A multicenter phase II randomized study of Cremophor‐free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline

Ranade, Anantbhushan; Bapsy, P. P.; Nag, Shona; Digumarti, Raghunadharao; Raina, Vinod; Advani, Suresh H.; Patil, Shekhar; Maru, Anish; Gangadharan, V P; Goswami, Chanchal; Sekhon, Jagdev S.; Sambasivaiah, K; Parikh, Purvish M.; Bakshi, Ashish; Mohapatra, Ranjan K.

doi:10.1111/ajco.12035

Cited by 15 publications

(9 citation statements)

References 12 publications

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“…We ultimately identified 22 independent studies published between March 2005 and March 2020 [9,10,12,13,16,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37]. A flow chart representing selection of studies is shown in Figure 1 Table 1.…”

Section: Identification and Characteristics Of Studiesmentioning

confidence: 99%

A Systematic Review and Meta-Analysis of Nab-Paclitaxel Mono-Chemotherapy for Metastatic Breast Cancer.

Zha

Zhang

et al. 2020

Preprint

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Background: Various clinical trials and real-life studies have tried to explore the value of nab-paclitaxel mono-chemotherapy for metastatic breast cancer (MBC). The safety and efficacy of nab-paclitaxel needs to be systematically evaluated. Methods : Electronic searches for prospective clinical trials containing nab-paclitaxel monotherapy for MBC were performed. Requisite data were extracted, integrated and analyzed from the included studies according to different purposes using systematic review and meta-analysis.Results: 22 studies with 3287 MBC patients were included. 1685 MBC patients received nab-paclitaxel as first-line therapy, 640 patients as further-line therapy, and 962 patients as mixed-line therapy. 1966 MBC patients (60.40%) received nab-paclitaxel weekly, while 1190 patients (36.56%) received nab-paclitaxel triweekly and 99 patients (3.04%) biweekly. The overall incidence of all grades neutropenia, leukopenia, peripheral sensory neuropathy, and fatigue was 52% (95% CI, 38%-66%), 58% (95% CI, 43%-73%), 58% (95% CI, 48%-68%), and 49% (95% CI, 41%-56%) respectively. The overall response rate (ORR) was 40% (95% CI, 35%-45%) and the clinical benefit rate (CBR) was 66% (95% CI, 59%-73%) following nab-paclitaxel monotherapy. The median progression free survival (PFS) was 7.64 months (95% CI, 6.89-8.40 months) and the median overall survival (OS) was 24.51 months (95% CI, 21.25-27.78 months). According to the meta-regression analysis, grade 3/4 neutropenia occurred less frequently in Her-2 negative patients compared with all population (P=0.046). Patients who received first-line nab-paclitaxel monotherapy showed higher ORR (P=0.006) and longer PFS (P=0.045). Patients who received further-line therapy was demonstrated to have shorter median OS versus first- and mixed-line therapy. Efficacy outcomes were not affected by the administration schedule. However, patients appeared to have more superior ORR (P=0.044) and longer PFS (P=0.03) along with the increasing dosage of nab-paclitaxel under the same schedule. Conclusions: Both weekly and triweekly nab-paclitaxel mono-chemotherapy were proved to be effective for MBC with generally reasonable toxicity profiles. Higher ORR, longer PFS and OS would be achieved in patients treated with nab-paclitaxel as first line. Increasing nab-paclitaxel dosage would result in better tumor control (higher ORR and PFS). Changing nab-paclitaxel schedule had no benefit on ameliorating the overall survival.

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Section: Identification and Characteristics Of Studiesmentioning

confidence: 99%

A Systematic Review and Meta-Analysis of Nab-Paclitaxel Mono-Chemotherapy for Metastatic Breast Cancer.

Zha

Zhang

et al. 2020

Preprint

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show abstract

“…We ultimately identi ed 22 independent studies published between March 2005 and March 2020 [9,10,12,13,16,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37]. A ow chart representing selection of studies is shown in Figure 1.…”

