Choice of Poster Presentations

Shota Fukuoka, Hiroki Hara, Naoki Takahashi, Takashi Kojima, et al

Regorafenib plus nivolumab in patients with advanced gastric (GC) or colorectal cancer (CRC): An open-label, dose-finding, and dose-expansion phase 1b trial (REGONIVO, EPOC1603).

Conclusions: The combination of regorafenib 80mg plus nivolumab had a manageable safety profiles and encouraging anti-tumor activity in MSS GC and CRC pts, which warrants further investigations in a larger cohort. Updated biomarker analysis will be presented. Clinical trial information: NCT03406871


Brendan John Guercio, Alan P. Venook, Sui Zhang, Fang-Shu Ou, et al.

Associations of insulin-like growth factor binding proteins and adiponectin with disease progression and mortality in metastatic colorectal cancer: Results from CALGB/SWOG 80405 (Alliance).

Conclusions: In patients with mCRC, high plasma IGFBP-3 and low IGFBP-7 were associated with reduced risk of disease progression and mortality. These data suggest that energy-balance associated biomarkers may offer prognostic and biologic insights into mCRC. Support: U10CA180821, U10CA180882, BMS, Genentech, Pfizer, Sanofi;


Ke-Feng Ding, Qian Xiao, Xiangxing Kong, Yeting Hu, et al.

Circulating bacterial DNA as a tool towards noninvasive biomarkers for colorectal adenocarcinoma and adenoma.

Conclusions: This study is the first effort to characterize circulating bacteria DNA in patients with ADC and ADM. Our findings revealed significant difference in relative abundance of several bacterial species between ADC, ADM and HC. A predictive model constructed with selected microbial features accurately distinguished ADC and ADM from HC. Circulating bacteria biomarkers represent potential non-invasive tools for early diagnosis of colorectal neoplasia.


Filippo Pietrantonio, Riccardo Lobefaro, Maria Antista, Rosalba Miceli, et al.

A randomized phase II trial of second-line CAPTEM versus FOLFIRI in MGMT methylated, RAS mutated metastatic colorectal cancer (mCRC) patients.

Conclusions: The use of TMZ should be explored by phase 3 trials enrolling MGMT IHC-negative +/- high MGMT % methylated mCRC.Clinical trial information: NCT02414009


Zhen Zhang, Xinchen Sun, Anwen Liu, Yuan Zhu, et al. 

A multicenter randomized phase III trial of capecitabine with or without irinotecan driven by UGT1A1 in neoadjuvant chemoradiation of locally advanced rectal cancer (CinClare).

Conclusions: Adding irinotecan guided by UGT1A1 to capecitabine-based neoadjuvant chemoradiotherapy significantly increases complete tumor response. The treatment toxicities were increased but tolerable. This treatment can be as an option for ‘watch and wait’ approach. Clinical trial information: NCT02605265


Michael Geissler, Jorge Riera-Knorrenschild, Uwe Marc Martens, Swantje Held, et al.

Final results and OS of the randomized phase II VOLFI trial (AIO- KRK0109): mFOLFOXIRI + panitumumab versus FOLFOXIRI as first-line treatment in patients with RAS wild- type metastatic colorectal cancer (mCRC).

Conclusions: The addition of Pmab to a mFOLFOXIRI regimen in patients with RASwildtype metastatic colorectal cancer significantly improved objective response rate and the rate of secondary resection of metastases. Although PFS was comparable, there was a strong trend towards improved OS in the Pmab arm. Future studies are warranted to confirm this trend towards improved overall survival with this regimen. Clinical trial information: NCT01328171


Heinz-Josef Lenz, Sara Lonardi, Vittorina Zagonel, Eric Van Cutsem, et al.

Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L) therapy in microsatellite instability-high/DNA mismatch repair deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Clinical update.

Conclusions: NIVO + low-dose IPI demonstrated robust and durable clinical benefit and was well tolerated. Evaluated subgroups had responses consistent with the overall population. NIVO + low-dose IPI may represent a new 1L treatment option for patients with MSI-H/dMMR mCRC. Clinical trial information: NCT02060188

ORR a,b in overall patients and subgroups.

