Chemoembolization Alone or Associated With Bevacizumab for Therapy of Colorectal Cancer Metastases: Preliminary Results of a Randomized Study

Abstract

Aim: to assess efficacy and safety of chemoembolization alone (TACE) and followed by bevacizumab (TACE-B) in patients with colorectal liver metastases (CRC-LM) (NCT03732235). Patients and Methods: The study included 30 consecutive patients with CRC-LM. They were informed about the types of treatment available: TACE with irinotecan loaded into polythylene glycol embolics alone or followed by bevacizumab therapy. Each patient underwent self-randomization and 17 chose TACE, whereas 13 chose TACE-B. Results: Tumor response at 3 months was complete response in one (6%) and four (31%) patients, and partial response in two (13%) and six (46%) patients, after TACE and TACE-B, respectively. No complications were observed during TACE. Most TACErelated adverse events were correlated with post-embolic syndrome. Conclusion: The preliminary results of the study showed that the TACE-B is feasible and tolerable. This study will be continued in order accrue a larger number of patients and longer follow-up.

Transarterial Chemoembolization Alone or Followed by Bevacizumab for Treatment of Colorectal Liver Metastases

“…Bevacizumab (Avastin ® ; Roche, Basel, Switzerland) at a dosage of 5 mg/kg was administered intravenously to the patients in the TACE + B group, starting from 15 days after the first TACE and then every 2 weeks for eight cycles [ 15 ]. The bevacizumab administration was started 15 days after TACE in order not to add the side effects of the two treatments.…”

“…For this reason bevacizumab is considered the first targeted therapy for patients with metastatic CRC [ 14 ]. Bevacizumab is used also in combination with TACE for CRC-LM therapy, with a median OS of 12 months (range: 7–18 months) versus 5.7 months (range: 1.5–7.7 months) for TACE alone [ 15 ].…”

Review of Intra-Arterial Therapies for Colorectal Cancer Liver Metastasis

“…The data on the efficacy of DEBIRI TACE is more established based on a series of limited Phase II trials [ 65 , 66 , 67 , 68 ], as well as a randomized phase III trial [ 69 ], summarized in Table 2 . In a multicenter, single-arm prospective study of 55 patients treated with multiple prior lines of chemotherapy who underwent a total of 99 DEBIRI treatments (median of 2 sessions, range: 1–5), overall RR was 75% at 1 year, with PFS and OS of 11 months and 19 months, respectively [ 65 ].…”

“…The efficacy of DEBIRI in addition to a biological agent alone, such as bevacizumab, has also been examined. In a prospective study of 30 pre-treated patients [ 68 ], randomized to either DEBIRI alone or DEBIRI with bevacizumab, the addition of bevacizumab showed an increase in RR (77% vs. 19%, p < 0.01), PFS (6 months vs. 4 months, p < 0.01) and median OS (12 months vs. 5.8 months, p < 0.01) when compared to the DEBIRI alone arm. In the only small phase III RCT conducted by Fiorentini et al [ 69 ], seventy-four patients with liver-only metastatic CRLM were randomized to receiving DEBIRI or FOLFIRI.…”

Immune response activation following hyperthermic intraperitoneal chemotherapy for peritoneal metastases: A pilot study

“…HIPEC, pressurized intraperitoneal aerosol chemotherapy, hepatic artery infusion, trans-arterial chemo-embolization and thermal ablation are all under investigation as approaches for locoregional treatment[ 7 , 8 ]. However, only thermal tumor ablation has been reported to induce a potential immunomodulatory effect, illustrated by the intense inflammatory cell response that is associated with thermally ablated tumors[ 9 , 10 ], and characterized by ablated tissue transitional zone infiltration by immune and inflammatory cell populations, including: Dendritic cells, neutrophils, macrophages, B and T lymphocytes and natural killer (NK) cells[ 10 ], with a systemic increase in immune cells also detected[ 8 ].…”