Evidence map›Paper›PMID 23478059›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

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.

Paul Sabbatini, Philipp Harter, Giovanni Scambia, Jalid Sehouli, Werner Meier, Pauline Wimberger, Klaus H Baumann, Christian Kurzeder, Barbara Schmalfeldt, David Cibula and 19 more

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 6 pooled it
20.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 6 syntheses or guidelines pooled it, 143 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
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  5. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
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  7. Trial
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  18. Targeted therapy for mucinous ovarian carcinoma: evidence from clinical trials.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Review
  19. Review
  20. Review

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 1 institution in 1 country.

Paul SabbatiniKliniken Essen-Mitte, Germany. sabbatip@mskcc.org
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
Memorial Sloan Kettering Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeTo determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission. PATIENTS AND

methodsPatients 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.

resultsCharacteristics 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.

conclusionAbagovomab 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.

Indexed as

Adenocarcinoma, MucinousAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCystadenocarcinoma, SerousDouble-Blind MethodEndometrial NeoplasmsFemaleFollow-Up StudiesHumansMiddle AgedNeoplasms, Glandular and EpithelialNeoplasm StagingOvarian NeoplasmsPrognosisabagovomabAntibodies, MonoclonalAntibodies, Monoclonal, Murine-Derived

Identifiers

PMID23478059
PMCPMC5795662
OpenAlexW2152242889

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.