186P - Bevacizumab in combination with 5-fluorouracil (5-FU) based doublet chemotherapy as neoadjuvant therapy for Chinese patients with previously untrea...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Colon and Rectal Cancer
Rectal Cancer
Presenter De-sen Wan
Citation Annals of Oncology (2016) 27 (suppl_9): ix53-ix67. 10.1093/annonc/mdw581
Authors D. Wan1, S. Zhang2, Y. Chen3, J. Xu4, K. Tao5, G. Wang6, C. Hao7
  • 1Department Of Colorectal Surgery, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2Department Of Colorectal Surgery, 2nd Affiliated Hospital of Zhejiang University University School of Medicine, 310309 - Hangzhou/CN
  • 3Department Of Colorectal Surgery, Liaoning Cancer Hospital & Institute, 310309 - Shenyang/CN
  • 4Department Of Colorectal Surgery, Zhongshan Hospital, Fudan University, 200032 - Shanghai/CN
  • 5Department Of Gasintestional Surgery, Union Hospital Tongji Medical College Huazhong University of Science and Technology, 430000 - Wuhan/CN
  • 6Department Of Colorectal Surgery, 2nd Affiliated Hospital of Harbin Medical University, 150070 - Harbin/CN
  • 7Department Of Surgery, Peking University Cancer Hospital-Beijing Cancer Hospital, 101102 - Beijing/CN

Abstract

Background

Pts with untreated unresectable liver-only metastases who benefited from perioperative chemotherapy plus BV was still not well known in Chinese mCRC pts. This open label, multi-center pilot study was primarily aimed to assess the R0 resection rate for selected initially unresectable liver-only mCRC pts.

Methods

Unresectable liver-only mCRC pts aged 18-75 years, ECOG PS 0-1, with no previous treatment against liver metastases were eligible. If pts had converted to be resectable, he or she took the surgery 6 weeks after the last administration of BV. The last cycle of chemotherapy pre-surgery was given without BV. Pts who took the surgery were restart the chemotherapy and BV 4 weeks after the surgery and after complete wound healing. The total number of cycles given pre and post-surgery was 12. The last cycle of chemotherapy given without BV pre-surgery was not included in the 12 combined cycles. This single-arm phase II study design was applied with R0 rate as the primary end point, and 50 pts required. We also assessed ORR, PFS, DFS and Safety as secondary objectives.

Results

50 pts (median age 56.1 years (37–73); ECOG PS 0-1: 82%) were enrolled from 7 centers. Of these 17 pts underwent surgery, with a R0 resection rate of 30.0% (95% CI: 17.9%-44.6%). ORR was 30.0% (95% CI: 17.9%-44.6%). Additional, mPFS was 9.3 months (95% CI, 6.5–12.4) for all 50 patients and the median DFS was 8.1 months (95% CI, 6.5–12.4) for 17 pts undergoing study defined surgery. The common BV related AEs (incidence rate > =5%) were reported as neutrophil count decreased (14.0%), hypertension (12.0%), bone marrow failure (8.0%), and white blood cell count decreased (6.0%). Six AEs of special interest were reported from 5 patients (10.0% of 50 patients) and all were hypertension with CTC Grade > = 3.

Conclusions

Neoadjuvant chemotherapy with BV showed high resection rate and response rates in Chinese untreated, unresectable liver-only mCRC pts. The toxicity is well tolerated. The study is continued as scheduled, to further evaluate the benefit of overall survival and quality of life. (Clinical Trail No. NCT01695772)

Clinical trial indentification

Clinical Trail No. NCT01695772

Legal entity responsible for the study

Roche

Funding

Shanghai Roche Pharmaceutical Ltd.

Disclosure

All authors have declared no conflicts of interest.