Evidence map›Paper›PMID 32871800›Full record

Trial reportIn vivo (Athens, Greece)

Metronomic Oral Vinorelbine: An Alternative Schedule in Elderly and Patients PS2 With Local/Advanced and Metastatic NSCLC Not Oncogene-addicted.

David Rossi, Paolo Lippe, Marco Bruno Luigi Rocchi, Donatella Sarti, Vincenzo Catalano, Francesco Graziano, Paolo Giordani, Annamaria Baldelli, Stefano Luzi Fedeli, Luca Imperatori and 5 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in In vivo (Athens, Greece). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

15 authors.

David RossiOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy david.rossi@ospedalimarchenord.it.
Paolo LippeOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Marco Bruno Luigi RocchiBiomolecular Science Department, University of Urbino, Urbino, Italy.
Donatella SartiOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Vincenzo CatalanoOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Francesco GrazianoOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Paolo GiordaniOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Annamaria BaldelliOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Stefano Luzi FedeliOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Luca ImperatoriOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Gianluca LaiciOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Claudia CappellettiOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Tiziana TamburranoOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Raffaella BracciOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.
Paolo AlessandroniOperative Oncology Unit, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe MILES and ELVIS studies showed that vinorelbine is one of the best options for elderly patients with advanced non-small-cell-lung cancer (NSCLC). Oral vinorelbine at standard schedule (60-80 mg/m PATIENTS AND

methodsA total of 25 patients entered the study: 11 with local/advanced and 14 with metastatic NSCLC (five squamous and 20 adenocarcinoma). None of the patients had epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocation, or programmed death ligand 1 (PDL1) expression; those with squamous carcinoma did not have PDL1 expression. The median age was 79 (range=44-90) years. The PS was 0 in 12 patients (48%), 1 in four patients (16%) and 2 in nine patients (36%). Oral vinorelbine was administered at 40 mg three times a week continuously.

resultsClinical benefit was achieved in eight patients (32%). Objective responses were partial response in two patients (8%), stable disease in seven (28%), progressive disease in nine (36%); seven patients were not evaluable for response (28%). Median progression-free survival was 2 months; median overall survival was 4 months but four out of eight patients with clinical benefit were still alive at 18 months. Overall survival at 1 year was 32%. Toxicity was mild: only one patient experienced grade 4 neutropenia, one grade 3 peripheral neuropathy, four grade 2 asthenia, one grade 2 mucositis, and one grade 2 diarrhoea. The dose needed to be reduced to 30 mg/m

conclusionOur study confirmed the activity and safety of metronomic oral vinorelbine in patients with wild-type local/advanced and metastatic NSCLC unsuitable for treatment with standard i.v. chemotherapy, allowing patients a comfortable home-based therapy, thereby avoiding frequent hospital visits.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdministration, MetronomicAgedAntineoplastic Combined Chemotherapy ProtocolsHumansTreatment OutcomeVinblastineVinorelbineVinblastineVinorelbinemetronomicNSCLCOralvinorelbine

Identifiers

PMID32871800
PMCPMC7652434

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.