Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor

Yamamoto, Yutaka; Masuda, Norikazu; Ohtake, Tohru; Yamashita, Hiroko; Kimijima, Izo; Kasahara, Yoshio; Ishikawa, Takashi; Sawaki, Masataka; Hozumi, Yasuo; Iwase, Hirotaka

doi:10.1007/s12282-009-0148-2

Cited by 11 publications

(14 citation statements)

References 18 publications

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“…Several studies showed that constitutively active ESR1 ligand-binding domain mutations in pretreated advanced ER-positive breast cancers confer partial resistance to antiestrogens such as tamoxifen and fulvestrant, and higher doses of these drugs could inhibit mutant ERα tumors [18][19][20]. Yamamoto and colleagues demonstrated that high-dose toremifene (120 mg daily) was effective in patients with metastatic breast cancer who showed progression of the disease during aromatase inhibitors therapy, although the mechanisms of action of high-dose toremifene have not fully been understood [14,21]. It is suggested that high-dose SERMs and fulvestrant 500 mg might be effective in tumors with constitutively active ESR1 mutations.…”

Section: Discussionmentioning

confidence: 99%

Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

et al. 2015

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Section: Discussionmentioning

confidence: 99%

Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

et al. 2015

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“…In a larger retrospective study in which the efficacy of 120 mg TOR was analyzed with AI-failure cases (n=80), ORR and CB were 15 and 45%, respectively (19). In cases where tamoxifen preceded AI, high-dose TOR was effective for tamoxifenresistant breast cancer (20)(21)(22).…”

Section: Discussionmentioning

confidence: 99%

High-dose toremifene as first-line treatment of metastatic breast cancer resistant to adjuvant aromatase inhibitor: A multicenter phase II study

et al. 2011

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Abstract. There is currently no standardized therapy available for metastatic breast cancer in patients with aromatase inhibitor (AI)-resistant breast cancer. We conducted a prospective study to examine the efficacy and safety of high-dose toremifene (TOR) treatment for the first-line treatment of metastatic breast cancer following AI adjuvant therapy. A multicenter phase II study was designed (Registry no.: UMIN000000489). Inclusion criteria comprised hormone-responsive postmenopausal women who had received adjuvant AI postoperatively for >1 year and had relapsed during the treatment or within 12 months of completion of adjuvant therapy. Treatment comprised oral intake of 120 mg TOR once a day. The primary endpoint was objective response rate (ORR). The secondary endpoints were evaluations of clinical benefit (CB), progression-free survival (PFS) and toxicity. A total of 13 patients were enrolled. ORR was 7.7% (1/13) [95% CI, 0.2-36.0%]. In total, 7 patients (53.8%) had stable disease (SD), 5 of whom were long SD, and 5 patients (38.5%) experienced progressive disease (PD). The CB rate was 46.2% (6/13) [95% CI, 19.2-74.9%]. The median time to PFS was 5.9 months. No serious adverse events were observed. Patients with HER2-positive disease exhibited marginally poorer PFS (p= 0.08). Patients with PD had a relatively short duration of AI treatment in contrast to responders, who had a longer period of AI treatment (p=0.02). High-dose TOR as a first-line treatment following AI adjuvant therapy was effective and well tolerated. A longer duration of adjuvant AI therapy and negative HER2 overexpression may, with further studies, be beneficial as positive predictive factors for the effectiveness of TOR treatment.

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“…The OR was 4.2 -10.0% and the clinical benefit rate was 20.0 -40.0%. Regarding TOR, a high dose TOR showed OR of 15% and CB rate of 45.0% in a retrospective study 12) , and it is suggested that high 13) . And high dose TOR has shown efficacy in patients who progressed on TAM 14,15) .…”

Section: Discussionmentioning

confidence: 95%

Prospective Study on the Effect of Toremifene in Patients With Adjuvant Anastrozole Failure in Postmenopausal Breast Cancer

Nishimura

Nakamura

Oba

et al. 2011

Ann. Cancer Res. Therap.

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Purpose; An endocrine treatment using aromatase inhibitor (AI) is a standard strategy for postmenopausal patients with hormone receptor positive breast cancer. Postmenopausal patients who relapsed during adjuvant AI treatment or progression within a year after completion of AI treatment were prospectively treated with 40 mg/day of toremifene (TOR) in order to examine the effect of the selective estrogen receptor modulator (SERM) in AI-refractory patients. Patients and Methods; Twenty-three postmenopausal breast cancer patients who relapsed during adjuvant AI treatment or relapsed within a year after completion of AI were enrolled in the prospective trial from January 2007 to February 2010. Out of the patients, 14 cases had measurable or evaluable lesions, and the other had only bone metastasis. All patients were treated with toremifene of 40 mg/day. The primary efficacy end point for the trial was clinical response and secondary end point was progression free survival (PFS). Result; The objective response rate in the patients with measurable lesions was 7.1% (1/14) and clinical benefit rate was 28.6%. In the patients with evaluable bone disease, clinical benefit was 44.4%. No serious adverse event was observed except a patient with grade 3 non-hematological toxicity (AST and ALT). Conclusion; The SERM, toremifene (40 mg/day), demonstrated a safe profile and a favorable effect on disease control after adjuvant AI failure.

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Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor

Cited by 11 publications

References 18 publications

Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

Fulvestrant 500 mg in postmenopausal patients with metastatic breast cancer: the initial clinical experience

High-dose toremifene as first-line treatment of metastatic breast cancer resistant to adjuvant aromatase inhibitor: A multicenter phase II study

Prospective Study on the Effect of Toremifene in Patients With Adjuvant Anastrozole Failure in Postmenopausal Breast Cancer

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