Paclitaxel (albumin-bound particles)

(Abraxane®)

Paclitaxel (albumin-bound particles)

Drug updated on 9/4/2024

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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  • Abraxane (paclitaxel (albumin-bound particles)) is 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. It is also 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. Additionally, it is used for the treatment of metastatic adenocarcinoma of the pancreas as first-line treatment in combination with gemcitabine.
  • This summary is based on the review of 26 systematic review(s)/meta-analysis(es). [1-26]
  • Overall Survival (OS) in Pancreatic Cancer: The NAPOLI 3 trial indicated shorter OS for GEM-NABP (10.4 months) compared to NALIRIFOX (11.1 months) and FOLFIRINOX (11.7 months). Retrospective studies showed no significant difference in OS between FOLFIRINOX and GnP (HR: 0.93). In neoadjuvant therapy, FOLFIRINOX showed superior OS compared to GEM/NAB in BRPC (22.0 vs. 16.9 months) and LAPC (17.1 vs. 12.5 months). A meta-analysis found similar OS between modified FOLFIRINOX and GEM-NAB (HR: 1.13).
  • Progression-Free Survival (PFS) in Pancreatic Cancer: In the NAPOLI 3 trial, median PFS was longer for NALIRIFOX (7.4 months) and FOLFIRINOX (7.3 months) compared to GEM-NABP (5.7 months). Retrospective studies associated FOLFIRINOX with increased PFS compared to GnP (HR: 0.88). FOLFIRINOX showed better PFS compared to GEM/NAB in neoadjuvant therapy for BRPC and LAPC (17.1 vs. 12.5 months). A meta-analysis found similar PFS between modified FOLFIRINOX and GEM-NAB (HR: 1.19).
  • Objective Response Rate (ORR) in Pancreatic Cancer: The NAPOLI 3 trial reported no significant differences in ORR among NALIRIFOX (41.8%), FOLFIRINOX (31.6%), and GEM-NABP (35.0%). Retrospective studies showed non-significant differences in ORR between FOLFIRINOX and GnP (OR: 0.90). GEM-NAB demonstrated varying ORR in neoadjuvant therapy for BRPC and LAPC, ranging from 0 to 67%.
  • Effectiveness in Breast Cancer and NSCLC: In breast cancer, nab-paclitaxel improved pCR compared to sb-taxanes (OR: 1.52), particularly in TNBC where it also enhanced EFS. In NSCLC, nab-paclitaxel showed improved ORR and PR rates compared to controls (RR: 1.35 and 1.34, respectively), along with better OS (HR: 0.90) and PFS (HR: 0.84).
  • NALIRIFOX had a lower incidence of grade ≥3 hematological toxic effects compared to GEM-NABP in pancreatic cancer patients, while GEM-NABP was associated with higher hematological toxicity and FOLFIRINOX caused more severe diarrhea.
  • Nab-paclitaxel increased the risks of sensory neuropathy in NSCLC and breast cancer patients compared to other treatments, with more frequent neuropathy observed compared to sb-taxanes.
  • Nab-paclitaxel combined with immune checkpoint inhibitors (ICIs) resulted in a lower risk of immune-related adverse events, such as pneumonitis and hyperthyroidism, compared to ICI monotherapy.
  • Significant differences in population types and subgroups were noted, with nab-paclitaxel showing higher efficacy in improving pCR rates for triple-negative breast cancer (TNBC) patients and demonstrating more significant therapeutic benefits and higher toxicity in Asian populations with dose-dense regimens.

Product Monograph / Prescribing Information

Document TitleYearSource
Abraxane (paclitaxel) Prescribing Information.2020Celgene Corporation., Summit, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
NALIRIFOX, FOLFIRINOX, and gemcitabine with nab-paclitaxel as first-line chemotherapy for metastatic pancreatic cancer: a systematic review and meta-analysis.2024JAMA Network Open
Folfirinox vs. Gemcitabine + Nab-Paclitaxel as the first-line treatment for pancreatic cancer: a systematic review and meta-analysis.2023World Journal of Oncology
FOLFIRINOX or Gemcitabine-based chemotherapy for borderline resectable and locally advanced pancreatic cancer: a multi-institutional, patient-level, meta-analysis and systematic review.2023Annals of Surgical Oncology
Synergistic effects of flavonoids and paclitaxel in cancer treatment: a systematic review.2023Cancer cell International
Immune-related adverse events associated with nab-paclitaxel/paclitaxel combined with immune checkpoint inhibitors: a systematic review and network meta-analysis.2023Frontiers in Immunology
Dose-dense regimen versus conventional three-weekly paclitaxel combination with carboplatin chemotherapy in first-line ovarian cancer treatment: a systematic review and meta-analysis.2023Journal of Ovarian Research
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 studies.2023Heliyon
Efficacy and safety of neoadjuvant therapy for triple-negative breast cancer: a Bayesian network meta-analysis.2022Expert Review of Anticancer Therapy
Efficacy and safety of neoadjuvant Folfirinox and Gemcitabine plus Nab-Paclitaxel for borderline resectable and locally advanced pancreatic cancer: a systematic review and meta-analysis.2022European Review for Medical and Pharmacological Sciences
A network meta-analysis for efficacies and toxicities of different concurrent chemoradiotherapy regimens in the treatment of locally advanced non-small cell lung cancer.2022BMC Cancer
Efficacy and safety of adding bevacizumab biosimilar or original drug to platinum-based chemotherapy as first-line treatment in patients with advanced NSCLC: a systematic review and meta-analysis.2022Therapeutic Advances in Medical Oncology
A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer.2021BMC Cancer
Potentially overestimated efficacy of nanoparticle albumin-bound paclitaxel compared with solvent-based paclitaxel in breast cancer: a systemic review and meta-analysis.2021Journal of Cancer
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 trials.2021Annals of Pharmacotherapy
Comparison between nab-paclitaxel and solvent-based taxanes as neoadjuvant therapy in breast cancer: a systematic review and meta-analysis.2021BMC Cancer
Efficacy and safety of neoadjuvant gemcitabine plus nab-paclitaxel in borderline resectable and locally advanced pancreatic cancer-a systematic review and meta-analysis.2021Cancers
Head-to-head comparison between FOLFIRINOX and gemcitabine plus nab-paclitaxel in the neoadjuvant chemotherapy of localized pancreatic cancer: a systematic review and meta-analysis.2021Gland Surgery
Meta-analysis and indirect treatment comparison of modified FOLFIRINOX and gemcitabine plus nab-paclitaxel as first-line chemotherapy in advanced pancreatic cancer.2021BMC Cancer
Neoadjuvant chemotherapy in early triple-negative breast cancer: a pairwise and network meta-analysis of pathological complete response.2021Inquiry
Effectiveness and safety of adding bevacizumab to platinum-based chemotherapy as first-line treatment for advanced non-small-cell lung cancer: a meta-analysis.2021Frontiers in Medicine
Is nab-paclitaxel better than conventional taxanes as neoadjuvant therapy for breast cancer? A meta-analysis.2020Journal of International Medical Research
Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: a meta-analysis.2020Scientific Reports
Efficacy and safety of nanoparticle albumin-bound paclitaxel in non-small cell lung cancer: a systematic review and meta-analysis.2019Artificial Cells, Nanomedicine, and Biotechnology
Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review.2019Therapeutic Advances in Medical Oncology
Nab-paclitaxel plus gemcitabine as first-line treatment for advanced pancreatic cancer: a systematic review and meta-analysis.2019Journal of Cancer
Triple negative breast cancer and platinum-based systemic treatment: a meta-analysis and systematic review.2019BMC Cancer

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