2LBA Fulvestrant Alone or with Concomitant Anastrozole Vs Exemestane Following Progression On Non-steroidal Aromatase Inhibitor – First Results of the SoFEa Trial (CRUKE/03/021 &amp; CRUK/09/007) (ISRCTN44195747)

Johnston, S.; Kilburn, Lucy; Ellis, P.; Cameron, D.; Dodwell, D.; Howell, Anthony; Im, Y-H.; Coombes, Gill; Dowsett, Mitch; Bliss, J

doi:10.1016/s0959-8049(12)70687-1

Cited by 19 publications

(14 citation statements)

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“…Sequential et remains the goal of treatment for these patients 5 . Four large phase iii trials-efect, sofea, confirm, and bolero-2-assessed the benefits of particular et regimens in this patient population [31][32][33]41 . Those studies demonstrated that F250 and exe are of comparable efficacy and that, compared with fulvestrant alone, the addition of anastrozole to fulvestrant does not improve outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Results from four large phase iii trials evaluating et for postmenopausal patients with hr+ abc that relapsed or progressed on prior nsai therapy have been reported to date ( Figure 1) [31][32][33]41 .…”

Section: Overview Of Key Trials Of Et For Hr+ Her2-abc Patients Resismentioning

confidence: 99%

“…This threearm trial accrued 750 hr+ patients and compared an intramuscular injection of fulvestrant [beginning with a loading dose of 500 mg, followed by 250 mg on day 15, and monthly thereafter (F250)] plus an oral daily dose of anastrozole 1 mg with F250 plus placebo and with an oral daily dose of exe 25 mg (Figure 1) 32 . Baseline patient and disease characteristics were balanced between the treatment arms, and the primary endpoint was progression-free survival (pfs In both the foregoing trials, F250 and exe were well tolerated, with low rates of treatment discontinuation because of toxicity and low rates of serious adverse events.…”

Section: Overview Of Key Trials Of Et For Hr+ Her2-abc Patients Resismentioning

confidence: 99%

“…For patients with more indolent visceral disease or those declining chemotherapy, a number of treatment options, including exe, F250, F500, and eve plus exe are available [31][32][33]41 . The strength of the evidence and the magnitude of clinical benefit observed in bolero-2 supports the use of eve plus exe in patients with asymptomatic or minimally symptomatic visceral disease, regardless of disease extent and receipt of prior chemotherapy.…”

Section: 32mentioning

confidence: 99%

“…Recommendation Many treatment options are available to elderly postmenopausal hr+ her2-patients who have recurrent or progressive disease on prior nsai therapy, including exe, F250, F500, and eve plus exe [31][32][33]41 . Clinical judgment should be used when selecting an et, and elderly patients should be well informed about the need for early toxicity reporting.…”

Section: 42mentioning

confidence: 99%

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Endocrine Therapy for Postmenopausal Women with Hormone Receptor–Positive her2–Negative Advanced Breast Cancer after Progression or Recurrence on Nonsteroidal Aromatase Inhibitor Therapy: A Canadian Consensus Statement

et al. 2013

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Approximately 22,700 Canadian women were expected to be diagnosed with breast cancer in 2012. Despite improvements in screening and adjuvant treatment options, a substantial number of postmenopausal women with hormone receptor positive (hr+) breast cancer will continue to develop metastatic disease during or after adjuvant endocrine therapy. Guidance on the selection of endocrine therapy for patients with hr+ disease that is negative for the human epidermal growth factor receptor 2 (her2–) and that has relapsed or progressed on earlier nonsteroidal aromatase inhibitor (nsai) therapy is of increasing clinical importance. Exemestane, fulvestrant, and tamoxifen are approved therapeutic options in this context. Four phase iii trials involving 2876 patients—efect, sofea, confirm, and bolero-2—have assessed the efficacy of various treatment options in this clinical setting. Data from those trials suggest that standard-dose fulvestrant (250 mg monthly) and exemestane are of comparable efficacy, that doubling the dose of fulvestrant from 250 mg to 500 mg monthly results in a 15% reduction in the risk of progression, and that adding everolimus to exemestane (compared with exemestane alone) results in a 57% reduction in the risk of progression, albeit with increased toxicity. Multiple treatment options are now available to women with hr+ her2– advanced breast cancer recurring or progressing on earlier nsai therapy, although current clinical trial data suggest more robust clinical efficacy with everolimus plus exemestane. Consideration should be given to the patient’s age, functional status, and comorbidities during selection of an endocrine therapy, and use of a proactive everolimus safety management strategy is encouraged.

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Section: Discussionmentioning

confidence: 99%

Section: Overview Of Key Trials Of Et For Hr+ Her2-abc Patients Resismentioning

confidence: 99%

Section: Overview Of Key Trials Of Et For Hr+ Her2-abc Patients Resismentioning

confidence: 99%

Section: 32mentioning

confidence: 99%

Section: 42mentioning

confidence: 99%

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Endocrine Therapy for Postmenopausal Women with Hormone Receptor–Positive her2–Negative Advanced Breast Cancer after Progression or Recurrence on Nonsteroidal Aromatase Inhibitor Therapy: A Canadian Consensus Statement

et al. 2013

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Fulvestrant for hormone-sensitive metastatic breast cancer

Lee

Goodwin

Wilcken

2017

Cochrane Database of Systematic Reviews

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For postmenopausal women with advanced hormone-sensitive breast cancer, fulvestrant is at least as effective and safe as the comparator endocrine therapies in the included studies. However, fulvestrant may be potentially more effective than current therapies when given at 500 mg, though this higher dosage was used in only one of the nine studies included in the review. We saw no advantage with combination therapy, and fulvestrant was equally as effective as control therapies in both the first- and second-line setting. Our review demonstrates that fulvestrant is a safe and effective systemic therapy and can be considered as a valid option in the sequence of treatments for postmenopausal women with hormone-sensitive advanced breast cancer.

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Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/recurrence after endocrine therapy: a network meta-analysis

Bachelot

McCool

Duffy

et al. 2013

Breast Cancer Res Treat

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Postmenopausal women with advanced breast cancer recurring/progressing on or after initial (adjuvant or first-line) endocrine therapy may be treated multiple times with one of several endocrine or combinatorial targeted treatment options before initiating chemotherapy. In the absence of direct head-to-head comparisons of these treatment options, an indirect comparison can inform treatment choice. This network meta-analysis compared the efficacy of everolimus plus exemestane with that of fulvestrant 250 and 500 mg in the advanced breast cancer setting following adjuvant or first-line endocrine therapy. The reported hazard ratios (HRs) for progression-free survival (PFS) or time to progression from six studies that formed a network to compare everolimus plus exemestane (BOLERO-2 trial) with fulvestrant were analyzed by means of a Bayesian network meta-analysis. In the primary comparison (PFS analysis based on the local review of disease progression from BOLERO-2 with the data from the other studies), everolimus plus exemestane appeared to be more efficacious than both fulvestrant 250 mg (HR = 0.47; 95 % credible interval [CrI] 0.38–0.58) and 500 mg (HR = 0.59; 95 % CrI 0.45–0.77). Similar results were obtained in an alternate comparison based on central review of disease progression from BOLERO-2 with the data from the other studies (HR = 0.40; 95 % CrI 0.31–0.51 and HR = 0.50; 95 % CrI 0.37–0.67, respectively), and in a subgroup analysis of patients who had received prior aromatase inhibitor therapy (HR = 0.47; 95 % CrI 0.38–0.58 and HR = 0.55; 95 % CrI 0.40–0.76, respectively). These results suggest that everolimus plus exemestane may be more efficacious than fulvestrant in patients with advanced breast cancer who progress on or after adjuvant or first-line therapy with a nonsteroidal aromatase inhibitor.

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2LBA Fulvestrant Alone or with Concomitant Anastrozole Vs Exemestane Following Progression On Non-steroidal Aromatase Inhibitor – First Results of the SoFEa Trial (CRUKE/03/021 & CRUK/09/007) (ISRCTN44195747)

Cited by 19 publications

References 0 publications

Endocrine Therapy for Postmenopausal Women with Hormone Receptor–Positive her2–Negative Advanced Breast Cancer after Progression or Recurrence on Nonsteroidal Aromatase Inhibitor Therapy: A Canadian Consensus Statement

Endocrine Therapy for Postmenopausal Women with Hormone Receptor–Positive her2–Negative Advanced Breast Cancer after Progression or Recurrence on Nonsteroidal Aromatase Inhibitor Therapy: A Canadian Consensus Statement

Fulvestrant for hormone-sensitive metastatic breast cancer

Comparative efficacy of everolimus plus exemestane versus fulvestrant for hormone-receptor-positive advanced breast cancer following progression/recurrence after endocrine therapy: a network meta-analysis

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