  NIVO + low-dose IPI
n/N (%)
ORR (all patients)c     27/45 (60)  
Age, years <65 ≥65 14/22 (64) 13/23 (57)
ECOG performance status 0 ≥1 13/25 (52) 14/20 (70)
Prior adjuvant/neoadjuvant therapy Yes No 12/19 (63) 15/26 (58)
Mutation status        
        BRAF/KRAS wild type     8/13 (62)  
        BRAF mutationc     12/17 (71)  
        KRAS mutation     5/10 (50)  
Unknown     2/5 (40)  

aInvestigator assessed. bMedian follow-up defined as time on study from first dose to data cutoff, which was 13.8 months (range 9–19). cPreviously reported.


Mohamad Bassam Sonbol, Luke Mountjoy, Belal Firwana, Diana Almader-Douglas, et al.

The role of maintenance strategy in metastatic colorectal cancer (mCRC): A systematic review and meta-analysis.

Conclusions: A maintenance strategy with at least a FP with or without the addition of bevacizumab is preferred. However, given the lack of a clear OS benefit, obs is an acceptable alternative. Optimal maintenance strategies should be dependent on factors including patient preferences, cost and toxicities.

Strategy SUCRA % for OS SUCRA % for PFS
Obs 0.3 0.3
Bev 32.6 36.5
FP 81.3 67.1
FP + Bev 73.2 99.8
CTX 46 46.3


Tony R. Reid, George A. Fisher

ROCKET: A randomized, multicenter phase 2 study of RRx-001 + irinotecan versus regorafenib in 3rd/4th line colorectal cancer.


Conclusions: The results of this trial demonstrate improved efficacy and efficacy of RRx-001 + irinotecan compared with regorafenib in patients with metastatic colorectal cancer. Clinical trial information: NCT02096354


Volker Heinemann, Dominik Paul Modest, Ludwig Fischer von Weikersthal, Thomas Decker, et al. 


Conclusions: In the overall RAS wt population, younger patients have a significant OS benefit when treated with FOLFIRI plus cetuximab compared to FOLFIRI plus bevacizumab, while this was not the case in patients older than 70 years.

≤ 65 years N ORR
p* PFS
FOLFIRI + Cet 104 75.6 0.08 11.2 0.42
33.1 0.01
FOLFIRI + Bev 105 63.0 10.2 24.8
≤ 70 years N ORR
FOLFIRI + Cet 136 79.1 0.02 10.7 0.52
33.3 0.02
FOLFIRI + Bev 150 65.2 10.5 27.5
> 70 years N ORR
p* PFS
FOLFIRI + Cet 63 72.7 0.28 8.8 0.90 23.6 0.25
FOLFIRI + Bev 51 61.9   10.4 0.98 23.8 0.67

*= Fisher`s exact test p; #= Logrank Test p


Eiji Oki, Akitaka Makiyama, Yuji Miyamoto, Masahito Kotaka, et al.

Trifluridine/tipiracil plus bevacizumab in elderly patients with previously untreated metastatic colorectal cancer (KSCC1602): A multicenter, phase II clinical trial.

Conclusions: The combination of trifluridine/tipiracil plus bevacizumab is an effective and well-tolerated regimen for elderly patients with metastatic colorectal cancer. Hematological adverse events were need for caution. The primary endpoint of PFS will be presented in the end of this year. Clinical trial information: UMIN000025241.


Enrique Aranda, Pilar Garcia-Alfonso, Jose María Vieitez, Maria Jose Ortiz, et a. 

Randomized phase II study on the influence of BRAF and PIK3CA mutations on the efficacy of FOLFIRI plus bevacizumab (Bev) or cetuximab (Cet), as first line therapy of patients (pts) with RAS wild-type metastatic colorectal carcinoma (mCRC) and <3 baseline circulating tumor cells (bCTCs).

Conclusions: In the low risk mCRC pts according to bCTCs, BRAFand/or PIK3CA MUT have a negative impact in OS and a trend to worse PFS in the ITT population. The impact of treatment is under evaluation and will be provided during the meeting. Clinical trial information: 2012-000840-90.

  ITT population
HR (IC95%)
p value
All HR (IC95%)
p value
All HR (IC95%)
p value
PFS m 12.7 9.1 1.136 (0.739-1.745) p=0.562 12.9 9.3 12.5 0.992 (0.554-1.776) p=0.978 12.5 8.5 11,5 1.452 (0.765-2.755)
OS m 34,7 20,7 1.878 (1.269-2.779) p=0.0016 36.0 18.6 32,9 2.022 (1.194-3.425) p=0.008 34.1 23.7 33.3 1.714 (0.947-3.102) p=0.078


Maria Alessandra Calegari, Ina Valeria Zurlo, Michele Basso, Armando Orlandi, et al.

