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Poster display session

3563 - Multicenter randomized phase II trial (BEVATOMOX) assessing the Raltitrexed, Oxaliplatin and Bevacizumab combination versus FOLFOX6 Bevacizumab as 2nd line treatment in metastatic colorectal cancer (mCRC)

Date

09 Sep 2017

Session

Poster display session

Presenters

Emmanuelle Samalin

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

E. Samalin1, H. Senellart2, S. Thezenas3, S. Jacquot4, S. Ellis5, F. Khemissa6, M. Ramdani7, F. Portales1, E. Assenat1, T. Mazard1, L. Mineur8, M. Ychou1

Author affiliations

  • 1 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 2 Medical Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 3 Biometrics Unit, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 4 Medical Oncology, Centre de Cancérologie du Grand Montpellier, 34070 - Montpellier/FR
  • 5 Radiotherapy Department, Centre Catalan d'Oncologie, 66000 - Perpignan/FR
  • 6 Department Of Hepatology Gastroenterology, CH Perpignan, Saint Jean Hospital, 66046 - Perpignan/FR
  • 7 Gastroenterology Department, CH de Béziers, 34525 - Béziers/FR
  • 8 Radiotherapy And Oncology Gi And Liver, Institut Ste Catherine, 84082 - Avignon/FR
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Resources

Abstract 3563

Background

The FOLFOX-Bev combination as 2nd line after Irinotecan-based chemotherapy (CT) failure is efficient in mCRC treatment, independently of the tumour RAS status. The Raltitrexed-Oxaliplatin (TOMOX) combination is reported with acceptable toxicity in mesothelioma patients (pts). Our multicentre randomized phase II study assessed the 6-month progression-free survival (6-PFS) of the TOMOX-Bev combination as 2nd line treatment in mCRC pts.

Methods

Pts OMS≤2 with histologically-proven mCRC, resected/asymptomatic primary tumor, unresectable metastases, and progressive metastatic disease (RECIST) after Irinotecan-based CT, were randomized (1:2) receiving either FOLFOX6 plus Bev (C arm, Bev IV 5mg/kg, then FOLFOX6 D1=D15, 12 cycles) or TOMOX plus Bev (Exp arm, Bev IV 7.5mg/kg, Raltitrexed IV 3mg/m2 according to creatinine clearance, then Oxaliplatin 130mg/m2 IV, D1=D21, 8 cycles). Primary endpoint was the 6-PFS. Main secondaries were toxicity, objective response and overall survival (OS). 92 pts, 30 and 62 in the C and Exp arms, were to be recruited.

Results

Due to low accrual rate, 83 pts (63.9% men) were included between 07.2011 and 05.2016, 33 and 50 in the C and Exp arms. Median age was 66 years (48-82). Primary tumour was localized in the left (48.2%) and right colon (37.3%) or rectum (18.1%), resected in 72.3% (36% with adjuvant CT). All pts (RASmt 54.2%) were pretreated with FOLFIRI, combined with anti-EGRF (7%) or Bev (92%). Median numbers of study treatment cycles were 8 and 4 in the C and Exp arms. Major grade 3-4 toxicities (C and Exp arms) were mucositis (12.1 vs 12.5%), paresthesia (0 vs 6.3%), hand-foot syndroma (3 vs 0%) and neutropenia/febrile (6.1/3 vs 8.2/2%). The 6-PFS rates were 51.5% (95%CI: 36-67) and 38% (95%CI: 26-51) in the C and Exp arms, and median OS was 11.1 (9.5-16.4) and 9.3 (5.7-11.6) months, respectively. In the Exp arm, OS was longer in pts with left colon tumour vs right (11.1 vs 4.6 months).

Conclusions

The TOMOX-Bev combination is feasible as 2nd line treatment in mCRC pts with acceptable toxicity. We cannot conclude in terms of efficacy due to low accrual rate. We confirm a longer OS in pts with left colon tumour.

Clinical trial identification

NCT01532804

Legal entity responsible for the study

ICM Regional Cancer Institute of Montpellier

Funding

Hospira

Disclosure

All authors have declared no conflicts of interest.

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