Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer
(2024) In New England Journal of Medicine 391(1). p.44-55- Abstract
BACKGROUND Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS A total of 502 patients underwent randomization (253 were assigned to the tisotumab... (More)
BACKGROUND Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; twosided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. CONCLUSIONS In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy.
(Less)
- author
- author collaboration
- organization
- publishing date
- 2024-07
- type
- Contribution to journal
- publication status
- published
- subject
- in
- New England Journal of Medicine
- volume
- 391
- issue
- 1
- pages
- 12 pages
- publisher
- Massachusetts Medical Society
- external identifiers
-
- scopus:85197777875
- ISSN
- 0028-4793
- DOI
- 10.1056/NEJMoa2313811
- language
- English
- LU publication?
- yes
- id
- f6b1ef0b-2d7a-49eb-a30b-03f8fff11fe2
- date added to LUP
- 2024-09-13 14:59:30
- date last changed
- 2024-09-13 14:59:30
@article{f6b1ef0b-2d7a-49eb-a30b-03f8fff11fe2,
abstract = {{<p>BACKGROUND Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; twosided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. CONCLUSIONS In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy.</p>}},
author = {{Vergote, Ignace and Gonzalez-Martin, Antonio and Fujiwara, Keiichi and Kalbacher, Elsa and Bagameri, Andrea and Ghamande, Sharad and Lee, Jung Yun and Banerjee, Susana and Maluf, Fernando Cotait and Lorusso, Domenica and Yonemori, Kan and Van Nieuwenhuysen, Els and Manso, Luis and Woelber, Linn and Westermann, Anneke and Covens, Allan and Hasegawa, Kosei and Kim, Byoung Gie and Raimondo, Miriam and Bjurberg, Maria and Cruz, Felipe Melo and Angelergues, Antoine and Cibula, David and Barraclough, Lisa and Oaknin, Ana and Gennigens, Christine and Nicacio, Leo and Teng, Melinda Siew Leng and Whalley, Elizabeth and Soumaoro, Ibrahima and Slomovitz, Brian M.}},
issn = {{0028-4793}},
language = {{eng}},
number = {{1}},
pages = {{44--55}},
publisher = {{Massachusetts Medical Society}},
series = {{New England Journal of Medicine}},
title = {{Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer}},
url = {{http://dx.doi.org/10.1056/NEJMoa2313811}},
doi = {{10.1056/NEJMoa2313811}},
volume = {{391}},
year = {{2024}},
}