Robotic Lobectomy Is Cost-effective and Provides Comparable Health Utility Scores to Video-assisted Lobectomy: Early Results of the RAVAL Trial.

OBJECTIVE: The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy). BACKGROUND: Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery. METHODS: Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations. RESULTS: Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months. CONCLUSION: Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.

Effect of Lymph Node Assessment on Outcomes in Surgery for Limited Stage Small Cell Lung Cancer.

BACKGROUND: The National Comprehensive Cancer Network guidelines recommend surgery for limited stage small cell lung cancer (SCLC). However, there is no literature on minimum acceptable lymph node retrieval in surgery for SCLC. METHODS: The National Cancer Database was queried for adult patients undergoing lobectomy for limited stage (cT1-2N0M0) SCLC from 2004 to 2015. Patients with unknown survival, staging, or nodal assessment, and patients who received neoadjuvant therapy were excluded. The number of lymph nodes assessed was studied both as a continuous variable and as a categoric variable stratified into distribution quartiles. The primary outcome was overall survival and the secondary outcome was pathologic nodal upstaging. RESULTS: A total of 1051 patients met study criteria. In multivariable analysis, only a retrieval of eight to 12 nodes was associated with a significant survival benefit (hazard ratio 0.73; 95% confidence interval, 0.56 to 0.98). However, when modeled as a continuous variable, there was no association between number of nodes assessed and survival (hazard ratio 1.00; 95% confidence interval, 0.98 to 1.02). The overall rate of pathologic nodal upstaging was 19%. Modeled as a continuous variable, more than seven lymph nodes assessed at time of resection was significantly associated with nodal upstaging in multivariable regression (odds ratio 1.03; 95% confidence interval, 1.01 to 1.06). CONCLUSIONS: In this study, there was no clear difference in survival based on increasing the number of lymph nodes assessed during lobectomy for limited stage SCLC. However, the number of retrieved lymph nodes was associated with pathologic nodal upstaging. Therefore, patients may benefit from retrieval of more than seven lymph nodes during lobectomy for SCLC.

Disparities in the Management of Patients With Stage I Small Cell Lung Carcinoma (SCLC): A Surveillance, Epidemiology and End Results (SEER) Analysis.

INTRODUCTION: Patients with stage I small cell lung carcinoma (SCLC) are candidates for surgery; however, not much is known regarding the utilization of surgical resection in the management of stage I SCLC and the factors that determine the patient's ability to receive surgery. METHODS: The Surveillance, Epidemiology and End Results database was used to identify patients with stage I SCLC from 2007 to 2013. Continuous variables were compared with 1-way analysis of variance, and categorical variables were compared with χ2 testing. Multivariable logistic regression analyses were used to obtain odds ratios. RESULTS: Of the 1902 patients with stage I SCLC, 427 (22.4%) underwent resection, 116 (6.1%) resection and radiation, 815 (42.8%) received radiation alone, and 544 (28.6%) did not undergo surgery or radiation. Median overall survival for patients with surgery plus radiation was 60+ months, followed by surgery alone at 50 months, radiation at 27 months, and no resection/radiation 16 months. Patients with ≥ 4 lymph nodes removed during surgery had better overall survival of 60+ months compared with patients with < 4 lymph nodes removed (25 months); P < .001. Multivariate analysis demonstrated that elderly patients, men, African American individuals, Medicaid recipients, and patients with left-sided tumors were less likely to undergo resection. However, county-level socioeconomic factors, such as level of poverty, education, unemployment, and median income did not affect the likelihood of undergoing resection. CONCLUSIONS: Fewer than one-third of all patients with stage I SCLC undergo resection despite better outcomes with resection. Elderly African American men with Medicaid insurance were less likely to receive resection.

Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.

OBJECTIVE: The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy. SUMMARY BACKGROUND DATA: No randomized trial evaluating alginate staple-line reinforcement has been performed to date. METHODS: The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis. RESULTS: Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups. CONCLUSIONS: FOREseal did not demonstrate a significant advantage over standard treatment alone.

