Medico-economic impact of thoracoscopy versus thoracotomy in lung cancer: multicentre randomised controlled trial (Lungsco01).

BACKGROUND: Lungsco01 is the first study assessing the real benefits and the medico-economic impact of video-thoracoscopy versus open thoracotomy for non-small cell lung cancer in the French context. METHODS: Two hundred and fifty nine adult patients from 10 French centres were randomised in this prospective multicentre randomised controlled trial, between July 29, 2016, and November 24, 2020. Survival from surgical intervention to day 30 and later was compared with the log-rank test. Total quality-adjusted-life-years (QALYs) were calculated using the EQ-5D-3L®. For medico-economic analyses at 30 days and at 3 months after surgery, resources consumed were valorised (€ 2018) from a hospital perspective. First, since mortality was infrequent and not different between the two arms, cost-minimisation analyses were performed considering only the cost differential. Second, based on complete cases on QALYs, cost-utility analyses were performed taking into account cost and QALY differential. Acceptability curves and the 95% confidence intervals for the incremental ratios were then obtained using the non-parametric bootstrap method (10,000 replications). Sensitivity analyses were performed using multiple imputations with the chained equation method. RESULTS: The average cumulative costs of thoracotomy were lower than those of video-thoracoscopy at 30 days (€9,730 (SD = 3,597) vs. €11,290 (SD = 4,729)) and at 3 months (€9,863 (SD = 3,508) vs. €11,912 (SD = 5,159)). In the cost-utility analyses, the incremental cost-utility ratio was €19,162 per additional QALY gained at 30 days (€36,733 at 3 months). The acceptability curve revealed a 64% probability of efficiency at 30 days for video-thoracoscopy, at a widely-accepted willingness-to-pay threshold of €25,000 (34% at 3 months). Ratios increased after multiple imputations, implying a higher cost for video-thoracoscopy for an additional QALY gain (ratios: €26,015 at 30 days, €42,779 at 3 months). CONCLUSIONS: Given our results, the economic efficiency of video-thoracoscopy at 30 days remains fragile at a willingness-to-pay threshold of €25,000/QALY. The economic efficiency is not established beyond that time horizon. The acceptability curves given will allow decision-makers to judge the probability of efficiency of this technology at other willingness-to-pay thresholds. TRIAL REGISTRATION: NCT02502318.

Does age over 80 years have to be a contraindication for lung cancer surgery-a nationwide database study.

BACKGROUND: Nowadays surgery remains the best treatment for localized lung cancer (LC). However, patients over 80 years old are often denied surgery because of the postoperative risk of death. This study aimed to estimate in-hospital mortality (IHM) and determine whether age over 80 is the most important predictor of IHM after LC surgery. METHODS: From January 2005 to December 2015, 97,440 patients, including 4,438 patients over 80 years old, were operated on for LC and recorded in the French Administrative Database. Characteristics of patients, hospitals and surgery were analysed. RESULTS: Crude IHM was 3.73% (n=3,639) and 7.77% (n=345) for the over 80s vs. 3.54% (n=3,294) for younger patients (P<0.0001). In multivariate analysis, predictive factors for IHM with the odds ratios (OR) were: 2.60 for age ≥80 (95% CI: 2.30-2.94; P=0.0001), 5.85 for a previous liver disease (95% CI: 4.79-7.16; P=0.0001) and 5 for previous lung disease (95% CI: 4.25-5.9; P=0.0001). IHM was also linked to hospital volume with an OR of 0.75 (95% CI: 0.69-0.81; P=0.0001) and a linear decrease for predicted IHM according to hospital volume for the over 80s. Adjusted ORs were 1.15 (95% CI: 0.96-1.4; P=0.0116) for lobectomy, 2.18 for bilobectomy (95% CI: 1.7-2.8; P=0.0001) and 3.83 (95% CI: 3.2-4.6; P=0.0001) for pneumonectomy. CONCLUSIONS: Concerning IHM, age ≥80 had a lower weight than did a previous pulmonary or liver disease and the type of pulmonary resection. Patients over 80s with localized LC and no significant comorbidities should be referred for surgery if lobectomy or sublobar resection could be performed.

A Predictive Score for Bronchopleural Fistula Established Using the French Database Epithor.

BACKGROUND: Bronchopleural fistula (BPF) remains a rare but fatal complication of thoracic surgery. The aim of this study was to develop and validate a predictive model of BPF after pulmonary resection and to identify patients at high risk for BPF. METHODS: From January 2005 to December 2012, 34,000 patients underwent major pulmonary resection (lobectomy, bilobectomy, or pneumonectomy) and were entered into the French National database Epithor. The primary outcome was the occurrence of postoperative BPF at 30 days. The logistic regression model was built using a backward stepwise variable selection. RESULTS: Bronchopleural fistula occurred in 318 patients (0.94%); its prevalence was 0.5% for lobectomy (n = 139), 2.2% for bilobectomy (n = 39), and 3% for pneumonectomy (n = 140). The mortality rate was 25.9% for lobectomy (n = 36), 16.7% for bilobectomy (n = 6), and 20% for pneumonectomy (n = 28). In the final model, nine variables were selected: sex, body mass index, dyspnea score, number of comorbidities per patient, bilobectomy, pneumonectomy, emergency surgery, sleeve resection, and the side of the resection. In the development data set, the C-index was 0.8 (95% confidence interval: 0.78 to 0.82). This model was well calibrated because the Hosmer-Lemeshow test was not significant (χ(2) = 10.5, p = 0.23). We then calculated the logistic regression coefficient to build the predictive score for BPF. CONCLUSIONS: This strong model could be easily used by surgeons to identify patient at high risk for BPF. This score needs to be confirmed prospectively in an independent cohort.