- Email: [email protected]
P214 Pathologic complete response after neoadjuvant chemotherapy in breast cancer molecular subtypes
14th St.Gallen International Breast Cancer Conference / The Breast 24S1 (2015) S87–S150
NAC, 34.9% of patients had SBR grade change, and 85.7% of patients decreased one grade. The rates of changes in the expression of ER, PR and HER2 were 42.4% (45/102), 55.4% (68/102) and 26.6% (21/102), respectively. Only the SBR grade had significant difference between before and after neoadjuvant chemotherapy (P = 0.049). Conclusion: Profiles for ER, PR and HER2 were not significantly different in primary breast carcinomas before and after neoadjuvant chemotherapy. Until more comparable studies are being published, it seems prudent to reevaluate immunohistochemical markers after neoadjuvant chemotherapy, since the findings will guide the strategy for implementation of adjuvant systemic treatment. Disclosure of Interest: No significant relationships. P213 Neoadjuvant nab-paclitaxel followed by FEC for operable breast cancer: KBC-SG 1103 trial Y. Yamamoto1 *, K. Anan2 , M. Tanaka3 , S. Maeda4 , H. Ueo5 , Y. Sagara6 , S. Ohno7 , H. Iwase8 , S. Mitsuyama9 , K. Tamura10 . 1 Molecular-targeting Therapy for Breast Cancer, Kumamoto University Hospital, Kumamoto, Japan, 2 Department of Surgery, Municipal Medical Center, Kitakyushu, Kitakyusyu, Japan, 3 Breast Surgery, Kurume General Hospital, Kurume, Japan, 4 Department of Surgery, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan, 5 Department of Breast Surgery, Ueo Breast Surgery, Ohita, Japan, 6 Department of Breast Oncology, Sagara Hospital, Kagoshima, Japan, 7 Clinical Research Institute, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, 8 Department of Breast and Endocrine Surgery, Faculty of Postgraduate Medical and Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan, 9 Kitakyushu Municipal Medical Center, Kitakyushu, Japan, 10 Division of Medical Oncology, Hematology and Infectious Disease, Fukuoka University, Fukuoka, Japan Goals: The aim of this study was to evaluate the efficacy and safety profile of neoadjuvant chemotherapy (NAC) with sequential nab-paclitaxel (nP) followed by 5-fluorouracil/epirubicin/ cyclophosphamide (FEC) for operable breast cancer. Methods: Patients were treated with 4 cycles of 260 mg/m2 nP every 3 weeks followed by FEC100 given every 3 weeks. Concurrent treatment with triweekly trastuzumab and nP was used in HER2-positive cases. Primary endpoint was pathological complete response (pCR) rate in the breast and axilla tumors. Secondary endpoints included objective response (OR), breast conservation (BCS) and pCR rates according to tumor subtype and safety. Results: Between Dec 2011 and Jun 2012, a total of 41 patients were enrolled, and 38 were eligible and evaluable for response and safety. Twenty-nine patients (76.3%) completed 8 cycles of NAC. The median relative dose intensity was 94.0% for nP and 83.7% for epirubicin, respectively. Adverse events (AEs) were generally mild with grade 1 to 2. The nP gave rise to grade 3 AEs were elevation of AST/ALT (15.8%), sensory neuropathy (7.9%), muscle pain (5.3%) and arthralgia (5.3%). Febrile neutropenia was not observed with nP, while it developed in 31.4% patients with FEC. The overall pCR rate was 31.6% (12 of 38, 95% CI: 19.1–47.5%). The pCR rates according to subtypes were 6.3% (1 of 16) in Luminal/HER2−, 33.3% (4 of 12) in triple-negative, 60% (3 of 5) in Luminal-HER2+ and 80% (4 of 5) in HER2-enriched patients. ORR and BCS rates were 86.8% (33 of 38) and 65.8% (25 of 38), respectively. Conclusion: Neoadjuvant nab-paclitaxel followed by FEC was feasible and had high activity. Further confirmatory studies are needed. Disclosure of Interest: No significant relationships.
