BACKGROUND: Abagovomab is a murine anti-idiotypic antibody against the antigen CA-125 which has been shown to elicit humoral and cellular immune responses against ovarian cancer (oc). PATIENTS AND METHODS: This phase I trial included 36 patients with recurrent oc comparing two subcutaneous (s.c.) vaccination schedules: nine (group L) versus six injections (group S), 18 patients in each group. Four injections of 2.0 mg abagovomab were administered every 2 weeks and then two or five additional doses monthly. Primary endpoint was drop-out rate due to toxicity, and the secondary endpoint was analysis of immunological response. RESULTS: Treatment was completed in eight (44%) and 16 (89%) patients in groups L and S, respectively. Premature termination occurred due to patient withdrawal or disease progression. No treatment-limiting toxicities occurred in either group. The most common toxicity related to the vaccine was grade 1/2 local injection site reaction. Induction of Ab3 was observed in all evaluable patients. There were no differences between the groups with regard to induction of human anti-mouse antibody (P = 0.1006). IFNgamma-expressing CA125-specific CD8+ T-cells were significantly more frequent in group L, while there was no significant difference between CD4+ T-cells in the two groups. CONCLUSIONS: Abagovomab s.c. vaccination is safe and well tolerated. The long vaccination schedule tended to be more effective with regard to AB3-induction and cellular cytotoxicity.
BACKGROUND:Abagovomab is a murine anti-idiotypic antibody against the antigen CA-125 which has been shown to elicit humoral and cellular immune responses against ovarian cancer (oc). PATIENTS AND METHODS: This phase I trial included 36 patients with recurrent oc comparing two subcutaneous (s.c.) vaccination schedules: nine (group L) versus six injections (group S), 18 patients in each group. Four injections of 2.0 mg abagovomab were administered every 2 weeks and then two or five additional doses monthly. Primary endpoint was drop-out rate due to toxicity, and the secondary endpoint was analysis of immunological response. RESULTS: Treatment was completed in eight (44%) and 16 (89%) patients in groups L and S, respectively. Premature termination occurred due to patientwithdrawal or disease progression. No treatment-limiting toxicities occurred in either group. The most common toxicity related to the vaccine was grade 1/2 local injection site reaction. Induction of Ab3 was observed in all evaluable patients. There were no differences between the groups with regard to induction of human anti-mouse antibody (P = 0.1006). IFNgamma-expressing CA125-specific CD8+ T-cells were significantly more frequent in group L, while there was no significant difference between CD4+ T-cells in the two groups. CONCLUSIONS:Abagovomab s.c. vaccination is safe and well tolerated. The long vaccination schedule tended to be more effective with regard to AB3-induction and cellular cytotoxicity.
Authors: Ajay P Singh; Shantibhusan Senapati; Moorthy P Ponnusamy; Maneesh Jain; Subodh M Lele; John S Davis; Steven Remmenga; Surinder K Batra Journal: Lancet Oncol Date: 2008-11 Impact factor: 41.316
Authors: Jennifer Aa Gubbels; Nick Claussen; Arvinder K Kapur; Joseph P Connor; Manish S Patankar Journal: J Ovarian Res Date: 2010-03-29 Impact factor: 4.234
Authors: Paul Sabbatini; Philipp Harter; Giovanni Scambia; Jalid Sehouli; Werner Meier; Pauline Wimberger; Klaus H Baumann; Christian Kurzeder; Barbara Schmalfeldt; David Cibula; Mariusz Bidzinski; Antonio Casado; Andrea Martoni; Nicoletta Colombo; Robert W Holloway; Luigi Selvaggi; Andrew Li; Jose del Campo; Karel Cwiertka; Tamas Pinter; Jan B Vermorken; Eric Pujade-Lauraine; Simona Scartoni; Monica Bertolotti; Cecilia Simonelli; Angela Capriati; Carlo Alberto Maggi; Jonathan S Berek; Jacobus Pfisterer Journal: J Clin Oncol Date: 2013-03-11 Impact factor: 44.544