Role of nab-paclitaxel in metastatic breast cancer: a meta-analysis of randomized clinical trials

Liu, Yun; Ye, Guoxin; Yan, Dali; Zhang, Lei; Fan, Fan; Feng, Jifeng

doi:10.18632/oncotarget.18900

Cited by 25 publications

(22 citation statements)

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“…There is no evidence that paclitaxel agents (solvent based or nanoparticle bound) are less effective than docetaxel; on the contrary, nab-paclitaxel demonstrated improved PFS compared with docetaxel in a prospective randomised trial [8]. Nanoparticle albumin-bound (nab)-paclitaxel appears to offer similar efficacy to docetaxel, with less frequent neutropenia but more frequent sensory neuropathy [9,10]. A single-arm study (N ¼ 51) evaluating weekly paclitaxel combined with trastuzumab and pertuzumab as first-or second-line therapy reported median PFS of 25.7 months and median OS of 33 months [11].…”

Section: Introductionmentioning

confidence: 99%

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Bachelot¹,

Ciruelos²,

Schneeweiß³

et al. 2019

Annals of Oncology

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See Appendix for individual names.Background: Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting. Patients and methods:In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8 mg/kg loading dose, then 6 mg/kg every 3 weeks (q3w)] and pertuzumab (840 mg loading dose, then 420 mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS). Results:Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nabpaclitaxel in 65; 7 discontinued before starting taxane). Median age was 54 years; 29% had received prior trastuzumab. Median treatment duration was 16 months for pertuzumab and trastuzumab and 4 months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months' median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9-22.7] months overall (19.6, 23.0 and 18.1 months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%-82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%).Conclusions: Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile.ClinicalTrials.gov: NCT01572038.

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Section: Introductionmentioning

confidence: 99%

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Bachelot¹,

Ciruelos²,

Schneeweiß³

et al. 2019

Annals of Oncology

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“…In Arm A, G2 neurotoxicity was reported after a median of 6.5 cycles (range, 2-11), with G3 reported after a median of 6 cycles (range, 3-9). In contrast, G2 neurotoxicity was reported in Arm B after a median of 5 cycles (range, 1-11), with G3 reported after a median of 4.5 cycles (range, [3][4][5][6][7][8]. Severe AEs were reported in ten patients (13%) in each arm.…”

Section: Safetymentioning

confidence: 94%

“…However, close monitoring is required as treatment-induced side-effects, particularly neurotoxicity and fatigue, place older patients at risk of subsequent functional decline (FD) (3)(4)(5). Nanoparticle albumin-bound paclitaxel (nabpaclitaxel) does not require steroid premedication, and is associated with a lower rate of hypersensitivity reactions (6)(7)(8), thus representing an efficacious and safe alternative to solventbased taxanes. Additionally, recovery from nab-paclitaxel-induced neurotoxicity is reputedly shorter than with solvent-based taxanes (6,7), which may subsequently produce a reduction in negative functional impact.…”

Section: Introductionmentioning

confidence: 99%

EFFECT: A Randomized Phase II Study of Efficacy and Impact on Function of Two Doses of Nab-paclitaxel as First-line Treatment in Older Women with Advanced Breast Cancer

Biganzoli

Cinieri²,

Berardi

et al. 2020

Preprint

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BackgroundLimited data are available on nab-paclitaxel in older breast cancer patients, with this population being under-represented in clinical trial. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population.MethodsEFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m2 (Arm A) or 125 mg/m2 (Arm B) on days 1,8,15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD) or death.ResultsAfter a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9-8.9) in Arm A, versus 8.3 months (90% CI, 6.2-9.7) in Arm B. Progression-free survival, overall survival and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in Arm B. The most frequently reported non-hematological AEs were fatigue (grade [G] 2-3 toxicity occurrence in Arm A versus B: 43% and 51%, respectively) and peripheral neuropathy (G2-3 Arm A versus B: 19% and 38%, respectively).ConclusionThe two weekly nab-paclitaxel regimens were comparable in all pre-specified outcomes. However, 100 mg/m2 was significantly better tolerated with fewer neurotoxicity-related events, representing a more feasible dose to be recommended for older patients with advanced disease.

