The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.
Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432
Open accessAbstract
BACKGROUND: High tumor mutational burden (TMB-H) is correlated with enhanced objective response rate (ORR) and progression-free survival (PFS) for certain cancers receiving immunotherapy. This study aimed to investigate the safety and efficacy of toripalimab, a humanized programmed death-1 (PD-1) antibody, in advanced gastric cancer (AGC), and the predictive survival benefit of TMB and PD-L1. PATIENTS AND METHODS: We reported on the AGC cohort of phase Ib/II trial evaluating the safety and activity of toripalimab in patients with AGC, oesophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma. In cohort 1, 58 chemo-refractory AGC patients received toripalimab (3 mg/kg d1, Q2W) as a monotherapy. In cohort 2, 18 chemotherapy-naive AGC patients received toripalimab (360 mg d1, Q3W) with oxaliplatin 130 mg/m2 qd, d1, capecitabine 1000 mg/m2 b.i.d., d1-d14, Q3W as first-line treatment. Primary end point was ORR. Biomarkers such as PD-L1 and TMB were evaluated for correlation with clinical efficacy. RESULTS: In cohort 1, the ORR was 12.1% and the disease control rate (DCR) was 39.7%. Median PFS was 1.9 months and median OS was 4.8 months. The TMB-H group showed significant superior OS than the TMB-L group [14.6 versus 4.0 months, HR = 0.48 (96% CI 0.24-0.96), P = 0.038], while PD-L1 overexpression did not correlate with significant survival benefit. A 77.6% of patients experienced at least one treatment-related adverse event (TRAE), and 22.4% of patients experienced a grade 3 or higher TRAE. In cohort 2, the ORR was 66.7% and the DCR was 88.9%. A 94.4% of patients experienced at least one TRAE and 38.9% of patients experienced grade 3 or higher TRAEs. CONCLUSIONS: Toripalimab has demonstrated a manageable safety profile and promising antitumor activity in AGC patients, especially in combination with XELOX. High TMB may be a predictive marker for OS of AGC patients receiving toripalimab as a single agent. TRIAL REGISTRATION: ClinicalTrials.gov NCT02915432.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
PD-1 and PD-L1 Immune Checkpoint Blockade to Treat Breast Cancer
Hartkopf, A. D., Taran, F.-A., Wallwiener, M., Walter, C. B., Krämer, B., Grischke, E.-M., & Brucker, S. Y. (2016) · Breast Care · doi:10.1159/000453569 · Cited by 30,845
Cancer statistics in China, 2015
Chen, W., Zheng, R., Baade, P. D., Zhang, S., Zeng, H., Bray, F., Jemal, A., Yu, X. Q., & He, J. (2016) · CA: A Cancer Journal for Clinicians · doi:10.3322/caac.21338 · Cited by 17,038
Mutational landscape determines sensitivity to PD-1 blockade in non–small cell lung cancer
Rizvi, N. A., Hellmann, M. D., Snyder, A., Kvistborg, P., Makarov, V., Havel, J. J., Lee, W., Yuan, J., Wong, P., Ho, T. S., et al. (2015) · Science · doi:10.1126/science.aaa1348 · Cited by 7,802
Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer
Gandhi, L., Rodríguez-Abreu, D., Gadgeel, S., Esteban, E., Felip, E., De Angelis, F., Domine, M., Clingan, P., Hochmair, M. J., Powell, S. F., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1801005 · Cited by 6,607 · cited 2×
“Additionally, the small number of patients with positive PD-L1 in this study may limit the assessment of PD-L1 as a biomarker [10].”
BackgroundTumor mutational load predicts survival after immunotherapy across multiple cancer types
Samstein, R. M., Lee, C.-H., Shoushtari, A. N., Hellmann, M. D., Shen, R., Janjigian, Y. Y., Barron, D. A., Zehir, A., Jordan, E. J., Omuro, A., et al. (2019) · Nature Genetics · doi:10.1038/s41588-018-0312-8 · Cited by 4,071
Kang, Y.-K., Boku, N., Satoh, T., Ryu, M.-H., Chao, Y., Kato, K., Chung, H. C., Chen, J.-S., Muro, K., Kang, W. K., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)31827-5 · Cited by 2,252
Fuchs, C. S., Doi, T., Jang, R. W., Muro, K., Satoh, T., Machado, M., Sun, W., Jalal, S. I., Shah, M. A., Metges, J.-P., et al. (2018) · JAMA Oncology · doi:10.1001/jamaoncol.2018.0013 · Cited by 1,784
Self-citationKim, S. T., Cristescu, R., Bass, A. J., Kim, K.-M., Odegaard, J. I., Kim, K., Liu, X. Q., Sher, X., Jung, H., Lee, M., et al. (2018) · Nature Medicine · doi:10.1038/s41591-018-0101-z · Cited by 1,654
Shitara, K., Özgüroğlu, M., Bang, Y.-J., Di Bartolomeo, M., Mandalà, M., Ryu, M.-H., Fornaro, L., Olesiński, T., Caglevic, C., Chung, H. C., et al. (2018) · The Lancet · doi:10.1016/s0140-6736(18)31257-1 · Cited by 1,296
Muro, K., Chung, H. C., Shankaran, V., Geva, R., Catenacci, D., Gupta, S., Eder, J. P., Golan, T., Le, D. T., Burtness, B., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)00175-3 · Cited by 1,121
Cited by
Tumor Mutational Burden as a Predictive Biomarker in Solid Tumors
Sha, D., Jin, Z., Budczies, J., Kluck, K., Stenzinger, A., & Sinicrope, F. A. (2020) · Cancer Discovery · doi:10.1158/2159-8290.cd-20-0522 · Cited by 859
Wang, F., Zhang, X., Li, Y., Tang, L., Qu, X., Ying, J., Zhang, J., Sun, L., Lin, R., Qiu, H., et al. (2021) · Cancer Communications · doi:10.1002/cac2.12193 · Cited by 624
Self-citationThe role of PD-1/PD-L1 and application of immune-checkpoint inhibitors in human cancers
Tang, Q., Chen, Y., Li, X., Long, S., Shi, Y., Yu, Y., Wu, W., Han, L., & Wang, S. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.964442 · Cited by 561
Self-citationKawazoe, A., Fukuoka, S., Nakamura, Y., Kuboki, Y., Wakabayashi, M., Nomura, S., Mikamoto, Y., Shima, H., Fujishiro, N., Higuchi, T., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(20)30271-0 · Cited by 269
Qiu, M.-Z., Wang, C., Wu, Z., Zhao, Q., Zhao, Z., Huang, C.-Y., Wu, W., Yang, L.-Q., Zhou, Z.-W., Zheng, Y., et al. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01622-1 · Cited by 58
Self-citation
Metadata
- Authors
- Wang, F., Wei, X. L., Wang, F. H., Xu, N., Shen, L., Dai, G. H., Yuan, X. L., Chen, Y., Yang, S. J., Shi, J. H., Hu, X. C., Lin, X. Y., Zhang, Q. Y., Feng, J. F., Ba, Y., Liu, Y. P., Li, W., Shu, Y. Q., Jiang, Y., Li, Q., Wang, J. W., Wu, H., Feng, H., Yao, S., & Xu, R. H.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2019-09
- Volume
- 30
- Issue
- 9
- Pages
- 1479-1486
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2954094199
- Cited by
- 455
- References
- 19
- FWCI
- 21.58
- Type
- journal article
- Language
- en
- Open access
- hybrid
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432. https://app.cochat.ai/papers/10.1093/annonc/mdz197
- The paper
- Wang, F., Wei, X. L., Wang, F. H., Xu, N., Shen, L., Dai, G. H., Yuan, X. L., Chen, Y., Yang, S. J., Shi, J. H., Hu, X. C., Lin, X. Y., Zhang, Q. Y., Feng, J. F., Ba, Y., Liu, Y. P., Li, W., Shu, Y. Q., Jiang, Y., . . . Xu, R. H. (2019). Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432. Annals of Oncology. https://doi.org/10.1093/annonc/mdz197
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
