1. A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma
- Author
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Venâncio Avancini Ferreira Alves, Roberto Blasbalg, Ronaldo L. Costa, Oren Smaletz, Geraldo Felício Cunha-Junior, Alberto Julius Wainstein, Eric W. Hoffman, Ana Maria Moro, Fernanda Perez Yeda, Claudio Calazan do Carmo, Vivian Madrigal, Sergio J Azevedo, Fernando Cotait Maluf, Andrew M. Scott, Maria Del Pilar Estevez Diz, Carlos H. Barrios, Ana Gabriela M. Fontana, and Jorge Sabbaga
- Subjects
Adult ,medicine.medical_specialty ,Organoplatinum Compounds ,Nausea ,Carcinoma, Ovarian Epithelial ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Disease-Free Survival ,Young Adult ,Primary peritoneal carcinoma ,Lewis Blood Group Antigens ,Refractory ,Monoclonal Antibody Hu3S193 ,Internal medicine ,Ascites ,medicine ,Fallopian Tube Neoplasms ,Humans ,Neoplasms, Glandular and Epithelial ,Stage (cooking) ,Adverse effect ,Peritoneal Neoplasms ,Aged ,Ovarian Neoplasms ,business.industry ,Obstetrics and Gynecology ,Middle Aged ,medicine.disease ,Surgery ,medicine.anatomical_structure ,Oncology ,Drug Resistance, Neoplasm ,Female ,medicine.symptom ,business ,Fallopian tube - Abstract
Objectives The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. Methods This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20 mg/m2 intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). Results 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24 + weeks [clinical benefit rate 23% (95% CI = 9.77%–46.71%)]. Median PFS was 8.4 weeks (95% CI = 6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p = 0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). Conclusions Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested.
- Published
- 2015