Lygidakis 1995.
| Methods | Randomised. Generation of the allocation sequence: not clear. Allocation concealment: not clear. Blinding: no. Follow‐up: adequate. Intention‐to‐treat analysis: no, four patients (two per group) who died during first 30 days after surgery excluded. Sample size calculations: no. | |
| Participants | 40 patients with hepatocellular carcinoma, tumour mass <50% of liver surface, Okuda stage I or II, no extrahepatic disease. | |
| Interventions | 1. Surgery: 20 patients, extended right, right and left hemihepatectomies. 2. Adjuvant/Neoadjuvant: 20 patients, 50 days preoperative, hepatic arterial infusion chemotherapy with lipiodol 10 ml, 58 % urographin 2 ml, mitomycin C 30 mg, farmorubicin 70 mg, leukovorin 100 mg, 5‐fluorouracil 750 mg, gamma‐interferon 100mcg. Chemotherapy repeated 20 days later followed by 5 daily immunotherapy courses by arterial infusion of lipiodol 3 ml, 58 % urographin 0.5 ml, proleukin 1 ml, gamma‐interferon 100 mcg directed to liver space occupied by tumour. Surgical resection done 30 days later (extended right, right and left hemihepatectomies). four weeks later, 10 daily immunotherapy courses given followed ten days later by the chemotherapy regimen as a bolus infusion. This postoperative immunotherapy‐chemotherapy combination was repeated every three months for the first year for a total of four courses. If lipiodol retention > 48 hrs after last course, treatment continued till no longer retained. In second year postoperative course given every six months and once for the third year. |
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| Outcomes | Follow‐up four‐ monthly by blood tests, AFP, CT for surgery group and on 10th day after each postoperative course for adjuvant group. 1. Survival: reported only mean survival times and survival fractions, but not standardized to a defined period. 2. Intra‐hepatic recurrence fraction, not standardized to a defined period. | |
| Notes | Groups comparable at baseline. Radicality of resection judged by histopathology (>= 1 cm tumour‐free margin), no data given. Moderate fever in all on adjuvant group. No survival curves reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |