Evidence map›Paper›PMID 27752847›Full record

Trial reportBreast cancer research and treatment2016

Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study.

M E Cazzaniga, L Cortesi, A Ferzi, L Scaltriti, F Cicchiello, M Ciccarese, S Della Torre, F Villa, M Giordano, C Verusio and 7 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
3.3field-weighted citation impact, top 6% 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

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  8. Article
  9. The efficacy and safety of metronomic vinorelbine combined with anlotinib in HER2-negative advanced breast cancer: a prospective, single-arm clinical study.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 1 country.

M E CazzanigaOncology Unit, ASST Monza, Via Pergolesi, 33 20900, Monza, MB, Italy. marina.cazzaniga@asst-monza.it.
L CortesiHaematology and Oncology Unit, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.
A FerziOncology Unit, ASST Ovest Milanese, Ospedale di Legnano, Legnano, Italy.
L ScaltritiOncology Day Hospital Unit, Ospedale Civile di Guastalla, Guastalla, Italy.
F CicchielloOncology Unit, ASST Monza, Via Pergolesi, 33 20900, Monza, MB, Italy.
M CiccareseOncology Unit, Ospedale Vito Fazzi, Lecce, Italy.
S Della TorreOncology Unit, ASST Rhodense-Presidio di Garbagnate Milanese e Presidio di Rho, Garbagnate, Italy.
F VillaOncology Unit, ASST, Lecco, Italy.
M GiordanoOncology Unit, ASST Lariana, Como, Italy.
C VerusioOncology Unit, ASST della Valle Olona, Saronno, Italy.
M NicoliniOncology Day Hospital Unit, Azienda USL Romagna, Cattolica, Italy.
A R GambaroOncology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.
L ZanlorenziOncology Unit, ASST della Valle Olona, Busto Arsizio, Italy.
E BiraghiOncology Unit, ASST Melegnano e Martesana, Gorgonzola, Italy.
L LegramandiMethodology for Clinical Research Laboratory, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
E RulliMethodology for Clinical Research Laboratory, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
VICTOR Study Group
Mario Negri Institute for Pharmacological Research · ITAccademia Italiana Medicina Osteopatica · ITAzienda Ospedaliero-Universitaria di Modena · ITPresidio Ospedaliero · ITASST Melegnano e della Martesana · ITAzienda Ospedaliera Ospedale Civile di Legnano · ITAzienda Socio Sanitaria Territoriale Lariana · ITAzienda Unità Sanitaria Locale Della Romagna · ITOspedale di Circolo di Busto Arsizio · ITOspedale Vito Fazzi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results.

methodsPatients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS).

resultsEighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8-63.4) and 51.1 % (95 % CI 35.8-66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2-54.6) and 25.6 % in ≥second-line (95 % CI 13.5-41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (N = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6-55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %).

conclusionThe VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients' dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.

Indexed as

Administration, MetronomicAdministration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm MetastasisNeoplasm StagingRetreatmentTreatment OutcomeCapecitabineErb-b2 Receptor Tyrosine KinasesVinblastineVinorelbineBreast cancerCapecitabineMetronomic chemotherapyVinorelbine

Identifiers

PMID27752847
PMCPMC5090011
OpenAlexW2538410666

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.