Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study

TY - JOUR

T1 - Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study

AU - Sabbatini, Paul

AU - Harter, Philipp

AU - Scambia, Giovanni

AU - Sehouli, Jalid

AU - Meier, Werner

AU - Wimberger, Pauline

AU - Baumann, Klaus H

AU - Kurzeder, Christian

AU - Schmalfeldt, Barbara

AU - Cibula, David

AU - Bidzinski, Mariusz

AU - Casado, Antonio

AU - Martoni, Andrea

AU - Colombo, Nicoletta

AU - Holloway, Robert W

AU - Selvaggi, Luigi

AU - Li, Andrew

AU - del Campo, Jose

AU - Cwiertka, Karel

AU - Pinter, Tamas

AU - Vermorken, Jan B

AU - Pujade-Lauraine, Eric

AU - Scartoni, Simona

AU - Bertolotti, Monica

AU - Simonelli, Cecilia

AU - Capriati, Angela

AU - Maggi, Carlo Alberto

AU - Berek, Jonathan S

AU - Pfisterer, Jacobus

PY - 2013/4/20

Y1 - 2013/4/20

N2 - PURPOSE: To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission.PATIENTS AND METHODS: Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response.RESULTS: Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, ≤ 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 ≤ 35 U/mL after third cycle, 80.9%. Mean exposure to study treatment (± standard deviation) was 449.7 ± 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization (≤ 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization (≤ 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.CONCLUSION: Abagovomab administered as repeated monthly injections is safe and induces a measurable immune response. Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS.

AB - PURPOSE: To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission.PATIENTS AND METHODS: Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response.RESULTS: Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, ≤ 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 ≤ 35 U/mL after third cycle, 80.9%. Mean exposure to study treatment (± standard deviation) was 449.7 ± 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization (≤ 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization (≤ 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.CONCLUSION: Abagovomab administered as repeated monthly injections is safe and induces a measurable immune response. Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS.

KW - Adenocarcinoma, Mucinous

KW - Antibodies, Monoclonal

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Cystadenocarcinoma, Serous

KW - Double-Blind Method

KW - Endometrial Neoplasms

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Middle Aged

KW - Neoplasm Staging

KW - Neoplasms, Glandular and Epithelial

KW - Ovarian Neoplasms

KW - Prognosis

KW - Survival Rate

U2 - 10.1200/JCO.2012.46.4057

DO - 10.1200/JCO.2012.46.4057

M3 - SCORING: Journal article

C2 - 23478059

VL - 31

SP - 1554

EP - 1561

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 12

ER -