Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study
Background: Emerging data have supported the immunostimulatory role of radiotherapy, which could exert a synergistic effect with immune checkpoint inhibitors (ICIs). With proven effective but suboptimal effect of ICI and chemotherapy in triple-negative breast cancer (TNBC), we designed a pilot study...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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eLife Sciences Publications Ltd
2023-12-01
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| Series: | eLife |
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| Online Access: | https://elifesciences.org/articles/91737 |
| _version_ | 1797382642205720576 |
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| author | Guanglei Chen Xi Gu Jinqi Xue Xu Zhang Xiaopeng Yu Yu Zhang Ailin Li Yi Zhao Guijin He Meiyue Tang Fei Xing Jianqiao Yin Xiaobo Bian Ye Han Shuo Cao Chao Liu Xiaofan Jiang Keliang Zhang Yan Xia Huajun Li Nan Niu Caigang Liu On behalf of the Northeastern Clinical Research Alliance of Oncology (NCRAO) |
| author_facet | Guanglei Chen Xi Gu Jinqi Xue Xu Zhang Xiaopeng Yu Yu Zhang Ailin Li Yi Zhao Guijin He Meiyue Tang Fei Xing Jianqiao Yin Xiaobo Bian Ye Han Shuo Cao Chao Liu Xiaofan Jiang Keliang Zhang Yan Xia Huajun Li Nan Niu Caigang Liu On behalf of the Northeastern Clinical Research Alliance of Oncology (NCRAO) |
| author_sort | Guanglei Chen |
| collection | DOAJ |
| description | Background: Emerging data have supported the immunostimulatory role of radiotherapy, which could exert a synergistic effect with immune checkpoint inhibitors (ICIs). With proven effective but suboptimal effect of ICI and chemotherapy in triple-negative breast cancer (TNBC), we designed a pilot study to explore the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) plus adebrelimab and chemotherapy in TNBC patients.
Methods: Treatment-naïve TNBC patients received two cycles of intravenous adebrelimab (20 mg/kg, every 3 weeks), and SBRT (24 Gy/3 f, every other day) started at the second cycle, then followed by six cycles of adebrelimab plus nab-paclitaxel (125 mg/m² on days 1 and 8) and carboplatin (area under the curve 6 mg/mL per min on day 1) every 3 weeks. The surgery was performed within 3–5 weeks after the end of neoadjuvant therapy. Primary endpoint was pathological complete response (pCR, ypT0/is ypN0). Secondary endpoints included objective response rate (ORR), residual cancer burden (RCB) 0-I, and safety.
Results: 13 patients were enrolled and received at least one dose of therapy. 10 (76.9%) patients completed SBRT and were included in efficacy analysis. 90% (9/10) of patients achieved pCR, both RCB 0-I and ORR reached 100% with three patients achieved complete remission. Adverse events (AEs) of all-grade and grade 3–4 occurred in 92.3% and 53.8%, respectively. One (7.7%) patient had treatment-related serious AEs. No radiation-related dermatitis or death occurred.
Conclusions: Adding SBRT to adebrelimab and neoadjuvant chemotherapy led to a substantial proportion of pCR with acceptable toxicities, supporting further exploration of this combination in TNBC patients.
Funding: None.
