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P203 Dual HER2 blockage with lapatinib and trastuzumab for Japanese patients with HER2+ breast cancer
14th St.Gallen International Breast Cancer Conference / The Breast 24S1 (2015) S87–S150
S95
P203 Dual HER2 blockage with lapatinib and trastuzumab for Japanese patients with HER2+ breast cancer
P204 Axillary nodal burden and chemotherapy influences PCR in advanced breast cancer treated with NACT
H. Iwata1 *, N. Yamamoto2 , N. Masuda3 , H. Bando4 , K. Kuroi5 , S. Ohno6 , H. Kasai7 , S. Morita8 , T. Sakurai9 , M. Toi10 , JBCRG-16 (Neo-LaTH) Study Group. 1 Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan, 2 Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan, 3 Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan, 4 Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan, 5 Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan, 6 Clinical Research Institute, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, 7 Department of Experimental Therapeutics Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan, 8 Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan, 9 Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan, 10 Department of Surgery (breast Surgery), Graduate School of Medicine, Kyoto University, Kyoto, Japan
D. Mondal1 , A. Srivastava2 , P. Ranjan2 , D.N. Sharma1 , R. Das1 , L. Kashyap1 , K.P. Haresh1 , P.K. Julka1 *, N. Manoharan3 , S. Gupta1 . 1 Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India, 2 Department of Surgery, All India Institute of Medical Sciences, New Delhi, India, 3 Department of Biostatistics, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
Goals: The JBCRG-16 (Neo-LaTH) trial was conducted to evaluate the efficacy and safety of lapatinib (La) + trastuzumab (T) therapy followed by LaT + weekly paclitaxel (wP) in a neoadjuvant setting for primary HER2+ breast cancer (BC). We also aimed to verify the period of LaT therapy (6 vs 18 weeks [wks]) and the effect of add-on endocrine therapy in ER(+) patients (pts). Methods: We recruited and randomized pts aged ≤70 years with central laboratory-confirmed HER2+ primary invasive BC (T1c–3, N0–1, M0, T ≤7 cm) into groups A and B (ER[−]), and C–E (ER[+]). Groups A, C and D received LaT for 6 wks; B and E for 18 wks. All groups received ongoing LaT plus wP for 12 wks following the initial LaT phase. La was administered at 1000 mg/day and 750 mg/day during the initial LaT periods and the LaT+wP period, respectively. Groups D and E received additional endocrine therapy. The primary endpoint was the comprehensive pathological complete response (CpCR) rate; safety, overall response rate (ORR) and breast conservation rate (BCR) were assessed as secondary endpoints. Results: A total of 215 pts were enrolled between April 2012 and September 2013; 213 were included in the safety analysis sets (44, 48, 41, 40 and 40 pts in groups A, B, C, D and E, respectively) and one was excluded for the full analysis sets. Pts had a median age of 52.5 years (range 26–70); 65.3% were classified as T2, and 55.4% as N0. The relative dose intensities [mean (SD)] of La during the LaT period were 97.1% (7.2), 91.7% (17.4), 94.9% (15.5), 96.0% (12.3) and 90.4% (21.1) in groups A, B, C, D and E, respectively, and during the LaT+wP period were 81.7% (27.3), 72.7% (38.8), 80.5% (30.4), 86.0% (24.0) and 78.2% (34.2). Grade ≥3 adverse events were observed in 42.3% of pts; the most common were neutropenia (19%), diarrhea (12%), skin and subcutaneous disorders and elevated ALT (5% each), and paronychia (3%). In groups A, B, C, D and E, respectively, CpCR was achieved by 65.9%, 60.4%, 34.1%, 33.3% and 41.0%; ORRs evaluated by MRI or CT were 81.8%, 81.3%, 85.4%, 92.5% and 92.5%; and BCRs were 63.6%, 55.3%, 70.7%, 53.8% and 68.4%. Conclusion: Safety and efficacy of LaT and LaT followed by wP for HER2+ BC were confirmed in Japanese pts, consistent with the results of the Neo-ALTTO study; the efficacy based on CpCR did not improve by alteration of LaT treatment period and/or addition of endocrine therapy. Disclosure of Interest: Please refer to the file sent to the secretariat.
