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Metastatic Breast Cancer Patients Who Achieved Clinical Complete Response after Multidisciplinary Therapy: Clinical Features from a Single Institution
Abstracts / The Breast 36 S1 (2017) S19–S76
Results: Our patients had a median survival after diagnosis of LM of 16.6 [0-93] months. The mean time elapsed between breast surgery and LM diagnosis was 58 (+/−51.5) months (with 3 cases of synchronous LM). In 32 patients multi-organ metastases was identified (the most common sites being bone, lung and lymph node). Median survival after diagnosis of LM in these patients was 14 months [4-51]. Of the remaining 23 patients, liver was the unique metastatic organ, 13 had diffuse bilobar hepatic metastasis (median survival after LM diagnoses of 18 [0-44] months). 10 patients were proposed for surgical treatment of which in 3 peritoneal carcinomatosis was identified and no hepatic metastasectomy was performed. So, only 7 patients underwent liver metastasectomy, of which 3 need a re-metastasectomy. Median time elapsed between breast surgery and LM diagnosis in these patients was 23 months [0-70] and 6 ot them received neoadjuvant systemic treatment for LM. There was no mortality or major morbidity (Clavien ≥ 3) in these procedures. Median survival after diagnosis of LM in this subgroup of patients was 56 [14-93] months ( p < 0.01, when we compared to survival of patients with isolated LM or LM and bone metastases non-operated). Discussion/Conclusion: Systemic therapies should be considered to the majority of patients with LM. Patients with small oligometastases confined to the liver, diagnosed 1 year or more after the treatment of the primary tumor and responding to systemic therapy, should be evaluated for liver metastasectomy. Management of these complex patients by an experienced multidisciplinary team is essential to provide the best treatment options.
S63
Patients randomized to the active arm, after diagnosis and biopsy will be treated with ECT before receiving systemic therapy (Chemotherapy or Hormone Therapy) according to physician’s preference. Patients randomized to the control arm, after diagnosis and biopsy will be treated with systemic therapy (Chemotherapy or Hormone Therapy) according to physician’s preference. In both arms, the response to treatment will be histologically evaluated qualitatively and quantitatively. Response rate in treated area will be evaluated by RECIST criteria and photographic images. Descriptive sample size calculation and analyses of Baseline Data. Based on our previous study GISEL study and other studies on breast cancer skin metastasis treated with ECT or other therapies, the hypothesized objective response in active arm has been evaluated at 80%, 25% more than expected in the control arm. Eligible patients will be randomly assigned (1:1) to treatment groups, after stratified randomization by ± radiotherapy after mastectomy and ± syncronous visceral metastases categories, as assessed by clinical examination and histologic evaluation. The number of patients required in each stratified group is 62. A total of 500 patients will be recruited. Subject participation from enrollment through study conclusion is expected to last 18 months.
PO114 METASTATIC BREAST CANCER PATIENTS WHO ACHIEVED CLINICAL COMPLETE RESPONSE AFTER MULTIDISCIPLINARY THERAPY: CLINICAL FEATURES FROM A SINGLE INSTITUTION Haruko Takuwa, Wakako Tsuji, Fumiaki Yotsumoto Shiga Medical Center for Adults, Breast Surgery, Moriyama-shi, Japan
PO113 GISEL STUDY GROUP PROPOSAL: A PHASE II RANDOMIZED CLINICAL TRIAL IN BREAST CANCER PATIENTS WITH SKIN METASTASES TREATED WITH OR WITHOUT ELECTROCHEMOTHERAPY (ECT) DURING THE FIRST LINE OF TREATMENT Roberto Agresti1, Giulia Bianchi2 1 Istituto Nazionale dei Tumori, Breast Surgery Unit, Milan, Italy; 2 Istituto Tumori Milano, SC Oncologia Medica 1, Milan, Italy Background: The multicentre cohort analysis conducted by GISEL (Italian Senological Group for Electrochemotherapy) confirmed that Electrochemotherapy (ECT) has high antitumor activity (> 90% ORR) on skin metastases of breast cancer. Findings are consistent previous studies. ECT showed a significant higher efficacy, i.e. %CR, in the treatment of small (<3 cm), non-ulcerated lesions, without visceral metastases. Moreover, ECT showed a significant better performance in estrogen receptors positive, low-proliferating tumours. ECT showed a low toxicity and good acceptance by all treated patients. Patients who achieved complete response experienced a durable locoregional control on superficial metastases. Phase II international multicentre randomized clinical trial: The study is a comparison between different therapeutic strategies in skin metastases from LUM-A-like and LUM-B-like breast. In order to define if ECT is an effective local treatment of superficial metastases from breast cancer we propose a two arms phase II international multicentre randomized clinical trial. The primary endpoint is to determine the efficacy of ECT used during the first therapeutic approach of breast cancer skin metastases vs delayed ECT or no ECT. The secondary endpoints are Overall Survival (OS), local disease free survival (LDFS) evaluated during a follow-up observation of 6-18 months, time to treatment failure, quality of life and pain evaluation.