Clinical trial number: NCT05132790. |
| first_indexed | 2024-03-08T21:09:21Z |
| format | Article |
| id | doaj.art-4d40ffdb0c304d388f1adabf0f97596c |
| institution | Directory Open Access Journal |
| issn | 2050-084X |
| language | English |
| last_indexed | 2024-03-08T21:09:21Z |
| publishDate | 2023-12-01 |
| publisher | eLife Sciences Publications Ltd |
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| spelling | doaj.art-4d40ffdb0c304d388f1adabf0f97596c2023-12-22T10:12:19ZengeLife Sciences Publications LtdeLife2050-084X2023-12-011210.7554/eLife.91737Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot studyGuanglei Chen0Xi Gu1Jinqi Xue2Xu Zhang3Xiaopeng Yu4Yu Zhang5Ailin Li6Yi Zhao7Guijin He8Meiyue Tang9Fei Xing10Jianqiao Yin11Xiaobo Bian12Ye Han13https://orcid.org/0000-0003-2929-8122Shuo Cao14Chao Liu15Xiaofan Jiang16Keliang Zhang17Yan Xia18Huajun Li19Nan Niu20Caigang Liu21https://orcid.org/0000-0003-2083-235XOn behalf of the Northeastern Clinical Research Alliance of Oncology (NCRAO)Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Department of Gastrointestinal Surgery, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaLiaoning Center for Drug Evaluation and Inspection, Shenyang, ChinaJiangsu Hengrui Pharmaceuticals, Shanghai, ChinaJiangsu Hengrui Pharmaceuticals, Shanghai, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, China; Cancer Stem Cell and Translational Medicine Laboratory, Shengjing Hospital of China Medical University, Shenyang, China; Innovative Cancer Drug Research and Development Engineering Center of Liaoning Province, Shenyang, ChinaBackground: Emerging data have supported the immunostimulatory role of radiotherapy, which could exert a synergistic effect with immune checkpoint inhibitors (ICIs). With proven effective but suboptimal effect of ICI and chemotherapy in triple-negative breast cancer (TNBC), we designed a pilot study to explore the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) plus adebrelimab and chemotherapy in TNBC patients. Methods: Treatment-naïve TNBC patients received two cycles of intravenous adebrelimab (20 mg/kg, every 3 weeks), and SBRT (24 Gy/3 f, every other day) started at the second cycle, then followed by six cycles of adebrelimab plus nab-paclitaxel (125 mg/m² on days 1 and 8) and carboplatin (area under the curve 6 mg/mL per min on day 1) every 3 weeks. The surgery was performed within 3–5 weeks after the end of neoadjuvant therapy. Primary endpoint was pathological complete response (pCR, ypT0/is ypN0). Secondary endpoints included objective response rate (ORR), residual cancer burden (RCB) 0-I, and safety. Results: 13 patients were enrolled and received at least one dose of therapy. 10 (76.9%) patients completed SBRT and were included in efficacy analysis. 90% (9/10) of patients achieved pCR, both RCB 0-I and ORR reached 100% with three patients achieved complete remission. Adverse events (AEs) of all-grade and grade 3–4 occurred in 92.3% and 53.8%, respectively. One (7.7%) patient had treatment-related serious AEs. No radiation-related dermatitis or death occurred. Conclusions: Adding SBRT to adebrelimab and neoadjuvant chemotherapy led to a substantial proportion of pCR with acceptable toxicities, supporting further exploration of this combination in TNBC patients. Funding: None. Clinical trial number: NCT05132790.https://elifesciences.org/articles/91737breast cancerimmunotherapyradiotherapyneoadjuvant treatment |
| spellingShingle | Guanglei Chen Xi Gu Jinqi Xue Xu Zhang Xiaopeng Yu Yu Zhang Ailin Li Yi Zhao Guijin He Meiyue Tang Fei Xing Jianqiao Yin Xiaobo Bian Ye Han Shuo Cao Chao Liu Xiaofan Jiang Keliang Zhang Yan Xia Huajun Li Nan Niu Caigang Liu On behalf of the Northeastern Clinical Research Alliance of Oncology (NCRAO) Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study eLife breast cancer immunotherapy radiotherapy neoadjuvant treatment |
| title | Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study |
| title_full | Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study |
| title_fullStr | Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study |
| title_full_unstemmed | Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study |
| title_short | Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study |
| title_sort | effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple negative breast cancer a pilot study |
| topic | breast cancer immunotherapy radiotherapy neoadjuvant treatment |
| url | https://elifesciences.org/articles/91737 |
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