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PR86 RETROSPECTIVE STUDY OF EVEROLIMUS WITH FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE METASTATIC BREAST CANCER PRETREATED WITH AROMATASE INHIBITORS(AI'S) AND SELECTIVE ESTROGEN MODIFIERS
Abstracts / The Breast 24 S3 (2015) S21–S75
2400 mg per day on days 1 to 21 every 28 days. Fulvestrant combined with capecitabine was administered as 2nd, 3rd, or 4th regimen of MBC following progression of fulvestrant monotherapy in 3 patients, and it was administered as 2nd or 4th regimen following progression of other regimens without fulvestrant in 2 patients. Fulvestrant combined with capecitabine was administered as 2nd, 3rd, or 4th regimen of MBC following progression of fulvestrant monotherapy in 3 patients, and administered as 2nd or 4th regimen following progression of other regimens without fulvestrant in 2 patients. Chemotherapy was an initial treatment in 1 patient with stage IV disease. Best responses were as follows. Partial response (PR) and stable disease (SD) were observed in 3 and 2 patients, respectively. Time to progression (TTP) was 15 months in 1 patient; however, 4 were censored in TTP analysis (3, 4, 7, and 13 months). No grade 3 or 4 adverse events were observed in fulvestrant combined with capecitabine regimen. Grade 2 palmarplantar erythrodysesthesia was observed in 2 patients, in one of whom the dose of capecitabine was reduced. No other grade 2 adverse events were observed. Our retrospective study indicates that fulvestrant combined with capecitabine is effective and well tolerated for patients with ER-positive, HER2-negative MBC. Further analyses will be needed in a prospective study setting.
PR85 OUR TREATMENT STRATEGY FOR PATIENTS WITH HORMONE-RECEPTOR-POSITIVE, HER2-POSITIVE METASTATIC BREAST CANCER Haruo Tanaka1, Shuyo Umeda1, Souichiro Murakami1, Mikimasa Ishikawa1, Kimiharu Tanaka2, Akihiko Uchiyama1 1 JCHO Kyushu Hospital, Surgery, Kitakyushu, Fukuoka, Japan; 2 Saiwaimaigeka Clinic, Surgery, Kitakyushu, Fukuoka, Japan Goals: TAndem Study and eLEcTRA trial showed that the combination of aromatase inhibitors (AIs) and trastuzumab is a safe and effective treatment option for patients with epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) positive metastatic breast cancer (MBC). Our goal is to re-validate these evidence, such as the safeness and efficacy of trastuzumab and AIs combination therapy for Her2 and HR positive MBC patients. Methods: We experienced 7 patients with HER2 and HR positive postmenopausal MBC patients. Four patients were treated with trastuzumab and AIs, and three patients were treated with trastuzumab and chemotherapy. No patients were treated without trastuzumab. Our indication of the combination therapy (trastuzumab and AIs) is restricted only non-life threatening MBC. Results: Patients treated with trastuzumab and AIs, three patients had clinical benefit. Only one patient with liver metastasis had no response and moved into chemotherapy plus trastuzumab. Especially, two patients with only lymph nodes metastasis showed complete response (one pathlogical complete response and one clinical complete response for three years) with trastuzumab and AIs. Adverse events including congestive heart failure are not observed in these patients. Conclusion: The combination therapy of AI and trastuzumab is a safe and effective treatment for patients with HER2 positive and HR positive MBC. Especially for non-life threatening metastatic site (lymph node, bone), this therapy is more sustainable for long periods without severe side effect than trastuzumab plus chemotherapy.
S51
PR86 RETROSPECTIVE STUDY OF EVEROLIMUS WITH FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE METASTATIC BREAST CANCER PRETREATED WITH AROMATASE INHIBITORS(AI’S) AND SELECTIVE ESTROGEN MODIFIERS Leen Vanacker Universitair Ziekenhuis Brussel, Medical Oncology Dpt., Brussels, Belgium We conducted a retrospective analysis of postmenopausal women with hormone receptor-positive metastatic breast cancer pretreated with AI’s and fulvestrant. We aimed to look at the response rate, clinical benefit rate and safety profile. The patients were administered monthly fulvestrant 500 mg I.M. and oral everolimus 7.5 mg daily. Results: Eight women with hormone receptor positive HER2 negative metastatic breast cancer were retrospectively included. The median age was 54.5 years old (range 4770). All tumors were ER-positive and the majority was PR-positive (75%). Three patients (37.5%) were diagnosed with de novo metastatic disease. The most common sites of metastases were bone and liver with 75% of patients having three or more sites of metastatic disease. All patients were heavily pretreated with endocrine therapy and received previously a SERM, AI and fulvestrant. Five patients (62.5%) had a partial response and 2 patients (25%) had stable disease with a clinical benefit rate of 57.1%. One patient was not evaluable for response due to rapidly progressive disease. The median time to progression was 30 weeks and the median overall survival was 22.5 months. All patients experienced some toxicity. The most common adverse events were edema (75%), mucositis (50%), diarrhea (50%), cough (50%) and metabolic changes (hyperglycemia (87.5%), hypertriglyceridemia (65.2%), and hypercholesterolemia (50%). Most common side effects were grade 1 or 2 and reversible with infrequent need for everolimus dose reduction. Four patients (50%) required dose reduction of everolimus due to edema, liver toxicity or infection. On the reduced dose there was an amelioration of the side effects. Most reasons for discontinuation were disease progression (71.5%) and drug related toxicity (28.6%). In conclusion, our findings suggest that the combination of everolimus with fulvestrant in postmenopausal women with hormone receptor-positive metastatic disease, who progressed on prior AI’s and fulvestrant, is an efficacious treatment option with an acceptable toxicity profile. Further randomized studies are needed to confirm these findings.
PR87 COMBINATION THERAPY PERUZUMAB, TRASTUZUMAB AND DOCETAXEL FOR ADVANCED OR RECURRENT BREAST CANCER PATIENTS IN THE LATE LINE Takashi Morimoto, Shintaro Michishita Yao Municipal Hospital, Breast Surgery Dept., Yao, Osaka, Japan Purpose: Combination therapy pertuzumab(PER), trastuzumab(HER) and docetaxel (DTX) is the standard regimen for advanced or recurrent breast cancer patients in the first line. The purpose of this study is to evaluate the effect of this combination therapy as the late line for advanced or recurrent breast cancer patients. Patients and Methods: Seven patients were evaluated (age 47-70). Three cases were administered as third line and others were as four or more lines. Six cases had pulmonary and/or liver metastasis and one had the distant LN metastasis. Five cases were HER2 type and two were luminal HER2 type. Results: The mean duration of administrated is 5.9 months (2-13 mo. Median 4 mo.). Three cases are still administrating and two of them were maintaining by PER and HER. Response rate is 43% (3PR, 1NC, 1PD and 2NE). The most of side effects were caused by DTX (alopecia, neuropathy and dysgeusia). All patients are alive at that time. Discussion: This regimen showed relative high response rate and long term administration as the third or more line. This combination therapy may be useful for HER2 positive advanced or recurrent breast cancer patients as the late line.
2400 mg per day on days 1 to 21 every 28 days. Fulvestrant combined with capecitabine was administered as 2nd, 3rd, or 4th regimen of MBC following progression of fulvestrant monotherapy in 3 patients, and it was administered as 2nd or 4th regimen following progression of other regimens without fulvestrant in 2 patients. Fulvestrant combined with capecitabine was administered as 2nd, 3rd, or 4th regimen of MBC following progression of fulvestrant monotherapy in 3 patients, and administered as 2nd or 4th regimen following progression of other regimens without fulvestrant in 2 patients. Chemotherapy was an initial treatment in 1 patient with stage IV disease. Best responses were as follows. Partial response (PR) and stable disease (SD) were observed in 3 and 2 patients, respectively. Time to progression (TTP) was 15 months in 1 patient; however, 4 were censored in TTP analysis (3, 4, 7, and 13 months). No grade 3 or 4 adverse events were observed in fulvestrant combined with capecitabine regimen. Grade 2 palmarplantar erythrodysesthesia was observed in 2 patients, in one of whom the dose of capecitabine was reduced. No other grade 2 adverse events were observed. Our retrospective study indicates that fulvestrant combined with capecitabine is effective and well tolerated for patients with ER-positive, HER2-negative MBC. Further analyses will be needed in a prospective study setting.