Introduction: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) in locally advanced breast cancer (LABC) is a surrogate marker for survival. A retrospective analysis of outcome to neoadjuvant chemotherapy being presented. Aims and objectives: To analyse impact of NACT on pCR in LABC patients and correlating with different factors. Methodology: Data of LABC patients treated with NACT with curative intent from 2010–2013 were collected and analysed retrospectively. Statistical analysis: Correlation with different factor were tested with SPSS version 16. Chi square test was used to assess significance. P value of 0.05 or less was considered significant. Results: 100 patients were retrieved. 1 patient was excluded from analysis for lack of information. 99 patients were finally analysed. 41, 54 and 5 patients were premenopausal, postmenopausal and perimenopausal respectively. 18, 22 and 44 patients had cT2, cT3 and cT4a tumor respectively. cN0, cN1, cN2 and cN3 disease were present in 30, 40, 22 and 3 patients respectively. 20 patients had oligometastases. 6, 11 and 3 patients had skeletal, visceral and both metastasis respectively. 96 patients had IDC. ER and PR were positive in 40 and 38 patients. 63 patients were Her2 negative, 32 positive and 4 were indeterminate. 20 patients were TNBC. DE was commonest chemotherapy followed by CEF (69 vs. 20). 73 patients received 6 cycles of NACT. Clinical response was assessed after each cycle. Poor responders were operated after 3 cycles. US guided biopsy was performed for axillary node. Axillary node positive and negative patients underwent ALND and SLNB respectively. SLN negative patients received no further axillary treatment. Positive SLNB patients underwent ALND. Poor responders were directly taken for ALND without evaluating for SLNB. 18 patients showed clinical CR in both breast and axilla. 36 patients did not show any response. BCS, radical mastectomy, MRM or mastectomy was performed in 22, 36, 28 and 13 patients respectively. SLNB was done in 38 patients. 24 patients were node negative. Minimum 3 and 10 nodes were removed for adequate SLNB or ALND. 75 patients underwent ALND. 53 patients showed axillary nodal disease. 40, 10 and 26 patients showed pCR in both breast and axilla, breast only and axilla only, respectively. 23 patients showed residual disease both in breast and axilla. 23 patients out of 40 with cN1 disease showed CR (statistically significant, P = 0.019). Among cN1 patients DE showed significantly better response (P = 0.001). No significant association was seen with other variables. Conclusion: cN1 axillary disease group showed more pCR compared to N0, N2 or N3 group and DE regimen showed better response in this group. DE is the current standard NACT regimen in our institute. Disclosure of Interest: No significant relationships.
S95
P203 Dual HER2 blockage with lapatinib and trastuzumab for Japanese patients with HER2+ breast cancer
P204 Axillary nodal burden and chemotherapy influences PCR in advanced breast cancer treated with NACT
H. Iwata1 *, N. Yamamoto2 , N. Masuda3 , H. Bando4 , K. Kuroi5 , S. Ohno6 , H. Kasai7 , S. Morita8 , T. Sakurai9 , M. Toi10 , JBCRG-16 (Neo-LaTH) Study Group. 1 Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan, 2 Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan, 3 Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan, 4 Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan, 5 Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan, 6 Clinical Research Institute, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, 7 Department of Experimental Therapeutics Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan, 8 Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan, 9 Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan, 10 Department of Surgery (breast Surgery), Graduate School of Medicine, Kyoto University, Kyoto, Japan
D. Mondal1 , A. Srivastava2 , P. Ranjan2 , D.N. Sharma1 , R. Das1 , L. Kashyap1 , K.P. Haresh1 , P.K. Julka1 *, N. Manoharan3 , S. Gupta1 . 1 Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India, 2 Department of Surgery, All India Institute of Medical Sciences, New Delhi, India, 3 Department of Biostatistics, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
