Evidence map›Paper›PMID 32346071›Full record

Trial reportBritish journal of cancer2020

Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL).

Francesco Gelsomino, Marcello Tiseo, Fausto Barbieri, Ferdinando Riccardi, Luigi Cavanna, Antonio Frassoldati, Angelo Delmonte, Lucia Longo, Claudio Dazzi, Saverio Cinieri and 7 more

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT03219762 phase2unknown statusnot on this map

Phase II Study of Nab-paclitaxel in Sensitive and Refractory Relapsed Small Cell Lung Cancer (Nabster Study)

TypeinterventionalSponsorGruppo Oncologico Italiano di Ricerca ClinicaRan2017 to 2019Enrolled65ConditionsSmall Cell Lung CancerArmsNabpaclitaxel
NCT04698941 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Clinical Study of Albumin Paclitaxel With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

TypeinterventionalSponsorShanghai Pulmonary Hospital, Shanghai, ChinaRan2021 to 2022Enrolled40ConditionsSmall Cell Lung CancerArmsAlbumin Paclitaxel, Simvastatin
NCT04985201 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

Clinical Study of Irinotecan With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy

TypeinterventionalSponsorShanghai Pulmonary Hospital, Shanghai, ChinaRan2021 to 2023Enrolled40ConditionsSmall Cell Lung CancerArmsIrinotecan, Simvastatin
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Rutin and Hesperidin Alleviate Paclitaxel-Induced Nephrocardiotoxicity in Wistar RatsEvidence-based complementary and alternative medicine : eCAM · 2023
    Article
  9. Rutin and Hesperidin Revoke the Hepatotoxicity Induced by Paclitaxel in Male Wistar RatsEvidence-based complementary and alternative medicine : eCAM · 2023
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 1 country.

Francesco GelsominoMedical Oncology Unit, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
Marcello TiseoMedical Oncology Unit, Azienda Ospedaliero-Universitaria of Parma, Parma, Italy. mtiseo@ao.pr.it.ORCID http://orcid.org/0000-0002-9204-1728
Fausto BarbieriMedical Oncology Unit, Policlinico of Modena, Modena, Italy.
Ferdinando RiccardiMedical Oncology Unit, Azienda Ospedaliera Cardarelli, Napoli, Italy.
Luigi CavannaMedical Oncology Unit, AUSL of Piacenza, Piacenza, Italy.
Antonio FrassoldatiMedical Oncology Unit, Azienda Ospedaliero-Universitaria of Ferrara, Ferrara, Italy.
Angelo DelmonteDepartment of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Lucia LongoMedical Oncology Unit, AUSL of Modena, Hospital of Carpi, Carpi, Italy.
Claudio DazziMedical Oncology Unit, AUSL of Romagna, Hospital of Ravenna, Ravenna, Italy.
Saverio CinieriMedical Oncology Unit, Hospital of Brindisi, Brindisi, Italy.
Ida ColantonioMedical Oncology Unit, Hospital of Cuneo, Cuneo, Italy.
Francesca SperandiMedical Oncology Unit, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
Giuseppe LambertiMedical Oncology Unit, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
Stefano BrocchiRadiology Unit, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
Lorenzo TofaniClinical Trial Center, Istituto Toscano Tumori, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
Luca BoniClinical Trial Center, Istituto Toscano Tumori, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
Andrea ArdizzoniMedical Oncology Unit, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITAzienda Ospedaliero-Universitaria Careggi · ITArcispedale Sant'Anna · ITAzienda Ospedaliero-Universitaria di Modena · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITAzienda Unità Sanitaria Locale Della Romagna · ITAzienda Unita' Sanitaria Locale Di Modena · ITAzienda Unità Sanitaria Locale Piacenza · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITOspedale Antonio Cardarelli · ITOspedale A. Perrino · ITOspedale di Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite sensitivity to first-line chemotherapy, most small-cell lung cancer (SCLC) patients relapse. In this setting, topotecan demonstrated modest activity with significant toxicity. Paclitaxel was also active. This study was designed to evaluate activity and safety of nab-paclitaxel in relapsed SCLC.

methodsIn this multicentre prospective Phase 2 trial, patients with refractory or sensitive SCLC progressed to first-line platinum-based chemotherapy received nab-paclitaxel 100 mg/smq on days 1, 8, 15 every 4 weeks up to six cycles, progressive disease or intolerable toxicity. Primary endpoint was investigator-assessed objective tumour response. Secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS).

resultsOf the 68 patients treated, partial response was 8% in the refractory cohort and 14% in the sensitive cohort. Most common toxicities of any grade were fatigue (54%), anaemia (38%), neutropenia (29%), leukopenia (26%) and diarrhoea (21%). Median PFS was similar in both refractory (1.8 months) and sensitive cohorts (1.9 months), while median OS was longer in sensitive one (6.6 versus 3.6 months).

conclusionsAlthough nab-paclitaxel has shown some modest anti-tumour activity in relapsed SCLC, associated with a favourable toxicity profile, the primary end-point of the study was not met. CLINICAL

trial registrationClinical Trial registration number is ClinicalTrials.gov Identifier: NCT03219762.

Indexed as

AdultAgedAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelProgression-Free SurvivalProspective StudiesSmall Cell Lung Carcinoma130-nm albumin-bound paclitaxelAlbuminsPaclitaxel

Identifiers

PMID32346071
PMCPMC7341887
OpenAlexW3017445798

What OpenQuestion holds

Textmetadata
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.