SemOpenAlex |

SemOpenAlex

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3155156689> ?p ?o ?g. }

Showing items 1 to 100 of ±200 with 100 items per page.

W3155156689 endingPage "619" @default.
W3155156689 startingPage "609" @default.
W3155156689 abstract "Background Few effective second-line treatments exist for women with recurrent or metastatic cervical cancer. Accordingly, we aimed to evaluate the efficacy and safety of tisotumab vedotin, a tissue factor-directed antibody–drug conjugate, in this patient population. Methods This multicentre, open-label, single-arm, phase 2 study was done across 35 academic centres, hospitals, and community practices in Europe and the USA. The study included patients aged 18 years or older who had recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer; disease progression on or after doublet chemotherapy with bevacizumab (if eligible by local standards); who had received two or fewer previous systemic regimens for recurrent or metastatic disease; had measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1); and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 2·0 mg/kg (up to a maximum of 200 mg) tisotumab vedotin intravenously once every 3 weeks until disease progression (determined by the independent review committee) or unacceptable toxicity. The primary endpoint was confirmed objective response rate based on RECIST (version 1.1), as assessed by the independent review committee. Activity and safety analyses were done in patients who received at least one dose of the drug. This study is ongoing with recruitment completed and is registered with ClinicalTrials.gov, NCT03438396. Findings 102 patients were enrolled between June 12, 2018, and April 11, 2019; 101 patients received at least one dose of tisotumab vedotin. Median follow-up at the time of analysis was 10·0 months (IQR 6·1–13·0). The confirmed objective response rate was 24% (95% CI 16–33), with seven (7%) complete responses and 17 (17%) partial responses. The most common treatment-related adverse events included alopecia (38 [38%] of 101 patients), epistaxis (30 [30%]), nausea (27 [27%]), conjunctivitis (26 [26%]), fatigue (26 [26%]), and dry eye (23 [23%]). Grade 3 or worse treatment-related adverse events were reported in 28 (28%) patients and included neutropenia (three [3%] patients), fatigue (two [2%]), ulcerative keratitis (two [2%]), and peripheral neuropathies (two [2%] each with sensory, motor, sensorimotor, and neuropathy peripheral). Serious treatment-related adverse events occurred in 13 (13%) patients, the most common of which included peripheral sensorimotor neuropathy (two [2%] patients) and pyrexia (two [2%]). One death due to septic shock was considered by the investigator to be related to therapy. Three deaths unrelated to treatment were reported, including one case of ileus and two unknown causes. Interpretation Tisotumab vedotin showed clinically meaningful and durable antitumour activity with a manageable and tolerable safety profile in women with previously treated recurrent or metastatic cervical cancer. Given the poor prognosis for this patient population and the low activity of current therapies in this setting, tisotumab vedotin, if approved, would represent a new treatment for women with recurrent or metastatic cervical cancer. Funding Genmab, Seagen, Gynaecologic Oncology Group, and European Network of Gynaecological Oncological Trial Groups. Few effective second-line treatments exist for women with recurrent or metastatic cervical cancer. Accordingly, we aimed to evaluate the efficacy and safety of tisotumab vedotin, a tissue factor-directed antibody–drug conjugate, in this patient population. This multicentre, open-label, single-arm, phase 2 study was done across 35 academic centres, hospitals, and community practices in Europe and the USA. The study included patients aged 18 years or older who had recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer; disease progression on or after doublet chemotherapy with bevacizumab (if eligible by local standards); who had received two or fewer previous systemic regimens for recurrent or metastatic disease; had measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1); and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received 2·0 mg/kg (up to a maximum of 200 mg) tisotumab vedotin intravenously once every 3 weeks until disease progression (determined by the independent review committee) or unacceptable toxicity. The primary endpoint was confirmed objective response rate based on RECIST (version 1.1), as assessed by the independent review committee. Activity and safety analyses were done in patients who received at least one dose of the drug. This study is ongoing with recruitment completed and is registered with ClinicalTrials.gov, NCT03438396. 