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P192 Study of neoadjuvant therapy with FEC followed by weekly nab-paclitaxel for breast cancer
S90
Poster Abstracts II / The Breast 24S1 (2015) S87–S150
node biopsy (SLNB) is currently the most accurate staging procedure for the axilla. The aim of our study is to assess the accuracy of sentinel node biopsy after neoadjuvant chemotherapy both for operable and locally advanced breast cancer. Methods: Between August 2004 and December 2013, we performed 67 SLNM after neoadjuvant chemotherapy. Patients received all chemotherapy cycles before surgery. The procedures were performed by a single surgeon, using dual technique (radioactive tracer and blue dye). Results: All patients were diagnosed with true-cut biopsy and had clips placement before neoadjuvant chemotherapy. Histology of primary cancer: infiltrating ductal carcinoma (IDC): 44; infiltrating lobular carcinoma (ILC): 13; IDC and ILC: 4; others (colloid, tubular, papillary): 6. Mollecular subtypes: Luminal A and B: 41; triple negative: 14; HER-2 overexpression: 12. Patients were divided into 3 groups according to axillary status. Group 1: histologically positive axillary node(s) by fine needle aspiration (FNA): 19. Group 2: clinically palpable and/or radiologically suspicious nodes: 20. Group 3: unknown axillary status and NAC given for primary breast cancer: 28. No patients progressed on chemotherapy. Identification rate: 94%. SLNB negative: 36 patients; SLNB positive: 27 patients; SLN not found: 4 patients. Group 1: SLN negative: 8/19, no axillary lymph node dissection (ALND) done; SLN positive: 9/19, ALND; SLN not found: 2/19, ALND. Group 2: SLN negative: 10/20, no ALND; SLN positive 9/20, ALND except 1 patient who received radiation therapy; SLN not found: 1/20, ALND. Group 3: SLN negative 18/28, no ALND; SLN positive 9/28 ALND; SLN not found: 1/28, ALND. 1 sentinel lymph node was removed in 22 patients, 2 in 21 patients, 3 in 15 patients, 4 in 4 patients, SLN not found in 4 patients. SLN positive: 27 patients; macrometastasis 21, micrometastasis 6. Completion ALND: no additional disease: 6 patients. Of 36 patients with SLN negative, 22 patients had no residual disease in the breast. Breast conserving surgery: 40 patients; nipple sparing mastectomy 20 patients, skin sparing mastectomy 5 patients, modified radical mastectomy 2 patients. Conclusion: Sentinel lymph node mapping is an accurate procedure after neoadjuvant chemotherapy. It provides accurate staging and local control of the axilla, while preventing unnecessary complications of axillary node dissection. Disclosure of Interest: No significant relationships. P192 Study of neoadjuvant therapy with FEC followed by weekly nab-paclitaxel for breast cancer S. Nakagawa1 *, U. Toh2 , N. Iwakuma2 , M. Mishima2 , R. Takahashi1 , M. Furukawa2 , M. Yamaguchi3 , M. Tanaka3 , E. Ogo4 , Y. Akagi2 . 1 Breast Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan, 2 Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan, 3 Breast Surgery, Kurume General Hospital, Kurume, Japan, 4 Radiology, Kurume University School of Medicine, Kurume, Fukuoka, Japan Goals: Nanoparticle albumin-bound paclitaxel (nab-PTX, 130 nm) provides tumor selective localization, potential tumor uptake, and improved pharmacokinetics vs cremophor-paclitaxel, and nab-PTX has demonstrated clinical benefit in metastatic breast cancer in a randomized phase III trial vs paclitaxel (CA012) and in a randomized phase II trial vs docetaxel (CA024). This multicentic phase II study (KSCOG-BC07) was conducted to confirm efficacy and safety of nabPTX in neoadjuvant chemotherapy setting for patients (pts) with operable breast cancer. Methods: This is an open-label, multicentre, single-arm, phase II study (Registry number: UMIN000010504). Pts receive 4 cycles of FEC100 (500 mg/m2 Fluorouracil+100 mg/m2 Epirubicin+500 mg/m2 Cyclophosphamide on day1 every 3 weeks) followed by 4 cycles of
weekly nab-PTX (100 mg/m2 ) administrating on days 1, 8 and 15. Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for conccurent administration) was administrated for Her2 positive pts on days 1, 8, 15 and 22 and treatment repeated every 4 weeks. Primary objective is the pCR rate; main secondary objectives are the assessment of preserving operation rate, safety and response rate (RR). Results: The study has been opened in 4/2013. 