Evidence map›Paper›PMID 29370781›Full record

Trial reportBMC cancer2018

The PANDA study: a randomized phase II study of first-line FOLFOX plus panitumumab versus 5FU plus panitumumab in RAS and BRAF wild-type elderly metastatic colorectal cancer patients.

Francesca Battaglin, Marta Schirripa, Federica Buggin, Filippo Pietrantonio, Federica Morano, Giorgia Boscolo, Giuseppe Tonini, Eufemia Stefania Lutrino, Jessica Lucchetti, Lisa Salvatore and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02904031 (Randomized Phase II Study of First-Line FOLFOX Plus Panitumumab Versus 5FU Plus Panitumumab in RAS And BRAF Wild-Type Metastatic Colorectal Cancer Elderly Patients), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.8field-weighted citation impact, top 23% 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.

NCT02904031 phase2unknown statusnot on this map

Randomized Phase II Study of First-Line FOLFOX Plus Panitumumab Versus 5FU Plus Panitumumab in RAS And BRAF Wild-Type Metastatic Colorectal Cancer Elderly Patients

TypeinterventionalSponsorGruppo Oncologico del Nord-OvestRan2016 to 2020Enrolled180ConditionsElderly Metastatic Colorectal Cancer PatientsArms5-fluorouracil, oxaliplatin, l-leucovorin, panitumumab
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Elderly Rectal Cancer: An Updated Review.Current oncology reports · 2024
    Review
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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

20 authors at 14 institutions in 1 country.

Francesca BattaglinIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Marta SchirripaIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Federica BugginIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Filippo PietrantonioFondazione IRCCS Istituto Nazionale Tumori, Dipartimento di Oncologia Medica, Via Venezian, 1, 20133, Milan, Italy.
Federica MoranoFondazione IRCCS Istituto Nazionale Tumori, Dipartimento di Oncologia Medica, Via Venezian, 1, 20133, Milan, Italy.
Giorgia BoscoloAzienda Unita Locale Socio-Sanitaria N°3 Serenissima - Distretto Mirano, Dolo, Noale - Dipartimento di Scienze Mediche, U.O.C. Oncologia ed Ematologia Oncologica, Via Don G. Sartor, 4, 30035, Mirano, VE, Italy.
Giuseppe ToniniPoliclinico Universitario Campus Bio-Medico, U.O.C. Oncologia Medica, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Eufemia Stefania LutrinoOspedale Senatore A. Perrino, U.O.C. Oncologia Medica, Strada Statale 7 (Appia), 72100, Brindisi, Italy.
Jessica LucchettiU.O. Oncologia Medica, Dipartimento di Medicina, Ospedale Universitario Policlinico Tor Vergata, Università degli Studi di Roma Tor Vergata, Viale Oxford, 81, 00133, Rome, Italy.
Lisa SalvatoreOncologia, Azienda Ospedaliera Universitaria Integrata di Verona, Piazzale Scuro, 10, 37134, Verona, Italy.
Alessandro PassardiIRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), U.O. Oncologia Medica, Via P. Maroncelli, 40, 47014, Meldola, FC, Italy.
Chiara CremoliniAzienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica 2 Universitaria, Via Roma, 67, 56126, Pisa, Italy.
Ermenegildo ArnoldiASST Papa Giovanni XXIII, U.O. Oncologia Medica, Piazza OMS, 1, 24127, Bergamo, Italy.
Mario ScartozziU.O. Oncologia Medica, Azienda Ospedaliero-Universitaria di Cagliari e Università di Cagliari, via Ospedale, 54, 09124, Cagliari, Italy.
Nicoletta PellaAzienda Sanitaria Universitaria Integrata di Udine, Dipartimento di Oncologia, Piazzale Santa Maria della Misericordia, 15, 33100, Udine, Italy.
Luca BoniCentro Coordinamento Sperimentazioni Cliniche - Istituto Toscano Tumori, Via Taddeo Alderotti, 26/N, 50139, Florence, Italy.
Francesca BergamoIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Vittorina ZagonelIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy.
Fotios LoupakisIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy. fotios.loupakis@iov.veneto.it.
Sara LonardiIstituto Oncologico Veneto - IRCCS, S.C. Oncologia Medica 1, Dipartimento di Oncologia Clinica e Sperimentale, Via Gattamelata, 64, 35128, Padova, Italy. sara.lonardi@iov.veneto.it.
Istituto Oncologico Veneto · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Ospedaliero-Universitaria Cagliari · ITCampus Bio Medico University Hospital · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITMedica (Italy) · ITOspedale A. Perrino · ITOspedale di Mirano · ITOspedale Santa Maria della Misericordia di Udine · ITTumour Institute of Tuscany · ITUniversity of Rome Tor Vergata · IT

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundFew data are available regarding the treatment of metastatic colorectal cancer elderly patients with anti-EGFR agents in combination with chemotherapy. FOLFOX plus panitumumab is a standard first-line option for RAS wild-type metastatic colorectal cancer. Slight adjustments in chemo-dosage are commonly applied in clinical practice to elderly patients, but those modified schedules have never been prospectively tested. Clinical definition of elderly (≥70 years old) patients that may deserve a more or less intensive combination therapy is still debated. Several geriatric screening tools have been developed to predict survival and risk of toxicity from treatment. Among those, the G8 screening tool has been tested in cancer patients showing the strongest prognostic value for overall survival, while the CRASH score can stratify patients according to an estimated risk of treatment-related toxicities.

methodsThe PANDA study is a prospective, open-label, multicenter, randomized phase II trial of first-line therapy with panitumumab in combination with dose-adjusted FOLFOX or with 5-fluorouracil monotherapy, in previously untreated elderly patients (≥70 years) with RAS and BRAF wild-type unresectable metastatic colorectal cancer. RAS and BRAF analyses are centralized. Geriatric assessment by means of G8 and CRASH score is planned at baseline and G8 will be re-evaluated at disease progression. The primary endpoint is duration of progression-free survival in both arms. Secondary endpoints include prospective evaluation of the prognostic role of G8 score and the correlation of CRASH risk categories with toxicity. DISCUSSION: The PANDA study aims at exploring safety and efficacy of panitumumab in combination with FOLFOX or with 5FU/LV in elderly patients affected by RAS and BRAF wild-type metastatic colorectal cancer, to identify the most promising treatment strategy in this setting. Additionally, this is the first trial in which the prognostic role of the G8 score will be prospectively evaluated. Results of this study will drive further experimental developments for one or both combinations.

trial registrationPANDA is registered at Clinicaltrials.gov : NCT02904031 , July 11, 2016. PANDA is registered at EudraCT-No.: 2015-003888-10, September 3, 2015.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDisease-Free SurvivalErbB ReceptorsFluorouracilHumansLeucovorinMutationOrganoplatinum CompoundsPanitumumabPrognosisProto-Oncogene Proteins B-rafras ProteinsTreatment OutcomeAntibodies, MonoclonalBRAF protein, humanEGFR protein, humanErbB ReceptorsFluorouracilLeucovorinOrganoplatinum CompoundsPanitumumabProto-Oncogene Proteins B-rafras ProteinsBRAFClinical trialCRASHElderlyG8Metastatic colorectal cancerPanitumumabRAS

Identifiers

PMID29370781
PMCPMC5784655
OpenAlexW2789151258

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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.