The safety and efficacy of immunotherapy with anti-programmed cell death 1 monoclonal antibody for lung cancer complicated with <i>Mycobacterium tuberculosis</i> infection

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Abstract

Background

Anti-programmed cell death 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) immunotherapy has boosted the prognosis in advanced lung cancer. Meanwhile, accumulating cases showed the correlation between tuberculosis (TB) reactivation and anti-PD-1/PD-L1 immunotherapy. However, the safety and efficacy of anti-PD-1/PD-L1 immunotherapy for lung cancer complicated with TB infection could only be learned from real-world data.

Methods

We retrospectively analyzed 562 patients with advanced lung cancer who received anti-PD-1/PD-L1 immunotherapy at Shanghai Pulmonary Hospital from 2015 to 2019, including 13 patients with TB infection. Besides, relevant literature reviews were performed online to analyze the safety and efficacy of immunotherapy and to explore the appropriate treatment strategies in this specific population.

Results

In our cohort, the initiation of anti-PD-1/PD-L1 immunotherapy was from June 2015 to December 2019. Among them, 13 patients had TB infection prior to immunotherapy including 11 latent TB and 2 active TB, and all of them were treated with anti-PD-1 immunotherapy. Patients with active TB infection were treated with concurrent anti-TB and anti-PD-1 treatments, and the remaining received either mono-immunotherapy or combined immunotherapy. Neither reactivation of latent TB nor progression of active TB was monitored in our cohort during immunotherapy. Severe immune-related adverse events (irAEs) were diagnosed in two patients. Treatment strategies such as discontinuation of immunotherapy and administration of corticosteroids were provided timely, and one with latent TB infection got gradually improved, but the other one with active TB died quickly. The median progression-free survival (PFS) was 5.5 months for tumor immunotherapy in our cohort. However, the PFS of immunotherapy was merely 2.1 and 2.2 months in lung cancer patients with active TB infection.

Conclusions

Immunotherapy is relatively safe for lung cancer patients complicated with previously treated latent TB, and the efficacy of immunotherapy in this specified population is not inferior to that in lung cancer patients without TB infection. TB screening before anti-PD-1/PD-L1 immunotherapy is strongly recommended, and irAEs should be monitored more cautiously in lung cancer patients with active TB infection.

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Most cited references 43

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Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.

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Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

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Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).

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Author and article information

Journal

Journal ID (nlm-ta): Transl Lung Cancer Res

Journal ID (iso-abbrev): Transl Lung Cancer Res

Journal ID (publisher-id): TLCR

Title: Translational Lung Cancer Research

Publisher: AME Publishing Company

ISSN (Print): 2218-6751

ISSN (Electronic): 2226-4477

Publication date (Print and electronic): October 2021

Publication date (Print): October 2021

Volume: 10

Issue: 10

Pages: 3929-3942

Affiliations

[1 ]deptDepartment of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer Institute, School of Medicine , Tongji University , Shanghai, China;

[2 ]deptDepartment of Pulmonary & Critical Care Medicine, Shanghai Pulmonary Hospital, School of Medicine , Tongji University , Shanghai, China;

[3 ]deptSchool of Medicine , Tongji University , Shanghai, China;

[4 ]deptDepartment of Lung Cancer and Immunology, Shanghai Pulmonary Hospital, School of Medicine , Tongji University , Shanghai, China

Author notes

Contributions: (I) Conception and design: F Wu, J Shi, J Li; (II) Administrative support: Z Zhang, C Zhou; (III) Provision of study materials or patients: G Gao, Y He, X Chen, C Su, S Ren; (IV) Collection and assembly of data: X Cheng, H Du, R Han; (V) Data analysis and interpretation: Q Wang, X Li, C Zhao; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

[#]

These authors contributed equally to this work.

Correspondence to: Prof. Fengying Wu. Department of Medical Oncology, Shanghai Pulmonary Hospital & Thoracic Cancer Institute, School of Medicine, Tongji University, No. 507, Zheng Min Road, Shanghai 200433, China. Email: fywu@ 123456163.com ; Prof. Zhemin Zhang. Department of Pulmonary & Critical Care Medicine, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, No. 507, Zheng Min Road, Shanghai 200433, China. Email: zhemindoc@ 123456163.com .

[^]

ORCID: 0000-0001-5140-3238.

Article

Publisher ID: tlcr-10-10-3929

DOI: 10.21037/tlcr-21-524

PMC ID: 8577979

PubMed ID: 34858782

SO-VID: 40e0938d-9b59-41d2-a240-1fe7537213cd

License:

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.

The safety and efficacy of immunotherapy with anti-programmed cell death 1 monoclonal antibody for lung cancer complicated with Mycobacterium tuberculosis infection

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Abstract

Background

Methods

Results

Conclusions

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Point-Of-Care Testing for Tuberculosis

Most cited references 43

New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

The blockade of immune checkpoints in cancer immunotherapy.

Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

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