P-0231 - Efficacy and safety of bevacizumab + hepatic arterial infusion chemotherapy of FOLFIRI for unresectable colorectal liver metastases

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Yoshiyuki Wada
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors Y. Wada1, H. Saitsu2, Y. Takami1, M. Tateishi1, T. Ryu1
  • 1Department of Hepato-Biliary-Pancreatic Surgery, National Hospital Organization Kyushu Medical Center, Fukuoka/JP
  • 2Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka/JP

Abstract

Introduction

Colorectal liver metastasis (CRLM) often occurs in patients with advanced colorectal cancer and many CRLM could not be resected on detection. Bevacizumab + FOLFOX (oxaliplatin, fluorouracil, and folinic acid) or FOLFIRI (irinotecan, fluorouracil, and folinic acid) is considered as standard 1st-line chemotherapy for metastatic colorectal cancer. However, after failure of bevacizumab + systemic chemotherapy of FOLFOX/FOLFIRI treatment, choices of chemotherapy are restricted and sufficient prognosis cannot be expected. We actively induced bevacizumab + hepatic arterial infusion chemotherapy of FOLFIRI (HAIC-FOLIRI) for patients with unresectable CRLM. This study was performed to evaluate the efficacy and safety of bevacizumab + HAIC-FOLFIRI for unresectable CRLM.

Methods

From January 2011 to December 2013, 20 patients with unresectable CRLM receiving bevacizumab + HAIC-FOLFIRI were enrolled. Efficacy [antitumor effect, time to progression (TTP), overall survival] and safety were assessed. Moreover, the efficacy of bevacizumab + HAIC-FOLFIRI for patients with CRLM refractory to bevacizumab + systemic chemotherapy of FOLFIRI was analyzed. Patients received bevacizumab [5 mg/kg intravenous infusion (iv.) on day 1] and HAIC-FOLFIRI [leucovorin 200 mg/m2 iv. on day 1, irinotecan 80 mg/body intra-arterial infusion (ia.) on day 1, and 5-fluorouracil 2000 mg/body continuous ia. on days 1 and 2] every 2 weeks via hepatic artery catheter.

Results

Of the 20 patients studied, bevacizumab + HAIC-FOLFIRI was induced as 1st/2nd/3rd, and more line of chemotherapy for 6/6/8 patients, respectively. Fourteen patients had received prior chemotherapy and 9 of them, experienced prior failure with bevacizumab + systemic chemotherapy of FOLFIRI. Of all patients studied, 11 (55%) exhibited partial response (PR), 8 (40%) exhibited stable disease (SD), and 1 (5%) exhibited progression disease (PD). The response and disease control rates were 55% and 95%, respectively. TTP was 10.2 months [95% confidence interval (CI), 8.1–19.9] for total evaluation including distant metastases. However, TTP for evaluation of only CRLM was 19.9 months (95% CI, 8.5–21.9). Median survival time (MST) was 24.9 months (95% CI, 17.2–32.6). Furthermore, of the 9 patients with CRLM refractory to bevacizumab + systemic chemotherapy of FOLFIRI, 3 (33%) exhibited PR, 5 (56%) exhibited SD, and only 1 (11%) exhibited PD. The response and disease control rates were 33.3% and 89%, respectively. TTP for total evaluation, including distant metastases, was 10.2 months (95% CI, 2.3–21.9). In contrast, TTP for evaluation of only CRLM was 21.9 months (95% CI, 2.3–21.9). Furthermore, MST for this group was 24.9 months (95% CI, 10.7–31.6). With regards to patients experiencing adverse events, 2 (10%) showed grade 1 liver dysfunction, 1 (5%) showed grade 1 neutropenia, and 10 (50%) showed grade 1 anorexia. No grade 3 or 4 adverse events were recognized.

Conclusion

Bevacizumab + HAIC-FOLFIRI treatment revealed a significant disease control rate, long survival, and safety. In particular for patients with CRLM refractory to bevacizumab + systemic chemotherapy of FOLFIRI, these data suggest that bevacizumab + HAIC-FOLFIRI is a significantly effective treatment.