Evidence map›Paper›PMID 33513474›Full record

ArticleOral oncology2021

A phase I trial adding poly(ADP-ribose) polymerase inhibitor veliparib to induction carboplatin-paclitaxel in patients with head and neck squamous cell carcinoma: Alliance A091101.

Michael J Jelinek, Nathan R Foster, Alex J Zoroufy, Gary K Schwartz, Pamela N Munster, Tanguy Y Seiwert, Jonas A de Souza, Everett E Vokes

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Oral oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-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

12 citing papers in PubMed, 20 citations in OpenAlex.

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  6. Precision Medicine forCancers · 2022
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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

8 authors at 5 institutions in 1 country.

Michael J JelinekDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Medicine, Division of Hematology, Oncology, and Cell Therapy, Rush University Medical Center, Chicago, IL, USA(1). Electronic address: Michael_Jelinek@rush.edu.
Nathan R FosterAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Alex J ZoroufyAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Gary K SchwartzDepartment of Medicine, Division of Hematology/Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
Pamela N MunsterDepartment of Medicine, Section of Hematology/Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, UCSF Medical Center-Mount Zion, San Francisco, CA, USA.
Tanguy Y SeiwertDepartment of Medicine, Section of Hematology/Oncology, The University of Chicago Comprehensive Cancer Center, Chicago, IL, USA.
Jonas A de SouzaDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA.
Everett E VokesDepartment of Medicine, Section of Hematology/Oncology, The University of Chicago Comprehensive Cancer Center, Chicago, IL, USA.
University of Chicago · USMayo Clinic · USColumbia University Irving Medical Center · USRush University Medical Center · USUniversity of California San Francisco Medical Center · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Winship National Clinical Trials Network Lead Academic Participating SiteUG1CA233247 · NCI · EMORY UNIVERSITY · PI Ashesh Jani, NABIL F SABA · 2019 to 2026
$6.0M
UG1 - NCTN (Network Lead)UG1CA233327 · NCI · UNIVERSITY OF CHICAGO · PI STEVEN J CHMURA, HEDY L KINDLER · 2019 to 2026
$4.4M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA233247NCI NIH HHS UG1 CA233327NCI NIH HHS UG1 CA233339NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

objectivesWe report the results of this phase I study to evaluate the maximum tolerated dose (MTD) and safety of veliparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, combined with carboplatin and paclitaxel induction chemotherapy (IC) for locoregionally advanced head and neck squamous cell carcinoma (HNSCC). MATERIALS AND

methodsIn a 3 + 3 cohort design, patients with stage IVA-B human papillomavirus-negative HNSCC received 2 cycles of carboplatin (AUC 6, day 1), paclitaxel (100 mg/m

resultsTwenty patients enrolled. Two withdrew before treatment; 18 patients were analyzed. Median age was 63 years. Primary disease sites included hypopharynx (n = 5), larynx (n = 5), oral cavity (n = 4), oropharynx (n = 3), and nasal cavity (n = 1). Through all of IC, the most common grade 3 + adverse events (AEs) were neutropenia (33%), thrombocytopenia (33%), anemia (11%), and white blood cell decrease (11%). One patient experienced a hematologic DLT at 350 mg BID. The RP2D for veliparib combined with carboplatin/paclitaxel is 350 mg BID. With 40.9 month median follow-up across dose levels for all patients, the 24-month overall and progression free survival was 77.8% (95% CI 60.8-99.6%) and 66.7% (95% CI 48.1-92.4%), respectively. Medians have not been reached.

conclusionAddition of veliparib to carboplatin and paclitaxel IC was well tolerated in patients with advanced HNSCC. Hematologic toxicities were the most common AEs.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarboplatinFemaleHumansMaleMiddle AgedPaclitaxelPoly(ADP-ribose) Polymerase InhibitorsSquamous Cell Carcinoma of Head and NeckYoung AdultBenzimidazolesCarboplatinPaclitaxelPoly(ADP-ribose) Polymerase InhibitorsveliparibHead and neck squamous cell carcinomaInduction therapyPARP inhibitionVeliparib

Identifiers

PMID33513474
PMCPMC7933088
OpenAlexW3121908754

What OpenQuestion holds

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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.