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confidence: 99%

“…treatment of metastatic breast cancer (MBC), and they concluded that nab-paclitaxel was associated with more frequent sensory neuropathy, but only equivalent survival and possibly higher overall response for only some specific subgroups 7 . They also cited that nab-paclitaxel chemotherapy was more expensive than conventional sb-taxane chemotherapy 7 . The findings of Liu et al seemed to be affected largely by the phase III trial of Rugo et al In this trial, they administered bevacizumab (10 mg/kg, day1, day15), along with nab-paclitaxel (for the experimental arm) or sb-paclitaxel (for the control arm) to chemotherapy-naive MBC patients.…”

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confidence: 99%

Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis

Lee

Park

Kang

et al. 2020

Sci Rep

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The curative effects of nanoparticle albumin-bound (nab)-paclitaxel in the first-line treatment of metastatic breast cancer (MBC) are still controversial, with even more after the removal of marketing approval of indication of bevacizumab. Five electronic databases and the related resources were searched for eligible randomized clinical trials (RCTs) without year and language restrictions to perform a meta-analysis. The studies were comparing the efficacy and safety between nab-paclitaxel chemotherapy versus solvent-based (sb)-taxanes chemotherapy such as sb-paclitaxel and docetaxel. The primary end points were overall response rate (ORR) and disease control rate (DCR). Secondary end points were progression-free survival (PFS), overall survival (OS), adverse events (AEs), and dose discontinuation rate (DDR). Five RCTs (1,554 patients) were finally identified from 1,902 studies. When compared to sb-paclitaxel, nab-paclitaxel showed significant beneficial effects in terms of ORR (OR 2.39, 95% CI 1.69-3.37, p < 0.001), DCR (OR 1.89, 95% CI 1.07-3.35, p = 0.03), and PFS (HR 0.75, 95% CI 0.62-0.90, p = 0.002). Nab-paclitaxel also showed significantly longer OS (HR 0.73, 95% CI 0.54-0.99, p = 0.04) than docetaxel. AEs and DDR were comparable between the two arms. Using nab-paclitaxel could significantly improve efficacy with comparable toxicities in the treatment of MBC. Nanoparticle albumin-bound (nab) paclitaxel is solvent free and employs a novel delivery mechanism for paclitaxel to tumors 1. Although nab-paclitaxel was initially developed to minimize the toxic effects of taxane treatment, several early clinical trials demonstrated that nab-paclitaxel was also more effective than the conventional solvent-based (sb) paclitaxel in the treatment of metastatic breast cancer 2-5. However, recent randomized controlled trials (RCTs) have suggested that nab-paclitaxel chemotherapy is not as efficacious as sb-taxanes, such as sb-paclitaxel and docetaxel, and that nab-paclitaxel is often associated with more frequent adverse events 6. For example, Rugo et al. showed that nab-paclitaxel was not superior to sb-paclitaxel (progression-free survival [PFS] 9.3 months vs 11 months, hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.00-1.45, p = 0.054). Results were concordant with overall survival (OS), and time to treatment failure was significantly shorter in the nab-paclitaxel arm vs the sb-paclitaxel arm 6. Hematologic and non-hematologic toxicity, including peripheral neuropathy, was more prevalent in the nab-paclitaxel arm, which also had more frequent and earlier dose reductions 6. After these conflicting results were generated, Liu et al. conducted a first meta-analysis of randomized clinical trials to evaluate the efficacy and toxicity of nab-paclitaxel compared with sb-paclitaxel and docetaxel in the

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Role of nab-paclitaxel in metastatic breast cancer: a meta-analysis of randomized clinical trials

Cited by 25 publications

References 40 publications

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

EFFECT: A Randomized Phase II Study of Efficacy and Impact on Function of Two Doses of Nab-paclitaxel as First-line Treatment in Older Women with Advanced Breast Cancer

Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis

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