Tumor Growth Rate (TGR) Predicts Clinical Outcomes for Advanced Non-small Cell Lung Cancer Undergoing Immunotherapy.

NCT04722406 | Unknown

• 1 other identifier: SHong
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

Brief Summary

We hypothesized that TGR could serve as an early predictor of outcomes for aNSCLC patients undergoing immune checkpoint inhibitors (ICIs). A retrospective analysis was conducted to investigate the association of TGR with response and long-term survival of aNSCLC patients undergoing ICI therapy.

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumor Growth Rate; NSCLC; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival of patients undergoing ICI monotherapy

  Overall survival (OS) was defined as the time from immunotherapy initiation to death from any causes.

  From date of ICI treatment initiation until the date of death from any causes, assessed up to 100 months.

Secondary Outcomes (1)

• Progression-free survival of patients undergoing ICI monotherapy.

  From date of ICI treatment initiation until the date of first documented progression or date of death from any causes, whichever came first, assessed up to 100 months.

Study Arms (2)

Low TGR group

Patients with low level of TGR determined by X-tile program

Other: This item is not applicable to our observational study.

High TGR group

Patients with high level of TGR determined by X-tile program

Other: This item is not applicable to our observational study.

Interventions

This item is not applicable to our observational study. OTHER

This item is not applicable to our observational study.

High TGR group; Low TGR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All histologically confirmed aNSCLC patients undergoing anti-PD-1/PD-L1 therapy (N = 172) at Sun Yat-Sen University Cancer Center (SYSUCC) between August 2016 and June 2018.

You may qualify if:

• Histologically confirmed aNSCLC patients
• Having received anti-PD-1/PD-L1 therapy
• Must have two consecutive computed tomography (CT) scans upon early treatment (from baseline to the first imaging evaluation)

You may not qualify if:

• Lacking available computed tomography (CT) evaluation at any of two time points-baseline and the first evaluation
• Without measurable lesions at baseline CT scan
• Having received local anticancer therapy during ICI treatment, for example, radiotherapy and radiofrequency ablation

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Shanghai Chest Hospital: collaborator

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Shaihai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (10)

• Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeno J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.

  PMID: 31422028 BACKGROUND

• Xia L, Liu Y, Wang Y. PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions. Oncologist. 2019 Feb;24(Suppl 1):S31-S41. doi: 10.1634/theoncologist.2019-IO-S1-s05.

  PMID: 30819829 BACKGROUND

• Mok TSK, Wu YL, Kudaba I, Kowalski DM, Cho BC, Turna HZ, Castro G Jr, Srimuninnimit V, Laktionov KK, Bondarenko I, Kubota K, Lubiniecki GM, Zhang J, Kush D, Lopes G; KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819-1830. doi: 10.1016/S0140-6736(18)32409-7. Epub 2019 Apr 4.

  PMID: 30955977 BACKGROUND

• Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. J Clin Oncol. 2018 Jun 10;36(17):1675-1684. doi: 10.1200/JCO.2017.77.0412. Epub 2018 Mar 23.

  PMID: 29570421 BACKGROUND

• Ferte C, Fernandez M, Hollebecque A, Koscielny S, Levy A, Massard C, Balheda R, Bot B, Gomez-Roca C, Dromain C, Ammari S, Soria JC. Tumor growth rate is an early indicator of antitumor drug activity in phase I clinical trials. Clin Cancer Res. 2014 Jan 1;20(1):246-52. doi: 10.1158/1078-0432.CCR-13-2098. Epub 2013 Nov 15.

  PMID: 24240109 BACKGROUND

• Lamarca A, Crona J, Ronot M, Opalinska M, Lopez Lopez C, Pezzutti D, Najran P, Carvhalo L, Franca Bezerra RO, Borg P, Vietti Violi N, Vidal Trueba H, de Mestier L, Schaefer N, Sundin A, Costa F, Pavel M, Dromain C; Knowledge Network. Value of Tumor Growth Rate (TGR) as an Early Biomarker Predictor of Patients' Outcome in Neuroendocrine Tumors (NET)-The GREPONET Study. Oncologist. 2019 Nov;24(11):e1082-e1090. doi: 10.1634/theoncologist.2018-0672. Epub 2019 Mar 25.

  PMID: 30910869 BACKGROUND

• Stein WD, Wilkerson J, Kim ST, Huang X, Motzer RJ, Fojo AT, Bates SE. Analyzing the pivotal trial that compared sunitinib and IFN-alpha in renal cell carcinoma, using a method that assesses tumor regression and growth. Clin Cancer Res. 2012 Apr 15;18(8):2374-81. doi: 10.1158/1078-0432.CCR-11-2275. Epub 2012 Feb 17.

  PMID: 22344231 BACKGROUND

• Gomez-Roca C, Koscielny S, Ribrag V, Dromain C, Marzouk I, Bidault F, Bahleda R, Ferte C, Massard C, Soria JC. Tumour growth rates and RECIST criteria in early drug development. Eur J Cancer. 2011 Nov;47(17):2512-6. doi: 10.1016/j.ejca.2011.06.012. Epub 2011 Jul 15.

  PMID: 21763126 BACKGROUND

• Camp RL, Dolled-Filhart M, Rimm DL. X-tile: a new bio-informatics tool for biomarker assessment and outcome-based cut-point optimization. Clin Cancer Res. 2004 Nov 1;10(21):7252-9. doi: 10.1158/1078-0432.CCR-04-0713.

  PMID: 15534099 BACKGROUND

• He LN, Fu S, Ma H, Chen C, Zhang X, Li H, Du W, Chen T, Jiang Y, Wang Y, Wang Y, Zhou Y, Lin Z, Yang Y, Huang Y, Zhao H, Fang W, Zhang H, Zhang L, Hong S. Early on-treatment tumor growth rate (EOT-TGR) determines treatment outcomes of advanced non-small-cell lung cancer patients treated with programmed cell death protein 1 axis inhibitor. ESMO Open. 2022 Dec;7(6):100630. doi: 10.1016/j.esmoop.2022.100630. Epub 2022 Nov 25.

  PMID: 36442353 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shaodong Hong, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaodong Hong, MD

CONTACT

+8615920527656; hongshd@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician, MD

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 25, 2021
• Study Start: August 15, 2019
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The IPD and any additional supporting information will become available 3 months after publication.
• Access Criteria: data can be obtained from the principal investigator by e-mail upon reasonable request.

Locations

CN (3)