ITH AN ESTIMATED NUMber of 232 000 new cases per year, pancreatic cancer is among the most common malignancies worldwide. 1 Moreover, it is one of the most lethal cancers, as indicated by a mortality incidence ratio of 98%. 1 Pancreatic cancer is the fourth leading cause of death from cancer in the United States, with 32 300 deaths estimated in 2006. 2 Sur-See also p 311 and Patient Page.
SummaryBackgroundSurgical 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.MethodsThis 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.FindingsIn 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.InterpretationPerioperative chemotherapy with FOLFOX4 is compatible with major liver surgery and reduces the risk of events of progression-free survival in eligible and resected patients.FundingSwedish Cancer Society, Cancer Research UK, Ligue Nationale Contre le Cancer, US National Cancer Institute, Sanofi-Aventis.
Selection of patients suffering from hepatocellular carcinoma (HCC) in cirrhosis for liver transplantation follows limits of number and diameter of tumor nodules. It has not been investigated whether there is a correlation of these parameters with vascular invasion. From 1989 to 2000, 1,188 liver transplantations were performed in 1,087 patients, including 120 patients (11%) with an HCC in cirrhosis. Selection criteria were a maximal diameter of up to 5 cm if the tumor appeared to be uninodular or of up to 3 cm in the case of 2 or 3 nodules. The postoperative mortality rate was 1.7%. One-, 5-, and 10-year survival was 90%, 71%, and 60%, respectively. In 940 transplantation patients without an HCC, these rates were 93%, 87%, and 83% (P < .0001). Vascular invasion and histopathologic grading were identified as prognostic parameters by multivariate analysis. In a logistic regression analysis, histopathologic grading and maximal diameter showed a significant correlation with a vascular invasion. Analyzing tumors larger than 5 cm, i.e., tumors not fulfilling the selection criteria as a result of diagnostic inaccuracy or progression thereafter, the rates of vascular invasion were significantly (P < .01) lower in patients suffering from well-differentiated tumors ( De novo hepatocellular carcinoma (HCC) within cirrhotic livers or missed small satellites in patients undergoing formally curative liver resection have been reported to occur at a rate of 60%. 1 Most of these recurrent intrahepatic tumors were detected in a distance from the resection margin of at least 2 cm. However, only half of the patients with HCC in cirrhosis die from recurrence after resection, while the remaining half dies as a result of the underlying chronic liver disease. 2,3 Today, liver transplantation is the only simultaneous treatment of cirrhosis as well as of HCC. A crucial factor for outcome after liver transplantation is the appropriate selection of patients. TNM and UICC classification of HCC must be considered with caution for therapeutic decision making, because they comprise biologically different tumors in common categories, e.g., carcinomas with and without vascular invasion in T stages 2 to 4. 4 Bismuth et al. 5 were the first to show that in the early era of liver transplantation, the surgical strategy for the treatment of HCC in cirrhosis had followed a misconception in selecting patients suffering from advanced, and therefore unresectable, cancers, as transplant candidates. Conversely, small HCC in cirrhosis with diameters of less than 3 cm comprising only 1 or 2 nodules-tumors frequently suitable for resection-showed the most favorable outcome. Patients in whom the cancer has exceeded the hepatic confines should be ruled out for liver transplantation. Gross metastases or lymph node infiltration as indicators of an extrahepatic spread may easily be detectable pretransplantation by imaging procedures, laparoscopic staging, or intraoperatively. 6,7 However, the current state of pretransplantation and even intraoperative diagnostic ...
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