Neo-/adjuvant phase III trial to compare intense dose-dense (idd) treatment with EnPC to tailored dose-dense (dt) therapy with dtEC-dtD for patients with high-risk early breast cancer: Results on pathological complete response (pCR) for patients treated within the neoadjuvant setting.

Moebus, Volker; Noeding, S; Ladda, E.; Klare, Peter; Schmidt, Marcus; Schneeweiß, Andreas; Janni, Wolfgang; Marmé, Frederik; Reimer, Toralf; Schmatloch, Sabine; Stickeler, Elmar; Untch, Michael; Sinn, Bruno Valentin; Müller, Volkmar; Fasching, Peter A.; Minckwitz, Gϋnter von; Furlanetto, Jenny; Burchardi, Nicole; Loibl, Sibylle

doi:10.1200/jco.2018.36.15_suppl.568

Cited by 3 publications

(8 citation statements)

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“…The pCR rate was significantly higher in patients treated with neoadjuvant nab-paclitaxel than those with sb-taxanes regardless of the definition used (ypT0 ypN0: OR = 1.52, 95%CI: 1.27-1.83, P < 0.001; ypT0/is ypN0: OR = 1.40, 95%CI: 1.17-1.68, P < 0.001). Regarding the study by Moebus et al [22], due to differences in both the drug used and the dosing schedule, we also showed subtotal OR (ypT0 ypN0: OR = 1.58, 95%CI: 1.26-1.97) by removing this study, and the conclusion of the metaanalysis did not change (Figs. 2).…”

Section: Comparison Of Efficacy Based On Pcrsupporting

confidence: 46%

“…3a). Removing the study by Moebus et al [22], the subtotal OR of RCTs was 1.47 (95%CI: 1.21-1.79). The benefit of nab-paclitaxel over sb-taxanes on pCR were also consistent across different comparators (sb-paclitaxel, n = 5 studies or sb-docetaxel, n = 2 studies) (Fig.…”

Section: Comparison Of Efficacy In Subgroupsmentioning

confidence: 84%

“…The initial screening identified 406 papers that met the search parameters. After removing duplicates (n = 40 papers) and excluding papers based on article type/study design (n = 198 papers) and eligibility criteria (n = 159 papers), seven studies remained, including five RCTs [16,17,[19][20][21][22] and two non-RCTs [15,18] (Table 1). The number of patients per study ranged from 30 to 1206 in RCTs (total, n = 2667 patients) and from 120 to 162 in non-RCTs (total, n = 282 patients), with a total of 2949 patients across all studies.…”

Section: Study Retrieval and Selectionmentioning

confidence: 99%

“…Fig. 2 presents the forest plot of the pCR by different definitions [15][16][17][18][19][20][21][22]. In studies reporting pCR by ypT0 ypN0 (n = 5 studies), the pooled proportion of patients with pCR was 40.1% (429/1069) for nab-paclitaxel and 31.3% (333/1065) for sb-taxanes.…”

Section: Comparison Of Efficacy Based On Pcrmentioning

confidence: 99%

“…Also, in the previous meta-analysis, only three randomized controlled trials (RCTs) were included and showed that using nab-paclitaxel instead of conventional sb-taxanes could improve the pCR rate, with reasonable toxicities [14]. Since 2017, new comparative clinical studies were reported about nab-paclitaxel versus sb-taxanes, and long-term outcomes have been updated for some previous trials [15][16][17][18][19][20][21][22]. Therefore, a comprehensive assessment of the effects of neoadjuvant nabpaclitaxel versus sb-taxanes in breast cancer treatment is needed.…”

Section: Introductionmentioning

confidence: 99%

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Comparison between nab-paclitaxel and solvent-based taxanes as neoadjuvant therapy in breast cancer: a systematic review and meta-analysis

Miao

Liu

et al. 2021

BMC Cancer

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Background To compare the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and solvent-based taxanes (sb-taxanes) as neoadjuvant therapy in the treatment of breast cancer. Methods We systematically searched the PubMed, Embase, and Cochrane Central Register databases. Randomized controlled trials (RCTs) and cohort studies, published in English, about the comparison between nab-paclitaxel and sb-taxanes as neoadjuvant therapy in patients with breast cancer were searched up to September 2019. Results The primary outcome was the proportion of patients with pathological complete response (pCR, defined as ypT0 ypN0 or ypT0/is ypN0). Other main outcomes included long-term survival and adverse events (AEs). Seven studies (five RCTs and two cohorts) and 2949 patients were included. Neoadjuvant nab-paclitaxel improved pCR compared with sb-taxanes (ypT0 ypN0: OR = 1.52, 95%CI: 1.27–1.83, P < 0.001; ypT0/is ypN0: OR = 1.40, 95%CI: 1.17–1.68, P < 0.001). The benefits of nab-paclitaxel on pCR were persistent in HER2-negative, hormone receptor (HR)-positive breast cancer (OR = 1.53, 95%CI: 1.07–2.19, P = 0.020), triple-negative breast cancer (weekly/every 2 weeks regimen; OR = 2.95, 95%CI: 1.54–5.67, P < 0.001), and tumors with Ki-67 > 20% (OR = 1.63, 95%CI: 1.26–2.12, P < 0.001). Patients treated with nab-paclitaxel had better event-free survival (EFS; HR = 0.69, 95%CI: 0.57–0.85, P < 0.001) than with sb-taxanes. There were no differences in most of grade > 3 AEs between nab-paclitaxel and sb-taxanes (all P > 0.05), besides of any grade hypersensitivity (OR = 0.29, 95%CI: 0.11–0.72, P = 0.008), any grade (OR = 2.10, 95%CI: 1.37–3.23, P = 0.001) and grade > 3 (OR = 4.01, 95%CI: 2.51–6.41, P < 0.001) neuropathy. Conclusion Nab-paclitaxel is effective for the treatment of non-metastatic breast cancer in the neoadjuvant setting. Nab-paclitaxel could improve pCR rate and EFS compared with sb-taxanes and with reasonable toxicities.

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Section: Comparison Of Efficacy Based On Pcrsupporting

confidence: 46%

Section: Comparison Of Efficacy In Subgroupsmentioning

confidence: 84%