In a phase III study (ORANGE II PLUS) reported in the Journal of Clinical Oncology, Fichtinger et al found that among patients with indications for hemihepatectomy suitable for both laparoscopic and open approaches, of whom the majority had cancer, the laparoscopic approach was associated with a shorter time to functional recovery vs open surgery.
Study Details
In the European multicenter trial, 332 patients (analysis group) who were to undergo hemihepatectomy for various indications were randomly assigned between November 2013 and December 2018 to undergo laparoscopic (n = 166) or open surgery (n = 166).
Among these patients, 141 (85%) in the laparoscopy group and 146 (88%) in the open surgery group had cancer, most commonly colorectal cancer metastases (54% vs 48%), hepatocellular carcinoma (13% vs 15%), and cholangiocarcinoma (10% vs 18%).
Key Findings
Among all patients, median time to functional recovery was 4 days (interquartile range [IQR] = 3–5 days, range = 1–30 days) in the laparoscopy group vs 5 days (IQR = 4–6 days, range = 1–33 days) in the open surgery group (difference = –17.5%, 96% confidence interval [CI] = –25.6% to –8.4%, P < .001). No difference in major complications was observed between the laparoscopy group and the open surgery group (14.5% vs 16.9%, odds ratio [OR] = 0.84, P = .58). Global health status (P < .001) and body image (P < .001) were significantly better in the laparoscopy group.
Among 136 evaluable patients in the laparoscopy group and 145 evaluable patients in the open surgery group with cancer, R0 resection was achieved in 77.9% vs 84.1% (OR = 0.60, P = .14). Time to adjuvant systemic therapy was shorter in the laparoscopy group (median = 46.5 days vs 62.8 days, hazard ratio = 2.20, P = .009). At a median follow-up of 53 months, no significant differences between the laparoscopy group vs the open surgery group were observed among all patients for disease-free survival (P = .59) or overall survival (P = .46) or among those with colorectal liver metastases (P = .96 for disease-free survival; P = .64 for overall survival).
The investigators concluded, “Among patients undergoing hemihepatectomy, the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition, it was associated with a better [quality of life] and in patients with cancer, a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed.”
Ronald M. van Dam, MD, PhD, of the Department of Surgery, Maastricht University Medical Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Cancer Research UK, the European Association of Endoscopic Surgery, and others. For full disclosures of the study authors, visit ascopubs.org.
