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Usefulness of FDG-PET/CT to predict the response after anti-PD-1/PD-L1 antibody in patients with advanced non-small cell lung cancer: a multi-institutional study (FDG PD-1/PD-L1 Study)

FDG-PET/CT and prediction of anti-PD-1/PD-L1 antibody in lung cancer (FDG PD-1/PD-L1 Study)

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A total of 54 patients (42 men, 12 women; median age, 73 years; age range, 42-84 years) were analyzed. Forty-two (77.8%) patients had a smoking history, and PS was 0, 1, and 2 in 12 (22.2%), 31 (57.4%), and 11 (20.4%) patients, respectively. Regarding the histological type, adenocarcinoma was observed in 29 (53.7%), squamous cell carcinoma in 15 (27.8%), and other in 10 (18.5%). As treatment lines, 22 (40.7%) patients received pembrolizumab in first-line and 32 (59.3%) in second or more lines (nivolumab in 25 patients, pembrolizumab in 6, and atezolizumab in 1). Among the 54 patients, 19, 16, and 19 exhibited PR, stable disease, and progressive disease, respectively. The objective response was 35.2% (50.0% in first-line; 25.0% in second or more lines).

This prospective study enrolled 58 patients with advanced NSCLC who received PD-1 blockade monotherapy at multiple institutions between January 2019 and October 2020. But four were excluded because of inadequate PET study and data unavailability. A total of 54 patients was registered for further analysis.

There was no evidence of adverse events related to FDG-PET

In 54 patients, partial metabolic response and progressive metabolic disease after PD-1 blockade were observed in 35.2% and 11.1% on SULmax, 22.2% and 51.8% on MTV, and 27.8% and 46.3% on TLG, respectively, whereas a PR and PD, respectively, based on RECIST were recognized in 35.2% and 35.2%, respectively. The predictive probability of PR (MTV 57.9% vesus 21.1%, p=0.044, and TLG 63.2% versus 21.1%, p=0.020) and PD (MTV 78.9% versus 47.3%, p=0.002, and TLG 73.7% versus 21.1%, p=0.007) detected based on RECIST at 4 weeks after PD-1 blockade initiation was significantly higher using MTV and TLG on 18F-FDG uptake than on CT. Multivariate analysis revealed that metabolic response by MTV or TLG at 4 weeks was an independent factor for response to PD-1 blockade treatment. Statistical analyses were performed using Student's t-test for continuous and categorical variables. Kaplan-Meier method was used to estimate survival as a function of time, and survival diferences were analyzed using log-rank test.

Metabolic assessment by MTV or TLG was superior to morphological changes on CT for predicting the therapeutic response and survival at 4 weeks after PD-1 blockade in patients with advanced NSCLC.

Feb. 01, 2023

July. 01, 2022

https://www.nature.com/articles/s41598-022-15964-3

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180036

Kaira Kyoichi

Saitama Medical University

1397-1,Yamane, Hidaka, Saitama

kkaira1970@yahoo.co.jp

Yamaguchi Ou

Saitama Medical University

1397-1,Yamane, Hidaka, Saitama

+81-42-984-4111

ouyamagu@saitama-med.ac.jp

Complete

Mar. 01, 2018

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1)Pathologically confirmed advanced non-small cell lung cancer (NSCLC)
2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3)Patient with evaluable lesion based on RECIST
4)Written informed consent

1)Pregnant woman
2)Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3)Patients with collagen vascular disease or autoimmune diseases
4)Other cases attending physician it is determined unsuitable for registration of the study

Both

Lung cancer

All patients undergo FDG-PET/CT before and 4 weeks and 9weeks after initiation of anti-PD-1/PD-L1 antibody therapy.

Lung cancer

1)Changeing of SUVmax, MTV and TLG, and the efficacy of anti-PD-1/PD-L1 antibody such as nivolumab or pembrolizumab.

2)Evaluation after 4weeks and 9weeks from administration of anti-PD-1/PD-L1 antibody.

Overall survival and progression-free survival

+81-49-276-1662

Aug. 28, 2018

none