The optimal locoregional treatments for inoperable, nonmetastatic cholangiocarcinoma (CCA) are still undetermined. Total removal and additional chemotherapy are the exclusive curative options, despite the fact that the majority cannot be surgically removed. Recent findings from a single-arm phase 2 study indicate that stereotactic body radiotherapy (SBRT) could potentially enhance clinical results. The objective of the ABC-07 study was to assess the effectiveness and safety of incorporating SBRT with gemcitabine and cisplatin (gem/cis) in cases of locally advanced inoperable CCA.
ABC-07 (ISRCTN:10639376) is a phase 2 multicenter randomized trial designed for patients with inoperable, histologically confirmed locally advanced CCA and WHO performance status 0-1. Following registration, patients who did not show progression after 4 cycles of gem/cis were randomly assigned (2:1) to receive either 4 cycles of gem/cis (gemcitabine 1000 mg/m2 plus cisplatin 25 mg/m2) or 2 cycles of gem/cis plus SBRT (50 Gy in 5 fractions or 67.5 Gy in 15 fractions, depending on tumor size). The primary end point of the study was progression-free survival (PFS). Secondary end points included overall survival (OS), toxicity, and patterns of failure. Quality assurance for radiotherapy was conducted.
A randomized trial involving 69 patients, with 45 in the SBRT group and 24 in the gem/cis-only group was conducted. The median PFS was 8.6 months in the SBRT group and 9.0 months in the gem/cis-only group. There were 43 (96%) PFS events in the SBRT group and 23 (96%) in the gem/cis-only group. There were 31 deaths in the SBRT group and 21 deaths in the gem/cis-only group. The primary causes of death included disease (21, 67% vs 11, 52%), sepsis plus progression of disease (5, 16% vs 3, 15%), sepsis (3, 9% vs 3, 15%), and hepatic failure (0 vs 5, 23%) for the SBRT and gem/cis-only groups, respectively.
SBRT did not demonstrate a PFS benefit compared with systemic chemotherapy alone. Nevertheless, it did show a longer median OS time and improved control of the primary tumor without any safety issues. However, additional mature survival data are needed.
Hawkins MA, Valle JW, Wasan HS, et al. Addition of stereotactic body radiotherapy (SBRT) to systemic chemotherapy in locally advanced cholangiocarcinoma (CC) (ABC-07): results from a randomized phase II trial. Chicago, IL, & online: presented at 2024 ASCO Annual Meeting; abstract 4006.
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