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
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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. / Sabbatini, Paul; Harter, Philipp; Scambia, Giovanni; Sehouli, Jalid; Meier, Werner; Wimberger, Pauline; Baumann, Klaus H; Kurzeder, Christian; Schmalfeldt, Barbara; Cibula, David; Bidzinski, Mariusz; Casado, Antonio; Martoni, Andrea; Colombo, Nicoletta; Holloway, Robert W; Selvaggi, Luigi; Li, Andrew; del Campo, Jose; Cwiertka, Karel; Pinter, Tamas; Vermorken, Jan B; Pujade-Lauraine, Eric; Scartoni, Simona; Bertolotti, Monica; Simonelli, Cecilia; Capriati, Angela; Maggi, Carlo Alberto; Berek, Jonathan S; Pfisterer, Jacobus.
In: J CLIN ONCOL, Vol. 31, No. 12, 20.04.2013, p. 1554-61.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -