A randomized trial comparing adjuvant chemotherapy with gemcitabine plus cisplatin with docetaxel plus cisplatin in patients with completely resected non-small-cell lung cancer with quality of life as the primary objective

International audienceOBJECTIVES: Adjuvant chemotherapy with vinorelbine plus cisplatin (VC) improves survival in resected non-small-cell lung cancer (NSCLC), but has negative impact on quality of life (QoL). In advanced NSCLC, gemcitabine plus cisplatin (GC) and docetaxel plus cisplatin (DC) exhibit comparable efficacy, with possibly superior QoL compared to VC. This trial investigated these regimens in the adjuvant setting. METHODS: Patients with Stage IB to III NSCLC were eligible following standardized surgery. Overall, 136 patients were included, with 67 and 69 assigned to the GC and DC arms, respectively. Cisplatin (75 mg/m(2), Day [D] 1) plus gemcitabine (1250 mg/m(2), D1 and D8) or docetaxel (75 mg/m(2) D1) were administered for three cycles. Primary end-point was QoL (EORTC QLQ-C30), with the study designed to detect a 10-point difference between arms. Overall survival, safety and cost were secondary end-points. RESULTS: No between-group imbalance was observed in terms of patient characteristics. At inclusion, global health status (GHS) scores (/100) were 63.5 and 62.7 in GC and DC, respectively (P = 0.8), improving to 64.5 and 65.4 after 3 months (P = 0.8). No significant difference in functional or symptoms scores was observed between the arms except for alopecia. Grade 3/4 haematological and non-haematological toxicities were found in 33.8 and 21.7% (P = 0.11), and 33.8 and 26.1% (P = 0.33) of patients, in GC and DC, respectively. At 2 years, 92.9 and 89.8% of patients remained alive in GC and DC, respectively (P = 0.88). CONCLUSIONS: DC and GC adjuvant chemotherapies for completely resected NSCLC were well tolerated and appear free of major QoL effects, and are therefore representing candidates for comparison with the standard VC regimen

Disease-free survival following resection in non-ductal periampullary cancers: A retrospective multicenter analysis

International audienceBACKGROUND:Predictors of recurrence following pancreaticoduodenectomy are well described for ductal periampullary cancers but lack reliability for non-ductal tumors. The purpose of this study is to analyze the disease-free survival (DFS) and to define the predictors of recurrence following resection for ampullary (AC), bile duct (BDC) and duodenal cancers (DC).MATERIALS AND METHODS:Clinico-pathological data of patients operated on between 2001 and 2011 were retrospectively reviewed. The effect of lymphatic invasion was specified using the lymph node ratio (LNR) and the number of positive nodes (NPN), with thresholds calculated with the likelihood ratio. Kaplan-Meier disease-free survival (DFS) curves were compared for all covariates by a log-rank test. Multivariate logistic regression analyses were performed to identify predictors of recurrence.RESULTS:135 patients were identified. Mean follow-up was 49 ± 35 months. Median DFS was not reached for AC and was 36 and 18 months for DC and BDC, respectively. Five-year DFS was 52%, 43% and 32% for AC, DC and BDC, respectively. Predictors of recurrence were T4 tumors, neural invasion and preoperative biliary drainage for DC, ≥3 positive nodes and ≥4% loss of BMI for AC, and T3-T4 tumors for BDC.CONCLUSION:Loss of BMI ≥4% is a strong predictor of recurrence in AC, and the recurrence risk increases with the total number of lymph nodes invaded (0; 1-3; ≥4). Only T stage influences recurrence for BDC. Considering DC, the adverse effect of preoperative biliary drainage should be validated in randomized series

Surgery for hilar cholangiocarcinoma: a multi-institutional update on practice and outcome by the AFC-HC study group.

