Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness

Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis

The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Immunotherapy

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable NSCLC (clinically staged as T1-4N0-2M0) who underwent neoadjuvant chemoimmunotherapy followed by surgery between January 2017 and January 2024 in Sun Yat-sen University Cancer Center were retrospectively reviewed.

Description

Inclusion Criteria:

• pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
• clinically staged as T1-4N0-2M0
• having undergo neoadjuvant chemoimmunotherapy
• the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
• having undergo surgery with lymph nodes (LNs) dissection
• having postoperative pathology reports with evaluation of primary tumor and LNs response
• having accessible pretreatment and preoperative radiology examinations imaging or reports

Exclusion Criteria:

• using PD-1/L1 inhibitors in the phase of clinical trials
• the agents of neoadjuvant therapy including angiogenesis inhibitors
• having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant immunochemotherapy NSCLC group; NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.	Drug: Immunotherapy; Received neoadjuvant chemotherapy plus immunotherapy; Other Names: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete pathologic response	Tumors with 0% viable tumor cells	through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathologic response	Tumors with ≤10% viable tumor cells	through study completion, an average of 3 months
Complete pathologic response in lymph nodes	Tumors with 0% viable tumor cells in lymph nodes	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Henan Cancer Hospital; Jiangmen Central Hospital

Publications and helpful links

General Publications

• Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.
• Prokhnevska N, Cardenas MA, Valanparambil RM, Sobierajska E, Barwick BG, Jansen C, Reyes Moon A, Gregorova P, delBalzo L, Greenwald R, Bilen MA, Alemozaffar M, Joshi S, Cimmino C, Larsen C, Master V, Sanda M, Kissick H. CD8+ T cell activation in cancer comprises an initial activation phase in lymph nodes followed by effector differentiation within the tumor. Immunity. 2023 Jan 10;56(1):107-124.e5. doi: 10.1016/j.immuni.2022.12.002. Epub 2022 Dec 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Lymphatic Metastasis; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: NSCLC-TDLN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will upload to ResMan after publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No