Evidence map›Paper›PMID 33452559›Full record

Trial reportCancer chemotherapy and pharmacology2021

Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study.

Jaime Feliu, Mónica Jorge Fernández, Teresa Macarulla, Bartomeu Massuti, Ana Albero, José Federico González González, Guillermo Quintero-Aldana, Juan Ignacio Delgado-Mingorance, Ana Fernández Montes, Carmen García Piernavieja and 7 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.5field-weighted citation impact, top 15% 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

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Article
  3. Update on the management of older patients with pancreatic adenocarcinoma: a perspective from medical oncology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Review
  4. Hyperthermia combined with chemotherapyWorld journal of clinical oncology · 2023
    Article
  5. Observational
  6. Review
  7. Review
  8. 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

17 authors at 17 institutions in 1 country.

Jaime FeliuMedical Oncology Department, IdiPAZ, CIBERONC, Cátedra UAM-AMGEN, Hospital Universitario La Paz, Paseo de la Castellana 261., 28046, Madrid, Spain. jaimefeliu@hotmail.com.ORCID 0000-0003-4867-1420
Mónica Jorge FernándezMedical Oncology Department, Hospital Álvaro Cunqueiro, Vigo, Spain.
Teresa MacarullaMedical Oncology Department, Vall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology, IOB Quirón, Barcelona, Spain.
Bartomeu MassutiMedical Oncology Department, Alicante University Hospital ISABIAL, Alicante, Spain.ORCID 0000-0002-7608-3952
Ana AlberoMedical Oncology Department, Hospital Virgen Macarena, Sevilla, Spain.
José Federico González GonzálezMedical Oncology Department, Hospital Universitario Quirónsalud Madrid, Madrid, Spain.
Guillermo Quintero-AldanaMedical Oncology Department, Hospital Universitario Lucus Augusti (HULA), Lugo, Spain.ORCID 0000-0002-1445-1887
Juan Ignacio Delgado-MingoranceMedical Oncology Department, Hospital Universitario Badajoz, Badajoz, Spain.
Ana Fernández MontesMedical Oncology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.ORCID 0000-0003-4630-5830
Carmen García PiernaviejaMedical Oncology Department, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.ORCID 0000-0003-2147-5841
Manuel Valladares-AyerbesMedical Oncology Department, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocio, Sevilla, Spain.ORCID 0000-0002-7950-9584
Ana María López MuñozMedical Oncology Department, Hospital Universitario de Burgos, Burgos, Spain.ORCID 0000-0002-5476-3957
Rebeca Mondéjar SolísMedical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.
Pilar VicenteMedical Oncology Department, Hospital Granollers, Granollers, Spain.
Esther Casado GonzalezMedical Oncology Department, Hospital Althaia, Manresa, Spain.ORCID 0000-0001-7892-034X
Irene González CebriánDigestive Cancer Department, San Cecilio Hospital, Granada, Spain.
Guillermo López-VivancoMedical Oncology Department, Hospital Universitario Cruces, Barakaldo, Spain.ORCID 0000-0003-3800-6224
Althaia · ESCentro de Implantología Cirugía Oral y Maxilofacial · ESComplexo Hospitalario Universitario A Coruña · ESHospital de Cruces · ESHospital General de Granollers · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Universitario de Burgos · ESHospital Universitario de La Princesa · ESHospital Universitario Insular de Gran Canaria · ESHospital Universitario La Paz · ESHospital Universitario Lucus Augusti · ESHospital Universitario Quirónsalud Madrid · ESHospital Universitario Virgen Macarena · ESInstituto de Biomedicina de Sevilla · ESInstituto de Investigación Biosanitaria de Granada · ESUniversity Hospital Complex Of Vigo · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the health-related quality of life (HRQoL), global health status (GHS), and deterioration-free survival of an elderly population (> 70 years) with unresectable locally advanced (LAPC) or metastatic pancreatic cancer (mPC) treated with nab-paclitaxel in combination with gemcitabine.

methodsIn this open-label, single-arm, multicenter, phase II trial, patients received 4-week cycles of intravenous (i.v.) nab-paclitaxel at a dose of 125 mg/m

resultsEighty patients (median age: 74.6 years) were enrolled (56 with mPC, 24 with LAPC). The percentage of patients who had not experienced deterioration at 3 months was 54.3% (95% CI 41.6-67.0%). The median (interquartile range) time until definite deterioration was 1.6 (1.1-3.7) months. The objective response rate and clinical benefit rate were achieved by 11 (13.8%, 95% CI 6.2-21.3%) and 54 patients (67.5%, 95% CI 57.2-77.8%), respectively. The median overall survival was 9.2 months (95% CI 6.9-11.5), and the median progression-free survival was 7.2 months (95% CI 5.8-8.5). Only fatigue and neutropenia demonstrated a grade 3-4 toxicity incidence > 20%.

conclusionsOur study confirms the clinical benefit of the combination of nab-paclitaxel and gemcitabine in an elderly population with pancreatic cancer in terms of improved survival and clinical response. However, we were unable to confirm a benefit in terms of quality-of-life.

Indexed as

AdenocarcinomaAgedAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineFemaleGemcitabineHumansMalePaclitaxelPancreatic NeoplasmsQuality of Life130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabinePaclitaxelDeterioration-free survivalElderlyGemcitabineGlobal health statusHealth-related quality of lifeMetastaticNab-paclitaxelPancreatic cancerUnresectable locally advanced

Identifiers

PMID33452559
OpenAlexW3120719469

What OpenQuestion holds

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Registered trials

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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.