1 0.5 1.0 2.0

Abstract #3511

KRAS mutation status and treatment effect: tumor response

mt, mutant; wt, wild-type

Benefit under chemotherapy + cetuximabBenefit under chemotherapy alone

2.01.00.50.1 10.0 20.0

Study Population Rates [%]chemotherapy + cetuximab vs. chemotherapy

OR [95% CI]

Pooled Analysis KRAS wt (n=845) 57.3 vs. 38.5 2.17 [1.64-2.86]

KRAS mt-G13D (n=83) 40.5 vs. 22.0 2.41 [0.90-6.45]

KRAS mt-G12V (n=125) 30.6 vs. 45.3 0.54 [0.26-1.12]

KRAS mt-other (n=325) 30.5 vs. 43.2 0.58 [0.36-0.91]

CRYSTAL KRAS wt (n=666) 57.3 vs. 39.7 2.08 [1.52-2.84]

KRAS mt-G13D (n=60) 35.5 vs. 17.2 2.38 [0.71-7.98]

KRAS mt-G12V (n=91) 33.3 vs. 40.0 0.77 [0.32-1.82]

KRAS mt-other (n=246) 29.5 vs. 39.5 0.63 [0.37-1.07]

OPUS KRAS wt (n=179) 57.3 vs. 34.0 2.53 [1.37-4.66]

KRAS mt-G13D (n=23) 54.5 vs. 33.3 2.47 [0.46-13.4]

KRAS mt-G12V (n=34) 23.8 vs. 61.5 0.20 [0.04-0.90]

KRAS mt-other (n=79) 33.3 vs. 55.9 0.44 [0.18-1.11]

Abstract #3511

Treatment interaction

• Significant treatment interaction by KRAS mutation status was observed for KRAS G13D vs other KRAS mutants– Response (p<0.0001) – PFS (p<0.0001) – OS (p=0.0201)

• Relative treatment effects were similar for KRAS G13D and KRAS wt patients

wt, wild-typeAbstract #3511

Conclusions

• A heterogeneous treatment effect according to KRAS mutation status was confirmed in the CRYSTAL and OPUS studies

• KRAS G13D mutations are associated with poor prognosis in mCRC patients treated first-line:

– More pronounced in those treated with FOLFOX4 alone

• Patients with KRAS G13D mutant mCRC appear to benefit from first-line chemotherapy + cetuximab:

– Both in CRYSTAL and OPUS studies

– At a lower absolute effect level than for patients with KRAS wt mCRC

– A reversal of the poor prognosis observed with chemotherapy alone

• Patients with other KRAS mutations do not benefit from first-line chemotherapy + cetuximab

Abstract #3511

Postoperative adjuvant chemoradiation for gastric or GE junction adenocarcinoma using ECF before and after 5-FU/radiotherapy compared to bolus 5-

FU/LV before and after 5-FU/radiotherapy: Intergroup trial CALGB 80101

CS Fuchs, JE Tepper, D Niedzwiecki, D Hollis, HJ Mamon, RS Swanson, DG Haller,

T Dragovich, SR Alberts, G Bjarnson, CG Willett, PC Enzinger, RM Goldberg, AP Venook, RJ Mayer

Abstract #4003

CALGB 80101: Study Schema

R

A

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5-FU/LV: 5-FU 425 mg/m2 d1-5, LV 20 mg/m2 d1-5

RT: 45 Gy (1.8 Gy X 25 fractions) with 5-FU 200 mg/m2/d CI

ECF (pre-RT): Epirubicin 50 mg/m2 d1, Cisplatin 60 mg/m2 d1, &

5-FU 200 mg/m2/d CI d1-21

ECF (post-RT): Epirubicin 40 mg/m2 d1, Cisplatin 50 mg/m2 d1, &

5-FU 200 mg/m2/d CI d1-21

5-FU/LV

X1

5-FU/LV

X2

5-FU IVCI

RT

ECF

X1

ECF

X2

5-FU IVCI

RT

Abstract #4003

Major (Grade ≥ 3) Adverse Events

5FU/LV ECF

Nausea 17% 15%

Diarrhea 15% 7%

Mucositis 15% 7%

Dehydration 9% 4%

Anorexia 16% 13%

Fatigue 11% 13%

Neutropenia 52% 48%

Grade ≥ 4 Neutropenia 33% 19%

Death 3% (8) 0% (1)

