Het lijkt me duidelijk dat deze studie ook toegevoegd kan worden in de aanvraag voor vergoeding van de behandeling met TACE en LITT.

Ook deze gerandomiseerde studie bewijst namelijk dat wanneer TACE - Transarteriele Chemo Embolisatie wordt gecombineerd met RFA - Radio Frequency Ablation in he behandelen van kankerpatienten met levertumoren groter dan 3 cm. de overall overleving significant beter wordt dan wanneer alleen RFA of TACE wordt toegepast. De mediane overleving ging omhoog van  24 maanden in de TACE groep (3.4 courses), 22 maanden in de RFA groep (3.6 courses), naar 37 maanden in de TACE-RFA groep (4.4 courses). Patienten behandeld met  TACE-RFA hadden betere kans op overall overleving dan de patienten behandeld met TACE alleen (hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.33-2.63; P < .001) or RFA (HR, 1.88; 95% CI, 1.34-2.65; P < .001).

Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial.

Department of Gastroenterology, Qilu Hospital School of Medicine, Jinan, China. dcbq@sohu.com

CONTEXT: Transarterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) therapy has been used for patients with large hepatocellular carcinoma tumors, but the survival benefits of combined treatment are not known.

OBJECTIVE: To compare rates of survival of patients with large hepatocellular carcinoma tumors who received treatment with TACE combined with RFA therapy (TACE-RFA), TACE alone, and RFA alone.

DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted from January 2001 to May 2004 among 291 consecutive patients with hepatocellular carcinoma larger than 3 cm at a single center in China.

INTERVENTION: Patients were randomly assigned to treatment with combined TACE-RFA (n = 96), TACE alone (n = 95), or RFA alone (n = 100). MAIN OUTCOME MEASURES: The primary end point was survival and the secondary end point was objective response rate.

RESULTS: During a median 28.5 months of follow-up, median survival times were 24 months in the TACE group (3.4 courses), 22 months in the RFA group (3.6 courses), and 37 months in the TACE-RFA group (4.4 courses). Patients treated with TACE-RFA had better overall survival than those treated with TACE alone (hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.33-2.63; P < .001) or RFA (HR, 1.88; 95% CI, 1.34-2.65; P < .001). In a preplanned substratification analysis, survival was also better in the TACE-RFA group than in the RFA group for patients with uninodular hepatocellular carcinoma (HR, 2.50; 95% CI, 1.42-4.42; P = .001) and in the TACE-RFA group than the TACE group for patients with multinodular hepatocellular carcinoma (HR, 1.99; 95% CI, 1.31-3.00; P < .001). The rate of objective response sustained for at least 6 months was higher in the TACE-RFA group (54%) than with either TACE (35%; rate difference, 0.19; 95% CI, 0.06-0.33; P = .009) or RFA (36%; rate difference, 0.18; 95% CI, 0.05-0.32; P = .01) treatment alone.

CONCLUSION: In this patient group, TACE-RFA was superior to TACE alone or RFA alone in improving survival for patients with hepatocellular carcinoma larger than 3 cm. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00479050.

PMID: 18398079 [PubMed - indexed for MEDLINE]