A multicenter randomized controlled trial to evaluate the efficacy of surgery versus radiofrequency ablation for small hepatocellular carcinoma (SURF trial): Analysis of overall survival.

4093 Background: The initial report of the multicenter SURF trial (surgery vs. radiofrequency ablation [RFA] for small hepatocellular carcinoma [HCC]) showed that recurrence-free survival (RFS) did not differ significantly between patients undergoing surgery and RFA. The focus of the present report was to assess the effect on overall survival (OS). Methods: The SURF trial was a multicenter, open-label, randomized, controlled, phase 3 trial conducted in 49 institutions in Japan. Patients (aged between 29 and 79 years) with Child-Pugh scores ≤ 7, largest HCC diameter ≤ 3 cm, and ≤ 3 HCC nodules were considered eligible. Before enrollment, both liver surgeons and hepatologists who perform RFA confirm that all the patients can be treated using both surgery and RFA. Patients were then randomly assigned in a 1:1 ratio to undergo surgery or RFA, stratified by age, hepatitis-C virus infection, numbers of HCC, largest HCC diameter, and institution. The co-primary endpoints were RFS and OS. As per the protocol, RFS was reported previously at 3 years after the last accrual of patients. OS was planned at 5 years after the last accrual. This trial is registered in UMIN000001795. Results: During 2009–2015, 308 patients were enrolled. After excluding ineligible patients, the surgery and RFA groups included 150 and 152 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range, 1.5–2.2 cm) in the surgery group and 1.8 cm (interquartile range, 1.5–2.3 cm) in the RFA group. The median (range) follow-up period was 6.4 (0.4–10.8) years in the surgery group and 6.6 (0–10.7) years in the RFA group. OS did not differ significantly between the surgery and RFA groups as the 5-year OS (95% confidence interval [CI]) was 74.6% (66.5%–81.0%) in the surgery group and 70.4% (62.2%–77.3%) in the RFA group (hazard ratio (HR), 0.96; 95% CI, 0.64–1.43; P= 0.828). The analysis after long-term follow-up in the current report showed that RFS was not significantly different between the surgery and RFA groups: the 5-year RFS (95% CI), 54.7% (46.0%–62.5%) vs. 50.5% (42.1%–58.3%); HR 0.90; 95% CI 0.67–1.22; P= 0.498. Conclusions: SURF trial revealed that OS and RFS were not significantly different between patients undergoing surgery and RFA for small HCC (≤ 3 cm and 3 nodules). Clinical trial information: 000001795.

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Surgery Versus Radiofrequency Ablation for Small Hepatocellular Carcinoma: a Randomized Controlled Trial (SURF-Trial)

Liver Cancer ◽

10.1159/000521665 ◽

2021 ◽

Author(s):

Tadatoshi Takayama ◽

Kiyoshi Hasegawa ◽

Namiki Izumi ◽

Masatoshi Kudo ◽

Mitsuo Shimada ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Controlled Trial ◽

Interquartile Range ◽

Small Hepatocellular Carcinoma ◽

Randomized Controlled ◽

Surgery Group ◽

Primary Endpoints ◽

Group Methods

Introduction: It remains unclear which of surgery or radiofrequency ablation (RFA) is the more effective treatment for small hepatocellular carcinoma (HCC). We aimed to compare survival between patients undergoing surgery (surgery group) and patients undergoing RFA (RFA group). Methods: We conducted a randomized controlled trial involving 49 institutions in Japan. Patients with Child-Pugh scores ≤ 7, largest HCC diameter ≤ 3 cm, and ≤ 3 HCC nodules were considered eligible. The co-primary endpoints were recurrence-free survival (RFS) and overall survival (OS). The current study reports the final result of RFS, and the follow-up of OS is still ongoing. Results: During 2009–2015, 308 patients were registered. After excluding ineligible patients, the surgery and RFA groups included 150 and 151 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range, 1.5–2.2 cm) in the surgery group and 1.8 cm (interquartile range, 1.5–2.3 cm) in the RFA group. The median procedure duration (274 versus 40 minutes, P<0.01) and the median duration of hospital stay (17 days versus 10 days, P<0.01) were longer in the surgery group than in the RFA group. RFS did not differ significantly between the groups as the median RFS was 3.5 (95% confidence interval [CI], 2.6–5.1) years in the surgery group and 3.0 (95% CI, 2.4–5.6) years in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P=0.58). Discussion/Conclusion: Our study did not show which of surgery or RFA is the better treatment option for small HCC.

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A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.4002 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 4002-4002 ◽

Cited By ~ 10

Author(s):

Namiki Izumi ◽

Kiyoshi Hasegawa ◽

Yujiro Nishioka ◽

Tadatoshi Takayama ◽

Naoki Yamanaka ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Early Stage ◽

Controlled Trial ◽

Small Hepatocellular Carcinoma ◽

Open Label ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

4002 Background: Surgery (SUR) and radiofrequency ablation (RFA) are both known to be effective therapy for treating patients with small oligonodular hepatocellular carcinoma (HCC), however there is only insufficient evidence about which therapy is more preferred approach. This randomized controlled trial was designed to prospectively compare the efficacy of SUR and RFA as the first approach to primary HCC. Methods: In this open-label trial undertaken at 49 hospital in Japan, we recruited patients having primary HCC with tumor foci numbering less than 3, each measuring 3 cm or less, Child-Pugh score of 7 or less, ages between 20 and 79 year. Before randomization, technical and liver functional feasibility for both treatment arms were confirmed by joint chart review by surgeons and hepatologists. Patients were then randomly assigned in a 1:1 ratio to undergo SUR or RFA, stratified by age, infection of hepatitis-C virus, number of tumors, tumor size and institution. The primary endpoint was recurrence free survival (RFS) and overall survival (OS). Results: Between April 2009 and August 2015, total 308 patients were enrolled to this trial. Because of ineligibility 15 patients were excluded, therefore 145 patients underwent SUR and 148 patients underwent RFA finally. There was no perioperative mortality. Under the median follow-up of 5 years, the 3-year RFS of patients underwent SUR and RFA was 49.8%, 47.7%, respectively (hazard ration [HR] 0.96, 95% CI 0.72-1.28; p = 0.793). OS will be analyzed and published after two years. Conclusions: SUR and RFA were both safe therapeutic approaches and provided equally RFS for early stage HCC smaller than 3 cm. Clinical trial information: UMIN000001795.

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A multicenter nonrandomized controlled trial to evaluate the efficacy of surgery versus radiofrequency ablation for small hepatocellular carcinoma (SURF cohort trial).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4581 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4581-4581

Author(s):

Ryosuke Tateishi ◽

Kiyoshi Hasegawa ◽

Yoshikuni Kawaguchi ◽

Tadatoshi Takayama ◽

Namiki Izumi ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Radiofrequency Ablation ◽

Early Stage ◽

Controlled Trial ◽

Patient Characteristics ◽

Small Hepatocellular Carcinoma ◽

Multicenter Randomized Controlled Trial ◽

Early Hcc ◽

The Difference

4581 Background: In parallel with a multicenter randomized controlled trial that reported an equal recurrence-free survival (RFS) of early-stage hepatocellular carcinoma (HCC) patients who underwent either surgery (SUR) or radiofrequency ablation (RFA), we also enrolled HCC patients who fulfilled the enrollment criteria but did not give consent to participate in the RCT. Methods: All patients gave informed consent to participate in this study. Inclusion criteria were as follows: primary HCC with less than or equal to 3 tumors, each measuring 3 cm or smaller; without vascular invasion or extrahepatic metastasis; Child-Pugh score of 7 or less; and ages between 20 and 79 years. The feasibility for both treatments was confirmed by a joint chart review by surgeons and hepatologists. The primary endpoint was RFS and overall survival. A pre-specified interim analysis was performed to compare RFS. Results: Between April 2009 and August 2015, 740 patients (371 in SUR, 369 in RFA) were enrolled from 49 participating hospitals in Japan. The SUR group had significantly fewer patients with chronic hepatitis C (56.6% vs. 69.4%), higher median value of platelet count (145 vs. 120 × 109/L), and more patients with > 2 cm tumors (49.9% vs. 27.9%); most patients had a single tumor (91.1% vs. 88.3%). During the median follow-up period of 5 years, tumor recurrence was observed in 192 of SUR and 218 of RFA with 3-year RFS being 66.0% and 61.7%, respectively ( P = 0.091). In subgroup analysis, RFS was significantly better in SUR in patients with ≤ 2 cm tumors (62.9% vs. 51.7% in 3 years; hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.56-0.93; P = 0.014), whereas the difference was not significant in those with > 2 cm tumors (52.7% vs. 46.4%; HR 0.85, 95% CI 0.63-1.18; P = 0.34). The adjusted HR for RFS using inversed probability of treatment weighting was 0.89 (95% CI, 0.72-1.10; P = 0.287). Conclusions: The imbalance in patient characteristics reflected a real-world practice. Factors related to background liver disease rather than tumor characteristics might have a larger impact on the recurrence in early HCC. Clinical trial information: C000001796 .

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Postoperative Surveillance in Patients With Colorectal Cancer Who Have Undergone Curative Resection: A Prospective, Multicenter, Randomized, Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2005.02.0826 ◽

2006 ◽

Vol 24 (3) ◽

pp. 386-393 ◽

Cited By ~ 173

Author(s):

Francisco Rodríguez-Moranta ◽

Joan Saló ◽

Àngels Arcusa ◽

Jaume Boadas ◽

Virgínia Piñol ◽

...

Keyword(s):

Colorectal Cancer ◽

Overall Survival ◽

Tumor Recurrence ◽

Controlled Trial ◽

Stage Ii ◽

Surveillance Strategy ◽

Postoperative Surveillance ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial

Purpose Although systematic postoperative surveillance of patients with colorectal cancer has been demonstrated to improve survival, it remains unknown whether a more intensive strategy provides any significant advantage. This prospective, multicenter, randomized, controlled trial was aimed at comparing the efficacy of two different surveillance strategies in terms of both survival and recurrence resectability. Patients and Methods Patients with stage II or III colorectal cancer were allocated randomly to either a simple surveillance strategy including clinical evaluation and serum carcinoembryonic antigen monitoring, or an intensive strategy in which abdominal computed tomography or ultrasonography, chest radiograph, and colonoscopy were added. Results A total of 259 patients were included: 132 were observed according to the simple strategy and 127 were observed according to the intensive strategy. Both groups were similar with respect to baseline characteristics and rate and type of tumor recurrence. After a median follow-up of 48 months, there was no difference in the probability of overall survival in the whole series (hazard ratio [HR] = 0.87; 95% CI, 0.49 to 1.54; P = .62). However, the intensive strategy was associated with higher overall survival in patients with stage II tumors (HR = 0.34; 95% CI, 0.12 to 0.98; P = .045) and in those with rectal lesions (HR = 0.09; 95% CI, 0.01 to 0.81; P = .03), mainly due to higher rate of resectability for recurrent tumors. Colonoscopy was responsible for the detection of the highest proportion (44%) of resectable tumor recurrence in the intensive arm. Conclusion A more intensive surveillance strategy improves the prognosis of patients with stage II colorectal cancer or those with rectal tumors. Inclusion of regular performance of colonoscopy seems justified up to the fifth year of follow-up, at least.

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