Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer

Defined as the proportion of patients experiencing postoperative complications graded as Clavien-Dindo classification grade III or higher within 30 days after radical surgery. Complication data are collected from postoperative records, discharge summaries, and follow-up documentation.

The incidence of treatment-related adverse events (TRAEs) graded ≥3 according to the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, occurring during the neoadjuvant/induction phase and within 90 days following the initiation of definitive local therapy (surgery or radiotherapy). TRAEs are assessed based on clinical presentation, laboratory findings, imaging results, and physician judgment, with causality reviewed by the research team.

Defined as the incidence of immune-related adverse events (irAEs) occurring from the start of neoadjuvant immunotherapy until 90 days after radical surgery or the initiation of definitive radiotherapy, whichever applies. irAEs are adverse events potentially attributable to immune checkpoint inhibitors and may involve organs such as the lung, liver, skin, or endocrine system. Events are graded according to CTCAE v5.0, and diagnosis is based on clinical presentation, laboratory/imaging findings, and expert clinical judgment.

Defined as the time from the initiation of neoadjuvant immunotherapy to the first documented disease progression or death from any cause, whichever occurs first. Disease progression includes local recurrence, regional relapse, distant metastasis, or any clinically or radiologically confirmed progression. Patients without an event will be censored at the date of the last follow-up.

Defined as the time from the initiation of neoadjuvant therapy to death from any cause. For patients who remain alive at the end of follow-up, OS will be censored at the date of the last known contact. Survival status is confirmed through electronic medical records, follow-up visits, or telephonic interviews. OS is measured in days and analyzed using time-to-event methods.

Defined as the proportion of patients initially planned for video-assisted thoracoscopic surgery (VATS) who required unplanned conversion to open thoracotomy during radical resection. Conversion events and their intraoperative causes will be extracted from operative records and confirmed by surgical documentation. The outcome reflects intraoperative difficulty and is used as a surrogate marker of surgical complexity.

Defined as the total operative time, measured in minutes, from the initial skin incision to the completion of skin closure during radical lung resection. Time data are extracted from intraoperative anesthesia or surgical records. Operative time is used as a continuous variable and may reflect the technical complexity of surgery.

Defined as the proportion of patients achieving a pathologic complete response (pCR), which is characterized by the absence of any viable tumor cells in the resected primary tumor and all sampled regional lymph nodes (ypT0N0), as confirmed by postoperative pathological examination. Pathologic assessments are conducted by experienced thoracic pathologists according to standardized criteria.

Defined as the proportion of patients achieving a major pathologic response (MPR), characterized by ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy, regardless of lymph node status. The percentage of residual tumor is assessed by experienced thoracic pathologists according to standardized pathological evaluation protocols.

Defined as the total number of lymph nodes dissected and pathologically examined from N1 and N2 stations during radical lung cancer resection. The counts are recorded separately for N1 and N2 regions based on operative and pathological reports. This outcome reflects the extent of mediastinal and hilar lymphadenectomy and may serve as an indicator of surgical thoroughness and potential prognostic value.

Defined as the number of lymph node stations sampled or dissected from the N1 and N2 regions during radical lung cancer surgery. The count is recorded separately for N1 and N2 stations based on operative and pathological reports. This measure reflects the anatomical extent of lymphadenectomy and is used to evaluate surgical thoroughness and adherence to oncologic guidelines.

Among patients whose anticipated surgical resection before neoadjuvant immunotherapy involved more than one pulmonary lobe, this outcome measures the proportion whose actual surgical resection was less extensive than originally planned. The anticipated extent is based on pre-treatment multidisciplinary evaluations, including imaging and bronchoscopy.