Tumor response assessment by measuring the single largest lesion per organ in advanced non-small cell lung cancer patients treated with PD-1/PD-L1 inhibitor

Li-Na He; Tao Chen; Sha Fu; Yongluo Jiang; Xuanye Zhang; Chen Chen; Wei Du; Linfeng Luo; Anlin Li; Yixing Wang; Hui Yu; Yixin Zhou; Yuhong Wang; Yunpeng Yang; Yan Huang; Hongyun Zhao; Wenfeng Fang; Li Zhang; Shaodong Hong

doi:10.1177/17588359231200463

Tumor response assessment by measuring the single largest lesion per organ in advanced non-small cell lung cancer patients treated with PD-1/PD-L1 inhibitor

Ther Adv Med Oncol. 2023 Oct 24:15:17588359231200463. doi: 10.1177/17588359231200463. eCollection 2023.

Authors

Li-Na He^{1

2}, Tao Chen^{1

2

3}, Sha Fu⁴, Yongluo Jiang^{1

2

3}, Xuanye Zhang^{1

2

5}, Chen Chen^{1

2

6}, Wei Du^{1

2

5}, Linfeng Luo^{1

2

5}, Anlin Li^{1

2

5}, Yixing Wang^{1

2

5}, Hui Yu^{1

2

5}, Yixin Zhou^{1

2

7}, Yuhong Wang^{1

2

8}, Yunpeng Yang^{1

2

5}, Yan Huang^{1

2

5}, Hongyun Zhao^{1

2

9}, Wenfeng Fang^{1

2

5}, Li Zhang^{1

2

10}, Shaodong Hong^{1

2

10

11}

Affiliations

¹ State Key Laboratory of Oncology in South China, Guangzhou, China.
² Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
³ Department of Nuclear Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
⁴ Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation of Sun Yat-sen University; Department of Cellular & Molecular Diagnostics Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
⁵ Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
⁶ Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
⁷ Department of VIP region, Sun Yat-sen University Cancer Center, Guangzhou, China.
⁸ Department of Endoscopy, Sun Yat-sen University Cancer Center, Guangzhou, China.
⁹ Department of Clinical Research, Sun Yat-sen University Cancer Center, Guangzhou, China.
¹⁰ Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, Guangdong 510060, China.
¹¹ Department of Oncology, The People's Hospital of Fengqing, No. 107, Qingyun Group 1, Pingcun Village Committee, Fengshan Town, Fengqing County, Lincang 675900, China.

Abstract

Background: For Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1), measuring up to two target lesions per organ is an arbitrary criterion.

Objectives: We sought to compare response assessment using RECIST1.1 and modified RECIST1.1 (mRECIST1.1, measuring the single largest lesion per organ) in advanced non-small cell lung cancer (aNSCLC) patients undergoing anti-PD-1/PD-L1 monotherapy.

Methods: Concordance of radiologic response categorization between RECIST1.1 and mRECIST1.1 was compared using the Kappa statistics. C-index was calculated to evaluate prognostic accuracy of radiologic response by the two criteria. The Kaplan-Meier method and Cox regression analysis were conducted for progression-free survival (PFS) and overall survival (OS).

Results: Eighty-seven patients who had at least two target lesions in any organ per the RECIST1.1 were eligible for comparison analysis. Tumor response showed excellent concordance when measured using the RECIST1.1 and mRECIST1.1 (Kappa = 0.961). C-index by these two criteria was similar for PFS (0.784 versus 0.785) and OS (0.649 versus 0.652). Responders had significantly longer PFS and OS versus non-responders (p < 0.05), whichever criterion adopted. Radiologic response remained a significant predictor of PFS and OS in multivariate analysis (p < 0.05).

Conclusion: The mRECIST1.1 was comparable to RECIST1.1 in response assessment among aNSCLC patients who received single-agent PD-1/PD-L1 inhibitor. The mRECIST1.1, with reduced number of lesions to be measured, may be sufficient and more convenient to assess antitumor activity in clinical practice.

Keywords: RECIST 1.1; immunotherapy; modified RECIST 1.1; non-small cell lung cancer; target lesion; tumor response.