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001-es BibID:BIBFORM120842
035-os BibID:(Scopus)85121124267 (WOS)000819873600002
Első szerző:Ledermann, Jonathan A.
Cím:Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab : results from a double-blind, placebo-controlled, randomized, phase II study / J. A. Ledermann, B. Zurawski, F. Raspagliesi, U. De Giorgi, J. Arranz Arija, M. Romeo Marin, A. Lisyanskaya, R. L. Póka, J. Markowska, C. Cebotaru, A. Casado Herraez, N. Colombo, E. Kutarska, M. Hall, A. Jacobs, I. Ahrens-Fath, H. Baumeister, A. Zurlo, J. Sehouli
Dátum:2022
ISSN:2059-7029
Megjegyzések:Background: Gatipotuzumab is a humanized monoclonal antibody recognizing the carbohydrate-induced epitope of the tumor-associated mucin-1 (TA-MUC1). This study aimed to evaluate the efficacy and safety of switch maintenance therapy with gatipotuzumab in patients with TA-MUC1-positive recurrent ovarian, fallopian tube, or primary high-grade serous peritoneal cancer. Patients and methods: In this double-blind, randomized, placebo-controlled, phase II trial, patients with at least stable disease (SD) following chemotherapy were randomized 2:1 to receive intravenous gatipotuzumab (500 mg followed by 1700 mg 1 week later) or placebo every 3 weeks until tumor progression or unacceptable toxicity occurred. Stratification factors were the number of prior chemotherapy lines (2 versus 3-5), response versus SD after the most recent chemotherapy, and progression-free survival (PFS) <6 versus 6-12 months following the prior therapy. Primary endpoint was PFS according to modified immune-related RECIST 1.1 response criteria. Secondary endpoints were PFS at 6 months, safety, overall response rate, CA-125 progression, overall survival, quality of life, and pharmacokinetics. Results: Overall, 216 patients were randomized to gatipotuzumab (n = 151) or placebo (n = 65). Median PFS with gatipotuzumab was 3.5 months as compared with 3.5 months with placebo (hazard ratio 0.96, 95% confidence interval 0.69-1.33, P = 0.80). No advantage for gatipotuzumab over placebo was seen in the secondary efficacy endpoints or in any stratified subgroups. Gatipotuzumab was well tolerated, with mild to moderate infusion-related reactions being the most common adverse events. Conclusions: Gatipotuzumab switch maintenance therapy does not improve outcome in TA-MUC1-positive ovarian cancer patients.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
ADCC
gatipotuzumab
ovarian cancer
palliative care
TA-MUC 1
Megjelenés:ESMO Open. - 7 : 1 (2022), p. 1-8. -
További szerzők:Zurawski, B. Raspagliesi, Francesco De Giorgi, U. Arranz Arija, J. Romeo Marin, M. Lisyanskaya, A. Póka Róbert (1960-) (szülész-nőgyógyász, klinikai onkológus) Markowska, J. Cebotaru, C. Casado Herraez, A. Colombo, N. Kutarska, E. Hall, M. Jacobs, A. Ahrens-Fath, I. Baumeister, H. Zurlo, A. Sehouli, Jalid
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001-es BibID:BIBFORM072577
Első szerző:Ledermann, J.
Cím:A double-blind, placebo-controlled, randomized, phase 2 study to evaluate the efficacy and safety of switch maintenance therapy with the anti-TA-MUC1 antibody PankoMab-GEX after chemotherapy in patients with recurrent epithelial ovarian carcinoma / J. Ledermann, J. Sehouli, B. Zurawski, F. Raspagliesi, U. De Giorgi, S. Banerjee, J. Arranz Arija, M. Romeo Marin, A. Lisyanskaya, R. L. Póka, S. Mihutiu, J. Markowska, C. Cebotaru, A. Casado Herraez, N. Colombo, N. Kovalenko, E. Kutarska, M. Hall, R. Belli, A. Zurlo
Dátum:2017
ISSN:0923-7534 1569-8041
Tárgyszavak:Orvostudományok Klinikai orvostudományok poszter
Chemotherapy
ovarian carcinoma
Megjelenés:Annals of Oncology 28 : Suppl. 5 (2017), p. 626. -
További szerzők:Sehouli, Jalid Zurawski, B. Raspagliesi, Francesco De Giorgi, U. Banerjee, Srijib Arranz Arija, J. Romeo Marin, M. Lisyanskaya, A. Póka Róbert (1960-) (szülész-nőgyógyász, klinikai onkológus) Mihutiu, S. Markowska, J. Cebotaru, C. Casado Herraez, A. Colombo, N. Kovalenko, N. Kutarska, E. Hall, M. Belli, R. Zurlo, A.
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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