18 of planned 32 pts have been recruited so far and 9 pts has been evaluated for the first analysis. The primary endpoint of pCR rate was 44.4% (4/9), RR was 88.9% (8/9) and preserving surgery rate was 66.7%. The most frequent treatment-related grade 3/4 toxicities were neutropenia (65%), leukopenia (54%). No cardiac events have yet to be reported. Conclusion: Neoadjuvant chemotherapy with FEC followed by weekly nab-PTX for operable breast cancer might be safe and feasible. Disclosure of Interest: No significant relationships. P193 Ki-67 as predictor of chemotherapy response in neoadjuvant chemotherapy for breast cancer A.K. Mishra *, A. Kapoor, S. Tewari, S. Gond, R. Kumar. Surgery, King George’s Medical University, Lucknow, India Goals: Aims of study to evaluate changes in Ki-67 before and after neoadjuvant anthracycline based chemotherapy in breast cancer in Indian women as a pilot prospective study. Background: The absence of Ki-67 in quiescent cells and its high levels in rapidly proliferating cells has created interest in its role in predicting whether a patient would benefit from primary systemic therapy. Methods: Tru Cut biopsy specimens were collected from carcinoma breast patients admitted in department of surgery KGMU. Ki-67 levels were estimated at start and at end of chemotherapy. Twenty-two patients of locally advanced breast cancer were enrolled in the study in one year period and received neoadjuvant chemotherapy (Docetaxel (75 mg/m2 ), Adriamycin (50 mg/m2 ), and Cyclophosphamide (500 mg/m2 ) at 3 weekly intervals with peglated granulocyte stimulating factor coverage. These patients underwent repeat Ki-67 estimation from histopathology specimen after 6 cycles. Results: Twenty patients received six cycles of chemotherapy, and proceeded to surgery. The complete clinical response rate was 20% (4/20). Thirteen patients (65%) achieved a partial response. All the 4 patients with complete clinical response also achieved a complete pathological response. Three patients (15%) were classified as having stable disease. On comparison of Ki-67 index between the patients showing complete clinical response (CCR) and those showing partial response and stable disease, we found a significant fall in Ki-67 levels by the 6th cycle of chemotherapy in only those patients showing CCR. CCR patients 4/20 had median Ki-67 at 1st cycle 34.6+18.2 which fell to 17.8+8.7 by 6th cycle (p value 0.01). In patients with stable disease Ki-67 changed from 35.3+20.3 to 22.65+10.2 by 6th cycle (p value 0.13) and in partial responders from 37.3+19.2 to 27.6+9.8 by 6th cycle (p value 0.11). Conclusion: Our results confirm that subjects showing significant change in Ki-67 (over 50%) are associated with complete response and can reliably benefit from primary systemic therapy. Disclosure of Interest: No significant relationships.
Poster Abstracts II / The Breast 24S1 (2015) S87–S150
node biopsy (SLNB) is currently the most accurate staging procedure for the axilla. The aim of our study is to assess the accuracy of sentinel node biopsy after neoadjuvant chemotherapy both for operable and locally advanced breast cancer. Methods: Between August 2004 and December 2013, we performed 67 SLNM after neoadjuvant chemotherapy. Patients received all chemotherapy cycles before surgery. The procedures were performed by a single surgeon, using dual technique (radioactive tracer and blue dye). Results: All patients were diagnosed with true-cut biopsy and had clips placement before neoadjuvant chemotherapy. Histology of primary cancer: infiltrating ductal carcinoma (IDC): 44; infiltrating lobular carcinoma (ILC): 13; IDC and ILC: 4; others (colloid, tubular, papillary): 6. Mollecular subtypes: Luminal A and B: 41; triple negative: 14; HER-2 overexpression: 12. Patients were divided into 3 groups according to axillary status. Group 1: histologically positive axillary node(s) by fine needle aspiration (FNA): 19. Group 2: clinically palpable and/or radiologically suspicious nodes: 20. Group 3: unknown axillary status and NAC given for primary breast cancer: 28. No patients progressed on chemotherapy. Identification rate: 94%. SLNB negative: 36 patients; SLNB positive: 27 patients; SLN not found: 4 patients. Group 1: SLN negative: 8/19, no axillary lymph node dissection (ALND) done; SLN positive: 9/19, ALND; SLN not found: 2/19, ALND. Group 2: SLN negative: 10/20, no ALND; SLN positive 9/20, ALND except 1 patient who received radiation therapy; SLN not found: 1/20, ALND. Group 3: SLN negative 18/28, no ALND; SLN positive 9/28 ALND; SLN not found: 1/28, ALND. 1 sentinel lymph node was removed in 22 patients, 2 in 21 patients, 3 in 15 patients, 4 in 4 patients, SLN not found in 4 patients. SLN positive: 27 patients; macrometastasis 21, micrometastasis 6. Completion ALND: no additional disease: 6 patients. Of 36 patients with SLN negative, 22 patients had no residual disease in the breast. Breast conserving surgery: 40 patients; nipple sparing mastectomy 20 patients, skin sparing mastectomy 5 patients, modified radical mastectomy 2 patients. Conclusion: Sentinel lymph node mapping is an accurate procedure after neoadjuvant chemotherapy. It provides accurate staging and local control of the axilla, while preventing unnecessary complications of axillary node dissection. Disclosure of Interest: No significant relationships. P192 Study of neoadjuvant therapy with FEC followed by weekly nab-paclitaxel for breast cancer S. Nakagawa1 *, U. Toh2 , N. Iwakuma2 , M. Mishima2 , R. Takahashi1 , M. Furukawa2 , M. Yamaguchi3 , M. Tanaka3 , E. Ogo4 , Y. Akagi2 . 