Background: The treatment of metastatic breast cancer (MBC) is diversified, and life expectancy of patients could be extended with appropriate treatment. Prognosis of MBC patients is improving as breast cancer treatment develops. Anti-HER2 therapy or small molecule drugs have greatly progressed and that lasts in this 10 years, and some cases obtained clinical complete response (cCR). However, the point at which treatment is terminated after obtaining cCR is not known. Unnecessary treatment should be avoided in cases with an adverse event due to treatment. Methods: In this retrospective study, 169 MBC patients who receive treatment between 2011 and 2017 at Shiga Medical Center for Adults were investigated. Median follow up period after diagnosis of metastatic breast cancer is 44 months (range; 0–217 months). Tumor characteristics and survival outcome were compared between the patients who achieved cCR and non-cCR. Neutrophil-to-lymphocytes ratio (NLR) from blood samples and Tumor infiltrating lymphocytes (TIL) from specimens before MBC treatment were investigated by physicians and pathologists. Results: Thirty-one cases (18.3%) including 8 HER2-positive breast cancer patients achieved complete clinical response. In our experience, patients terminated metastatic breast cancer treatment acquired cCR in first or second lines after metastatic diagnosis. A majority of them had multiple metastases sites, but at the most, limited in 2 organs. NLR were significantly lower in cCR group than non-cCR (1.46 ± 0.35 v.s. 2.69 ± 2.16, p < 0.001). Patient with low TIL also could aquire cCR, but with multidisciplinary therapy such as local resection. Conclusions: In achieving cCR without second recurrence, several conditions are needed. The most important facter is appropriate treatment selection. In future, an increase of the number of cCR patients is expected especially in HER 2 positive breast cancer patients. Establishment of stable bio-markers or elucidation of cCR mechanisms are needed.
Results: Our patients had a median survival after diagnosis of LM of 16.6 [0-93] months. The mean time elapsed between breast surgery and LM diagnosis was 58 (+/−51.5) months (with 3 cases of synchronous LM). In 32 patients multi-organ metastases was identified (the most common sites being bone, lung and lymph node). Median survival after diagnosis of LM in these patients was 14 months [4-51]. Of the remaining 23 patients, liver was the unique metastatic organ, 13 had diffuse bilobar hepatic metastasis (median survival after LM diagnoses of 18 [0-44] months). 10 patients were proposed for surgical treatment of which in 3 peritoneal carcinomatosis was identified and no hepatic metastasectomy was performed. So, only 7 patients underwent liver metastasectomy, of which 3 need a re-metastasectomy. Median time elapsed between breast surgery and LM diagnosis in these patients was 23 months [0-70] and 6 ot them received neoadjuvant systemic treatment for LM. There was no mortality or major morbidity (Clavien ≥ 3) in these procedures. Median survival after diagnosis of LM in this subgroup of patients was 56 [14-93] months ( p < 0.01, when we compared to survival of patients with isolated LM or LM and bone metastases non-operated). Discussion/Conclusion: Systemic therapies should be considered to the majority of patients with LM. Patients with small oligometastases confined to the liver, diagnosed 1 year or more after the treatment of the primary tumor and responding to systemic therapy, should be evaluated for liver metastasectomy. Management of these complex patients by an experienced multidisciplinary team is essential to provide the best treatment options.
S63
Patients randomized to the active arm, after diagnosis and biopsy will be treated with ECT before receiving systemic therapy (Chemotherapy or Hormone Therapy) according to physician’s preference. Patients randomized to the control arm, after diagnosis and biopsy will be treated with systemic therapy (Chemotherapy or Hormone Therapy) according to physician’s preference. In both arms, the response to treatment will be histologically evaluated qualitatively and quantitatively. Response rate in treated area will be evaluated by RECIST criteria and photographic images. Descriptive sample size calculation and analyses of Baseline Data. Based on our previous study GISEL study and other studies on breast cancer skin metastasis treated with ECT or other therapies, the hypothesized objective response in active arm has been evaluated at 80%, 25% more than expected in the control arm. Eligible patients will be randomly assigned (1:1) to treatment groups, after stratified randomization by ± radiotherapy after mastectomy and ± syncronous visceral metastases categories, as assessed by clinical examination and histologic evaluation. The number of patients required in each stratified group is 62. A total of 500 patients will be recruited. Subject participation from enrollment through study conclusion is expected to last 18 months.