102 patients were enrolled between June 12, 2018, and April 11, 2019; 101 patients received at least one dose of tisotumab vedotin. Median follow-up at the time of analysis was 10·0 months (IQR 6·1–13·0). The confirmed objective response rate was 24% (95% CI 16–33), with seven (7%) complete responses and 17 (17%) partial responses. The most common treatment-related adverse events included alopecia (38 [38%] of 101 patients), epistaxis (30 [30%]), nausea (27 [27%]), conjunctivitis (26 [26%]), fatigue (26 [26%]), and dry eye (23 [23%]). Grade 3 or worse treatment-related adverse events were reported in 28 (28%) patients and included neutropenia (three [3%] patients), fatigue (two [2%]), ulcerative keratitis (two [2%]), and peripheral neuropathies (two [2%] each with sensory, motor, sensorimotor, and neuropathy peripheral). Serious treatment-related adverse events occurred in 13 (13%) patients, the most common of which included peripheral sensorimotor neuropathy (two [2%] patients) and pyrexia (two [2%]). One death due to septic shock was considered by the investigator to be related to therapy. Three deaths unrelated to treatment were reported, including one case of ileus and two unknown causes. Tisotumab vedotin showed clinically meaningful and durable antitumour activity with a manageable and tolerable safety profile in women with previously treated recurrent or metastatic cervical cancer. Given the poor prognosis for this patient population and the low activity of current therapies in this setting, tisotumab vedotin, if approved, would represent a new treatment for women with recurrent or metastatic cervical cancer." @default.
W3155156689 created "2021-04-26" @default.
W3155156689 creator A5000568505 @default.
W3155156689 creator A5003174489 @default.
W3155156689 creator A5003944586 @default.
W3155156689 creator A5006402876 @default.
W3155156689 creator A5007536723 @default.
W3155156689 creator A5007606531 @default.
W3155156689 creator A5008683883 @default.
W3155156689 creator A5009234043 @default.
W3155156689 creator A5009459069 @default.
W3155156689 creator A5009523282 @default.
W3155156689 creator A5013681510 @default.
W3155156689 creator A5014369144 @default.
W3155156689 creator A5014611244 @default.
W3155156689 creator A5015188639 @default.
W3155156689 creator A5018118709 @default.
W3155156689 creator A5018343544 @default.
W3155156689 creator A5019340479 @default.
W3155156689 creator A5020292607 @default.
W3155156689 creator A5021105630 @default.
W3155156689 creator A5021359849 @default.
W3155156689 creator A5022867463 @default.
W3155156689 creator A5023977098 @default.
W3155156689 creator A5024519202 @default.
W3155156689 creator A5025519748 @default.
W3155156689 creator A5026048739 @default.
W3155156689 creator A5027894385 @default.
W3155156689 creator A5028034211 @default.
W3155156689 creator A5029323312 @default.
W3155156689 creator A5031590505 @default.
W3155156689 creator A5031700821 @default.
W3155156689 creator A5032446221 @default.
W3155156689 creator A5034429208 @default.
W3155156689 creator A5038827419 @default.
W3155156689 creator A5041403788 @default.
W3155156689 creator A5042084238 @default.
W3155156689 creator A5054390362 @default.
W3155156689 creator A5056412323 @default.
W3155156689 creator A5058535647 @default.
W3155156689 creator A5061939825 @default.
W3155156689 creator A5069415804 @default.
W3155156689 creator A5070209020 @default.
W3155156689 creator A5071060598 @default.
W3155156689 creator A5071242826 @default.
W3155156689 creator A5071527937 @default.
W3155156689 creator A5073232598 @default.
W3155156689 creator A5077728628 @default.
W3155156689 creator A5078233816 @default.
W3155156689 creator A5078567055 @default.
W3155156689 creator A5079485962 @default.
W3155156689 creator A5080866057 @default.
W3155156689 creator A5081736939 @default.
W3155156689 creator A5083348008 @default.
W3155156689 creator A5083659627 @default.
W3155156689 date "2021-05-01" @default.
W3155156689 modified "2023-10-17" @default.
W3155156689 title "Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study" @default.
W3155156689 cites W1972332254 @default.
W3155156689 cites W2006287686 @default.
W3155156689 cites W2011887157 @default.
W3155156689 cites W2012980582 @default.
W3155156689 cites W2017283588 @default.
W3155156689 cites W2019607817 @default.
W3155156689 cites W2027938725 @default.
W3155156689 cites W2030611514 @default.
W3155156689 cites W2070622518 @default.
W3155156689 cites W2097914739 @default.
W3155156689 cites W2100694656 @default.
W3155156689 cites W2100756525 @default.
W3155156689 cites W2118508302 @default.
W3155156689 cites W2126768246 @default.
W3155156689 cites W2126834211 @default.
W3155156689 cites W2138550445 @default.
W3155156689 cites W2170574224 @default.
W3155156689 cites W2170825221 @default.
W3155156689 cites W2171725862 @default.
W3155156689 cites W2553088533 @default.
W3155156689 cites W2623658063 @default.
W3155156689 cites W2889646458 @default.
W3155156689 cites W2914068327 @default.
W3155156689 cites W2925815206 @default.
W3155156689 cites W2954313815 @default.
W3155156689 cites W2962985284 @default.
W3155156689 cites W2967526516 @default.
W3155156689 cites W2994242812 @default.
W3155156689 cites W3032571309 @default.
W3155156689 cites W3033281359 @default.
W3155156689 doi "https://doi.org/10.1016/s1470-2045(21)00056-5" @default.
W3155156689 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/33845034" @default.
W3155156689 hasPublicationYear "2021" @default.
W3155156689 type Work @default.
W3155156689 sameAs 3155156689 @default.
W3155156689 citedByCount "144" @default.
W3155156689 countsByYear W31551566892021 @default.
W3155156689 countsByYear W31551566892022 @default.
W3155156689 countsByYear W31551566892023 @default.
W3155156689 crossrefType "journal-article" @default.