- Email: [email protected]
Baseline quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): The French multicentric prospective CANTO cohort study
abstracts
Advisory / Consultancy: Novartis. M.A. Colleoni: Honoraria (self): Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Pfizer; Advisory / Consultancy: OBI Pharma; Advisory / Consultancy: Puma Biotechnology; Advisory / Consultancy: Celldex; Advisory / Consultancy: AstraZeneca. G. Cancello: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili. E. Munzone: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Genomic Health. S. Dellapasqua: Travel / Accommodation / Expenses: Roche. M. Mazza: Advisory / Consultancy: Novartis; Advisory / Consultancy: Gentili; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.
227P
Baseline quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): The French multicentric prospective CANTO cohort study
I. Licaj1, S. Dabakuyo2, S. Dauchy3, I. Vaz Luis4, C. Charles5, C. Lemogne6, O. Tredan7, L. Vanlemmens8, C. Jouannaud9, C. Levy10, O. Rigal11, M. Fournier12, T. Petit13, F. Dalenc14, P. Rouanet15, A. Arnaud16, J. Lemonnier17, S. Everhard17, P.H. Cottu18, F. Joly10 1 Clinical Research, Centre Francois Baclesse, Caen, France, 2Biostatistics and Quality of Life Unit, Centre Georges Franc¸ois Leclerc, Dijon, France, 3Department of Supportive Care, Gustave Roussy, Villejuif, France, 4Departement of Medical Oncology, Gustave Roussy, Villejuif, France, 5Psycho-Oncology Unit, Gustave Roussy, Villejuif, France, 6 Hopital Europe´en Georges-Pompidou, APHP, Paris, France, 7Department of Oncology, Centre Leon Berard, Lyon, France, 8De´partement de Cance´rologie Se´nologique, Centre Oscar Lambert, Lille, France, 9Department of Medical Oncology, Institut Jean Godinot, Reims, France, 10Department of Medical Oncology, Centre Francois Baclesse, Caen, France, 11Medical Oncology, Centre Henri-Becquerel, Rouen, France, 12Surgery, Institut Bergonie´, Bordeaux, France, 13Medical Oncology, Centre Paul Strauss, Strasbourg, France, 14Medical Oncology, Centre Claudius-Regaud, Toulouse, France, 15Surgical oncology, ICM, Montpellier, France, 16Medical oncology, Clinique Ste Catherine, Avignon, France, 17Clinical Research, Unicancer, Paris, France, 18Medical Oncology, Institut Curie, Paris, France,
better performance status PS ¼ 0 vs 1þ, (68 vs 60 p < 0.001) and 91 vs 78 p < 0.001) respectively. 952 (31%) BC pts developed 1 CRT: 23% had an infection, 7% thrombosis, 0.3% G3-4 diarrhea, nausea or vomiting, 4% G2-4 neurological and 0.2% G3-4 pulmonary toxicities. 16% had chemotherapy dose reduction. Pts with a baseline GHS <70 had 19 % higher odds of CRT vs to those with GHS70, OR ¼ 1.19 [95% CI 1.021.41] and similarly those with a PF < 90 had a 23% higher odds of CRT when compared to those with PF 90 (OR ¼ 1.23 [95% CI 1.03-1.49]). Conclusions: Global and physical QoL before BC treatments are independently associated with CRT. QoL should be assessed before any treatment to identify patients at risk CRT. Clinical trial identification: NCT01993498. Legal entity responsible for the study: UNICANCER/Villejuif, France, 94805 Principal Investigator: Fabrice Andre´ Gustave Roussy – Villejuif. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
228P
Effects of aerobic and resistance exercise on android: Gynoid fat ratio in breast cancer survivors
C. Dieli-Conwright, N. Sami, K. Lee Biokinesiology and Physical Therapy, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA Background: The android:gynoid percent fat ratio (AGFR) is associated with increased risk of cardiovascular disease and type 2 diabetes in breast cancer survivors (BCS). Exercise reduces fat mass in BCS; however, few studies have focused on AGFR. The study purpose was to examine the effects of a 16-week aerobic and resistance exercise intervention on AGFR among BCS. We assessed whether exercise-induced changes in AGFR were associated with improved insulin resistance. Methods: BCS (Stage I-III) were randomized to exercise (n ¼ 50) or usual care (n ¼ 50). The thrice weekly 16-week intervention included supervised, progressive moderate-vigorous aerobic and resistance exercise. AGFR was obtained from a wholebody dual-energy x-ray absorptiometry. Insulin resistance was estimated using homeostatic model assessment of insulin resistance (HOMA-IR) calculated from fasting insulin and glucose levels. Within and between group differences were assessed by paired ttest and repeated measures ANOVA. Pearson’s correlation was computed to assess the association between AGFR and HOMA-IR in the exercise group. Results: Participants were 53 6 10.4 years old, overweight (BMI>25.0 kg/m2; 54%), Hispanic (63.1%), and had undergone a mastectomy (90%) and chemotherapy þ radiation therapy (76%). Adherence to the intervention was 95% and post-intervention assessments were available on 91% of participants. Post-intervention, AGFR significantly decreased in the exercise group from baseline and when compared to usual care (p < 0.001). Post-intervention, strong correlations were found between AGFR and HOMA-IR (r ¼ 0.95; p < 0.01). Conclusions: A progressive aerobic and resistance exercise intervention is an effective strategy to decrease AGFR in BCS. BCS who experience exercise-induced improvements in AGFR may also experience improved insulin resistance thereby reducing the risk for comorbid conditions. Clinical trial identification: NCT01140282. Legal entity responsible for the study: The authors. Funding: National Cancer Institute. Disclosure: All authors have declared no conflicts of interest.
229P
Impact of education for breast self examination in rural Indian women on early detection: Results of POC study
S.S. Parchuri1, S. Dattatreya Palanki1, S.S. Nirni1, S.S. Atilli2, V.V. Andra1, V.M. Ch3 Medical Oncology, Omega Hospitals, Hyderabad, India, 2Medical Oncology, Omega Hospitals, Gachibowli, India, 3Surgical Oncology, Omega Hospitals, Hyderabad, India
1
Background: In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC. Methods: We included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variable of this study was baseline Qol defined by the EORTC QLQ-C30 subscales of general global health status (GHS) (< or 70) and physical functioning PF (< or 90). The defined cutoffs correspond to the average values in the French general population. Clinical relevant adjustment covariates included stage, age, performance status (PS), body mass index (BMI), HR and HER2 status, baseline lymphopenia, albumin, creatinine clearance, alcohol consumption, and smoking status. Multivariable logistic models were performed. Results: Among 3079 BC pts included in this analysis, 33% received neoadjuvant and 77% adjuvant treatment. Median age at diagnosis was 53 years, median BMI¼ 25 kg/ m2, 94% of patients had a PS ¼ 0 and 83% stage I-II disease. Pts reported on average a good GHS ¼ 68 (619) and PF ¼ 90 (614). GHS and PF were higher in women with
v76 | Breast Cancer, Early Stage
Background: Breast cancer contributes to 19-34% of all malignancies- indicating the high disease burden. In view of various socio-economic and cultural reasons, patients usually present at an advanced stage because of lack of awareness and nonexistent breast cancer screening programs in India. Breast self-examination (BSE) is easy cost effective and proven way for early detection. Methods: Objective: 1. To train women for Breast self-examination in health camps 2. To determine the effectiveness of planned teaching program with respect to BSE Materials & methods: Trained workers and physician prepared a visual aid and short video in local language for breast self examination and spend average 8-12 minutes to educate a group of women. 15:1 random check was done to known their level of understanding and correctness of adopting the method. The participants were observed and supervised by doctors to complete the procedure successfully. The results of Breast SelfExamination were documented. Results: BSE was successfully trained for a total of 4965 women across 19 camps between 2018-2019. Out of the samples 93% of women understood accurately the right method of BSE and re-traing was felt necessary in 35% as per their perception. Among the camps 165 new cases were reported in participants. Upon physician’s examination
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz240.052/5578324 by guest on 24 October 2019
However, HT is associated with side effects. The aim of the present study was to determine the preferences of women treated with adjuvant HT for breast cancer. Methods: Preferences have been elicited with a self-completed, validated questionnaire administered at study entry in eligible patients. The questionnaires, showing hypothetical scenarios based on potential survival times (5 or 15 years) and rates (60% or 80% at 5 years) without HT, were used to determine the lowest gains women judged necessary to make the treatment. The analyses were conducted into three different groups of early breast cancer patients to evaluate the expected survival benefit before starting HT (A), after a few months from the beginning (B) and after several years of HT (C). Patients also completed psychological questionnaires and the patient reported symptoms form. Results: A total of 452 patients were included in the study: 149 in group A, 150 in group B and 153 in group C. In group C, 65% of patients were receiving HT with aromatase inhibitors (with or without a LHRH analogue). 12%, 24% and 35% of patients received adjuvant chemotherapy in group A, B and C, respectively. Overall, 355 women (79%) had children. The responses were quite similar between the three groups. A mean gain of 13 years was judged necessary to make adjuvant endocrine therapy worthwhile based on the hypothetical scenario of untreated mean survival time of 15 years. A mean gain of 22% more women surviving was judged necessary to make adjuvant HT worthwhile based on an untreated 5-year survival rate expectation of 60%. Cognitive dysfunction was considered the side effect least compatible with the continuation of treatment in all three groups. The willingness to continue therapy was unrelated to age, marriage and presence of children. Conclusions: This is a large study of patient preferences on HT. Preferences have been elicited also in premenopausal patients treated with aromatase inhibitors. Compared with other studies with similar design, the patients included in the present study required larger benefits to make adjuvant therapy worthwhile. Clinical trial identification: NCT 03939156 Release date 05.03.2019. Legal entity responsible for the study: The authors. Funding: Women cancer center. Disclosure: E. Montagna: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili;
Annals of Oncology
Advisory / Consultancy: Novartis. M.A. Colleoni: Honoraria (self): Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Pfizer; Advisory / Consultancy: OBI Pharma; Advisory / Consultancy: Puma Biotechnology; Advisory / Consultancy: Celldex; Advisory / Consultancy: AstraZeneca. G. Cancello: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili. E. Munzone: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Genomic Health. S. Dellapasqua: Travel / Accommodation / Expenses: Roche. M. Mazza: Advisory / Consultancy: Novartis; Advisory / Consultancy: Gentili; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.
227P
Baseline quality of life (QoL) and chemotherapy related toxicities (CRT) in localized breast cancer (BC) patients (pts): The French multicentric prospective CANTO cohort study
I. Licaj1, S. Dabakuyo2, S. Dauchy3, I. Vaz Luis4, C. Charles5, C. Lemogne6, O. Tredan7, L. Vanlemmens8, C. Jouannaud9, C. Levy10, O. Rigal11, M. Fournier12, T. Petit13, F. Dalenc14, P. Rouanet15, A. Arnaud16, J. Lemonnier17, S. Everhard17, P.H. Cottu18, F. Joly10 1 Clinical Research, Centre Francois Baclesse, Caen, France, 2Biostatistics and Quality of Life Unit, Centre Georges Franc¸ois Leclerc, Dijon, France, 3Department of Supportive Care, Gustave Roussy, Villejuif, France, 4Departement of Medical Oncology, Gustave Roussy, Villejuif, France, 5Psycho-Oncology Unit, Gustave Roussy, Villejuif, France, 6 Hopital Europe´en Georges-Pompidou, APHP, Paris, France, 7Department of Oncology, Centre Leon Berard, Lyon, France, 8De´partement de Cance´rologie Se´nologique, Centre Oscar Lambert, Lille, France, 9Department of Medical Oncology, Institut Jean Godinot, Reims, France, 10Department of Medical Oncology, Centre Francois Baclesse, Caen, France, 11Medical Oncology, Centre Henri-Becquerel, Rouen, France, 12Surgery, Institut Bergonie´, Bordeaux, France, 13Medical Oncology, Centre Paul Strauss, Strasbourg, France, 14Medical Oncology, Centre Claudius-Regaud, Toulouse, France, 15Surgical oncology, ICM, Montpellier, France, 16Medical oncology, Clinique Ste Catherine, Avignon, France, 17Clinical Research, Unicancer, Paris, France, 18Medical Oncology, Institut Curie, Paris, France,
better performance status PS ¼ 0 vs 1þ, (68 vs 60 p < 0.001) and 91 vs 78 p < 0.001) respectively. 952 (31%) BC pts developed 1 CRT: 23% had an infection, 7% thrombosis, 0.3% G3-4 diarrhea, nausea or vomiting, 4% G2-4 neurological and 0.2% G3-4 pulmonary toxicities. 16% had chemotherapy dose reduction. Pts with a baseline GHS <70 had 19 % higher odds of CRT vs to those with GHS70, OR ¼ 1.19 [95% CI 1.021.41] and similarly those with a PF < 90 had a 23% higher odds of CRT when compared to those with PF 90 (OR ¼ 1.23 [95% CI 1.03-1.49]). Conclusions: Global and physical QoL before BC treatments are independently associated with CRT. QoL should be assessed before any treatment to identify patients at risk CRT. Clinical trial identification: NCT01993498. Legal entity responsible for the study: UNICANCER/Villejuif, France, 94805 Principal Investigator: Fabrice Andre´ Gustave Roussy – Villejuif. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
228P
Effects of aerobic and resistance exercise on android: Gynoid fat ratio in breast cancer survivors
C. Dieli-Conwright, N. Sami, K. Lee Biokinesiology and Physical Therapy, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA Background: The android:gynoid percent fat ratio (AGFR) is associated with increased risk of cardiovascular disease and type 2 diabetes in breast cancer survivors (BCS). Exercise reduces fat mass in BCS; however, few studies have focused on AGFR. The study purpose was to examine the effects of a 16-week aerobic and resistance exercise intervention on AGFR among BCS. We assessed whether exercise-induced changes in AGFR were associated with improved insulin resistance. Methods: BCS (Stage I-III) were randomized to exercise (n ¼ 50) or usual care (n ¼ 50). The thrice weekly 16-week intervention included supervised, progressive moderate-vigorous aerobic and resistance exercise. AGFR was obtained from a wholebody dual-energy x-ray absorptiometry. Insulin resistance was estimated using homeostatic model assessment of insulin resistance (HOMA-IR) calculated from fasting insulin and glucose levels. Within and between group differences were assessed by paired ttest and repeated measures ANOVA. Pearson’s correlation was computed to assess the association between AGFR and HOMA-IR in the exercise group. Results: Participants were 53 6 10.4 years old, overweight (BMI>25.0 kg/m2; 54%), Hispanic (63.1%), and had undergone a mastectomy (90%) and chemotherapy þ radiation therapy (76%). Adherence to the intervention was 95% and post-intervention assessments were available on 91% of participants. Post-intervention, AGFR significantly decreased in the exercise group from baseline and when compared to usual care (p < 0.001). Post-intervention, strong correlations were found between AGFR and HOMA-IR (r ¼ 0.95; p < 0.01). Conclusions: A progressive aerobic and resistance exercise intervention is an effective strategy to decrease AGFR in BCS. BCS who experience exercise-induced improvements in AGFR may also experience improved insulin resistance thereby reducing the risk for comorbid conditions. Clinical trial identification: NCT01140282. Legal entity responsible for the study: The authors. Funding: National Cancer Institute. Disclosure: All authors have declared no conflicts of interest.
229P
Impact of education for breast self examination in rural Indian women on early detection: Results of POC study
S.S. Parchuri1, S. Dattatreya Palanki1, S.S. Nirni1, S.S. Atilli2, V.V. Andra1, V.M. Ch3 Medical Oncology, Omega Hospitals, Hyderabad, India, 2Medical Oncology, Omega Hospitals, Gachibowli, India, 3Surgical Oncology, Omega Hospitals, Hyderabad, India
1
Background: In this study we aimed to examine the independent effect of baseline QoL and persistent CRT among pts with early BC. Methods: We included data stage I-III BC pts treated with chemotherapy who were included in the CANTO prospective cohort study (NCT-01993498) from 03/2012 to 12/2014. The primary outcome was CRT defined as the presence at 3-6 months after the end of treatment, of any of the following toxicities (NCI-CTC-AE): infection, venous or arterial thrombosis, neurological G2-4, digestive G3-4 or pulmonary toxicities G3-4). Treatment deliver including chemotherapy dose reductions were also examined. The independent variable of this study was baseline Qol defined by the EORTC QLQ-C30 subscales of general global health status (GHS) (< or 70) and physical functioning PF (< or 90). The defined cutoffs correspond to the average values in the French general population. Clinical relevant adjustment covariates included stage, age, performance status (PS), body mass index (BMI), HR and HER2 status, baseline lymphopenia, albumin, creatinine clearance, alcohol consumption, and smoking status. Multivariable logistic models were performed. Results: Among 3079 BC pts included in this analysis, 33% received neoadjuvant and 77% adjuvant treatment. Median age at diagnosis was 53 years, median BMI¼ 25 kg/ m2, 94% of patients had a PS ¼ 0 and 83% stage I-II disease. Pts reported on average a good GHS ¼ 68 (619) and PF ¼ 90 (614). GHS and PF were higher in women with
v76 | Breast Cancer, Early Stage
Background: Breast cancer contributes to 19-34% of all malignancies- indicating the high disease burden. In view of various socio-economic and cultural reasons, patients usually present at an advanced stage because of lack of awareness and nonexistent breast cancer screening programs in India. Breast self-examination (BSE) is easy cost effective and proven way for early detection. Methods: Objective: 1. To train women for Breast self-examination in health camps 2. To determine the effectiveness of planned teaching program with respect to BSE Materials & methods: Trained workers and physician prepared a visual aid and short video in local language for breast self examination and spend average 8-12 minutes to educate a group of women. 15:1 random check was done to known their level of understanding and correctness of adopting the method. The participants were observed and supervised by doctors to complete the procedure successfully. The results of Breast SelfExamination were documented. Results: BSE was successfully trained for a total of 4965 women across 19 camps between 2018-2019. Out of the samples 93% of women understood accurately the right method of BSE and re-traing was felt necessary in 35% as per their perception. Among the camps 165 new cases were reported in participants. Upon physician’s examination
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz240.052/5578324 by guest on 24 October 2019
However, HT is associated with side effects. The aim of the present study was to determine the preferences of women treated with adjuvant HT for breast cancer. Methods: Preferences have been elicited with a self-completed, validated questionnaire administered at study entry in eligible patients. The questionnaires, showing hypothetical scenarios based on potential survival times (5 or 15 years) and rates (60% or 80% at 5 years) without HT, were used to determine the lowest gains women judged necessary to make the treatment. The analyses were conducted into three different groups of early breast cancer patients to evaluate the expected survival benefit before starting HT (A), after a few months from the beginning (B) and after several years of HT (C). Patients also completed psychological questionnaires and the patient reported symptoms form. Results: A total of 452 patients were included in the study: 149 in group A, 150 in group B and 153 in group C. In group C, 65% of patients were receiving HT with aromatase inhibitors (with or without a LHRH analogue). 12%, 24% and 35% of patients received adjuvant chemotherapy in group A, B and C, respectively. Overall, 355 women (79%) had children. The responses were quite similar between the three groups. A mean gain of 13 years was judged necessary to make adjuvant endocrine therapy worthwhile based on the hypothetical scenario of untreated mean survival time of 15 years. A mean gain of 22% more women surviving was judged necessary to make adjuvant HT worthwhile based on an untreated 5-year survival rate expectation of 60%. Cognitive dysfunction was considered the side effect least compatible with the continuation of treatment in all three groups. The willingness to continue therapy was unrelated to age, marriage and presence of children. Conclusions: This is a large study of patient preferences on HT. Preferences have been elicited also in premenopausal patients treated with aromatase inhibitors. Compared with other studies with similar design, the patients included in the present study required larger benefits to make adjuvant therapy worthwhile. Clinical trial identification: NCT 03939156 Release date 05.03.2019. Legal entity responsible for the study: The authors. Funding: Women cancer center. Disclosure: E. Montagna: Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: gentili;
Annals of Oncology