Chemotherapy rechallenge or reintroduction (CTr/r), regofenib (REG) and TAS-102 for metastatic pretreated colorectal cancer (mCRC) patients (pts): A propensity score analysis of treatment beyond second-line (PROSERpINA Study).

Conclusions: Our analysis, although underpowered, generates the hypothesis of a superiority of CTr/r in comparison to REG or TAS-102, in both efficacy and activity. Given the retrospective nature of our analysis, and the potential role of selection bias in treatment assignment, a prospective validation is mandatory.


Stefan Kasper, Gerrit zur Hausen, Alexander Stein, Sebastian Stintzing, et al.

A phase IIb study of ramucirumab in combination with TAS102 versus TAS102 monotherapy in metastatic, chemotherapy refractory colorectal cancer patients: The RAMTAS trial of the German AIO (KRK-0316).

Methods: This is an interventional, randomized, open label, multicenter, phase IIb study in patients with advanced mCRC. Eligible patients will be randomized 1:1 and receive either ramucirumab and TAS102 (ramucirumab 8 mg/kg on d1+15, q4w and TAS102 35 mg/m² on d1-5 and d8-12, q4w) or TAS102 alone. Primary endpoint is overall survival as assessed by the Kaplan-Meier method, assuming a 6 months survival probability of 70% with ramucirumab in combination with TAS102 and 58% with TAS102 alone. Treatment groups are compared using the log-rank test. A total of 144 patients will be enrolled at 30 sites (1-sided alpha 0.10, power 0.80). Main secondary endpoints are overall response rate, disease control rate, progression free survival and quality of life. In addition, a large comprehensive translational research program will be conducted to identify novel predictive and prognostic biomarkers. The study started in December 2018. By February 2019, a total of 3 patients have been enrolled. Clinical trial information: NCT03520946


Ramon Salazar, Alfredo Carrato, Teresa Garcia Garcia, Javier Gallego Plazas, et al.

Phase III randomized sequential open-label study to evaluate the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX+ bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left (L)-sided, unresectable colorectal cancer (CRC): The CR-SEQUENCE.

Methods: A phase III, multicentre, open-label and randomized two-arm clinical trial. Untreated patients with wild-type RAS mCRC (determined locally), primary L-sided and unresectable will be screened for this trial. Eligible patients will be randomized 1:1 to receive first-line (1L) panitumumab plus FOLFOX and then bevacizumab plus FOLFIRI as second-line (2L) treatment (Seq. 1) or bevacizumab plus FOLFOX as 1L and then panitumumab plus FOLFIRI as 2L treatment (Seq. 2). Randomization will be stratified by number of metastatic organs involved (1 vs > 1). Primary objective is the comparison of the progression free survival (PFS) rate at 35 months (m) of Seq 1 vs Seq. 2. Secondary objectives: PFS from randomization to 2nd progression or death, OS rate at 35 months and OS of Seq. 1 vs Seq. 2; PFS, objective response rate, disease control rate, early tumour shrinkage, Depth of Response, duration and time to response and safety in 1L treatment and in 2L treatment in each Sequence arm. Exploratory objectives: impact of baseline biomarkers predictive of the efficacy in each Sequence arm and the clinical impact of clonal dynamics by longitudinal analysis of circulating tumour deoxyribonucleic acid (ctDNA) in plasma. The trial is in progress; 28 of up to 370 planned patients have been recruited at the end of January 2019 (first patient in 31 October 2018). Clinical trial information: NCT03635021


Toshiki Masuishi, Toshikazu Moriwaki, Shota Fukuoka, Atsuo Takashima, et al.

Predictive factors for early mortality after initiation of regorafenib or trifluridine/tipiracil in refractory metastatic colorectal cancer.

Conclusions: Our predictive model for early mortality after initiation of REG or FTD/TPI might be useful for selecting pts who should not receive either these drugs.


Pashtoon Murtaza Kasi, Saivaishnavi Kamatham, Dorin Colibaseanu, Amit Merchea, et al.

