Evidence map›Paper›PMID 36288238›Full record

Trial reportThe oncologist2022

Phase II Single-Arm Study of Palbociclib and Cetuximab Rechallenge in Patients with KRAS/NRAS/BRAF Wild-Type Colorectal Cancer.

Jonathan D Sorah, Dominic T Moore, Matthew J Reilley, Mohamed E Salem, Tammy Triglianos, Hanna K Sanoff, Autumn J McRee, Michael S Lee

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03446157 (Phase II Single-arm Study of the Combination of Palbociclib and Cetuximab in KRAS/NRAS/BRAF Wild-type Metastatic Colorectal Cancer), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT03446157 phase2completednot on this map

Phase II Single-arm Study of the Combination of Palbociclib and Cetuximab in KRAS/NRAS/BRAF Wild-type Metastatic Colorectal Cancer

TypeinterventionalSponsorUNC Lineberger Comprehensive Cancer CenterRan2018 to 2026Enrolled24ConditionsCancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic CancerArmsCetuximab, Palbociclib
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
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.

Jonathan D SorahDivision of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-2501-720X
Dominic T MooreDivision of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Matthew J ReilleyDivision of Hematology/Oncology, Department of Medicine, University of Virginia, Charlottesville, VA, USA.
Mohamed E SalemLevine Cancer Institute, Charlotte, NC, USA.
Tammy TriglianosDivision of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Hanna K SanoffDivision of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Autumn J McReeThe Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, NJ, USA.
Michael S LeeDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
University of North Carolina at Chapel Hill · USJohnson & Johnson (United States) · USLevine Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCetuximab is often administered to patients with KRAS wild-type (KRAS-WT) metastatic colorectal cancer (mCRC), although resistance inevitably develops. We hypothesized that co-inhibition of the epidermal growth factor receptor (EGFR) with cetuximab and downstream cyclin-dependent kinases (CDK) 4/6 with palbociclib would be effective for anti-EGFR rechallenge in KRAS-WT mCRC.

methodsWe designed a single-arm, Simon's 2-stage, phase II trial of cetuximab and palbociclib in KRAS-WT mCRC treated with ≥2 prior lines of therapy. We report here on cohort B rechallenging patients with anti-EGFR-based therapy who had disease control of at least 4 months on prior anti-EGFR therapy. Primary endpoint was disease control rate (DCR) at 4 months.

resultsTen evaluable patients were enrolled in this cohort. The 4-month DCR was 20%, which did not fulfill the prespecified 4-month DCR rate to continue. Median progression-free survival was 1.8 months and median overall survival was 6.6 months. Three patients had stable disease, although overall response rate was 0%. Most common treatment-related grades 3-4 adverse events were lymphopenia and leukopenia.

conclusionSelection of patients for anti-EGFR rechallenge using clinical criteria alone was insufficient to identify response to palbociclib + cetuximab. Additional biomarkers are needed to select anti-EGFR rechallenge and circulating tumor DNA (ctDNA) analysis is planned for samples collected in this study. (ClinicalTrials.gov Identifier: NCT03446157).

Indexed as

Colorectal NeoplasmsCetuximabGTP PhosphohydrolasesHumansMembrane ProteinsProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)BRAF protein, humanCetuximabGTP PhosphohydrolasesKRAS protein, humanMembrane ProteinsNRAS protein, humanProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)anti-EGFR therapycetuximabcolorectal cancerKRAS wild typepalbociclib

Identifiers

PMID36288238
PMCPMC10249423
OpenAlexW4307343657

What OpenQuestion holds

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LicenceCC BY-NC
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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.