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L. Hao



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    MS06 - Surgeons as Drivers of NSCLC Research (ID 23)

    • Event: WCLC 2013
    • Type: Mini Symposia
    • Track: Surgery
    • Presentations: 1
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      MS06.3 - Randomized Trial of VATS vs Axillary Thoracotomy for Lobectomy (ID 483)

      14:00 - 15:30  |  Author(s): L. Hao

      • Abstract
      • Presentation
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      Abstract
      Background: Since video-assisted thoracoscopic surgery (VATS) was first reported in the 1990s, this approach has been rapidly gaining popularity worldwide because of its less morbidity and expedited patient recovery. As a milestone, VATS lobectomy was first introduced into NCCN Guidelines in 2006, and then has been recommended as a reasonable and acceptable alternative in the treatment of non-small cell lung cancer (NSCLC) since 2007. However, whether VATS’s superiority really exists in the domain of NSCLC has raised unprecedented dispute in the past two decades, especially when compared to other minimally invasive approaches like axillary thoracotomy. Major debates have involved surgical trauma, post-operative neuralgia, shoulder dysfunction, influence on respiratory function/quality of life (QOL), and finally oncologic outcomes. So far, strong evidence demonstrating decreased morbidity and equivalent long-term survival of the new technique is lacking. In an attempt to obtain a better answer, we designed and initiated this multicenter randomized controlled trial (RCT) in China, which compared VATS and axillary approaches in terms of various surgical and oncologic outcomes for early stage NSCLC. Methods: 400 patients were planned to be recruited in this study since 2008, and then randomized into VATS group (Experimental group) and axillary thoracotomy group (Control group). The Inclusion Criteria include: ①Clinical early stage NSCLC, no hilar and mediastinal lymphadenopathy (short diameter ≤ 1 cm assessed on computed tomography scan); ②No medical contraindications to lung resection; ③Age ≤ 75 years old and ≥18 years old; ④Ability to give informed consent. And the Exclusion Criteria are: ①Evidence of invasion into neighboring organs; ②Extensive pleura symphysis; ③Central tumors; ④Inability to tolerate single-lung ventilation; ⑤Previous thoracotomy or high-dose radiation on the chest ; ⑥Pregnant or lactating female patients; ⑦Inability to sign the informed consent form because of psychological, family and society factors; ⑧History of other malignancies in the past 5 years except for non-melanoma skin cancer, cervix cancer in situ or early-stage prostate cancer; ⑨Other uncontrolled factors (like intra-operative conversion to thoracotomy). Surgery criteria would be a radical lobectomy plus hilar and mediastinal lymph node dissection. Also, the VATS lobectomy was defined by the avoidance of rib-spreading and use of the thoracoscope for visualization. The total number of ports is not relevant in this definition, but is typically 3 and 4. Five-year overall survival (OS) and disease-free survival (DFS), as the primary endpoints will be evaluated. Peri-operative parameters, including post-operative chest pain, cytokines response, post-operative respiratory reserve, Karnofsky performance status and QOL would be explored. In addition, operation time, intra-operative blood loss, chest tube drainage, indwelling period of chest tube, etc. would be documented and compared between two groups. Lung Cancer Symptom Scale (LCSS) was adopted to estimate the QOL before operation and at post-operative standpoints of 1, 3, 6, 9 and 12 months. Post-operative respiratory function would be measured in first three months, while Karnofsky performance status and chest pain at the standpoint of 1 year after surgery. Cytokines response, to be exact, serum levels of IL-2, IL-4, IL-6, IL-10, TNF and IFN-r, would be analyzed in first 48 hours after surgery. Randomization was done via an interactive web response system with computer-generated randomization codes. This study has been registered in Clinicaltrials.gov (NCT01102517) and sponsored by Sun Yat-sen University Clinical Research 5010 plan as well as Guangdong provincial high-tech projects. Result: Five leading hospitals throughout China contributed to this RCT. 425 patients was recruited up to May 2013; nonetheless, 336 patients were finally analyzed in the study. The latest DMC review happened on May 2013 and our RCT was regarded to be strictly adhering to the protocol with good quality control. No surgery-related mortality was documented in both VATS and axillary thoracotomy groups. Unfortunately, four patients in the study group were excluded because of intra-operative conversion to axillary thoracotomy. The conversion rate was 0.94% (4/425) in our study. Another fact needs to be clarified that the remaining 85 patients were excluded due to a variety of reasons, which included extensive pleura symphysis (9 patients), benign pulmonary lesions (35 patients), small cell lung cancer (3 patients), accidental pleural metastasis (2 patients), Age > 75 years old (2 patients), invalid case report forms (13 patients), and inability to adhere to the randomized surgical approaches (21 patients). As a result, 175 patients in VATS group and 161 patients in axillary thoracotomy group were finalized and analyzed by the database. No significant difference between the two groups in terms of the anatomical location of the tumors, histological subtypes and clinical stages. Impressively, the operation time for the VATS lobectomy group was significantly shorter than that of the control group (150 min vs. 170 min, P<0.05). There was also remarkably less intra-operative blood loss in the study group (100 ml vs. 150 ml, P<0.001). Another important finding was that no significant differences were identified regarding the number of cleared lymph nodes and number of lymph node regions (10 vs 12; 5 vs 5, respectively). The peri-operative complication rates, once again, showed no significant difference between the two groups. Patients who undertook VATS lobectomy experienced significantly better post-operative QOL, and the superiority was showed in all the aspects of LCSS. When looking at cytokines response which may reflect the acute surgical injuries or trauma, IL-2, IL-4, IL-6, IL-10, TNF and IFN-r consistently demonstrated lower expression levels throughout the time in the VATS group. However, only the patients who recruited in Sun Yat-sen University Cancer Center underwent the evaluation of cytokines response (180 patients). Regarding the primary endpoints, although longer follow-up is still needed before drawing a clear conclusion, initial analyze did show no significant difference was seen between the two groups regarding OS and DFS. We considered these results were premature, but we also believed current data tended to demonstrate a statistical non-inferiority result. Conclusions: Our multicenter RCT has illustrated that VATS approach is a safe approach for the treatment of early stage NSCLC, and may be superior to axillary thoracotomy approach in terms of intra-operative blood loss, acute surgical injuries and post-operative QOL. However, we also realized that longer follow-up is necessary to determine its oncologic equivalency.

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