Evidence map›Paper›PMID 33683482›Full record

Trial reportMedical oncology (Northwood, London, England)2021

nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2) for locally advanced head and neck squamous-cell carcinoma: a multicenter, non-randomized phase 2 trial.

Peter Oppelt, Jessica Ley, Mackenzie Daly, Jason Rich, Randal Paniello, Ryan S Jackson, Patrik Pipkorn, Jingxia Liu, Hiram Gay, Kevin Palka and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Medical oncology (Northwood, London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02573493 (Phase II Non-Randomized Three Arm Trial of Induction Chemotherapy With Nab-Paclitaxel and Cisplatin), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT02573493 phase2completednot on this map

Phase II Non-Randomized Three Arm Trial of Induction Chemotherapy With Nab-Paclitaxel and Cisplatin (AP: Arms 1 and 3) or Single Agent Nab-paclitaxel (A: Arm 2) as Induction Therapy Followed by Definitive Concurrent Chemoradiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC): "The APA Trial".

TypeinterventionalSponsorWashington University School of MedicineRan2016 to 2024Enrolled96ConditionsSquamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell of the Head and Neck, Cancer of Head and Neck, Cancer of the Head and NeckArmsnab-Paclitaxel, Cisplatin, Cetuximab, Intensity-Modulated Radiation Therapy
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

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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

17 authors at 3 institutions in 1 country.

Peter OppeltAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Jessica LeyDivision of Medical Oncology, Washington University School of Medicine, 660 South Euclid, Campus, Box 8056, St. Louis, MO, 63110, USA.
Mackenzie DalyAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Jason RichAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Randal PanielloAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Ryan S JacksonAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Patrik PipkornAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Jingxia LiuDivision of Public Health Sciences, Washington University School of Medicine, St. Louis, MO, USA.
Hiram GayAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Kevin PalkaAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Prakash NeupaneDivision of Oncology, University of Kansas School of Medicine, Kansas, MO, USA.
Steven PowellSanford Cancer Center, Sanford Health, Sioux Falls, SD, USA.
William C SpanosSanford Cancer Center, Sanford Health, Sioux Falls, SD, USA.
Mark GitauSanford Cancer Center, Sanford Health, Fargo, ND, USA.
Jose ZevallosAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Wade ThorstadAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.
Douglas AdkinsAlvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA. dadkins@wustl.edu.ORCID http://orcid.org/0000-0003-3207-8227
Washington University in St. Louis · USSanford Health · USUniversity of Kansas · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI TIMOTHY J. EBERLEIN · 2001 to 2026
$128.0M
NCI NIH HHS P30 CA091842NCI NIH HHS P30 CA91842
6 · The paper itself

Abstract

In locally advanced head and neck squamous-cell carcinoma (LA-HNSCC), clinical complete response (cCR) at the primary site, assessed by clinical examination, after induction chemotherapy predicts for a low relapse risk after subsequent chemoradiotherapy. Prior studies showed a cCR rate of 77% with induction nanoparticle albumin-bound (nab)-paclitaxel given with cisplatin and 5-fluorouracil (APF). The primary aims of this non-randomized phase 2 trial were to determine the cCR rate after induction nab-paclitaxel and cisplatin (Arm 1) and after nab-paclitaxel monotherapy (Arm 2). Eligibility required LA-HNSCC, T2-T4 stage classification, and suitable (Arm 1) or unsuitable (Arm 2) candidates for cisplatin. Arm 1 patients received nab-paclitaxel and cisplatin, then cisplatin with radiation. Arm 2 patients received nab-paclitaxel, then cetuximab with radiation. The primary endpoint was cCR after two cycles of induction chemotherapy. Each arm enrolled forty patients. cCR at the primary site occurred in 28 patients (70%) after nab-paclitaxel and cisplatin and in 8 patients (20%) after nab-paclitaxel monotherapy. The overall clinical response rate was 98% after nab-paclitaxel and cisplatin and 90% after nab-paclitaxel monotherapy. In subset analyses, cCR rates by T stage classifications (T2, T3, T4) were 54, 86, and 69% after nab-paclitaxel and cisplatin, and 14, 11, and 26% after nab-paclitaxel. cCR rates by human papillomavirus status (p16 positive oropharynx vs other) were 72 and 64% after nab-paclitaxel and cisplatin and 35 and 9% after nab-paclitaxel. The cCR rate after nab-paclitaxel and cisplatin was similar to APF; however, the cCR rate after nab-paclitaxel monotherapy was lower. The trial was registered at ClinicalTrials.gov NCT02573493 on October 9, 2015.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntineoplastic Combined Chemotherapy ProtocolsCetuximabChemoradiotherapyCisplatinFemaleHead and Neck NeoplasmsHumansInduction ChemotherapyMaleMiddle AgedNeoplasm StagingPaclitaxel130-nm albumin-bound paclitaxelAlbuminsCetuximabCisplatinPaclitaxelCetuximabCisplatinHead and neck squamous-cell carcinomanab-paclitaxelRadiation

Identifiers

PMID33683482
PMCPMC12560083
OpenAlexW3135202131

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

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.