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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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