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.

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01).

INTRODUCTION: In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact. METHODS AND ANALYSIS: The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients. ETHICS AND DISSEMINATION: The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02502318.