Neoadjuvant therapy followed by tracheal/carinal resection and reconstruction: perioperative and long-term outcomes

Introduction

Primary tracheal tumors represent a distinctly rare category of malignancies, accounting for only 0.01–0.4% of all cancer cases (1). Surgical resection remains the cornerstone of treatment, albeit with limited therapeutic alternatives. Nevertheless, tracheal resection and reconstruction is a technically demanding procedure associated with considerable operative morbidity and mortality (2-5). In recent years, refinements in anesthetic management and accumulated surgical experience have contributed to improved postoperative outcomes. Data from Massachusetts General Hospital (MGH) between 1997 and 2017 reported 30-day and 90-day mortality rates of 6.8% and 7%, respectively (6).

Most airway tumors manifest with non-specific symptoms such as cough and dyspnea, which are often not initially attributed to malignancy, leading to frequent delays in diagnosis. When tumors exceed 3 cm in length or extend beyond the tracheal wall, more extensive resection is required to achieve negative margins. However, longer resections have been correlated with a higher incidence of anastomotic complications (6-8). Grillo and colleagues (9) demonstrated that anastomotic tension increases progressively with the length of tracheal resection, recommending a safe limit of 4.5 cm to minimize such risks. Consequently, achieving complete resection with clear margins remains challenging when the tumor extends beyond 3 cm or invades extratracheal structures.

Multiple clinical trials (10-13) have established the significant benefits of neoadjuvant therapy, including substantial reduction in primary tumor size and eradication of micrometastatic disease. Importantly, neoadjuvant approaches have been shown to enhance resectability in patients with initially unresectable tumors, thereby improving long-term survival. Effective neoadjuvant treatment may reduce tumor burden and limit the extent of resection required for primary tracheal tumors. However, evidence regarding the utility of neoadjuvant therapy specifically for tracheal tumors remains limited. In particular, it is still unclear whether neoadjuvant treatment influences pathological response rates or surgical safety in this setting.

This study aims to evaluate the safety and feasibility of neoadjuvant therapy for primary tracheal tumors, addressing a significant gap in the current clinical evidence. We present this article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0242/rc).

Methods

Between May 2019 and June 2024, 22 patients who received neoadjuvant therapy followed by tracheal or carinal reconstruction at a high-volume center (The First Affiliated Hospital of Guangzhou Medical University) were retrospectively reviewed. Demographic, surgical, perioperative, and survival data were collected and analyzed.

Tracheal/carinal resection and reconstruction were considered only when complete resection seemed feasible after neoadjuvant therapy. Resection was not performed if it would have resulted in grossly positive tracheal margins.

Preoperative assessment

Patients were carefully evaluated for preoperative comorbidities and surgical candidacy. All patients underwent standard diagnosis and staging procedures. Computed tomography (CT) scans and bronchoscopy were routinely performed to evaluate primary tumors before and after neoadjuvant treatment. Magnetic resonance imaging (MRI) and positron emission tomography (PET) were utilized to rule out presence or absence of distant metastases. Histological confirmation of tracheal tumor was obtained through bronchoscopic biopsy before neoadjuvant therapy (Figure 1).

Figure 1 Flowchart of the clinical treatment strategy. CT, computed tomography; MRI, magnetic resonance imaging; PET, positron emission tomography.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of The First Affiliated Hospital of Guangzhou Medical University. Informed consent was waived in this retrospective study.

Neoadjuvant treatment and response evaluation

Neoadjuvant therapy was collaboratively decided through multidisciplinary team (MDT) discussions, involving oncologists, thoracic surgeons, radiologists and patients. The preoperative treatment strategy included immunochemotherapy, chemotherapy, chemoradiotherapy, and radiotherapy. Specifically, immunochemotherapy regimens were mainly composed of platinum-based chemotherapy combined with programmed cell death protein 1 (PD-1) inhibitors, and chemotherapy alone was primarily platinum-based regimens. Squamous cell carcinoma (SCC) patients primarily received 2–4 cycles of immunochemotherapy or chemotherapy alone, whereas adenoid cystic carcinoma (ACC) patients were treated with radiotherapy alone or combined chemoradiotherapy, with radiotherapy doses ≤3,500 cGy. In patients unable to tolerate radiotherapy, alternative regimens—including immunochemotherapy or chemotherapy alone—were used based on MDT assessment of tumor characteristics and patient factors. Tumor staging before and after neoadjuvant therapy, as well as postoperative staging, was determined according to Bhattacharyya’s criteria (14). The radiologic response to preoperative therapy was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (15).

