Cited by 77Cancer Treatment and PharmacologyBreast Cancer Treatment StudiesAdvanced Breast Cancer Therapies

A pilot phase II trial of all-trans retinoic acid (Vesanoid) and paclitaxel (Taxol) in patients with recurrent or metastatic breast cancer

Bryan, Margarette, Pulte, E. Dianne, Toomey, Kathleen C., Pliner, Lillian, Pavlick, Anna C., Saunders, Tracie, Wieder, Robert·2011·Investigational New Drugs

Abstract

Purpose We investigated a combination therapy with weekly paclitaxel and all trans-retinoic acid (ATRA) for tolerability, response to treatment, time to progression and survival in previously treated patients with metastatic or recurrent breast cancer. Our rationale was based on preclinical studies demonstrating potentiation of the cytotoxic effects of taxanes and induction of differentiation by ATRA.Patients and methods Seventeen patients with previously treated metastatic or recurrent breast cancer were enrolled to a regimen of all-trans retinoic acid (Vesanoid, tretinoin, Hoffman-La Roche, Inc.) 45 mg/m(2) PO daily for 4 days starting 2 days before a 1 h treatment with paclitaxel (Taxol, Bristol-Myers Squibb, Plainsboro, NJ) 80 mg/m(2) IV administered weekly for 3 weeks, repeated in 28 day cycles until disease progression or until no longer tolerated. Patients were evaluated for toxicity, response, time to progression and survival. Patients were primarily African American and Latino, representative of the population served by our Cancer Center.Results The regimen was relatively well tolerated. There were nine grade 3 and one grade 4 toxic events. We administered 162 treatment cycles with a mean of 7.5 per patient (range 1-22, median 5). Three patients had a partial response (17.6%) and ten patients had stable disease (58.8%), with an overall clinical benefit of 76.4%. Median time to progression was 6.0 months (range 1-21, mean 7.7 months). Fourteen evaluable patients had a median survival of 16 months (range 1-68 months, mean 25.2 months).Conclusions The data suggest this is a well tolerated regimen with modest response rates but with time to progression and survival rates similar to those reported for paclitaxel alone and relatively high rates of stable disease in this sample of patients.

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Crossref · 10.1007/s10637-010-9478-3

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Authors
Bryan, M., Pulte, E. D., Toomey, K. C., Pliner, L., Pavlick, A. C., Saunders, T., & Wieder, R.
Affiliations
  • Rutgers New Jersey Medical School (US)
  • Somerset Medical Center (US)
  • New York University (US)
Corresponding author
Wieder, Robert
Venue
Investigational New Drugs
Published
2010-07-02
Volume
29
Issue
6
Pages
1482-1487
ISSN
  • 0167-6997 (ISSN-L)
  • 1573-0646
OpenAlex
W2076400885
Cited by
77
References
21
Citations by year
2025: 3 · 2024: 7 · 2023: 3 · 2022: 2 · 2021: 6 · 2020: 4 · 2019: 7 · 2018: 5 · 2017: 7 · 2016: 4 · 2015: 5 · 2014: 9 · 2013: 7 · 2012: 3
FWCI
2.37
Type
journal article
Language
en
Open access
closed
Locations
  • Investigational New Drugs (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Keywords
all-trans retinoic acid, paclitaxel, combination chemotherapy, breast cancer recurrence, metastatic breast cancer, previously treated patients, treatment toxicity, time to progression, survival, stable disease, differentiation therapy
MeSH terms
Aged, Antineoplastic Combined Chemotherapy Protocols, Black or African American, Breast Neoplasms, Female, Hispanic or Latino, Humans, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Pilot Projects, Tretinoin, Survival Rate, Treatment Outcome, Paclitaxel, Disease Progression

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