Background: Anastomotic insufficiency is a feared complication after sleeve lobectomy. Bronchoscopy can help to identify anastomoses at risk. We evaluated negative predictors of anastomotic healing using a bronchoscopic grading system in a large collective of lung cancer patients.Methods: From 2006 to 2019, 541 sleeve lobectomies for lung cancer were performed. Anastomotic healing was documented by bronchoscopy on the seventh postoperative day using a standardized classification system for anastomotic grading (grade 1, perfect healing to 5, insufficiency). Grade 1 and 2 were considered satisfactory and the patients were discharged. Grade 3 or higher was considered critical. These patients received systemic antibiotic treatment and re-bronchoscopy was performed 4 days later.Results: In 18.5% of the patients, the anastomosis was assessed as critical. 19% of patients with critical anastomosis on the 7th postoperative day developed anastomotic insufficiency during the postoperative course, compared to 0.2% in patients with satisfactory anastomotic healing. Bilobectomies, low preoperative forced expiratory volume in 1 second (FEV1) values, high preoperative levels of C-reactive protein and neoadjuvant radiation were identified as independent risk factors for critical anastomotic healing.Conclusions: Bronchoscopic assessment of anastomotic healing is an effective tool to identify critical anastomoses. Neoadjuvant radiation, bilobectomies and acute or chronic inflammation were independent risk factors for bronchial healing disorders and should be considered at the planning stage of surgery.
TPS8585 Background: Non-small cell lung cancer (NSCLC) is the most common cause of cancer death worldwide highlighting the importance of improving current therapeutic options. In particular, elderly and frail patients are not only underrepresented in clinical trials, but also frequently do not receive standard treatment regimens due to comorbidities. For example, patients with unresectable stage III NSCLC who are unfit for chemotherapy (CHT) do not benefit from the recent seminal therapy algorithm change for this disease, i.e. consolidation therapy with the immune checkpoint inhibitor (ICI) durvalumab after combined radiochemotherapy (RChT). Instead, these patients are treated with radiotherapy only, raising the serious concern of undertreatment. This issue is addressed by the TRADE-hypo clinical trial that investigates a novel therapy option for NSCLC stage III patients not capable of receiving CHT. To this end, thoracic radiotherapy (TRT) is administered together with durvalumab, employing the synergism created by the combination of restoring anti-tumor immune response by the ICI with the induction of immunogenicity by irradiation. The latter effect has been suggested to be further boosted by hypofractionated radiotherapy, which could also be more practicable for the patient. Taken these considerations into account, the TRADE-hypo trial addresses safety and efficacy of durvalumab therapy combined with either conventional or hypofractionated TRT. Methods: The TRADE-hypo trial is a prospective, randomized, open-label, multicentric phase II trial. Eligible patients are diagnosed with unresectable stage III NSCLC and not capable of receiving sequential RChT due to high vulnerability as reflected by a poor performance status (ECOG 2 or ECOG1 and CCI≥ 1) and/or high age (≥ 70)]. Two treatment groups are evaluated: Both receive durvalumab (1,5000 mg, Q4W) for up to 12 months. In the CON-group this is combined with conventionally fractionated TRT (30 x 2 Gy), while in the HYPO-group patients are treated with hypofractionated TRT (20 x 2.75 Gy). In the HYPO-arm, a safety stop-and-go lead-in phase precedes full enrollment. Here, patients are closely monitored with regard to toxicity (i.e., pneumonitis grade ≥ 3 within 8 weeks after TRT) in small cohorts of 6. The primary objective of the trial is safety and tolerability. As a primary efficacy endpoint, the objective response rate after 3 months will be evaluated. Further endpoints are additional parameters of safety and efficacy, as well as the comprehensive collection of biomaterials to be analyzed regarding treatment-induced changes and potential novel biomarkers. As of February 10, 2021, 9 patients of planned 88 patients have been enrolled in the TRADE-hypo trial. Clinical trial information: NCT04351256.
Introduction Sleeve resection is an established oncological operative treatment for centrally located tumors with reduced complications compared to pneumonectomy. In cases of neoadjuvant chemoradiotherapy, the optimal timing of surgery for bronchial anastomotic healing has not been adequately explored. Materials and Methods Between 2006 and 2017, 584 tracheobronchial sleeve resections were retrospectively analyzed. We selected all patients (n = 88) after sleeve lobectomy or sleeve bilobectomy for lung cancer with fully completed neoadjuvant chemoradiotherapy. Bronchial healing was assessed by bronchoscopy on the 7th postoperative day using our earlier published classification from grades 1 to 5. Results The median interval to surgery was 50 days (interquartile range 46‐53, mean 50.03 ± 3.72). Mean anastomotic grade was 2.05 ± 1.03 and in 29.5% of the patients a critical anastomosis (grade ≥3) was documented. Anastomotic healing showed optimal results (bronchoscopic grade mean value: 1.5 ± 0.70) between the 6th and 8th postchemoradiotherapy week (P = .001). All patients operated before (bronchoscopic grade mean value: 2.3 ± 1.02) or after the above period (bronchoscopic grade mean value: 2.5 ± 1.15) had an increased ratio of anastomotic healing complications. Conclusion It is safer to perform sleeve‐resections for non‐small cell lung cancer after neoadjuvant trimodal treatment between the 6th and 8th week of completion of chemoradiotherapy.
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