S99
P214 Pathologic complete response after neoadjuvant chemotherapy in breast cancer molecular subtypes E. Sari1 *, S. Aksoy2 , M. Dogan3 , M. Altinbas1 , N. Zengin3 , Y. Ozisik2 , K. Altundag2 . 1 Medical Oncology, Diskapi Yildirim Beyazit Research Hospital, Ankara, Turkey, 2 Medical Oncology, Hacettepe University, Institude of Oncology, Ankara, Turkey, 3 Medical Oncology, Numune Research Hospital, Ankara, Turkey Goals: Our aim is to ascess the effect of molecular subtypes on attainig pathologic complete response (pCR) in breast cancer patients receiving neoadjuvant chemotherapy and also to investigate the impact of pCR on survival. Methods: A total of 310 stage II and III breast cancer patients who received neoadjuvant chemotherapy were investigated retrospectively. Patients were classified according to 4 molecular subtypes. Pathologic complete response is defined as the absence of invasive tumor both in breast and axillary lymph nodes. Results: In the study group, the molecular subtypes were classified as 51.7% HR+/Her2−, 18.8% HR+/Her2+, 13.4% HR-/Her2+ and 16.4% triple negative. pCR was achieved in 72 (23.2%) patients. Clinical stage at diagnosis was 18.4% Stage IIA, 27.7% Stage IIB, 24.2% Stage IIIA, 20.3% Stage IIIB, 6.8% Stage IIIC. As neoadjuvant chemotheraphy, 64.8% of the patients received both antracyclines and taxanes, 29% received only antracyclines, 5.5% received only taxanes. Among patients receiving only antracyclines as neoadjuvant treatment, 64.4% also received taxanes as adjuvant treatment. Among patients receiving only taxanes as neoadjuvant treatment, 41% also received antracyclines as adjuvant treatment. 71.3% of Her2+ patients received neoadjuvant trastuzumab containing regimens and 14.7% received trastuzumab at only adjuvant setting. The pCR rate was significantly different between the molecular subtypes (9.1% in HR+/Her2−, 26.8% in HR+/Her2+, 51.3% in HR-/Her2+, 40.8% in triple negatives; P < 0.001). Overall survival (OS) of the patients who achieved a pCR was significantly better than those who did not achieve pCR (P = 0.038). Conclusion: The molecular subtypes of breast cancer patients might affect pCR rates in favor of HR-/Her2+ and triple negative subtypes. The patients achieveing pCR with neoadjuvant chemotherapy also have significantly higher OS. However, we need further prospective randomized trials in this issue. Disclosure of Interest: No significant relationships. P215 Phase II study with S-1 + low dose docetaxel (N-1 study) for operable breast cancer patients Y. Tadokoro *, M. Morimoto, M. Nakagawa, H. Takechi, A. Tangoku. Department of Thoracic, Endocrine Surgery and Oncology, Tokushima University Graduate School, Tokushima, Japan Goals: We have reported the efficacy of S-1 combined with low dose docetaxel (S-1+DOC) in ASCO 2011 (abstract No. 1075). It showed good objective response rate (ORR) and complete response (CR) could be realized within three months (4 cycles). But this therapy was difficult to keep compliance, because S-1 is oral medicine. To improve pathological CR (pCR) rate, we planed new protocol of primary chemotherapy. Methods: Patients with operable breast cancer (stage II–III) were treated with i.v. docetaxel (40 mg/m2 ) on day1 and oral S-1 (80 mg as FT/m2 /day) on day1 to 14 every 3 weeks for 4 cycles. According to the RECIST criteria, patients with CR were underwent operation, partial response were continued more 4 cycles of S-1+DOC. Stable disease or progressive disease cases were added EC or trastuzumab and paclitaxel (HT) according to their HER2 status. Supportive therapy was provided for typical adverse events. Primary endpoint is a pCR rate. Secondary endpoints are ORR, breast conservation rate and safety.