PO114 METASTATIC BREAST CANCER PATIENTS WHO ACHIEVED CLINICAL COMPLETE RESPONSE AFTER MULTIDISCIPLINARY THERAPY: CLINICAL FEATURES FROM A SINGLE INSTITUTION Haruko Takuwa, Wakako Tsuji, Fumiaki Yotsumoto Shiga Medical Center for Adults, Breast Surgery, Moriyama-shi, Japan
PO113 GISEL STUDY GROUP PROPOSAL: A PHASE II RANDOMIZED CLINICAL TRIAL IN BREAST CANCER PATIENTS WITH SKIN METASTASES TREATED WITH OR WITHOUT ELECTROCHEMOTHERAPY (ECT) DURING THE FIRST LINE OF TREATMENT Roberto Agresti1, Giulia Bianchi2 1 Istituto Nazionale dei Tumori, Breast Surgery Unit, Milan, Italy; 2 Istituto Tumori Milano, SC Oncologia Medica 1, Milan, Italy Background: The multicentre cohort analysis conducted by GISEL (Italian Senological Group for Electrochemotherapy) confirmed that Electrochemotherapy (ECT) has high antitumor activity (> 90% ORR) on skin metastases of breast cancer. Findings are consistent previous studies. ECT showed a significant higher efficacy, i.e. %CR, in the treatment of small (<3 cm), non-ulcerated lesions, without visceral metastases. Moreover, ECT showed a significant better performance in estrogen receptors positive, low-proliferating tumours. ECT showed a low toxicity and good acceptance by all treated patients. Patients who achieved complete response experienced a durable locoregional control on superficial metastases. Phase II international multicentre randomized clinical trial: The study is a comparison between different therapeutic strategies in skin metastases from LUM-A-like and LUM-B-like breast. In order to define if ECT is an effective local treatment of superficial metastases from breast cancer we propose a two arms phase II international multicentre randomized clinical trial. The primary endpoint is to determine the efficacy of ECT used during the first therapeutic approach of breast cancer skin metastases vs delayed ECT or no ECT. The secondary endpoints are Overall Survival (OS), local disease free survival (LDFS) evaluated during a follow-up observation of 6-18 months, time to treatment failure, quality of life and pain evaluation.
Background: The treatment of metastatic breast cancer (MBC) is diversified, and life expectancy of patients could be extended with appropriate treatment. Prognosis of MBC patients is improving as breast cancer treatment develops. Anti-HER2 therapy or small molecule drugs have greatly progressed and that lasts in this 10 years, and some cases obtained clinical complete response (cCR). However, the point at which treatment is terminated after obtaining cCR is not known. Unnecessary treatment should be avoided in cases with an adverse event due to treatment. Methods: In this retrospective study, 169 MBC patients who receive treatment between 2011 and 2017 at Shiga Medical Center for Adults were investigated. Median follow up period after diagnosis of metastatic breast cancer is 44 months (range; 0–217 months). Tumor characteristics and survival outcome were compared between the patients who achieved cCR and non-cCR. Neutrophil-to-lymphocytes ratio (NLR) from blood samples and Tumor infiltrating lymphocytes (TIL) from specimens before MBC treatment were investigated by physicians and pathologists. Results: Thirty-one cases (18.3%) including 8 HER2-positive breast cancer patients achieved complete clinical response. In our experience, patients terminated metastatic breast cancer treatment acquired cCR in first or second lines after metastatic diagnosis. A majority of them had multiple metastases sites, but at the most, limited in 2 organs. NLR were significantly lower in cCR group than non-cCR (1.46 ± 0.35 v.s. 2.69 ± 2.16, p < 0.001). Patient with low TIL also could aquire cCR, but with multidisciplinary therapy such as local resection. Conclusions: In achieving cCR without second recurrence, several conditions are needed. The most important facter is appropriate treatment selection. In future, an increase of the number of cCR patients is expected especially in HER 2 positive breast cancer patients. Establishment of stable bio-markers or elucidation of cCR mechanisms are needed.