This study shows that weight-loss surgery significantly decreases overall mortality as well as the development of new health-related conditions in morbidly obese patients.
Objective
The recent increased detection of small-sized peripheral non-small cell lung cancer (NSCLC) has renewed interest in sub-lobar resection in-lieu of lobectomy, the traditional standard of care. CALGB/ALLIANCE 140503 is a multicenter international non-inferiority phase III trial in which NSCLC patients clinically staged as T1aN0 were randomly assigned to lobar or sub-lobar resection. The primary endpoint is disease-free survival. We conducted an exploratory comparative analysis of the perioperative mortality and morbidity associated with both arms of the trial.
Patients and Methods
Between June 15/2007 and March 13/2017, 697 patients with peripheral NSCLC clinically staged as T1aN0 were intraoperatively randomized (after pathological confirmation of absence of nodal metastases in major hilar and mediastinal nodes) to either lobar (Arm A: 357) or sublobar resection (Arm B: 340; 58% wedge resections). Randomization assignment was based on a stratified permuted-block randomization scheme without concealment. Randomized was stratified according to radiographic tumor size (< 1 cm, 1–1.5 cm, and > 1.5– 2.0 cm), histology (squamous carcinoma, adenocarcinoma and other) and smoking status (never, former, current). The assignment was not concealed. Perioperative mortality was defined as death from any cause within 30 and 90 days of surgical intervention and was calculated on all randomized patients. Morbidity was graded using the Common Terminology Criteria for Adverse Events (CTCAE v4.0). All analyses were done on an intention to treat basis.
Results
Overall 30 and 90- day mortality for 697 randomized patients were 0.86% (n=6) and 1.4% (n=10). Thirty and 90-day mortality were 1.1% (n=4) and 1.7% (n=6) after lobar resection and 0.6% (n=2) and 1.2% (n=4) after sub-lobar resection yielding a difference between arms of 0.5% (95%CI: −1.1,2.3) and 0.5% (95%CI: −1.5,2.6), respectively, without reaching statistical significance. No complications were observed in 47% of patients (Arm A: 46%, Arm B: 49%). Grade 3/4/5 AEs occurred in 15.2% in Arm A and 14.2% in Arm B. There were no differences between the two arms in cardiac or pulmonary complications. Grade 3 hemorrhage (requiring transfusion) occurred in 6 patients (1.6%) in Arm A and 8 patients (2.3%) in Arm B. Prolonged air leak occurred in 9 patients (2.5%) in Arm A and 2 patients (0.6%) in Arm B.
Conclusions
In this large, multicenter randomized international trial, post-hoc analysis showed no significant differences in perioperative mortality and morbidity between lobar and sub-lobar resection in physically and functionally fit patients with clinical T1aN0 NSCLC. These data may impact the daily choices made by patients and their physicians in determining the optimal treatment approach for stage I lung cancer.
Trial registration
This trial is registered as an international standard randomized trial with ClinicalTrials.gov Identifier: NCT00499330
Role of funding source
The Cancer Therapy Evaluation Program of the National Cancer Institute (CTEP) approved the t...
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