Goals: The JBCRG-16 (Neo-LaTH) trial was conducted to evaluate the efficacy and safety of lapatinib (La) + trastuzumab (T) therapy followed by LaT + weekly paclitaxel (wP) in a neoadjuvant setting for primary HER2+ breast cancer (BC). We also aimed to verify the period of LaT therapy (6 vs 18 weeks [wks]) and the effect of add-on endocrine therapy in ER(+) patients (pts). Methods: We recruited and randomized pts aged ≤70 years with central laboratory-confirmed HER2+ primary invasive BC (T1c–3, N0–1, M0, T ≤7 cm) into groups A and B (ER[−]), and C–E (ER[+]). Groups A, C and D received LaT for 6 wks; B and E for 18 wks. All groups received ongoing LaT plus wP for 12 wks following the initial LaT phase. La was administered at 1000 mg/day and 750 mg/day during the initial LaT periods and the LaT+wP period, respectively. Groups D and E received additional endocrine therapy. The primary endpoint was the comprehensive pathological complete response (CpCR) rate; safety, overall response rate (ORR) and breast conservation rate (BCR) were assessed as secondary endpoints. Results: A total of 215 pts were enrolled between April 2012 and September 2013; 213 were included in the safety analysis sets (44, 48, 41, 40 and 40 pts in groups A, B, C, D and E, respectively) and one was excluded for the full analysis sets. Pts had a median age of 52.5 years (range 26–70); 65.3% were classified as T2, and 55.4% as N0. The relative dose intensities [mean (SD)] of La during the LaT period were 97.1% (7.2), 91.7% (17.4), 94.9% (15.5), 96.0% (12.3) and 90.4% (21.1) in groups A, B, C, D and E, respectively, and during the LaT+wP period were 81.7% (27.3), 72.7% (38.8), 80.5% (30.4), 86.0% (24.0) and 78.2% (34.2). Grade ≥3 adverse events were observed in 42.3% of pts; the most common were neutropenia (19%), diarrhea (12%), skin and subcutaneous disorders and elevated ALT (5% each), and paronychia (3%). In groups A, B, C, D and E, respectively, CpCR was achieved by 65.9%, 60.4%, 34.1%, 33.3% and 41.0%; ORRs evaluated by MRI or CT were 81.8%, 81.3%, 85.4%, 92.5% and 92.5%; and BCRs were 63.6%, 55.3%, 70.7%, 53.8% and 68.4%. Conclusion: Safety and efficacy of LaT and LaT followed by wP for HER2+ BC were confirmed in Japanese pts, consistent with the results of the Neo-ALTTO study; the efficacy based on CpCR did not improve by alteration of LaT treatment period and/or addition of endocrine therapy. Disclosure of Interest: Please refer to the file sent to the secretariat.
Introduction: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) in locally advanced breast cancer (LABC) is a surrogate marker for survival. A retrospective analysis of outcome to neoadjuvant chemotherapy being presented. Aims and objectives: To analyse impact of NACT on pCR in LABC patients and correlating with different factors. Methodology: Data of LABC patients treated with NACT with curative intent from 2010–2013 were collected and analysed retrospectively. Statistical analysis: Correlation with different factor were tested with SPSS version 16. Chi square test was used to assess significance. P value of 0.05 or less was considered significant. Results: 100 patients were retrieved. 1 patient was excluded from analysis for lack of information. 99 patients were finally analysed. 41, 54 and 5 patients were premenopausal, postmenopausal and perimenopausal respectively. 18, 22 and 44 patients had cT2, cT3 and cT4a tumor respectively. cN0, cN1, cN2 and cN3 disease were present in 30, 40, 22 and 3 patients respectively. 20 patients had oligometastases. 6, 11 and 3 patients had skeletal, visceral and both metastasis respectively. 96 patients had IDC. ER and PR were positive in 40 and 38 patients. 63 patients were Her2 negative, 32 positive and 4 were indeterminate. 20 patients were TNBC. DE was commonest chemotherapy followed by CEF (69 vs. 20). 73 patients received 6 cycles of NACT. Clinical response was assessed after each cycle. Poor responders were operated after 3 cycles. US guided biopsy was performed for axillary node. Axillary node positive and negative patients underwent ALND and SLNB respectively. SLN negative patients received no further axillary treatment. Positive SLNB patients underwent ALND. Poor responders were directly taken for ALND without evaluating for SLNB. 18 patients showed clinical CR in both breast and axilla. 36 patients did not show any response. BCS, radical mastectomy, MRM or mastectomy was performed in 22, 36, 28 and 13 patients respectively. SLNB was done in 38 patients. 24 patients were node negative. Minimum 3 and 10 nodes were removed for adequate SLNB or ALND. 75 patients underwent ALND. 53 patients showed axillary nodal disease. 40, 10 and 26 patients showed pCR in both breast and axilla, breast only and axilla only, respectively. 23 patients showed residual disease both in breast and axilla. 23 patients out of 40 with cN1 disease showed CR (statistically significant, P = 0.019). Among cN1 patients DE showed significantly better response (P = 0.001). No significant association was seen with other variables. Conclusion: cN1 axillary disease group showed more pCR compared to N0, N2 or N3 group and DE regimen showed better response in this group. DE is the current standard NACT regimen in our institute. Disclosure of Interest: No significant relationships.