Evidence map›Paper›PMID 34416469›Full record

Trial reportESMO open2021

Impact of age and gender on the efficacy and safety of upfront therapy with panitumumab plus FOLFOX followed by panitumumab-based maintenance: a pre-specified subgroup analysis of the Valentino study.

A Raimondi, G Fucà, A G Leone, S Lonardi, C Antoniotti, V Smiroldo, A Amatu, M Tampellini, G Ritorto, R Murialdo and 9 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.3field-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.

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

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Evidence-Based Care of Older Adults With Metastatic Colorectal Cancer: Insights From Landmark Clinical Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  8. Risk factor analysis for anti-epidermal growth factor receptor monoclonal antibody-induced skin toxicities in real-world metastatic colorectal cancer treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  9. Review
  10. Article
  11. 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 13 institutions in 1 country.

A RaimondiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
G FucàDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
A G LeoneDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
S LonardiMedical Oncology Unit 3, Department of Oncology, Istituto Oncologico Veneto-IRCCS, Padua, Italy.
C AntoniottiUnit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
V SmiroldoMedical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Italy.
A AmatuNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
M TampelliniDepartment of Oncology, AOU San Luigi di Orbassano, University of Torino, Orbassano, Italy.
G RitortoSSD ColoRectal Cancer Unit, Oncology Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Torino, Italy.
R MurialdoDepartment of Internal Medicine, University of Genoa and IRCCS AOU San Martino-IST, Genoa, Italy.
M ClavarezzaMedical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy.
A ZaniboniMedical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.
R BerenatoMedical Oncology Unit, A.O. Papardo, Messina, Italy.
M RattiMedical Oncology Unit, ASST Ospedale di Cremona, Cremona, Italy.
S CoralloDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
F MoranoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
M Di BartolomeoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
M Di MaioDepartment of Oncology, University of Turin, Ordine Mauriziano Hospital, Torino, Italy.
F PietrantonioDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: filippo.pietrantonio@istitutotumori.mi.it.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliera Ospedali Riuniti Papardo Piemonte · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITEnte Ospedaliero Ospedali Galliera · ITFondazione Poliambulanza Istituto Ospedaliero · ITIRCCS Humanitas Research Hospital · ITIstituti Ospitalieri di Cremona · ITIstituto Oncologico Veneto · ITOspedale Policlinico San Martino · ITOspedale San Luigi Gonzaga · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and efficacy outcome of elderly metastatic colorectal cancer (mCRC) patients fit enough to receive combination chemotherapy plus biological agents is an issue of growing interest. Also, gender-specific differential toxicity and efficacy of anti-epidermal growth factor receptor (EGFR)-based upfront treatments need to be explored. PATIENTS AND

methodsValentino was a multicenter, randomized, phase II trial, investigating two panitumumab-based maintenance strategies following first-line panitumumab plus FOLFOX in RAS wild-type mCRC patients. We carried out a subgroup analysis, aimed at assessing the differences in efficacy, safety and quality of life (QoL) according to age (<70 versus ≥70 years) and gender (male versus female). Efficacy endpoints were progression-free survival (PFS), overall survival (OS) and overall response rate (ORR); safety endpoints were rates of any grade and grade 3/4 adverse events (AEs).

resultsNo significant differences in terms of PFS, OS and ORR were observed between patients aged <70 or ≥70 years and the effect of the maintenance treatment arm on survival outcomes was similar in the two subgroups. The safety profile of both induction and maintenance treatment and the impact on QoL were similar in elderly and younger patients. No significant differences in PFS, OS, ORR or clinical benefit rate were observed according to gender. A significantly higher rate of overall grade 3/4 AEs (P = 0.008) and of grade 3/4 thrombocytopenia (P = 0.017), any grade and grade 3/4 neutropenia (P < 0.0001) and any grade conjunctivitis (P = 0.033) was reported in female as compared to male patients. Conversely, we reported a significantly higher incidence of any grade skin rash (P = 0.0007) and hypomagnesemia (P = 0.029) in male patients.

conclusionsThe upfront choice of an anti-EGFR-based doublet chemotherapy followed by a maintenance strategy represents a valuable option in RAS wild-type mCRC irrespective of gender and age, though a careful evaluation of patients to maximize the risk/benefit ratio is warranted.

Indexed as

Colorectal NeoplasmsQuality of LifeAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleFluorouracilHumansMalePanitumumabFluorouracilPanitumumabageanti-EGFRcolorectal cancergendermetastasis

Identifiers

PMID34416469
PMCPMC8379288
OpenAlexW3193447626

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.