Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission

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dc.contributorLab. Biofármacospt_BR
dc.contributor.authorSmaletz, Orenpt_BR
dc.contributor.authorIsmael, Gustavopt_BR
dc.contributor.authorEstevez-Diz, Maria Del Pilarpt_BR
dc.contributor.authorNascimento, Ivana L Opt_BR
dc.contributor.authorMorais, Ana Luiza Gomes dept_BR
dc.contributor.authorCunha-Junior, Geraldo Felíciopt_BR
dc.contributor.authorAzevedo, Sergio Jpt_BR
dc.contributor.authorAlves, Venancio Apt_BR
dc.contributor.authorMoro, Ana Mariapt_BR
dc.contributor.authorYeda, Fernanda Perezpt_BR
dc.contributor.authorLopes dos Santos, Marianapt_BR
dc.contributor.authorMajumder, Indranipt_BR
dc.contributor.authorHoffman, Eric Wpt_BR
dc.identifier.citationSmaletz O, Ismael G, Estevez-Diz MDP, Nascimento ILO, Morais ALG, Cunha-Junior GF, et al. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi:10.1136/ijgc-2020-002239.pt_BR
dc.description.abstractObjective To investigate the efficacy and safety of hu3S193, a humanized anti-Lewis-Y monoclonal antibody, as a consolidation strategy in patients with platinum-sensitive recurrent epithelial ovarian cancer who achieved a second complete response after salvage platinum-doublet chemotherapy. Methods This single-arm phase II study accrued patients with recurrent epithelial ovarian cancer with Lewis-Y expression by immunohistochemistry who had achieved a second complete response after five to eight cycles of platinum-based chemotherapy. Patients received intravenous infusions of hu3S193, 30 mg/m2 every 2 weeks starting no more than 8 weeks after the last dose of chemotherapy and continuing for 12 doses, until disease progression, or unacceptable toxicity. The primary endpoint was progression-free survival of the second remission. Secondary objectives were safety and pharmacokinetics. Results Twenty-nine patients were enrolled. Most had a papillary/serous histology tumor (94%), stage III disease at diagnosis (75%), and five (17%) underwent secondary cytoreduction before salvage chemotherapy. Two patients were not eligible for efficacy but were considered for toxicity analysis. Eighteen patients (62%) completed the full consolidation treatment while nine patients progressed on treatment. At the time of analysis, 23 patients (85%) of the eligible population had progressed and seven of these patients (26%) had died. Median progression-free survival of the second remission was 12.1 months (95% CI: 10.6–13.9), with a 1-year progression-free survival of the second remission rate of 50.1%. The trial was terminated early since it was unlikely that the primary objective would be achieved. The most commonly reported treatment-related adverse events were nausea (55%) and vomiting (51%). Conclusions Hu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy.pt_BR
dc.description.sponsorshipRecepta Biopharmapt_BR
dc.relation.ispartofInternational Journal of Gynecological Cancerpt_BR
dc.rightsRestricted Accesspt_BR
dc.titlePhase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remissionpt_BR
dc.contributor.externalHospital Israelita Albert Einsteinpt_BR
dc.contributor.externalHospital Amaral Carvalhopt_BR
dc.contributor.externalUniversidade de São Paulo (USP)pt_BR
dc.contributor.externalNúcleo de Oncologia da Bahia (NOB)pt_BR
dc.contributor.externalHospital Erasto Gaertnerpt_BR
dc.contributor.externalHospital da Baleiapt_BR
dc.contributor.externalHospital de Clínicas de Porto Alegre (HCPA)pt_BR
dc.contributor.externalRecepta Biopharmapt_BR
dc.contributor.externalLudwig Cancer Researchpt_BR
dc.relation.ispartofabbreviatedInt J Gynecol Cancerpt_BR
dc.identifier.citationabntv. 31, n. 4, p. 562-568, abr. 2021pt_BR
dc.identifier.citationvancouver2021 Apr;31(4):562-568pt_BR
dc.contributor.butantanMoro, Ana Maria|:Pesquisadorpt_BR
dc.contributor.butantanYeda, Fernanda Perez|:Aluno|:Lab. Biofármacospt_BR
dc.contributor.butantanLopes dos Santos, Mariana|:Técnico|:Lab. Biofármacospt_BR
dc.sponsorship.butantanRecepta Biopharma¦¦pt_BR
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