Section: Identi Cation and Characteristics Of Studiesmentioning

confidence: 99%

A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer

Zha

Zhang

et al. 2020

Preprint

View full text Add to dashboard Cite

Background Various clinical trials and real-life studies have tried to explore the value of nab-paclitaxel mono-chemotherapy for metastatic breast cancer (MBC). The safety and efficacy of nab-paclitaxel needs to be systematically evaluated. Methods Electronic searches for prospective clinical trials containing nab-paclitaxel monotherapy for MBC were performed. Requisite data were extracted, integrated and analyzed from the included studies according to different purposes using systematic review and meta-analysis. Results 22 studies with 3287 MBC patients were included. 1685 MBC patients received nab-paclitaxel as first-line therapy, 640 patients as further-line therapy, and 962 patients as mixed-line therapy. 1966 MBC patients (60.40%) received nab-paclitaxel weekly, while 1190 patients (36.56%) received nab-paclitaxel triweekly and 99 patients (3.04%) biweekly. The overall incidence of all grades neutropenia, leukopenia, peripheral sensory neuropathy, and fatigue was 52% (95% CI, 38%-66%), 58% (95% CI, 43%-73%), 58% (95% CI, 48%-68%), and 49% (95% CI, 41%-56%) respectively. The overall response rate (ORR) was 40% (95% CI, 35%-45%) and the clinical benefit rate (CBR) was 66% (95% CI, 59%-73%) following nab-paclitaxel monotherapy. The median progression free survival (PFS) was 7.64 months (95% CI, 6.89–8.40 months) and the median overall survival (OS) was 24.51 months (95% CI, 21.25–27.78 months). According to the meta-regression analysis, grade 3/4 neutropenia occurred less frequently in Her-2 negative patients compared with all population (P = 0.046). Patients who received first-line nab-paclitaxel monotherapy showed higher ORR (P = 0.006) and longer PFS (P = 0.045). Patients who received further-line therapy was demonstrated to have shorter median OS versus first- and mixed-line therapy. Efficacy outcomes were not affected by the administration schedule. However, patients appeared to have more superior ORR (P = 0.044) and longer PFS (P = 0.03) along with the increasing dosage of nab-paclitaxel under the same schedule. Conclusions Both weekly and triweekly nab-paclitaxel mono-chemotherapy were proved to be effective for MBC with generally reasonable toxicity profiles. Higher ORR, longer PFS and OS would be achieved in patients treated with nab-paclitaxel as first line. Increasing nab-paclitaxel dosage would result in better tumor control (higher ORR and PFS). Changing nab-paclitaxel schedule had no benefit on ameliorating the overall survival.

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“…The incidence of musculoskeletal events, gastrointestinal toxicity, and skin/subcutaneous toxicity were comparable in all the treatment arms. Overall, the nanoparticle polymer-based paclitaxel formulation was well-tolerated and could be safely administered without any premedication ( 55 ).…”

Section: Paclitaxelmentioning

confidence: 99%

[Experts' Opinion] Novel formulations of docetaxel, paclitaxel and doxorubicin in the management of metastatic breast cancer

et al. 2018

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The management of breast cancer with advanced disease or metastasis is a common problem in India and other countries. A panel of 13 oncology experts deliberated on the sidelines of the 35th Indian Cooperative Oncology Network Conference held in Mumbai to formulate an expert opinion recommendation on the novel drug delivery system (NDDS) formulations in the treatment of metastatic breast cancer (MBC). The survey comprised of 39 questions related to limitations of conventional formulations and therapeutic positioning of NDDS formulations of docetaxel, paclitaxel and doxorubicin in the management of MBC. The experts used data from published literature and their practical experience to provide expert opinion and recommendations for use by the community oncologists. The experts opined that the newer NDDS formulations should provide a significant efficacy advantage in terms of overall survival and progression-free survival, or demonstrate better tolerability when compared with conventional formulations. The newer NDDS formulations of taxanes should be considered in special circumstances such as diabetes, in patients who have had hypersensitivity reactions and in cases where steroids need to be avoided. The novel formulations of doxorubicin should be used in the elderly and in patients with borderline cardiac function.

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A multicenter phase II randomized study of Cremophor‐free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline

Abstract: NP is well tolerated and can be safely administered without any premedication in comparison to conventional paclitaxel, which requires the use of premedication before administration. NP demonstrates promising efficacy with a favorable safety profile.

Cited by 15 publications

References 12 publications

A Systematic Review and Meta-Analysis of Nab-Paclitaxel Mono-Chemotherapy for Metastatic Breast Cancer.

A Systematic Review and Meta-Analysis of Nab-Paclitaxel Mono-Chemotherapy for Metastatic Breast Cancer.

A systematic review and meta-analysis of nab-paclitaxel mono-chemotherapy for metastatic breast cancer

[Experts' Opinion] Novel formulations of docetaxel, paclitaxel and doxorubicin in the management of metastatic breast cancer

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