International audienceINTRODUCTION: Surgical resection is the only option for long-term survival in patients with hilar cholangiocarcinoma (HC), but it is associated with high morbidity and mortality. The aim of the present study was to prospectively assess the perioperative management and short-term outcomes of surgical treatment of HC in a recent, multi-institutional study with a short inclusion period. METHODS: Between January and December 2008, a register prospectively collected data on patients operated on for HC (exploratory or curative surgery) in eight tertiary centers. The register focused on perioperative management, resectability, surgical procedures employed, morbidity, and mortality. The study cohort consisted of 56 patients (40 men and 16 women) with a median age of 63 years (range, 33-83 years). RESULTS: Among the 56 patients, 47 (84%) were jaundiced and 42 (75%) tumors were classified as Bismuth-Corlette type III-IV. Nine patients (16%) underwent staging laparoscopy and four (7%) received neoadjuvant chemotherapy. Preoperative biliary drainage (endoscopy, 42%) was performed in 38 (81%) jaundiced patients and portal vein embolization (right side, 83%) was performed prior to surgery in 18 patients (32%). Among these 56 patients, curative resection was achieved in 39 (70%). All underwent major liver resection (>3 segments), bile duct resection, and lymphadenectomy. Thirteen patients (36%) underwent portal vein resection, one of whom also required pancreaticoduodenectomy. Eighty-two percent of resected patients (n = 32) had no proof of malignancy prior to hepatectomy. Clear surgical margins were obtained in 77% (n = 30). The postoperative mortality was 8% and complications occurred in 72% of the resected patients. Seven (25%) patients required reoperation, and 15 (54%) patients required percutaneous drainage. In a univariate analysis, the risk factors for morbidity were intraoperative blood transfusion (p = 0.009) and vascular clamping (p = 0.006). The median length of hospitalization was 20 ± 13 days. CONCLUSION: Curative resection for HC is associated with a high rate of R0 resection. However, surgery is associated with high levels of morbidity and mortality, despite intensive perioperative management

Oncological relevance of major hepatectomy with inferior vena cava resection for intrahepatic cholangiocarcinoma

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Medial pancreatectomy: A multi-institutional retrospective study of 53 patients by the French Pancreas Club

Background. The results of medial pancreatectomy have been previously reported anecdotally. The purpose of the study was to provide short- and long-term results of ALP in a large multicenter collective series. Methods. From 1990 to 1998, 53 patients (mean age +/- SD = 49 15 years) underwent medial pancreatectomy for primary cystic neoplasms of pancreas (n = 19), endocrine neoplasms (n = 17), intraductal papillary mucinous neoplasms (IPMN) (n = 6), fibrotic stenosis of the Wirsungs duct (n = 4), or other benign (n = 4) or malignant (n = 3) diseases. The proximal (right) pancreatic remnant was sutured (n = 53), and the distal (left) remnant was either anastomosed to a jejunal loop (n = 26), to the stomach (n = 25), or oversewn (n = 2). Medial pancreatectomy was indicated in 3 patients (6%) because of failed enucleation, in 3 (6%) to prevent worsening of preexisting diabetes, or to prevent de novo diabetes in a patient with chronic pancreatitis, and deliberately in the 4 7 others. Results. The length of the resected pancreas was 5.0 +/- 2.2 cm (range, 2-15). One Patient (2%) died from a pancreatic fistula and portal thrombosis. Three patients were reoperated on because of complications related to the left pancreas, which was partially or totally resected. Pancreatic fistula developed in 16 patients (30%). Mean delay for the return of oralfeeding was related to the Presence of a pancreatic fistula. At follow-up (median = 26 months, range, 12-131), 1 pancreatic recurrence and 1 de novo diabetes occurred in patients without IPMN. In patients with IPMN, the rates of pancreatic recurrence and diabetes were 40% (215), respectively. Conclusions. Medial pancreatectomy effectively preserves long-term endocrine function and is associated with a low risk of local recurrence, except in patients with IPMN. However, there is a high risk (30%) of PF after medial pancreatectomy

Model for end-stage liver disease exceptions in the context of the French model for end-stage liver disease score-based liver allocation system

Model for End-Stage Liver Disease (MELD) score-based allocation systems have been adopted by most countries in Europe and North America. Indeed, the MELD score is a robust marker of early mortality for patients with cirrhosis. Except for extreme values, high pretransplant MELD scores do not significantly affect posttransplant survival. The MELD score can be used to optimize the allocation of allografts according to a sickest first policy. Most often, patients with small hepatocellular carcinomas (HCCs) and low MELD scores receive extra points, which allow them appropriate access to transplantation comparable to the access of patients with advanced cirrhosis and high MELD scores. In addition to patients with advanced cirrhosis and HCC, patients with a number of relatively uncommon conditions have low MELD scores and a poor prognosis in the short term without transplantation but derive excellent benefits from transplantation. These conditions, which correspond to the so-called MELD score exceptions, justify the allocation of a specific score for appropriate access to transplantation. Here we report the conclusions of the French consensus meeting. The goals of this meeting were (1) to identify which conditions merit MELD score exceptions, (2) to list the criteria needed for defining each of these conditions, and (3) to define a reasonable time interval for organ allocation for each MELD exception in the general context of organ shortages. MELD exceptions were discussed in an attempt to reconcile the concepts of transparency, equity, justice, and utility

Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial

International audiencePurpose: Maintenance chemotherapy is a reasonable choice for patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.Patients and methods: We conducted a randomised trial in patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non-squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).Results: 632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0-17.0) in the observation arm and 14 months (95% CI: 10.9-16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).Conclusion: Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC