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Meta-analysis in HER2+ early breast cancer therapies and cost-effectiveness in a Brazilian perspective
abstracts
Annals of Oncology
Genentech; Research grant / Funding (self): Novartis; Research grant / Funding (self): Seattle Genetics; Research grant / Funding (self): EMD Serono; Research grant / Funding (self): Bayer; Research grant / Funding (self): AstraZeneca. All other authors have declared no conflicts of interest.
253P
Meta-analysis in HER21 early breast cancer therapies and costeffectiveness in a Brazilian perspective
M. Magalhaes1, P. Aguiar1, B. Haaland2, A. del Giglio1, G. Lopes3 Oncology, ABC Medical School-Santo Andre, Santo Andre, Brazil, 2Statistics, Industrial and Systems Engineering, Atlanta, GA, USA, 3Oncology, Sylvester Comprehensive Cancer, Miami, FL, USA
1
Background: HER2-targeted therapy was a paradigm shift for breast cancer. However, the optimal duration of adjuvant trastuzumab remain unknown. This issue is important in lower and middle-income countries such as Brazil where financial resources are scarce. The aim of this study is to determine which patients will benefit most with the addition of Pertuzumab to trastuzumab [TþP], trastuzumab for 12 months [T12] or trastuzumab for 6 months [T6]. Methods: Individual data meta-analysis was performed using 5 studies (Persephone, Phare, Horg, Aphinity and Katherine) for the intention to treat (ITT) population. Through pooled analyzes of the Persephone, Phare and Horg studies, we compared 12 months and 6 months of trastuzumab. The comparison between TþP and T6 was performed through an indirect comparison using Bayesian methodology. For cost-effectiveness analysis, we compared the treatment lining up in pairs exclusively considering the data from the Aphinity (TþP vs T12), Persephone (T12 vs T6) and Katherine (T12 vs T-DM1), setting a 30 years period of time and costs of adjuvant treatments and after progression in the Brazilian perspective. Results: Individual data were analyzed from 12,753 patients. Patients who progressed in a 4-year period were 7.1% for T þ P, 10.2% for T12 (HR 1.37, 95% CI 1.16-1.63) and 12.9% for T6 (HR 1.73, 95% CI 1.45-2.06). Regarding DFS in the Nþ subgroup, TþP showed HR 0.77 (95% CI 0.62-0.96) and 0.74 (95% CI 0.49-1.11) compared to T12 and T6, respectively. Among patients N-, TþP compared to T12 showed a HR 1.13 (95%CI 0.68-1.86) and compared to T6 HR 0.83 (95%CI 0.45-1.52). ERþ patients, TþP showed HR 0.86 (95%CI 0.66-1.13) compared to T12 and HR 0.74 (95%CI 0.49-1.11) to T6. Among ER-, the values were HR 0.76 (95%CI 0.56-1.04) and HR 0.59 (95%CI 0.41-0.85), respectively. In the cost-effectiveness analysis, TþP demonstrated an ICER of $ 332,903 compared to T12, while T12 set side by side of T6 resulted in $ 42,774. In the subgroup Nþ, TþP presented $ 308,019 when compared to T12. T-DM1 was considered a cost-effective treatment with $ 3,031 compared to T12.
Volume 30 | Supplement 5 | October 2019
Conclusions: The combination TþP presented an benefit in the subgroup Nþ, but it was not considered cost-effective. T6 may be considered a therapeutic option in low budget scenarios for patients HRþ/N-. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
254P
Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer (BC): A prospective clinical study
C. Ordu1, F. Gachayev2, F. Elbuken3, B. Baysal2, K.N. Pilanci4, G. Alco5, A.S. Ilgun6, M. Ucuncu2, A. Ozturk7, Z. Erdogan8, F. Agacayak9, G. Ozdem10, T. Kayan11, T. Uyar12, E. Hocao glu2, G. Soybir13, F. Aktepe14, V. Ozmen15 1 Medical Oncology, Ozel Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 2 Surgical Oncology, Istanbul FN Hospital, Istanbul, Turkey, 3Radiology, Gayrettepe Florence Nightingale Hospiatl, Istanbul, Turkey, 4Medical Oncology, Memorial Hospital, Istanbul, Turkey, 5Radiation Oncology, Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 6Surgery, Taksim Hospital, Istanbul, Turkey, 7Surgery, Biruni University, Istanbul, Turkey, 8Physical Therapy and Rehabilitation, Bilim University, Istanbul, Turkey, 9 Radiology, Istanbul Florence Hospital, Istanbul, Turkey, 10Physicology, Ozel Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 11Nutrition, Bilim University, Istanbul, Turkey, 12Physical Therapy and Rehabilitation, _Istanbul Bilgi Universirty, _Istanbul, Turkey, 13 Surgery, Memorial Hospital, Istanbul, Turkey, 14Pathology, Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 15Surgery, Istanbul University - Faculty of Medicine, Istanbul, Turkey Background: Systemic chemotherapy (SC) has a negative effect on ovarian functions. The aim of this study is to investigate the effect of SC on anti-mu¨llerian hormone (AMH) levels, antral follicle counts (AFC) and ovarian volumes (MOV) in patients with BC. Methods: The demographic, clinical and pathological features of premenopausal breast cancer (BC) patients who were operated in the Istanbul Florence Nightingale Hospital were recorded. AMH levels, AFC and MOV measurements were performed before and after adjuvant SC in 3-month periods. The patients who did not have menstruel cycles for 6 months or longer had been classified as chemotherapy induced amenorrhea (CIA). The effects of different chemotherapy regimens on AMH, AFC and MOV in terms menstruel cycles resumption and CIA were investigated. Results: Seventy one patients were eligible for the study, and median age of them was 38 years (ranged from 23 to 51 years). Median follow-up was 37 months (ranged from 20 to 51 months), CIA developed in 62% of patients. AMH, AFC, and MOV significantly decreased one year after SC (p < 0.0001). AMH before chemotherapy (median: 1,520 vs 0,755, p ¼ 0.001), at the end of first year (median: 0,073 vs 0,010 ng/ml, p ¼ 0.030) and pre-treatment AFC (median12 vs 4,50, p ¼ 0.026) was lower in patients with CIA comparing those without CIA. In multivariate logistic regression analysis, AMH levels (OR:0.273, 95%: 0.102 – 0.733, p ¼ 0.010) and AFC (OR: 1,180, 95% CI; 1,016-1,369, p ¼ 0.030) before SC were the most valuable and earliest factors to predict CIA. There were no significant relationships between age of the patients (30vs>30 ), BMI (30vs> 30), SC regimen and number of cycles (4 vs > 4) and CIA (p > 0.05).
doi:10.1093/annonc/mdz240 | v85
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz240.077/5576354 by guest on 24 October 2019
group was 58 (range, 27-74). All patients in this group were stage II-III, with no stage I identified. 59% of patients in the LOC group had stage III disease compared with 26% in the other groups (p ¼ 0.02), Also, 47% of patients in this group had AR 10% compared to 19% in the other biological groups (p ¼ 0.04). Conclusions: Patients with low-overall change in their tumors had later-stage disease and higher AR expression. Previous analysis by Seth et al. has demonstrated a lower pCR rate in this group with standard neoadjuvant chemotherapy. This analysis highlights the potential role of androgen deprivation in this class of tumors. Legal entity responsible for the study: The authors. Funding: The University of Texas MD Anderson Cancer Center Moonshots Program and a CPRIT Multi-Investigator Research Award (MIRA). Disclosure: S. Moulder: Research grant / Funding (self): Pfizer; Research grant / Funding (self):
Annals of Oncology
Genentech; Research grant / Funding (self): Novartis; Research grant / Funding (self): Seattle Genetics; Research grant / Funding (self): EMD Serono; Research grant / Funding (self): Bayer; Research grant / Funding (self): AstraZeneca. All other authors have declared no conflicts of interest.
253P
Meta-analysis in HER21 early breast cancer therapies and costeffectiveness in a Brazilian perspective
M. Magalhaes1, P. Aguiar1, B. Haaland2, A. del Giglio1, G. Lopes3 Oncology, ABC Medical School-Santo Andre, Santo Andre, Brazil, 2Statistics, Industrial and Systems Engineering, Atlanta, GA, USA, 3Oncology, Sylvester Comprehensive Cancer, Miami, FL, USA
1
Background: HER2-targeted therapy was a paradigm shift for breast cancer. However, the optimal duration of adjuvant trastuzumab remain unknown. This issue is important in lower and middle-income countries such as Brazil where financial resources are scarce. The aim of this study is to determine which patients will benefit most with the addition of Pertuzumab to trastuzumab [TþP], trastuzumab for 12 months [T12] or trastuzumab for 6 months [T6]. Methods: Individual data meta-analysis was performed using 5 studies (Persephone, Phare, Horg, Aphinity and Katherine) for the intention to treat (ITT) population. Through pooled analyzes of the Persephone, Phare and Horg studies, we compared 12 months and 6 months of trastuzumab. The comparison between TþP and T6 was performed through an indirect comparison using Bayesian methodology. For cost-effectiveness analysis, we compared the treatment lining up in pairs exclusively considering the data from the Aphinity (TþP vs T12), Persephone (T12 vs T6) and Katherine (T12 vs T-DM1), setting a 30 years period of time and costs of adjuvant treatments and after progression in the Brazilian perspective. Results: Individual data were analyzed from 12,753 patients. Patients who progressed in a 4-year period were 7.1% for T þ P, 10.2% for T12 (HR 1.37, 95% CI 1.16-1.63) and 12.9% for T6 (HR 1.73, 95% CI 1.45-2.06). Regarding DFS in the Nþ subgroup, TþP showed HR 0.77 (95% CI 0.62-0.96) and 0.74 (95% CI 0.49-1.11) compared to T12 and T6, respectively. Among patients N-, TþP compared to T12 showed a HR 1.13 (95%CI 0.68-1.86) and compared to T6 HR 0.83 (95%CI 0.45-1.52). ERþ patients, TþP showed HR 0.86 (95%CI 0.66-1.13) compared to T12 and HR 0.74 (95%CI 0.49-1.11) to T6. Among ER-, the values were HR 0.76 (95%CI 0.56-1.04) and HR 0.59 (95%CI 0.41-0.85), respectively. In the cost-effectiveness analysis, TþP demonstrated an ICER of $ 332,903 compared to T12, while T12 set side by side of T6 resulted in $ 42,774. In the subgroup Nþ, TþP presented $ 308,019 when compared to T12. T-DM1 was considered a cost-effective treatment with $ 3,031 compared to T12.
Volume 30 | Supplement 5 | October 2019
Conclusions: The combination TþP presented an benefit in the subgroup Nþ, but it was not considered cost-effective. T6 may be considered a therapeutic option in low budget scenarios for patients HRþ/N-. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
254P
Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer (BC): A prospective clinical study
C. Ordu1, F. Gachayev2, F. Elbuken3, B. Baysal2, K.N. Pilanci4, G. Alco5, A.S. Ilgun6, M. Ucuncu2, A. Ozturk7, Z. Erdogan8, F. Agacayak9, G. Ozdem10, T. Kayan11, T. Uyar12, E. Hocao glu2, G. Soybir13, F. Aktepe14, V. Ozmen15 1 Medical Oncology, Ozel Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 2 Surgical Oncology, Istanbul FN Hospital, Istanbul, Turkey, 3Radiology, Gayrettepe Florence Nightingale Hospiatl, Istanbul, Turkey, 4Medical Oncology, Memorial Hospital, Istanbul, Turkey, 5Radiation Oncology, Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 6Surgery, Taksim Hospital, Istanbul, Turkey, 7Surgery, Biruni University, Istanbul, Turkey, 8Physical Therapy and Rehabilitation, Bilim University, Istanbul, Turkey, 9 Radiology, Istanbul Florence Hospital, Istanbul, Turkey, 10Physicology, Ozel Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 11Nutrition, Bilim University, Istanbul, Turkey, 12Physical Therapy and Rehabilitation, _Istanbul Bilgi Universirty, _Istanbul, Turkey, 13 Surgery, Memorial Hospital, Istanbul, Turkey, 14Pathology, Gayrettepe Florence Nightingale Hospital, Istanbul, Turkey, 15Surgery, Istanbul University - Faculty of Medicine, Istanbul, Turkey Background: Systemic chemotherapy (SC) has a negative effect on ovarian functions. The aim of this study is to investigate the effect of SC on anti-mu¨llerian hormone (AMH) levels, antral follicle counts (AFC) and ovarian volumes (MOV) in patients with BC. Methods: The demographic, clinical and pathological features of premenopausal breast cancer (BC) patients who were operated in the Istanbul Florence Nightingale Hospital were recorded. AMH levels, AFC and MOV measurements were performed before and after adjuvant SC in 3-month periods. The patients who did not have menstruel cycles for 6 months or longer had been classified as chemotherapy induced amenorrhea (CIA). The effects of different chemotherapy regimens on AMH, AFC and MOV in terms menstruel cycles resumption and CIA were investigated. Results: Seventy one patients were eligible for the study, and median age of them was 38 years (ranged from 23 to 51 years). Median follow-up was 37 months (ranged from 20 to 51 months), CIA developed in 62% of patients. AMH, AFC, and MOV significantly decreased one year after SC (p < 0.0001). AMH before chemotherapy (median: 1,520 vs 0,755, p ¼ 0.001), at the end of first year (median: 0,073 vs 0,010 ng/ml, p ¼ 0.030) and pre-treatment AFC (median12 vs 4,50, p ¼ 0.026) was lower in patients with CIA comparing those without CIA. In multivariate logistic regression analysis, AMH levels (OR:0.273, 95%: 0.102 – 0.733, p ¼ 0.010) and AFC (OR: 1,180, 95% CI; 1,016-1,369, p ¼ 0.030) before SC were the most valuable and earliest factors to predict CIA. There were no significant relationships between age of the patients (30vs>30 ), BMI (30vs> 30), SC regimen and number of cycles (4 vs > 4) and CIA (p > 0.05).
doi:10.1093/annonc/mdz240 | v85
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz240.077/5576354 by guest on 24 October 2019
group was 58 (range, 27-74). All patients in this group were stage II-III, with no stage I identified. 59% of patients in the LOC group had stage III disease compared with 26% in the other groups (p ¼ 0.02), Also, 47% of patients in this group had AR 10% compared to 19% in the other biological groups (p ¼ 0.04). Conclusions: Patients with low-overall change in their tumors had later-stage disease and higher AR expression. Previous analysis by Seth et al. has demonstrated a lower pCR rate in this group with standard neoadjuvant chemotherapy. This analysis highlights the potential role of androgen deprivation in this class of tumors. Legal entity responsible for the study: The authors. Funding: The University of Texas MD Anderson Cancer Center Moonshots Program and a CPRIT Multi-Investigator Research Award (MIRA). Disclosure: S. Moulder: Research grant / Funding (self): Pfizer; Research grant / Funding (self):