Surgical technique

The operative approach was individualized according to tumor location, extent of airway involvement, involvement of adjacent structures, and the planned reconstruction. Approaches included posterolateral thoracotomy, median sternotomy, and selected minimally invasive procedures, all performed by an experienced airway surgery team. Before airway division, needle-guided bronchoscopy was used to reconfirm the extent of the lesion and define the proximal and distal resection margins. Tumors were resected with 0.5 cm margins above and below the lesion, and both margins were routinely assessed by intraoperatively frozen sections. Depending on the extent and location of resection, airway reconstruction was performed as primary tracheal anastomosis or neocarinal reconstruction. Release maneuvers, including laryngeal suprahyoid release, hilar release, and division of the inferior pulmonary ligament, were used to reduce anastomotic tension. After completion of airway reconstruction, intraoperative bronchoscopy was routinely performed to assess anastomotic integrity, inspect the suture line, and clear distal airway secretions. The anastomosis was buttressed with autologous tissue to improve local vascularity and reduce the risk of anastomotic complications.

Follow-up policy

CT scans and bronchoscopy were routinely performed to assess the anastomosis on postoperative day 7 or prior to discharge. Outpatients CT were scheduled at 1-, 3-, 6-, and 12-months post-surgery, then biannually for up to 5 years, with additional exams as needed for surgical-related symptoms. The MDT evaluated the need for adjuvant therapy at 2 months postoperatively, based on recovery status and pathological findings.

Data collection and evaluation

The primary analysis was conducted to assess survival outcomes, including overall survival (OS) and disease-free survival (DFS). DFS and OS were calculated from the date of surgical resection to death, recurrence/progression, or last follow-up. Oncological outcomes included major pathological response (MPR) and pathological complete response (pCR). MPR was defined as the presence of 10% or less viable tumor cells in the resected primary tumor, and pCR was defined as no viable tumor cells in the resected specimen. The surgical outcomes of operating time, intraoperative bleeding, postoperative drainage, and duration of intensive care unit (ICU) stay were analyzed. Postoperative complications were classified according to the Clavien-Dindo classification.

Statistical analyses

Given the small sample size (n=22) and the retrospective, exploratory nature of the study, descriptive analyses were primarily used. Categorical variables are reported as frequencies and percentages, whereas continuous variables are reported as the mean ± standard deviation or median [interquartile range (IQR)]. The Kaplan-Meier method was used to analyze the survival outcomes, which was compared using the log-rank test. Statistical analysis was performed using R version 4.3.1 (https://www.r-project.org/) and SPSS version 25.0 (IBM Corp., New York, NY, USA).

Results

Patient characteristics

A total of 22 patients underwent tracheal and carinal reconstruction following neoadjuvant therapy were retrospectively identified from May 2019 to June 2024. Lesions were distributed across the carina (n=9, 40.9%) and trachea (n=13, 59.1%). The average tumor size prior to treatment was 3.0 cm, and 9 tumors (40.9%) extended outside of the trachea. Pre-treatment biopsy revealed that the most common histological subtypes were SCC and ACC, each accounting for 45.5% (n=10) of cases. Lymphoepithelioma-like carcinoma (LELC) and mucoepidermoid carcinoma (MEC) were each identified in one patient (4.5%). The demographic and clinical characteristics are presented in Table 1.

Efficacy of neoadjuvant therapy

Totally 22 patients underwent neoadjuvant therapy before surgery, 11 (50%) patients received immunochemotherapy, 6 (27.3%) received chemotherapy alone, 3 (13.6%) received chemoradiotherapy and 2 (9.1%) received radiotherapy alone. No grade ≥3 treatment-related adverse events were observed. The median interval between last treatment to surgery was 36 (IQR, 30, 42) days, and no patient experienced treatment-related delay in surgery. Radiological and pathological responses in different neoadjuvant therapy modalities are shown in Table 2 and Figure 2. After neoadjuvant therapy, the mean tumor size was 2.4 cm. Patients who received neoadjuvant immunochemotherapy demonstrated a higher partial response (PR) rate compared with those treated with other regimens (75.0% vs. 25.0%). Among all patients, 4 patients (18.2%) achieved pCR and 4 (18.2%) achieved MPR. Notably, 5 of them (5/8, 62.5%) had received neoadjuvant immunochemotherapy. Radiologic and pathologic responses were both more favorable in the immunochemotherapy group, suggesting superior efficacy over alternative neoadjuvant strategies.

Figure 2 Clinical outcomes following neoadjuvant therapy, including therapy type, tumor pattern, location, ORR, resection status, pathological outcomes, and lymph node status. ACC, adenoid cystic carcinoma; LELC, lymphoepithelioma-like carcinoma; MEC, mucoepidermoid carcinoma; MPR, major pathological response; ORR, objective response rate; pCR, pathological complete response; PD, progressive disease; PR, partial response; SCC, squamous cell carcinoma; SD, stable disease.

