Evidence map›Paper›PMID 25943747›Full record

Trial reportBMC cancer2015

Metronomic oral vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer: results of a phase II trial (MOVE trial).

Andrea Camerini, Cheti Puccetti, Sara Donati, Chiara Valsuani, Maria Cristina Petrella, Gianna Tartarelli, Paolo Puccinelli, Domenico Amoroso

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 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.

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

35 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. General recommendations paper on the management of older patients with cancer: the SEOM geriatric oncology task force's position statement.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Efficacy and safety of metronomic oral vinorelbine and its combination therapy as second- and later-line regimens for advanced non-small-cell lung cancer: a retrospective analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Treatment Sequencing Strategies in Lung Cancer.Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2022
    Article
  19. Metronomic Therapy in Oral Squamous Cell Carcinoma.Journal of clinical medicine · 2021
    Review
  20. Review
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

8 authors.

Andrea CameriniMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. andreacamerini@katamail.com.
Cheti PuccettiMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. c.puccetti@usl12.toscana.it.
Sara DonatiMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. s.donati@usl12.toscana.it.
Chiara ValsuaniMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. chiara.valsuani@libero.it.
Maria Cristina PetrellaMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. mariacristina.petrella@gmail.com.
Gianna TartarelliMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. g.tartarelli@usl12.toscana.it.
Paolo PuccinelliMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. p.puccinelli@usl12.toscana.it.
Domenico AmorosoMedical Oncology, Versilia Hospital and Istituto Toscano Tumori, Lido di Camaiore, Italy. d.amoroso@usl12.toscana.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetronomic oral vinorelbine could be a safe option for elderly patients with advanced non small cell lung cancer (NSCLC). Metronomic administration of chemotherapy leads to a cytostatic action shifting treatment target from cancer cell to tumor angiogenesis.

methods43 chemotherapy naive elderly (≥ 70 yrs) PS 0-2 patients with stage IIIB-IV NSCLC were prospectively recruited. Median age was 80 yrs (M/F 36/7) with predominantly squamous histology. PS distribution was 0-1(16)/2(27) with a median of 3 serious co-morbid illnesses. Study treatment consisted of oral vinorelbine 50mg three times weekly (Monday-Wednesday-Friday) continuously until disease progression, unacceptable toxicity or patient refusal. Primary endpoints were overall response rate (ORR), clinical benefit (CB--disease response plus disease stabilization >12 weeks) and safety. Health-related QoL (HRQoL) was also assessed with FACT-L V4 scoring questionnaire. We conducted an exploratory time-course analysis of VEGF and thrombospondin-1 (TSP1) serum levels in a subgroup of patients.

resultsPatients received a median of 5 (range 1-21) cycles with a total of 272 cycles delivered. ORR was 18.6% with 7 partial and 1 complete responses; 17/43 experienced stable disease lasting more than 12 weeks leading to an overall CB of 58.1%. Median time to progression was 5 (range 2-21) and median overall survival 9 (range 3-29) months. Treatment was well tolerated with rare serious toxicity. Regardless of severity main toxicities observed were anemia in 44%, fatigue in 32.4%, and diarrhoea 10.5%. FACT-L v4 scores did not significantly vary during treatment. Baseline VEGF levels were lower and showed a rapid increase during treatment in non-responders pts only while TSP1 levels did not change.

conclusionsMetronomic oral vinorelbine is safe in elderly patients with advanced NSCLC with an interesting activity mainly consisting in long-term disease stabilization coupled with an optimal patient compliance (Eudra-CT 2010-018762-23, AIFA OSS on 26 February 2010).

Indexed as

Administration, MetronomicAdministration, OralAgedAged, 80 and overAntineoplastic Agents, PhytogenicBiomarkers, TumorCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleNeoplasm StagingTreatment OutcomeVascular Endothelial Growth Factor AVinblastineVinorelbineAntineoplastic Agents, PhytogenicBiomarkers, TumorVascular Endothelial Growth Factor AVEGFA protein, humanVinblastineVinorelbine

Identifiers

PMID25943747
PMCPMC4424528

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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.