PR85 OUR TREATMENT STRATEGY FOR PATIENTS WITH HORMONE-RECEPTOR-POSITIVE, HER2-POSITIVE METASTATIC BREAST CANCER Haruo Tanaka1, Shuyo Umeda1, Souichiro Murakami1, Mikimasa Ishikawa1, Kimiharu Tanaka2, Akihiko Uchiyama1 1 JCHO Kyushu Hospital, Surgery, Kitakyushu, Fukuoka, Japan; 2 Saiwaimaigeka Clinic, Surgery, Kitakyushu, Fukuoka, Japan Goals: TAndem Study and eLEcTRA trial showed that the combination of aromatase inhibitors (AIs) and trastuzumab is a safe and effective treatment option for patients with epidermal growth factor receptor 2 (HER2) and hormone receptor (HR) positive metastatic breast cancer (MBC). Our goal is to re-validate these evidence, such as the safeness and efficacy of trastuzumab and AIs combination therapy for Her2 and HR positive MBC patients. Methods: We experienced 7 patients with HER2 and HR positive postmenopausal MBC patients. Four patients were treated with trastuzumab and AIs, and three patients were treated with trastuzumab and chemotherapy. No patients were treated without trastuzumab. Our indication of the combination therapy (trastuzumab and AIs) is restricted only non-life threatening MBC. Results: Patients treated with trastuzumab and AIs, three patients had clinical benefit. Only one patient with liver metastasis had no response and moved into chemotherapy plus trastuzumab. Especially, two patients with only lymph nodes metastasis showed complete response (one pathlogical complete response and one clinical complete response for three years) with trastuzumab and AIs. Adverse events including congestive heart failure are not observed in these patients. Conclusion: The combination therapy of AI and trastuzumab is a safe and effective treatment for patients with HER2 positive and HR positive MBC. Especially for non-life threatening metastatic site (lymph node, bone), this therapy is more sustainable for long periods without severe side effect than trastuzumab plus chemotherapy.
S51
PR86 RETROSPECTIVE STUDY OF EVEROLIMUS WITH FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE METASTATIC BREAST CANCER PRETREATED WITH AROMATASE INHIBITORS(AI’S) AND SELECTIVE ESTROGEN MODIFIERS Leen Vanacker Universitair Ziekenhuis Brussel, Medical Oncology Dpt., Brussels, Belgium We conducted a retrospective analysis of postmenopausal women with hormone receptor-positive metastatic breast cancer pretreated with AI’s and fulvestrant. We aimed to look at the response rate, clinical benefit rate and safety profile. The patients were administered monthly fulvestrant 500 mg I.M. and oral everolimus 7.5 mg daily. Results: Eight women with hormone receptor positive HER2 negative metastatic breast cancer were retrospectively included. The median age was 54.5 years old (range 4770). All tumors were ER-positive and the majority was PR-positive (75%). Three patients (37.5%) were diagnosed with de novo metastatic disease. The most common sites of metastases were bone and liver with 75% of patients having three or more sites of metastatic disease. All patients were heavily pretreated with endocrine therapy and received previously a SERM, AI and fulvestrant. Five patients (62.5%) had a partial response and 2 patients (25%) had stable disease with a clinical benefit rate of 57.1%. One patient was not evaluable for response due to rapidly progressive disease. The median time to progression was 30 weeks and the median overall survival was 22.5 months. All patients experienced some toxicity. The most common adverse events were edema (75%), mucositis (50%), diarrhea (50%), cough (50%) and metabolic changes (hyperglycemia (87.5%), hypertriglyceridemia (65.2%), and hypercholesterolemia (50%). Most common side effects were grade 1 or 2 and reversible with infrequent need for everolimus dose reduction. Four patients (50%) required dose reduction of everolimus due to edema, liver toxicity or infection. On the reduced dose there was an amelioration of the side effects. Most reasons for discontinuation were disease progression (71.5%) and drug related toxicity (28.6%). In conclusion, our findings suggest that the combination of everolimus with fulvestrant in postmenopausal women with hormone receptor-positive metastatic disease, who progressed on prior AI’s and fulvestrant, is an efficacious treatment option with an acceptable toxicity profile. Further randomized studies are needed to confirm these findings.
PR87 COMBINATION THERAPY PERUZUMAB, TRASTUZUMAB AND DOCETAXEL FOR ADVANCED OR RECURRENT BREAST CANCER PATIENTS IN THE LATE LINE Takashi Morimoto, Shintaro Michishita Yao Municipal Hospital, Breast Surgery Dept., Yao, Osaka, Japan Purpose: Combination therapy pertuzumab(PER), trastuzumab(HER) and docetaxel (DTX) is the standard regimen for advanced or recurrent breast cancer patients in the first line. The purpose of this study is to evaluate the effect of this combination therapy as the late line for advanced or recurrent breast cancer patients. Patients and Methods: Seven patients were evaluated (age 47-70). Three cases were administered as third line and others were as four or more lines. Six cases had pulmonary and/or liver metastasis and one had the distant LN metastasis. Five cases were HER2 type and two were luminal HER2 type. Results: The mean duration of administrated is 5.9 months (2-13 mo. Median 4 mo.). Three cases are still administrating and two of them were maintaining by PER and HER. Response rate is 43% (3PR, 1NC, 1PD and 2NE). The most of side effects were caused by DTX (alopecia, neuropathy and dysgeusia). All patients are alive at that time. Discussion: This regimen showed relative high response rate and long term administration as the third or more line. This combination therapy may be useful for HER2 positive advanced or recurrent breast cancer patients as the late line.