First-line bevacizumab plus paclitaxel in Japanese patients with HER2-negative metastatic breast cancer: subgroup results from the randomized Phase III MERiDiAN trial

Masuda, Norikazu; Takahashi, Masato; Nakagami, Kazuhiko; Okumura, Yasuhiro; Nakayama, Takahiro; Sato, Nobuaki; Kanatani, Kazumitsu; Tajima, Kosei; Kashiwaba, Masahiro

doi:10.1093/jjco/hyx001

Cited by 11 publications

(11 citation statements)

References 13 publications

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“…Safety results in the Japanese subgroup population were consistent with the overall population, although there was a higher incidence of alopecia, peripheral sensory neuropathy, decreased neutrophil count, nasopharyngitis and decreased white blood cell count and a lower incidence of fatigue than in the overall population. Higher incidences of neutropenia and peripheral sensory neuropathy in Japanese and Asian patients have also been reported in other clinical trials (24, 26–29). Overall, atezolizumab was well tolerated with no treatment-related deaths, although more patients in the atezolizumab arm had neutrophil count decreases, nasopharyngitis, white blood cell count decreases, stomatitis, vomiting and pruritis than patients in the placebo arm.…”

Section: Discussionsupporting

confidence: 69%

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Iwata

Inoue

Kaneko

et al. 2019

Japanese Journal of Clinical Oncology

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Background In the randomised Phase 3 IMpassion130 trial, atezolizumab combined with nab-paclitaxel (atezo + nab-P) in 902 patients with triple-negative breast cancer (TNBC) showed prolonged progression-free survival (PFS) in both the intention-to-treat (ITT) population and programmed death-ligand 1 (PD-L1)–positive subgroup compared with placebo plus nab-P (plac + nab-P). This study assessed the efficacy and safety of atezo + nab-P in the IMpassion130 Japanese subpopulation. Methods Eligible patients had unresectable locally advanced or metastatic TNBC previously untreated with chemotherapy for metastatic disease. Patients were randomised 1:1 to receive either atezo + nab-P or plac + nab-P. Co-primary endpoints were investigator-assessed PFS and overall survival (ITT population and PD-L1–positive subgroup). These were also assessed in the Japanese subpopulation. Results There were 65 Japanese patients (34 atezo + nab-P; 31 plac + nab-P). The PD-L1–positive subgroup included 25 patients (12 atezo + nab-P; 13 plac + nab-P). Median PFS was 7.4 months (atezo + nab-P) versus 4.6 months (plac + nab-P; hazard ratio [HR], 0.47; 95% CI, 0.25–0.90). In the PD-L1–positive subgroup, median PFS was 10.8 months (atezo + nab-P) versus 3.8 months (plac + nab-P; HR, 0.04; 95% CI, <0.01–0.35). Safety results in the Japanese subgroup were consistent with those in the overall population. The Japanese subgroup had a lower incidence of adverse events leading to treatment withdrawal than the overall population. More patients in the atezo + nab-P arm had neutrophil count decreases and stomatitis than patients in the plac + nab-P arm. Conclusions Atezo + nab-P efficacy in Japanese patients was consistent with the overall IMpassion130 population. No new safety signals were observed, and tolerability was consistent with that of the overall population.

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Section: Discussionsupporting

confidence: 69%

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Iwata

Inoue

Kaneko

et al. 2019

Japanese Journal of Clinical Oncology

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“…The use of indirect comparisons within this network meta-analysis adds additional information beyond the multiple direct comparison meta-analysis that have compared Bev + Tax, Bev + Cap, Bev + Tax+-Cap with Tax, Cap and with other new chemotherapy. According to our results, it is certain that the addition of bevacizumab improved PFS and ORR compared with chemotherapy alone, which is consistent with previous studies [7,8,21]. Moreover, we found that more patients who received Bev + Tax had an objective response than did those who received Bev + Cap, and that Bev + Tax is superior to Bev + Cap in therapeutic strategies ranking, but there was no significant difference between Bev + Tax and Bev + Cap on PFS in HER2-negative breast cancer.…”

Section: Discussionsupporting

confidence: 93%

“…Finally, sixteen studies were identified involving 589 patients that fulfilled the inclusion criteria in Fig. 1 [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Figure 2 demonstrates all available direct comparisons across outcomes in this network meta-analysis.…”

Section: Search Resultsmentioning

confidence: 99%

“…In four randomized controlled trials (RCTs), adding bevacizumab to taxanes for HER2-negative metastatic breast cancer significantly increased PFS and ORR, while combination of bevacizumab with taxanes did certainly impact on the safety profile of taxanes [7][8][9][10]. The RCT has showed that patients receiving bevacizumab-taxanes have better PFS and objective response than receiving bevacizumab-capecitabine as first-line treatment for HER2-negative metastatic breast cancer [11].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy of bevacizumab combined with chemotherapy in the treatment of HER2-negative metastatic breast cancer: a network meta-analysis

Sun

Lan

et al. 2020

BMC Cancer

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Background: It is not known what combination of bevacizumab and chemotherapy agents is the best therapeutic regimen. Comparative study results among the efficacies of bevacizumab plus chemotherapy remain controversial in patients with HER2-negative metastatic breast cancer. Methods: We searched Pubmed, Embase, and Cochrane Library Central Resister of Controlled Trials through were July 2019 for randomized controlled trials that evaluated the efficacy of bevacizumab plus chemotherapy in HER2negative metastatic breast cancer. Data on included study characteristics, outcomes, and risk of bias were abstracted by two reviewers. Results: A total of 16 RCT studies involving 5689 patients were included. The results showed that bevacizumab (Bev)-taxanes (Tax)-capecitabine (Cap) has highest-ranking and is probably more effective for prolonging progression-free survival (PFS) than Tax, Cap, Bev-Tax and Bev-Cap, which was no convincing differences among Bev-Cap-vinorelbine, Bev-Tax-everolimus, Bev-Tax-trebananib, Bev-exemestane, Bev-Cap-cyclophosphamide in Bevcontaining regimens. For overall response rate (ORR), Bev-Tax-Cap is superior to Tax, Cap and Bev-Cap, while Bev-Tax-trebananib is superior to Cap. The cumulative probability ranking showed that Bev-Tax-Cap or Bev-Taxtrebananib may have best pathological response rate in HER2-negative metastatic breast cancer. Conclusion: Our results provide moderate quality evidence that bevacizumab-taxanes-capecitabine maybe the most effective bevacizumab plus chemotherapy on PFS and ORR in HER2-negative metastatic breast cancer, however it should be also considered that bevacizumab may add toxicity to chemotherapy and whether improve overall survival (OS) or not.

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“…No evidence in support of the predictive role of pVEGF-A emerged from the MERiDian trial or from the separately published analysis exclusively focused on the subgroup of Japanese patients from this same study. 5,6 We have previously addressed treatment outcomes in a larger cohort of HER2-negative MBC patients treated with bevacizumab and paclitaxel in first-line chemotherapy. 7 In light of the evidence emerged from recent literature and within our previously established research pipeline on the role of anthropometric and metabolic determinants of treatment efficacy in breast and ovarian cancer, we have now focused on a more restricted subgroup of patients from the original cohort with available data on body mass index (BMI) values at baseline assessment.…”

Section: Introductionmentioning

confidence: 99%

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

Pizzuti

Sergi

Sperduti

et al. 2018

Cancer Biology & Therapy

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The evidence emerged from the TOURANDOT trial encourages evaluating the role of anthropometric determinants on treatment outcomes in HER2-negative metastatic breast cancer patients treated with bevacizumab-including regimens. We thus analyzed data from a subgroup of these patients from a larger cohort previously assessed for treatment outcomes. Patients were included in the present analysis if body mass index values had been recorded at baseline. Clinical benefit rates, progression free survival and overall survival were assessed for the overall study population and subgroups defined upon molecular subtype. One hundred ninety six patients were included (N:196). Body mass index showed no impact on clinical benefit rates in the overall study sample and in the luminal cancer subset (p = 0.12 and p = 0.79, respectively), but did so in the triple negative subgroup, with higher rates in patients with body mass index ≥25 (p = 0.03). In the overall study sample, body mass index did no impact progression free or overall survival (p = 0.33 and p = 0.67, respectively). Conversely, in triple negative patients, progression free survival was significantly longer with body mass index ≥25 (6 vs 14 months, p = 0.04). In this subset, overall survival was more favorable (25 vs 19 months, p = 0.02). The impact of the molecular subtype was confirmed in multivariate models including the length of progression free survival, and number of metastatic sites (p < 0.0001). Further studies are warranted to confirm our findings in more adequately sized, ad hoc, prospective studies.

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First-line bevacizumab plus paclitaxel in Japanese patients with HER2-negative metastatic breast cancer: subgroup results from the randomized Phase III MERiDiAN trial

Abstract: Bevacizumab-paclitaxel efficacy in Japanese patients was consistent with the MERiDiAN ITT population. No new safety signals were seen and tolerability was consistent with previous experience.

Cited by 11 publications

References 13 publications

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Subgroup analysis of Japanese patients in a Phase 3 study of atezolizumab in advanced triple-negative breast cancer (IMpassion130)

Efficacy of bevacizumab combined with chemotherapy in the treatment of HER2-negative metastatic breast cancer: a network meta-analysis

Body mass index in HER2-negative metastatic breast cancer treated with first-line paclitaxel and bevacizumab

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