1 Breast Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan, 2 Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan, 3 Breast Surgery, Kurume General Hospital, Kurume, Japan, 4 Radiology, Kurume University School of Medicine, Kurume, Fukuoka, Japan Goals: Nanoparticle albumin-bound paclitaxel (nab-PTX, 130 nm) provides tumor selective localization, potential tumor uptake, and improved pharmacokinetics vs cremophor-paclitaxel, and nab-PTX has demonstrated clinical benefit in metastatic breast cancer in a randomized phase III trial vs paclitaxel (CA012) and in a randomized phase II trial vs docetaxel (CA024). This multicentic phase II study (KSCOG-BC07) was conducted to confirm efficacy and safety of nabPTX in neoadjuvant chemotherapy setting for patients (pts) with operable breast cancer. Methods: This is an open-label, multicentre, single-arm, phase II study (Registry number: UMIN000010504). Pts receive 4 cycles of FEC100 (500 mg/m2 Fluorouracil+100 mg/m2 Epirubicin+500 mg/m2 Cyclophosphamide on day1 every 3 weeks) followed by 4 cycles of
weekly nab-PTX (100 mg/m2 ) administrating on days 1, 8 and 15. Trastuzumab (4 mg/kg for the initial dosing and 2 mg/kg for conccurent administration) was administrated for Her2 positive pts on days 1, 8, 15 and 22 and treatment repeated every 4 weeks. Primary objective is the pCR rate; main secondary objectives are the assessment of preserving operation rate, safety and response rate (RR). Results: The study has been opened in 4/2013. 18 of planned 32 pts have been recruited so far and 9 pts has been evaluated for the first analysis. The primary endpoint of pCR rate was 44.4% (4/9), RR was 88.9% (8/9) and preserving surgery rate was 66.7%. The most frequent treatment-related grade 3/4 toxicities were neutropenia (65%), leukopenia (54%). No cardiac events have yet to be reported. Conclusion: Neoadjuvant chemotherapy with FEC followed by weekly nab-PTX for operable breast cancer might be safe and feasible. Disclosure of Interest: No significant relationships. P193 Ki-67 as predictor of chemotherapy response in neoadjuvant chemotherapy for breast cancer A.K. Mishra *, A. Kapoor, S. Tewari, S. Gond, R. Kumar. Surgery, King George’s Medical University, Lucknow, India Goals: Aims of study to evaluate changes in Ki-67 before and after neoadjuvant anthracycline based chemotherapy in breast cancer in Indian women as a pilot prospective study. Background: The absence of Ki-67 in quiescent cells and its high levels in rapidly proliferating cells has created interest in its role in predicting whether a patient would benefit from primary systemic therapy. Methods: Tru Cut biopsy specimens were collected from carcinoma breast patients admitted in department of surgery KGMU. Ki-67 levels were estimated at start and at end of chemotherapy. Twenty-two patients of locally advanced breast cancer were enrolled in the study in one year period and received neoadjuvant chemotherapy (Docetaxel (75 mg/m2 ), Adriamycin (50 mg/m2 ), and Cyclophosphamide (500 mg/m2 ) at 3 weekly intervals with peglated granulocyte stimulating factor coverage. These patients underwent repeat Ki-67 estimation from histopathology specimen after 6 cycles. Results: Twenty patients received six cycles of chemotherapy, and proceeded to surgery. The complete clinical response rate was 20% (4/20). Thirteen patients (65%) achieved a partial response. All the 4 patients with complete clinical response also achieved a complete pathological response. Three patients (15%) were classified as having stable disease. On comparison of Ki-67 index between the patients showing complete clinical response (CCR) and those showing partial response and stable disease, we found a significant fall in Ki-67 levels by the 6th cycle of chemotherapy in only those patients showing CCR. CCR patients 4/20 had median Ki-67 at 1st cycle 34.6+18.2 which fell to 17.8+8.7 by 6th cycle (p value 0.01). In patients with stable disease Ki-67 changed from 35.3+20.3 to 22.65+10.2 by 6th cycle (p value 0.13) and in partial responders from 37.3+19.2 to 27.6+9.8 by 6th cycle (p value 0.11). Conclusion: Our results confirm that subjects showing significant change in Ki-67 (over 50%) are associated with complete response and can reliably benefit from primary systemic therapy. Disclosure of Interest: No significant relationships.