Surgical technique and outcomes

Procedures included 40.9% (n=9) neocarinal reconstruction, and 59.1% (n=13) primary tracheal reconstruction. Prior to neoadjuvant therapy, lung resection was planned in 7 patients (31.8%). Following treatment, only 3 patients (13.6%) ultimately required lung resection—one underwent pneumonectomy and two received lobectomy. Minimally invasive surgery, including video-assisted thoracoscopic surgery (VATS) and robot-assisted thoracoscopic surgery (RATS), was attempted in 7 patients (31.8%), and 2 patients (28.6%) converted to thoracotomy due to pulmonary artery hemorrhage. The resection length was 3.7±1.2 cm. There were 10 patients (45.5%) resected ≥4 cm. The duration of the surgical procedure was 406.1±186.5 min, and the intraoperative bleeding was 100.0 (IQR, 50.0, 262.5) mL. In 19 patients, tracheal anastomoses were buttressed with a single vascularized tissue flap (Table 3).

Based on pathological evaluation of the resected specimens, complete resection (R0) was achieved in 72.7% (16 of 22) of patients. Although frozen sections were sent intraoperatively in all cases, 5 patients (22.7%) with ACC concerns about increased anastomotic tension prevented the ability to resect more of the tracheal extent and thus to achieve complete resection. Final histology showed microscopic presence of neoplastic emboli in only one patient with SCC, which was not found at the intraoperative analysis. Positive lymph nodes were identified in 4 patients (18.2%).

Postoperative complications

A total of 13 patients (59.1%) developed postoperative complications, with 10 of them experiencing more than one event. Major postoperative complications (Grade III–V) occurred in 5 (22.7%) patients, while minor complications (Grade I–II) were observed in 8 patients (36.4%). The anastomotic complication rate was 18.2% (n=4). Three patients suffered localized bronchopleural fistula due to anastomotic dehiscence. Two patients were managed with chest tube drainage and eventually recovered. Intact anastomosis with eschar was observed in one patient treated conservatively with no intervention and ultimate improvement. Another patient with anastomosis stenosis was successfully treated with a stent. No perioperative mortality (30 or 90 days) was observed (Table 4).

Survival analysis

The median duration of follow-up was 29.5 months (range, 6 to 88 months). OS rate was 86.4% (95% CI: 73.2–100.0) at 1 year and 68.7% (95% CI: 47.8–98.7) at 5 years, respectively. DFS rates after 1 and 5 years were 86.4% (95% CI: 73.2–100.0%) and 58.8% (95% CI: 38.1–90.7%), respectively. During the follow-up, 18.2% (n=4) develop metastases, including 2 patients with SCC, 1 with ACC, and 1 with LELC. Notably, endobronchial recurrence occurred in only one patient with R1 resection, and no anastomosis recurrence was observed. Distant metastases were identified in 2 patients (9.1%) with tumors extending beyond the trachea. Twelve patients (54.5%) received adjuvant therapy following tracheal or carinal reconstruction, based on MDT discussion. No one experienced serious adverse events during treatment.

Median survival in patients with ACC (n=10) was 33.5 vs. 30 months in patients with SCC (n=10). Although the difference did not reach statistical significance, patients with ACC exhibited a trend toward improved long-term outcomes compared to those with SCC. Five-year OS was 90.0% (95% CI: 73.2–100.0%) for ACC and 26.7% (95% CI: 5.2–100.0%) for SCC (P=0.08). Similarly, DFS at 5 years was 78.7% (95% CI: 56.4–100.0%) for ACC vs. 32% (95% CI: 7.2–100.0%) for SCC (P=0.20). Kaplan-Meier curves indicated a favorable survival trend in the ACC subgroup. Non-tumor-related mortality occurred in 2 patients with SCC. Multivariate analysis was not applicable due to the limited statistical sample (Figure 3).

Figure 3 Survival outcomes of patients. (A,B) OS and DFS for all patients. (C,D) Comparison of OS and DFS between the most common histological subtypes in this cohort. Number-at-risk tables are shown below each curve. ACC, adenoid cystic carcinoma; DFS, disease-free survival; OS, overall survival; SCC, squamous cell carcinoma.

Discussion

Given the extremely low incidence and non-specific clinical presentations, tracheal tumors are frequently subject to misdiagnosis. The rarity of these neoplasms also contributes to a scarcity of established, effective treatment strategies for improving survival. Surgical resection remains the mainstay of management for primary tracheal tumors (16). Mathisen and colleagues (17) have shown that resection of the trachea or carina is associated with superior long-term survival compared with palliative approaches. Nevertheless, safe resection and reconstruction become technically challenging in cases of widely invasive tumors, particularly when the lesion exceeds 3 cm in length or exhibits extratracheal extension.

