Chirurgia del Fegato a Firenze!

Dal 1° Marzo 2023, Chirurgia del Fegato sarà all'Università di Firenze
AOUC Azienda Ospedaliero-Universitaria Careggi - Largo Brambilla, 3 - 50134 Firenze

Lo studio EORTC cambia la terapia delle metastasi epatiche da tumore del colon

La rivista The Lancet pubblica lo studio EORTC Intergroup trial 40983. Lo studio avrebbe dimostrato un aumento della sopravvivenza libera da malattia nei pazienti portatori di metastasi epatiche da tumore colon rettale che facevano chemioterapia sistemica prima e dopo l’intervento di resezione epatica.

Lo studio ha cambiato in maniera significativa la gestione dei pazienti con metastasi al fegato da tumore del colon-retto, anche se sarebbero potuti essere operati.

Nel novembre 2013 sono poi stati pubblicati su “The Lancet Oncology” i risultati dello stesso studio con un periodo osservazione aumentato nel tempo di 5 anni.

Alla fine, i risultati complessivi dello studio non hanno mostrato alcuna differenza sia in termini di sopravvivenza, sia degli altri indici a lungo termine, dei pazienti in base al fatto di avere ricevuto o di non avere ricevuto la chemioterapia.

La referenza bibliografica per questo evento è:

Bernard Nordlinger, Halfdan Sorbye, Bengt Glimelius, Graeme J Poston, Peter M Schlag, Philippe Rougier, Wolf O Bechstein, John N Primrose, Euan T Walpole, Meg Finch-Jones, Daniel Jaeck, Darius Mirza, Rowan W Parks, Laurence Collette, Michel Praet, Ullrich Bethe, Eric Van Cutsem, Werner Scheithauer, Thomas Gruenberger: Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. In: The Lancet, vol. 371, no. 9617, pp. 1007 – 1016, 2008, ISSN: 01406736, (Cited by: 1543; All Open Access, Green Open Access).

Abstract

Background: Surgical resection alone is regarded as the standard of care for patients with liver metastases from colorectal cancer, but relapse is common. We assessed the combination of perioperative chemotherapy and surgery compared with surgery alone for patients with initially resectable liver metastases from colorectal cancer. Methods: This parallel-group study reports the trial's final data for progression-free survival for a protocol unspecified interim time-point, while overall survival is still being monitored. 364 patients with histologically proven colorectal cancer and up to four liver metastases were randomly assigned to either six cycles of FOLFOX4 before and six cycles after surgery or to surgery alone (182 in perioperative chemotherapy group vs 182 in surgery group). Patients were centrally randomised by minimisation, adjusting for centre and risk score. The primary objective was to detect a hazard ratio (HR) of 0·71 or less for progression-free survival. Primary analysis was by intention to treat. Analyses were repeated for all eligible (171 vs 171) and resected patients (151 vs 152). This trial is registered with ClinicalTrials.gov, number NCT00006479. Findings: In the perioperative chemotherapy group, 151 (83%) patients were resected after a median of six (range 1-6) preoperative cycles and 115 (63%) patients received a median six (1-8) postoperative cycles. 152 (84%) patients were resected in the surgery group. The absolute increase in rate of progression-free survival at 3 years was 7·3% (from 28·1% [95·66% CI 21·3-35·5] to 35·4% [28·1-42·7]; HR 0·79 [0·62-1·02]; p=0·058) in randomised patients; 8·1% (from 28·1% [21·2-36·6] to 36·2% [28·7-43·8]; HR 0·77 [0·60-1·00]; p=0·041) in eligible patients; and 9·2% (from 33·2% [25·3-41·2] to 42·4% [34·0-50·5]; HR 0·73 [0·55-0·97]; p=0·025) in patients undergoing resection. 139 patients died (64 in perioperative chemotherapy group vs 75 in surgery group). Reversible postoperative complications occurred more often after chemotherapy than after surgery (40/159 [25%] vs 27/170 [16%]; p=0·04). After surgery we recorded two deaths in the surgery alone group and one in the perioperative chemotherapy group. Interpretation: Perioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients. Funding: Swedish Cancer Society, Cancer Research UK, Ligue Nationale Contre le Cancer, US National Cancer Institute, Sanofi-Aventis. © 2008 Elsevier Ltd. All rights reserved.

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