NAC, 34.9% of patients had SBR grade change, and 85.7% of patients decreased one grade. The rates of changes in the expression of ER, PR and HER2 were 42.4% (45/102), 55.4% (68/102) and 26.6% (21/102), respectively. Only the SBR grade had significant difference between before and after neoadjuvant chemotherapy (P = 0.049). Conclusion: Profiles for ER, PR and HER2 were not significantly different in primary breast carcinomas before and after neoadjuvant chemotherapy. Until more comparable studies are being published, it seems prudent to reevaluate immunohistochemical markers after neoadjuvant chemotherapy, since the findings will guide the strategy for implementation of adjuvant systemic treatment. Disclosure of Interest: No significant relationships. P213 Neoadjuvant nab-paclitaxel followed by FEC for operable breast cancer: KBC-SG 1103 trial Y. Yamamoto1 *, K. Anan2 , M. Tanaka3 , S. Maeda4 , H. Ueo5 , Y. Sagara6 , S. Ohno7 , H. Iwase8 , S. Mitsuyama9 , K. Tamura10 . 1 Molecular-targeting Therapy for Breast Cancer, Kumamoto University Hospital, Kumamoto, Japan, 2 Department of Surgery, Municipal Medical Center, Kitakyushu, Kitakyusyu, Japan, 3 Breast Surgery, Kurume General Hospital, Kurume, Japan, 4 Department of Surgery, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan, 5 Department of Breast Surgery, Ueo Breast Surgery, Ohita, Japan, 6 Department of Breast Oncology, Sagara Hospital, Kagoshima, Japan, 7 Clinical Research Institute, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, 8 Department of Breast and Endocrine Surgery, Faculty of Postgraduate Medical and Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan, 9 Kitakyushu Municipal Medical Center, Kitakyushu, Japan, 10 Division of Medical Oncology, Hematology and Infectious Disease, Fukuoka University, Fukuoka, Japan Goals: The aim of this study was to evaluate the efficacy and safety profile of neoadjuvant chemotherapy (NAC) with sequential nab-paclitaxel (nP) followed by 5-fluorouracil/epirubicin/ cyclophosphamide (FEC) for operable breast cancer. Methods: Patients were treated with 4 cycles of 260 mg/m2 nP every 3 weeks followed by FEC100 given every 3 weeks. Concurrent treatment with triweekly trastuzumab and nP was used in HER2-positive cases. Primary endpoint was pathological complete response (pCR) rate in the breast and axilla tumors. Secondary endpoints included objective response (OR), breast conservation (BCS) and pCR rates according to tumor subtype and safety. Results: Between Dec 2011 and Jun 2012, a total of 41 patients were enrolled, and 38 were eligible and evaluable for response and safety. Twenty-nine patients (76.3%) completed 8 cycles of NAC. The median relative dose intensity was 94.0% for nP and 83.7% for epirubicin, respectively. Adverse events (AEs) were generally mild with grade 1 to 2. The nP gave rise to grade 3 AEs were elevation of AST/ALT (15.8%), sensory neuropathy (7.9%), muscle pain (5.3%) and arthralgia (5.3%). Febrile neutropenia was not observed with nP, while it developed in 31.4% patients with FEC. The overall pCR rate was 31.6% (12 of 38, 95% CI: 19.1–47.5%). The pCR rates according to subtypes were 6.3% (1 of 16) in Luminal/HER2−, 33.3% (4 of 12) in triple-negative, 60% (3 of 5) in Luminal-HER2+ and 80% (4 of 5) in HER2-enriched patients. ORR and BCS rates were 86.8% (33 of 38) and 65.8% (25 of 38), respectively. Conclusion: Neoadjuvant nab-paclitaxel followed by FEC was feasible and had high activity. Further confirmatory studies are needed. Disclosure of Interest: No significant relationships.