A Population-Based Cost Analysis of Thoracoscopic Versus Open Lobectomy in Primary Lung Cancer.

BACKGROUND: Thoracoscopic lobectomy for primary lung cancer has become increasingly popular worldwide due to several advantages over open lobectomy including reduced pain, reduced length of hospital stay, and comparable oncologic outcomes. The costs of thoracoscopic versus conventional open lobectomy have been compared in several studies with variable results. We compared the costs of thoracoscopic versus open lobectomy in lung cancer patients in Taiwan. METHODS: Patients who underwent lobectomy for primary lung cancer from the Taiwan National Health Insurance Research Database (NHIRD) between 2004 and 2010 were identified. Patient characteristics, operative data, and costs for each part of the hospitalization for surgery and 30 days of care after discharge were analyzed. RESULTS: A total of 5366 patients with complete clinical data who underwent either conventional open lobectomy (n = 3166, 59 %) or thoracoscopic lobectomy (n = 2200, 41 %) for primary lung cancer were identified from the database. Compared with open lobectomy, thoracoscopic lobectomy was associated with younger age, less comorbidity, shorter anesthesia times, and reduced lengths of hospital stay. Total hospital costs, operative costs, and other costs were significantly higher in the thoracoscopic group. The 30-day after discharge costs were significantly lower in the thoracoscopic group. CONCLUSIONS: Thoracoscopic lobectomy for primary lung cancer in Taiwan was associated with higher total hospital costs but lower 30 days after discharge costs than open lobectomy. These differences may have resulted from higher operative and instrument costs in the thoracoscopic group.

Incidence, risk factors and management of delayed wound dehiscence after craniotomy for tumor resection.

Dehiscence after a wound has healed is a known complication of craniotomy for tumor resection. We conducted a retrospective analysis of 64 patients who underwent craniotomy for tumor resection followed by radiation or radiosurgery between 2006 and 2010. Five patients (7.8%) were identified who showed wound dehiscence from two to eight months after the craniotomy wound had healed. Four patients had previously undergone additional craniotomies, additional radiosurgery or had been treated with the anti-angiogenic factor, bevacizumab. These treatments may be risk factors for developing delayed dehiscence and, in combination, may potentiate local wound healing problems. Potential mechanisms and management strategies are discussed.

Differences in practice patterns and costs between small cell and non-small cell lung cancer patients in Japan.

Many reports exist regarding the economic evaluation of evolving chemotherapeutic regimens or diagnostic images for lung cancer (LC) patients. However, it is not clear whether clinical information, such as pathological diagnosis or cancer stage, should be considered as a risk adjustment in lung cancer. This study compared the cost and practice patterns between small cell lung carcinoma (SCLC) and non-small cell lung carcinoma (NSCLC) patients. 6,060 LC patients treated at 58 academic hospitals and 14,507 at 257 community hospitals were analyzed. Study variables included demographic variables, comorbid status, cancer stage, use of imaging and surgical procedures, type of adjuvant therapy (chemotherapy, radiation or chemo-radiation), use of ten chemotherapeutic agents, length of stay (LOS), and total charges (TC; US$1 = 100 yen) in SCLC and NSCLC patients. The impact of pathological diagnosis on LOS and TC was investigated using multivariate analysis. We identified 3,571 SCLC and 16,996 NSCLC patients. The proportion of demographic and practice-process variables differed significantly between SCLC and NSCLC patients, including diagnostic imaging, adjuvant therapy and surgical procedures. Median LOS and TC were 20 days and US$6,015 for SCLC and 18 days and US$6,993 for NSCLC patients, respectively (p < 0.001 for each variable). Regression analysis revealed that pathological diagnosis was not correlated with TC. Physicians should acknowledge that pathological diagnosis dose not accounts for any variation in cost of LC patients but that should remain as an indicator of appropriate care like selection of chemotherapeutic agents.