Paclitaxel protein-bound particles

(Abraxane®)

Abraxane®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 100 mg)
Drug ClassMicrotubule inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
  • Prior therapy should have included an anthracycline unless clinically contraindicated
  • Indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy
  • Indicated for the treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

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Summary
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  • This summary is based on the review of 25 systematic review(s)/meta-analysis(es). [1-25]
  • Non-small cell lung cancer (NSCLC): Nab-paclitaxel improved the overall response rate (ORR) (relative risk (RR) = 1.35, 95% confidence interval (CI): 1.19–1.53; RR = 1.67, 95% CI: 1.30–2.14) and partial response (PR) rate (RR = 1.34, 95% CI: 1.18–1.53; RR = 1.59, 95% CI: 1.22–2.07) compared to control, with pronounced benefits in squamous cell carcinoma and second-line treatments.
  • Breast Cancer: Nab-paclitaxel showed a significantly higher ORR (RR = 1.21, 95% CI: 1.07–1.37) and pathologic complete response (pCR) rate (RR = 1.33, 95% CI: 1.17–1.51) over conventional taxanes, especially in human epidermal growth factor receptor 2 (HER2)-rich and triple-negative breast cancer (TNBC) subtypes.
  • Progression-Free Survival (PFS): In NSCLC, nab-paclitaxel increased PFS (hazard ratio (HR) = 0.84, 95% CI: 0.76–0.93), with a meta-analysis of 6,011 patients further supporting PFS benefits when combined with platinum compounds (HR = 0.84, 95% CI: 0.74–0.94). Median PFS for breast cancer patients was 7.64 months (95% CI: 6.89–8.40 months).
  • Overall Survival (OS): Nab-paclitaxel showed a marginal OS improvement in NSCLC (HR = 0.90, 95% CI: 0.81–0.99) and a median OS of 24.51 months (95% CI: 21.25–27.78 months) in breast cancer studies.
  • Hematologic Adverse Events: Nab-paclitaxel was associated with a higher risk of grade ≥3 anemia (RR = 0.39, 95% CI: 0.20–0.77) and an increased incidence of thrombocytopenia (RR = 1.42, 95% CI: 0.91–2.23), while demonstrating a lower risk of grade ≥4 neutropenia (RR = 0.39, 95% CI: 0.20–0.77) compared to traditional taxanes.
  • Non-Hematologic Adverse Events: Patients treated with nab-paclitaxel experienced a higher incidence of peripheral neuropathy (OR = 2.17, 95% CI: 1.38–3.40 for all grades; OR = 3.92, 95% CI: 2.44–6.28 for grade ≥3) but had fewer hypersensitivity reactions than those treated with conventional taxanes (OR = 0.29, 95% CI: 0.11–0.72).
  • Neurotoxicity: Nab-paclitaxel showed a notable risk for grade 3/4 neurotoxicity, although recovery times were shorter compared to traditional taxanes.
  • Nab-paclitaxel demonstrated enhanced efficacy in elderly NSCLC patients, particularly in squamous cell carcinoma and as a second-line treatment. In breast cancer, it was more effective in HER2-rich subtypes, tumors with Ki-67 > 20%, and TNBC patients, with higher pathological complete response rates observed.

Product Monograph / Prescribing Information

Document TitleYearSource
Abraxane (paclitaxel protein-bound particles) Prescribing Information.2020Bristol-Myers Squibb, Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The Omission of Anthracycline Chemotherapy in Women with Early HER2-Negative Breast Cancer-A Systematic Review and Meta-Analysis2024Current Oncology (toronto, Ont.)
Proteasome inhibitors in the treatment of nonsmall cell lung cancer: A systematic review of clinical evidence2023Health Science Reports
Efficacy and safety of nanoparticle albumin-bound paclitaxel in advanced non-small cell lung cancer: A systematic review and meta-analysis of clinical trials and observational studies2023Heliyon
Immunotherapy for advanced or metastatic urothelial carcinoma2023The Cochrane Database of Systematic Reviews
Efficacy and safety of nab-paclitaxel plus platinum in non-small cell lung cancer: a meta-analysis2023Frontiers in Medicine
Combination Chemotherapy with Selected Polyphenols in Preclinical and Clinical Studies-An Update Overview2023Molecules (basel, Switzerland)
Effectiveness and cost-effectiveness analysis of 11 treatment paths, seven first-line and three second-line treatments for Chinese patients with advanced wild-type squamous non-small cell lung cancer: A sequential model2023Frontiers in Public Health
A systemic review of taxanes and their side effects in metastatic breast cancer2022Frontiers in Oncology
Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer2022Cancer Treatment Reviews
Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with conventional taxanes in women with breast cancer: a systematic review and meta-analysis2022Annals of Palliative Medicine
Cost-effectiveness of pembrolizumab for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma in the United States2022Journal of Medical Economics
Adverse Event Profile for Nanoparticle Albumin-Bound Paclitaxel Compared With Solvent-Based Taxanes in Solid-Organ Tumors: A Systematic Review and Meta-Analysis of Randomized Clinical Trials2022The Annals of Pharmacotherapy
Cost-Effectiveness of Pembrolizumab Versus Carboplatin and Paclitaxel in Patients With Unresectable or Metastatic Melanoma After First-Line Treatment in China2022Value in Health Regional Issues
Adverse events of different chemotherapy regimens in the first-line treatment of patients with advanced or metastatic urothelial cancer: A systematic review and network meta-analysis of randomized controlled trials2021Seminars in Oncology
A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer2021Bmc Cancer
Relative Risk of Peripheral Neuropathy With Ado-Trastuzumab Emtansine (T-DM1) Compared to Taxane-Based Regimens in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Cancers: A Systematic Review and Meta-Analysis2021Cureus
Meta-analysis of nanoparticle albumin-bound paclitaxel used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data (JBCRG-S01 study)2021Breast Cancer (tokyo, Japan)
Comparison between nab-paclitaxel and solvent-based taxanes as neoadjuvant therapy in breast cancer: a systematic review and meta-analysis2021Bmc Cancer
Salvage systemic therapy for advanced gastric and oesophago-gastric junction adenocarcinoma2020The Cochrane Database of Systematic Reviews
The Efficacy and Safety of First-Line Chemotherapy in Patients With Non-small Cell Lung Cancer and Interstitial Lung Disease: A Systematic Review and Meta-Analysis2020Frontiers in Oncology
Is nab-paclitaxel better than conventional taxanes as neoadjuvant therapy for breast cancer? A meta-analysis2020The Journal of International Medical Research
The efficacy and safety of PD-1/PD-L1 inhibitors in breast cancer: a systematic review and meta-analysis2020Translational Cancer Research
Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis2020Scientific Reports
Cisplatin versus carboplatin in combination with third-generation drugs for advanced non-small cell lung cancer2020The Cochrane Database of Systematic Reviews
Efficacy and safety of nanoparticle albumin-bound paclitaxel in non-small cell lung cancer: a systematic review and meta-analysis2019Artificial Cells, Nanomedicine, and Biotechnology

Clinical Practice Guidelines

Document TitleYearSource
Non–small cell lung cancer, version 3.2022, NCCN clinical practice guidelines in oncology.2022Journal of the National Comprehensive Cancer Network
SEOM clinical guidelines for pancreatic and biliary tract cancer (2020).2021Clinical & Translational Oncology