Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 100 mg) |
Drug Class | Microtubule 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Abraxane (paclitaxel) Prescribing Information. | 2020 | Celgene Corporation., Summit, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Non–small cell lung cancer, version 3.2022, NCCN clinical practice guidelines in oncology. | 2022 | Journal of the National Comprehensive Cancer Network |
SEOM clinical guidelines for pancreatic and biliary tract cancer (2020). | 2021 | Clinical & Translational Oncology |