Evidence map›Paper›PMID 30497432›Full record

ArticleBMC cancer2018

Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study.

Ana Fernández, Mercedes Salgado, Adelaida García, Elvira Buxò, Ruth Vera, Jorge Adeva, Paula Jiménez-Fonseca, Guillermo Quintero, Cristina Llorca, Mamen Cañabate and 16 more

5 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article 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 5 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

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

NCT01964430 phase3completednot on this map

A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

TypeinterventionalSponsorCelgeneRan2014 to 2022Enrolled866ConditionsPancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, NeoplasmsArmsnab-Paclitaxel, Gemcitabine
NCT02027428 phase3completednot on this map

A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorCelgeneRan2014 to 2019Enrolled427ConditionsSquamous Cell Carcinoma, Non-Small-Cell LungArmsAbraxane (Induction), Carboplatin (Induction), Abraxane (Maintenance), Best Supportive Care (Maintenance)
NCT02250326 phase2completednot on this map

A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+

TypeinterventionalSponsorCelgeneRan2015 to 2023Enrolled240ConditionsCarcinoma, Non-Small-Cell LungArmsnab-paclitaxel IV, CC-486, Duravalumab
NCT02555813 completednot on this map

Multicenter Non-interventional Study to Investigate Safety, Tolerability and Efficacy of Nab-paclitaxel in Clinical Routine Treatment of First-line Pancreatic Cancer Patients

TypeobservationalSponsorCelgeneRan2015 to 2020Enrolled317ConditionsMetastatic Pancreatic CancerArmsAbraxane, Gemcitabine
NCT02670746 terminatednot on this map

Non-interventional Observational Post-authorization Study to Assess Clinical and Patient Reported Outcomes With Nab-paclitaxel in Combination With Gemcitabine in Routine Clinical Practice Treating Pancreatic Cancer (TRUST)

TypeobservationalSponsorCelgeneRan2015 to 2017Enrolled44ConditionsPancreatic Neoplasms
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  13. Clinical outcomes of FOLFIRINOX and gemcitabine-nab paclitaxel for metastatic pancreatic cancer in the real world setting.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
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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

26 authors.

Ana FernándezComplejo Hospitalario Universitario Ourense, Calle Ramon Puga Noguerol, 54, 32005, Ourense, Spain. ana.fernandez.montes@sergas.es.
Mercedes SalgadoComplejo Universitario Ourense, Ourense, Spain.
Adelaida GarcíaInstitut Català d'Oncologia (ICO) Hospital Dr. Trueta, Girona, Spain.
Elvira BuxòHospital Clínic de Barcelona, Barcelona, Spain.
Ruth VeraComplejo Hospitalario de Navarra, Navarra, Spain.
Jorge AdevaHospital 12 de Octubre, Madrid, Spain.
Paula Jiménez-FonsecaHospital Universitario Central de Asturias, Asturias, Spain.
Guillermo QuinteroHospital Lucus Agustí, Lugo, Spain.
Cristina LlorcaHospital de Elda, Alicante, Spain.
Mamen CañabateHospital Público Lluis Alcanyis de Xátiva, Xátiva, Spain.
Luis Jesús LópezHospital Virgen de la Salud, Toledo, Spain.
Andrés MuñozHospital Gregorio Marañón, Madrid, Spain.
Patricia RamírezHospital Puerta del Mar, Cadiz, Spain.
Paula GonzálezHospital Universitario de Vigo, Vigo, Spain.
Carlos LópezHospital Marqués de Valdecilla, Santander, Spain.
Margarita ReboredoHospital A Coruña Teresa Herrera, A Coruña, Spain.
Elena GallardoHospital de Pontevedra, Pontevedra, Spain.
Manuel Sanchez-CánovasHospital Morales Meseguer, Murcia, Spain.
Javier GallegoHospital de Elche, Elche, Spain.
Carmen GuillénHospital Ramón y Cajal, Madrid, Spain.
Nuria Ruiz-MiravetHospital Provincial Castellón, Castellón de la Plana, Spain.
Víctor Navarro-PérezComplejo Hospitalario de Jaén, Jaén, Spain.
Juan De la CámaraHospital del Ferrol, Ferrol, Spain.
Inmaculada Alés-DíazHospital Regional Universitario, Málaga, Spain.
Roberto Antonio Pazo-CidHospital Miguel Servet, Zaragoza, Spain.
Alberto Carmona-BayonasHospital Morales Meseguer, Murcia, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment with nab-paclitaxel plus gemcitabine increases survival in patients with metastatic pancreatic cancer. However, the assessment of treatment efficacy and safety in non-selected patients in a real-life setting may provide useful information to support decision-making processes in routine practice.

methodsRetrospective, multicenter study including patients with metastatic pancreatic cancer, who started first-line treatment with nab-paclitaxel plus gemcitabine between December 2013 and June 2015 according to routine clinical practice. In addition to describing the treatment pattern, overall survival (OS) and progression-free survival (PFS) were assessed for the total sample and the exploratory subgroups based on the treatment and patients' clinical characteristics.

resultsAll 210 eligible patients had a median age of 65.0 years (range 37-81). Metastatic pancreatic adenocarcinoma was recurrent in 46 (21.9%) patients and de novo in 164 (78.1%); 38 (18%) patients had a biliary stent. At baseline, 33 (18.1%) patients had an ECOG performance status ≥2. Patients received a median of four cycles of treatment (range 1-21), with a median duration of 3.5 months; 137 (65.2%) patients had a dose reduction of nab-paclitaxel and/or gemcitabine during treatment, and 33 (17.2%) discontinued treatment due to toxicity. Relative dose intensity (RDI) for nab-paclitaxel, gemcitabine, and the combined treatment was 66.7%. Median OS was 7.2 months (95% CI 6.0-8.5), and median PFS was 5.0 months (95% CI 4.3-5.9); 50 patients achieved either a partial or complete response (ORR 24.6%). OS was influenced by baseline ECOG PS, NLR and CA 19.9, but not by age ≥ 70 years and/or the presence of hepatobiliary stent or RDI < 85%. All included variables, computed as dichotomous, showed a significant contribution to the Cox regression model to build a nomogram for predicting survival in these patients: baseline ECOG 0-1 vs. 2-3 (p = 0.030), baseline NLR > 3 vs. ≤ 3 (p = 0.043), and baseline CA 19.9 > 37 U/mL vs. ≤37 U/mL (p = 0.004).

conclusionsNab-Paclitaxel plus gemcitabine remain effective in a real-life setting, despite the high burden of dose reductions and poorer performance of these patients. A nomogram to predict survival using baseline ECOG performance status, NLR and CA 19.9 is proposed.

Indexed as

AdultAgedAlbuminsAntineoplastic Combined Chemotherapy ProtocolsComorbidityDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingPaclitaxelPancreatic NeoplasmsPrognosis130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabinePaclitaxelFirst-line chemotherapyGemcitabineMetastatic pancreatic adenocarcinomaNab-paclitaxelReal-lifeSurvival

Identifiers

PMID30497432
PMCPMC6267080

What OpenQuestion holds

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LicenceCC BY
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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.