Abstract #4003

0 1 2 3 4 5 6 7

Years from Study Entry

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ECF5-FU

Overall Survival by Arm

P, log rank = 0.80

CALGB 80101Overall Survival by Treatment Arm

Abstract #4003

CALGB 80101 Conclusion

Following curative resection of gastric or GE jxn

adenocarcinoma, post-operative chemoradiotherapy

using ECF & 5-FU/RT does not improve survival when

compared to 5-FU/LV & 5-FU/RT

Abstract #4003

Adjuvant capecitabine and oxaliplatin for gastric cancer: results of the Phase III

CLASSIC trial (LBA4002)

Yung-Jue Bang

on behalf of Young-Woo Kim, Han-Kwang Yang, Hyun Cheol Chung, Young-Kyu Park, Kyung Hee Lee, Keun-Wook Lee,

Yong Ho Kim, Sang-Ik Noh, Jiafu Ji, Michael Johnston, Florin Sirzén, Sung Hoon Noh, and the CLASSIC trial investigators

Abstract #LBA 4002

Rationale for CLASSIC

• High recurrence rates following surgical resection of GC (40%–80%)1,2

• Adjuvant chemotherapy aims to reduce recurrences; however, there is currently no universally accepted adjuvant regimen

• INT-01163 and MAGIC4 demonstrated a survival benefit of postoperative chemoradiotherapy and perioperative chemotherapy, respectively

• In Asia there is concern regarding the adequacy of surgery used in these trials

1Gallo et al. World J Gastroenterol 2006; 2Gunderson. Semin Radiat Oncol 20023Macdonald et al. N Engl J Med 2001; 4Cunningham et al. N Engl J Med 2006

Abstract #LBA 4002

Surgically (D2) resected Stage II, IIIA, or IIIB GC, 6 weeks prior to randomization

No prior chemotherapy or

radiotherapy

n=1035

Capecitabine: 1,000mg/m2 bid, d1–14, q3wOxaliplatin: 130mg/m2, d1, q3w

RANDO MIZATION

1:1†

n=520

n=515

• Primary endpoint: 3-year DFS‡

• Secondary endpoints: overall survival and safety profile†Stratified by stage and country with age, sex, and nodal status as covariates‡GASTRIC project: 3-year DFS and 5-year overall survival are strongly associated, Burzykowski et al. ASCO 2009

CLASSIC study design

8 cycles of XELOX (6 months)

Observation: No adjuvant therapy

Abstract #LBA 4002

Primary endpoint (3-year DFS) met at interim analysis

ITT population; DFS = disease-free survivalMedian follow-up 34.4 months (range 16–51)

1.0

0.0

0.2

0.4

0.6

0.8

3-year DFS

74%

60%

HR=0.56 (95% CI 0.44–0.72)P<0.0001

Time (months)

Observation, n=515

XELOX, n=520

520 410 333 246 166 74 30 10443515 352 286 209 147 58 22 6414

XELOXObservation

No. left

0 6 12 18 24 30 36 42 48

Abstract #LBA 4002

Summary

• Adjuvant XELOX following D2 dissection significantly improved 3-year DFS compared with observation alone

• The benefit of XELOX was observed for all disease stages

• The safety of adjuvant XELOX in GC was consistent with the known safety profile of XELOX, with no new or unexpected findings

• Longer follow-up is needed to determine the effect of adjuvant XELOX on overall survival

Abstract #LBA 4002

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ASCO 2011

End of GI Oncology Section