Evidence map›Paper›PMID 26640370›Full record

Trial reportDrug design, development and therapy2015

Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer: clinical results and biological observations in taxane-pretreated patients.

Alessandra Fabi, Diana Giannarelli, Paola Malaguti, Gianluigi Ferretti, Sabrina Vari, Paola Papaldo, Cecilia Nisticò, Mauro Caterino, Roy De Vita, Marcella Mottolese and 2 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 16% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. 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

12 authors at 4 institutions in 3 countries.

Alessandra FabiDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Diana GiannarelliBiostatistic Unit, Regina Elena National Cancer Institute, Rome, Italy.
Paola MalagutiDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Gianluigi FerrettiDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Sabrina VariDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Paola PapaldoDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Cecilia NisticòDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Mauro CaterinoService of Radiology, Regina Elena National Cancer Institute, Rome, Italy.
Roy De VitaOperative Unit of Plastic and Reconstructive Surgery, Department of Pathology, Regina Elena National Cancer Institute, Rome, Italy.
Marcella MottoleseDepartment of Pathology, University of Rome "Tor Vergata", Rome, Italy.
Laura IacorossiDepartment of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.
Francesco CognettiDepartment of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Biostatistical Consulting (United States) · USNational Cancer Institute · MYSociety of Interventional Radiology · USUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a deep need to improve the care of metastatic breast cancer (MBC) patients, since even today it remains an incurable disease. Taxanes are considered the most effective cytotoxic drugs for the treatment of MBC, both in monotherapy and in combined schedules, but the need for synthetic solvents contributes to the severe toxicities and may have a negative impact on the efficacy. Nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a colloidal suspension of paclitaxel and human serum albumin initially developed to avoid the toxicities associated with conventional taxanes. PATIENTS AND

methodsThe aim of this prospective, single-center open-label, noncomparative study was to evaluate the efficacy and safety of nab-paclitaxel in MBC patients pretreated with taxanes. The patients were treated with nab-paclitaxel as a single agent, 260 mg/m(2) on day 1 of each 3-week cycle or 125 mg/m(2) weekly. The primary endpoint was the overall response rate (ORR). Secondary objectives were duration of response, clinical benefit rate, progression-free survival (PFS), overall survival, and safety.

resultsA total of 42 patients (median age 48 years, median Eastern Cooperative Oncology Group performance status 0, triple-negative MBC 19%, all pretreated with a taxane-based therapy, mainly in advanced disease) were enrolled in the study. The ORR was 23.8%, including one complete response (2.4%) and nine partial responses (21.4%); the disease control rate was 50%. The median duration of response was 7.2 months. After a median follow-up of 9 months, the median PFS was 4.6 months. ORR and PFS were similar irrespective of the previous chemotherapy lines, metastatic sites, and biomolecular expression. Nab-paclitaxel was well tolerated, and the most frequent treatment-related toxicities were mild to moderate (grades 1-2).

conclusionThis real-life study shows that nab-paclitaxel has a significant antitumor activity and a manageable safety profile in patients pretreated with taxanes and experiencing a treatment failure after at least one line of chemotherapy.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntineoplastic Agents, PhytogenicDisease-Free SurvivalFemaleFollow-Up StudiesHumansMiddle AgedNanoparticlesNeoplasm MetastasisPaclitaxelProspective StudiesSurvival RateTaxoids130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelTaxoidsanthracyclinesmetastatic breast cancernab-paclitaxel

Identifiers

PMID26640370
PMCPMC4662373
OpenAlexW2178665864

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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.