Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer
Abstract Therapeutic anti-PD-L1 antibodies are safe as a monotherapy, albeit with minimal efficacy in triple-negative breast cancer (TNBC). This trial aimed to test the safety and efficacy of Durvalumab and Paclitaxel in metastatic TNBC. In this open-label, one-arm trial, five cycles of weekly pacli...
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| Format: | Article |
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Nature Portfolio
2021-09-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-021-98113-6 |
| _version_ | 1818742636751618048 |
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| author | Hazem Ghebeh Adher Al-Sayed Riham Eiada Leilani Cabangon Dahish Ajarim Kausar Suleman Asma Tulbah Taher Al-Tweigeri |
| author_facet | Hazem Ghebeh Adher Al-Sayed Riham Eiada Leilani Cabangon Dahish Ajarim Kausar Suleman Asma Tulbah Taher Al-Tweigeri |
| author_sort | Hazem Ghebeh |
| collection | DOAJ |
| description | Abstract Therapeutic anti-PD-L1 antibodies are safe as a monotherapy, albeit with minimal efficacy in triple-negative breast cancer (TNBC). This trial aimed to test the safety and efficacy of Durvalumab and Paclitaxel in metastatic TNBC. In this open-label, one-arm trial, five cycles of weekly paclitaxel were delivered intravenously (IV) concurrent with Durvalumab that was given IV every 2 weeks. The combination was preceded by one cycle of paclitaxel alone, for immunological priming, followed by Durvalumab solo until disease progression or unacceptable toxicity. Between 2017 and 2019, 14 patients received at least one cycle of the combination therapy. The therapy was safe with no-dose limiting toxicity, except one case of skin lesions. Adverse events (AEs) were reported in 71% of patients, and there was no death due to the combination therapy. Regardless of grade, the most common AEs were headache and peripheral neuropathy, as each happened in four patients (29%), followed by fatigue and skin rash in three patients (21%) each. Grade 3/4 AEs were experienced by three patients (21%), with the most common being headache and anemia, which happened in two patients (14%). The confirmed objective response rate (ORR) was observed in five patients with a median duration of 10.0 months. Median Progression-free survival (PFS) and overall survival (OS) were 5 and 20.7 months, respectively. The combination of Durvalumab and Paclitaxel is safe, leaving room for additional agents. This is the first report on the combination of Durvalumab and Paclitaxel in the treatment of TNBC (NCT02628132). |
| first_indexed | 2024-12-18T02:15:40Z |
| format | Article |
| id | doaj.art-4082da344ce44ce6b8b8a7859e11152b |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-18T02:15:40Z |
| publishDate | 2021-09-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-4082da344ce44ce6b8b8a7859e11152b2022-12-21T21:24:22ZengNature PortfolioScientific Reports2045-23222021-09-011111910.1038/s41598-021-98113-6Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancerHazem Ghebeh0Adher Al-Sayed1Riham Eiada2Leilani Cabangon3Dahish Ajarim4Kausar Suleman5Asma Tulbah6Taher Al-Tweigeri7Research Centre, King Faisal Specialist Hospital and Research CentreOncology Centre, King Faisal Specialist Hospital and Research CentreDepartment of Radiology, King Faisal Specialist Hospital and Research CentreOncology Centre, King Faisal Specialist Hospital and Research CentreOncology Centre, King Faisal Specialist Hospital and Research CentreOncology Centre, King Faisal Specialist Hospital and Research CentreDepartment of Pathology and Laboratory Medicine, King Faisal Specialist Hospital and Research CentreOncology Centre, King Faisal Specialist Hospital and Research CentreAbstract Therapeutic anti-PD-L1 antibodies are safe as a monotherapy, albeit with minimal efficacy in triple-negative breast cancer (TNBC). This trial aimed to test the safety and efficacy of Durvalumab and Paclitaxel in metastatic TNBC. In this open-label, one-arm trial, five cycles of weekly paclitaxel were delivered intravenously (IV) concurrent with Durvalumab that was given IV every 2 weeks. The combination was preceded by one cycle of paclitaxel alone, for immunological priming, followed by Durvalumab solo until disease progression or unacceptable toxicity. Between 2017 and 2019, 14 patients received at least one cycle of the combination therapy. The therapy was safe with no-dose limiting toxicity, except one case of skin lesions. Adverse events (AEs) were reported in 71% of patients, and there was no death due to the combination therapy. Regardless of grade, the most common AEs were headache and peripheral neuropathy, as each happened in four patients (29%), followed by fatigue and skin rash in three patients (21%) each. Grade 3/4 AEs were experienced by three patients (21%), with the most common being headache and anemia, which happened in two patients (14%). The confirmed objective response rate (ORR) was observed in five patients with a median duration of 10.0 months. Median Progression-free survival (PFS) and overall survival (OS) were 5 and 20.7 months, respectively. The combination of Durvalumab and Paclitaxel is safe, leaving room for additional agents. This is the first report on the combination of Durvalumab and Paclitaxel in the treatment of TNBC (NCT02628132).https://doi.org/10.1038/s41598-021-98113-6 |
| spellingShingle | Hazem Ghebeh Adher Al-Sayed Riham Eiada Leilani Cabangon Dahish Ajarim Kausar Suleman Asma Tulbah Taher Al-Tweigeri Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer Scientific Reports |
| title | Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer |
| title_full | Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer |
| title_fullStr | Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer |
| title_full_unstemmed | Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer |
| title_short | Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer |
| title_sort | weekly paclitaxel given concurrently with durvalumab has a favorable safety profile in triple negative metastatic breast cancer |
| url | https://doi.org/10.1038/s41598-021-98113-6 |
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