Conclusions: While ctDNA testing may not be ready for primetime in all advanced cancers, it is increasingly being adopted in practice for especially metastatic CRC. Of particular value is the serial ctDNA testing in the RAS/RAF wildtype subset and now BRAF V600E mutant CRC on anti-EGFR based therapies.

Total number of patients 322
Total number of tests 607
Number of serial analyses 127
RAS/RAF wild-type 214 (66.4%)
Number of RAS mutations 83 (25.8%)
Number of V600E BRAF mutations 18 (5.6%)
Number of non-V600EBRAF mutations 7 (2.2%)
Number of HER2 amplifications 13 (4%)
Number of HER2 mutations 7 (2.2%)
MSI-High* 3 (1%)

*Of note, 25(7.8%) of CRC were dMMR/MSI-High in the cohort. CtDNA testing company started reporting MSI-High later in 3rd quarter of 2018.


Alberto F. Sobrero, Heinz-Josef Lenz, Cathy Eng, Werner Scheithauer, et al. 

Retrospective analysis of overall survival (OS) by subsequent therapy in patients (pts) with RAS wild-type (wt) metastatic colorectal cancer (mCRC) receiving irinotecan ± cetuximab in the EPIC study.

Conclusions: Post-study cetuximab was associated with improved OS in both treatment arms compared with post-study therapy without cetuximab and no subsequent therapy, suggesting that cetuximab-based therapy may be suitable as a standard treatment for pts with RAS wt mCRC in the rechallenge setting. Study limitations include a potential bias due to the differences in proportion of subsequent therapies with and without cetuximab between arms (almost 50% of pts in the irinotecan arm received post-study cetuximab) as well as the likelihood for pts who live longer to receive cetuximab in any subsequent therapy line.

therapy with
therapy without
No subsequent
Cetuximab + irinotecan        
n 26 98 107 231
mOS (95% CI), mo 28.0 (26.55-NE) 13.8 (12.16-17.12) 8.2 (6.51-11.76) 12.3 (11.37-14.09)
n 104 37 80 221
mOS (95% CI), mo 19.1 (13.21-21.45) 9.5 (8.18-17.91) 3.9 (3.12-5.88) 12.0 (9.36-14.92)

NE, not estimable.


Arndt Stahler, Sebastian Stintzing, Dominik Paul Modest, Ivan Jelas, et al.

Conclusions: mCRC subtypes by MAPK mRNA expression might contain prognostic information for the treatment with bevacizumab beyond mutational status in patients with left sided tumors of the FIRE-3 trial.
Allan Andresson Lima Pereira, Aparna Raj Parikh, Emily E. Van Seventer,et al.
Conclusions: Our validated prediction model provides clinicians and researchers with a tool to screen for patients in whom ctDNA testing can outperform tissue-based testing in detecting genomic alterations.
Lisa Miller-Phillips, Volker Heinemann, Arndt Stahler, Ludwig Fischer von Weikersthal,et al.
Conclusions: MiR-21 expression level might be a predictive biomarker for anti-EGFR-therapy by modulating KRAS signaling in FIRE-3 patients.
David Lau, David Cunningham, Angela Gillbanks, Richard Crux, et al.
Methods: We are recruiting patients with curatively resected, stage III colon cancer which are dMMR or have a centrally confirmed POLE exonuclease domain mutation. Eligible patients are randomised in a 1:1 ratio to standard fluoropyrimidine-based chemotherapy (CAPOX [capecitabine, oxaliplatin] for 12 weeks or capecitabine for 24 weeks) or chemotherapy followed by avelumab (10mg/kg, 2 weekly for 24 weeks). Stratification is by chemotherapy received and MMR status. The primary endpoint is DFS. Secondary endpoints include overall survival, toxicity, quality of life, and health resource use. Exploratory objectives will investigate circulating, tumor and stool based biomarkers of avelumab benefit. The 3-year DFS rate in the control arm is expected to be ~75%. Avelumab is expected to improve the 3-year DFS rate by 12% (i.e. 87%). Target accrual is 402 patients which provides 80% power to detect a hazard ratio of 0.48 for DFS at a two–sided alpha of 0.05. This trial is a national, multi-centre phase III trial and it is anticipated that approximately 40 centres in the UK will participate. This study opened to recruitment in August 2018. Clinical trial information: NCT0382704