In recent years, multiple clinical trials (10-13) have demonstrated that neoadjuvant therapy can reduce or eliminate metastatic disease, improve resectability, and prolong survival, leading to its growing adoption in clinical practice. Although preliminary studies (18-20) suggest promising efficacy of neoadjuvant treatment for tracheal tumors, the overall evidence remains limited, and its definitive therapeutic role has not been clearly established. In our cohort, 36.4% of patients (n=8) achieved a PR. Additionally, among 7 patients initially planned for concomitant lung resection, 4 (57.1%) ultimately avoided lung resection after neoadjuvant therapy and reassessment. These findings indicated that preoperative treatment can substantially reduce tumor burden and facilitate less extensive surgical interventions. Pathologic assessment revealed favorable pathologic response, including 4 with pCR (18.2%) and 4 with MPR (18.2%). Notably, both radiologic and pathologic responses were more pronounced in the immunochemotherapy subgroup, suggesting a potential for higher pathologic remission in SCC patients.

The primary objective of airway resection and reconstruction is to achieve a tension-free anastomosis with negative margins. Neoadjuvant therapy may facilitate complete tumor resection in selected patients (17). However, complete resection is not always attainable due to technical challenges or excessive anastomotic tension. As reported by Mathisen and colleagues (18), microscopic margin involvement was considered acceptable when the airway appeared grossly normal and no additional resection was feasible. In our series, postoperative pathology confirmed R0 resection in 16 patients (72.7%), a rate appears higher than those documented in previous studies (29–47.6%) (6,18-21). These results underscore the potential oncologic and surgical advantages of neoadjuvant therapy for primary tracheal tumors.

Evidence for neoadjuvant therapy in tracheal tumors remains limited (Table 5). Previous reports (3,6,7,23,26-28) have suggested that neoadjuvant therapy, particularly thoracic radiotherapy, may be associated with increased surgical difficulty and postoperative morbidity. High-dose preoperative radiation has been correlated with tracheal complications in a dose-dependent manner (22,24,29). In our study, neoadjuvant radiotherapy was infrequently administered (5/22, 22.7%), and all doses were below 3,500 cGy. Two patients (28.6%) who initially underwent minimally invasive airway surgery required conversion to thoracotomy due to pulmonary artery hemorrhage. Based on the experience at MGH (22), it is crucial to reinforce the anastomosis with a vascularized tissue flap to enhance local perfusion and minimize the risk of anastomotic complications. The remaining 3 patients, who had received preoperative immunochemotherapy or chemotherapy alone, did not have their anastomoses wrapped. Overall, 13 patients (59.1%) experienced postoperative complications, including 5 (22.7%) experienced major postoperative complications (Grade III-V) and 4 (18.2%) with anastomotic issues—three with dehiscence and one with stenosis—consistent with rates reported previously (6,26,30).

Despite the technical complexity and inherent risks of airway surgery, neoadjuvant therapy offers a pathway to convert unresectable disease into resectable cases, thereby potentially improving long-term survival. Moreover, it may enable lung-preserving strategies, which can contribute to better postoperative quality of life (QoL) (24). In our cohort, only three patients required lung resection. Greater preservation of pulmonary function may enhance patient capacity to tolerate subsequent adjuvant therapies, which have been associated with improved survival outcomes (16,31,32). Overall, 12 patients (54.5%) received adjuvant treatment, which may have contributed to the favorable survival observed. With a median follow-up of 29.5 months (range, 6–88 months), the 5-year overall and DFS rates were 68.7% and 58.8%, respectively. Both overall and DFS for patients with ACC and SCC appeared more favorable than historical controls (6,18,21,26), showing encouraging survival from neoadjuvant therapy. Distant metastasis occurred in only two patients (9.1%) with extratracheal tumor extension, a rate lower than that in earlier publications. Among the four patients who developed metastases during follow-up, three remained alive at the last assessment.

Although this series represents one of the largest contemporary cohorts evaluating neoadjuvant therapy followed by airway resection, several limitations should be acknowledged. The primary constraint is the small sample size (n=22). In addition, the study is retrospective, reflects the experience of a single institution, and spans a prolonged period. PD-L1 expression could not be incorporated due to missing values in the earlier study period, particularly for SCC patients. Postoperative functional outcomes and patient-reported QoL data were not systematically collected. While these factors may limit generalizability, the consistency in patient selection, surgical technique, and perioperative management are notable strengths of this analysis. In the absence of a contemporaneous control group, the efficacy of neoadjuvant therapy in this setting remains to be further explored.

Conclusions

In conclusion, for selected patients with primary tracheal tumors—particularly those with lesions >3 cm or extratracheal extension—neoadjuvant therapy may be a safe and feasible strategy. It facilitates tumor reduction and lung-preserving resection, achieves high rates of complete removal, and yields promising long-term survival without increasing surgical mortality.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0242/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0242/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0242/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0242/coif). S.L. serves as an unpaid editorial board member of Translational Lung Cancer Research from February 2025 to January 2026. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of The First Affiliated Hospital of Guangzhou Medical University. Informed consent was waived in this retrospective study.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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