S99
P214 Pathologic complete response after neoadjuvant chemotherapy in breast cancer molecular subtypes E. Sari1 *, S. Aksoy2 , M. Dogan3 , M. Altinbas1 , N. Zengin3 , Y. Ozisik2 , K. Altundag2 . 1 Medical Oncology, Diskapi Yildirim Beyazit Research Hospital, Ankara, Turkey, 2 Medical Oncology, Hacettepe University, Institude of Oncology, Ankara, Turkey, 3 Medical Oncology, Numune Research Hospital, Ankara, Turkey Goals: Our aim is to ascess the effect of molecular subtypes on attainig pathologic complete response (pCR) in breast cancer patients receiving neoadjuvant chemotherapy and also to investigate the impact of pCR on survival. Methods: A total of 310 stage II and III breast cancer patients who received neoadjuvant chemotherapy were investigated retrospectively. Patients were classified according to 4 molecular subtypes. Pathologic complete response is defined as the absence of invasive tumor both in breast and axillary lymph nodes. Results: In the study group, the molecular subtypes were classified as 51.7% HR+/Her2−, 18.8% HR+/Her2+, 13.4% HR-/Her2+ and 16.4% triple negative. pCR was achieved in 72 (23.2%) patients. Clinical stage at diagnosis was 18.4% Stage IIA, 27.7% Stage IIB, 24.2% Stage IIIA, 20.3% Stage IIIB, 6.8% Stage IIIC. As neoadjuvant chemotheraphy, 64.8% of the patients received both antracyclines and taxanes, 29% received only antracyclines, 5.5% received only taxanes. Among patients receiving only antracyclines as neoadjuvant treatment, 64.4% also received taxanes as adjuvant treatment. Among patients receiving only taxanes as neoadjuvant treatment, 41% also received antracyclines as adjuvant treatment. 71.3% of Her2+ patients received neoadjuvant trastuzumab containing regimens and 14.7% received trastuzumab at only adjuvant setting. The pCR rate was significantly different between the molecular subtypes (9.1% in HR+/Her2−, 26.8% in HR+/Her2+, 51.3% in HR-/Her2+, 40.8% in triple negatives; P < 0.001). Overall survival (OS) of the patients who achieved a pCR was significantly better than those who did not achieve pCR (P = 0.038). Conclusion: The molecular subtypes of breast cancer patients might affect pCR rates in favor of HR-/Her2+ and triple negative subtypes. The patients achieveing pCR with neoadjuvant chemotherapy also have significantly higher OS. However, we need further prospective randomized trials in this issue. Disclosure of Interest: No significant relationships. P215 Phase II study with S-1 + low dose docetaxel (N-1 study) for operable breast cancer patients Y. Tadokoro *, M. Morimoto, M. Nakagawa, H. Takechi, A. Tangoku. Department of Thoracic, Endocrine Surgery and Oncology, Tokushima University Graduate School, Tokushima, Japan Goals: We have reported the efficacy of S-1 combined with low dose docetaxel (S-1+DOC) in ASCO 2011 (abstract No. 1075). It showed good objective response rate (ORR) and complete response (CR) could be realized within three months (4 cycles). But this therapy was difficult to keep compliance, because S-1 is oral medicine. To improve pathological CR (pCR) rate, we planed new protocol of primary chemotherapy. Methods: Patients with operable breast cancer (stage II–III) were treated with i.v. docetaxel (40 mg/m2 ) on day1 and oral S-1 (80 mg as FT/m2 /day) on day1 to 14 every 3 weeks for 4 cycles. According to the RECIST criteria, patients with CR were underwent operation, partial response were continued more 4 cycles of S-1+DOC. Stable disease or progressive disease cases were added EC or trastuzumab and paclitaxel (HT) according to their HER2 status. Supportive therapy was provided for typical adverse events. Primary endpoint is a pCR rate. Secondary endpoints are ORR, breast conservation rate and safety.