Evidence map›Paper›PMID 28109627›Full record

ArticleGynecologic oncology2017

A final report of a phase I study of veliparib (ABT-888) in combination with low-dose fractionated whole abdominal radiation therapy (LDFWAR) in patients with advanced solid malignancies and peritoneal carcinomatosis with a dose escalation in ovarian and fallopian tube cancers.

Kim A Reiss, Joseph M Herman, Deborah Armstrong, Marianna Zahurak, Anthony Fyles, Anthony Brade, Michael Milosevic, Laura A Dawson, Angela Scardina, Patricia Fischer and 9 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Gynecologic oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
3.2field-weighted citation impact, top 7% 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

28 citing papers in PubMed, 52 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Article
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

19 authors at 7 institutions in 2 countries.

Kim A ReissSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Medical Oncology, United States.
Joseph M HermanSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Radiation Oncology, United States.
Deborah ArmstrongSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Medical Oncology, United States.
Marianna ZahurakSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Statistics, United States.
Anthony FylesPrincess Margaret Cancer Centre/University Health Network, Department of Radiation Oncology, University of Toronto, Canada.
Anthony BradePrincess Margaret Cancer Centre/University Health Network, Department of Radiation Oncology, University of Toronto, Canada.
Michael MilosevicPrincess Margaret Cancer Centre/University Health Network, Department of Radiation Oncology, University of Toronto, Canada.
Laura A DawsonPrincess Margaret Cancer Centre/University Health Network, Department of Radiation Oncology, University of Toronto, Canada.
Angela ScardinaSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Medical Oncology, United States.
Patricia FischerSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Medical Oncology, United States.
Amy Hacker-PrietzSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Radiation Oncology, United States.
Robert J KindersNational Cancer Institute, Office of the Director, United States.
Lihua WangNational Cancer Institute, Office of the Director, United States.
Alice ChenNational Cancer Institute, Cancer Therapy Evaluation Program, United States.
Sarah TemkinThe University of Maryland School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.
Naomi HoribaThe University of Maryland School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, United States.
Lee-Anne StaynerPrincess Margaret Cancer Centre/University Health Network, Department of Medical Oncology and Hematology, University of Toronto, Canada.
Lillian L SiuPrincess Margaret Cancer Centre/University Health Network, Department of Medical Oncology and Hematology, University of Toronto, Canada.
Nilofer S AzadSidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Department of Medical Oncology, United States. Electronic address: nazad2@jhmi.edu.
Sidney Kimmel Comprehensive Cancer Center · USJohns Hopkins Hospital · USPrincess Margaret Cancer Centre · CAUniversity of Toronto · CAOffice of the Director · USUniversity of Maryland, Baltimore · USNational Cancer Institute · US

Funding

The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
Wisconsin and New Jersey Alliance in Precision Experimental TherapeuticsUM1CA186716 · NCI · RBHS -CANCER INSTITUTE OF NEW JERSEY · PI JABBOUR, SALMA, LIU, GLENN · 2014 to 2019
$4.1M
Princess Margaret Hospital Phase I ConsortiumU01CA132123 · NCI · UNIVERSITY HEALTH NETWORK · PI SIU, LILLIAN L · 2008 to 2013
$3.8M
NCI NIH HHS U01 CA070095NCI NIH HHS U01 CA132123NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186716
6 · The paper itself

Abstract

backgroundThe combination of low-dose radiation therapy with PARP inhibition enhances anti-tumor efficacy through potentiating DNA damage. We combined low-dose fractionated whole abdominal radiation (LDFWAR) with ABT-888 in patients with peritoneal carcinomatosis with a dose escalation in ovarian and fallopian cancer patients (OV).

methodsPatients were treated with veliparib, 40-400mg orally BID on days 1-21 of 3 28-day cycles on 6 dose levels. Dose levels 5 and 6 included only OV patients. LDFWAR consisted of 21.6Gy in 36 fractions, 0.6Gy twice daily on days 1 and 5 for weeks 1-3 of each cycle. Circulating tumor material and quality of life were serially assessed.

results32pts were treated. Median follow-up was 45months (10-50). The most common treatment-related grade 3 and 4 toxicities were lymphopenia (59%), anemia (9%), thrombocytopenia (12%), neutropenia (6%), leukopenia (6%), nausea (6%), diarrhea (6%), anorexia (6%), vomiting (6%) and fatigue (6%). The maximum tolerated dose was determined to be 250mg PO BID. Median PFS was 3.6months and median OS was 9.1months. In OV patients, OS was longer for platinum-sensitive patients (10.9mo) compared to platinum-resistant patients (5.8mo). QoL decreased for all groups during treatment. Germline BRCA status was known for 14/18 patients with OV cancers, 5 of whom were BRCA mutation carriers. One objective response (3%) was observed.

conclusionABT-888 plus LDFWAR is tolerable with gastrointestinal symptoms, fatigue and myelosuppression as the most common toxicities. The single observed objective response was in a germline BRCA mutated, platinum-sensitive patient.

Indexed as

AgedBenzimidazolesChemoradiotherapyDose Fractionation, RadiationDose-Response Relationship, DrugFallopian Tube NeoplasmsFemaleHumansMiddle AgedOvarian NeoplasmsPeritoneal NeoplasmsPoly(ADP-ribose) Polymerase InhibitorsBenzimidazolesPoly(ADP-ribose) Polymerase InhibitorsveliparibBRCAOvarian cancerPARP inhibitionPeritoneal carcinomatosisRadiationVeliparib

Identifiers

PMID28109627
PMCPMC5330287
OpenAlexW2572611801

What OpenQuestion holds

Textmetadata
LicenceTDM
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.