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Bisphosphonate-associated Osteonecrosis of the Jaw (BONJ) in Metastatic Breast Cancer Patients in Greater Glasgow and Clyde
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Abstracts / Clinical Oncology 29 (2017) e95ee104
early breast who had undergone an EndoPredict (EPclin) assay were identified. The policy at this time was to test postmenopausal cases fit enough for chemotherapy and to test premenopausal patients only in exceptional cases; also to consider chemotherapy in all patients with N1 disease. The clinicopathological features and EPclin score were recorded. For 5 patients with micrometastases only, EPclin assays were calculated for both stage N1 and N0. The absolute percentage increase in breast cancer-specific survival from chemotherapy at 10 years above endocrine therapy was calculated using the ‘PREDICT!’ online algorithm, with N1mi patients assigned as such on PREDICT! v2.0. An absolute benefit of 3% was used as the threshold to offer chemotherapy (‘high risk’ by ‘PREDICT’ if 3%). Results: 22 patients were identified, 20 postmenopausal. The median age was 62.5, range 36e73. 7/22 (32%) had an EPclin score <3.4/low risk (N1mi assigned as N1); of these, 1/7 (14%) received chemotherapy. 8/22 (36%) were estimated ‘low risk’ by ‘PREDICT!’ and 3/8 (38%) received chemotherapy. Of the 15 patients assigned to high risk by EPClin (68%), 9/15 (60%) received chemotherapy and 7/14 (50%) assigned high risk by ‘PREDICT!’ received chemotherapy. Conclusion: About one-third of patients were classified as low risk by ‘PREDICT!’ and by EPclin. In this small cohort, chemotherapy prescribing appeared more in keeping with EPClin score than ‘PREDICT!’ estimates of risk but patients did not always receive chemotherapy in accordance with either clinical or EPClin risk assessment.
A Review of the Safe Introduction of Everolimus in York and Harrogate A. Stansfeld *, A. Proctor *, J. Joseph y * York Hospital, York, UK y Harrogate Hospital, Harrogate, UK
Purpose: To review the prescription, tolerance and toxicity profile of everolimus and exemestane and to compare with outcomes from the published data (BOLERO-2, BRAWO) [1,2]. Methods: A prospective database was maintained from February 2013 and reviewed in July 2016. Data were collected from online patient records and the chemotherapy prescribing software. Results: 34 patients were included. 4 patients are still on treatment. 23 patients stopped treatment due to progressive disease. 7 patients stopped due to toxicity. Of the 7 patients who stopped due to toxicity, 4 had a dose reduction before stopping. In total, 276 cycles were prescribed. 32/34 patients started on everolimus at 10 mg, 2/34 started on 5 mg. Of cycles prescribed, 63% were at 10 mg, 10% at 7.5 mg, 12% at 5 mg and 15% of cycles were prescribed without everolimus. 9 patients (26%) had 10 mg continuously before developing progressive disease. Reported toxicities included stomatitis (63%), dermatological conditions (53%), nausea (29%), pneumonitis (26%) and hyperlipidaemia (24%). 18% of patients developed evidence of transaminitis leading to a treatment break or cessation. The mean number of cycles prescribed per patient was 8 (range 1e24). Conclusion: Of the 7 patients who stopped treatment due to toxicity, 5 had 3 cycles. This suggests that severe toxicity is usually idiosyncratic rather than cumulative. This analysis will enable the breast oncology team to educate both patients and other members of the healthcare team about expectations of toxicity and treatment duration. An improved understanding of the anticipated side-effects will enable early intervention and management of toxicities. As the first drug approved for endocrine resistance, the safe introduction of everolimus can act as a model for incorporation of similar therapies in the future (PALOMA-2, MONALEESA-2) [3,4]. References [1] Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366:520e529. [2] Luefter D, Schuetz F, Grischke E, et al. Breast cancer treatment with everolimus and exemestane for ERþ women: results of the first interim
analysis of the noninterventional trial BRAWO. J Clin Oncol 2014;32:5s (abstract 578). [3] Finn R, Martin M, Rugo H, et al. PALOMA-2: primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ERþ/HER2e advanced breast cancer (ABC). J Clin Oncol 2016;34(Suppl):abstract 507. [4] Clinicaltrials.gov [Internet]. 2013 Dec e ongoing. Identifier NCT01958021. A randomized double-blind, placebo-controlled study of LEE011 (ribociclib) in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2 negative, advanced breast cancer who received no prior therapy for advanced disease.
Bisphosphonate-associated Osteonecrosis of the Jaw (BONJ) in Metastatic Breast Cancer Patients in Greater Glasgow and Clyde Y. Tan, S. Barrett Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK
Purpose: Osteonecrosis of the jaw (ONJ) is an uncommon complication of bisphosphonate treatment for bone metastases, with dental extractions being a precipitating factor [1]. The incidence of bisphosphonate-associated osteonecrosis of the jaw (BONJ) in metastatic breast cancer patients is estimated at 2.5e3.1% in the literature [1,2], with higher rates quoted in populations of lower socio-economic status [3]. This audit served to study the incidence of BONJ in Greater Glasgow & Clyde (GGC), the management of bisphosphonate treatment post-diagnosis of BONJ as there is currently no consensus of practice, and documentation of dental assessment prior to bisphosphonate initiation. Methods: 181 metastatic breast cancer patients in GGC who received more than one dose of bisphosphonate via electronic prescription in 2009e2011 were included. Patient electronic records were reviewed for information on demographic and clinical characteristics, documentation of dental preassessment, subsequent diagnoses of BONJ after at least 4 years of follow-up, and management post-diagnosis. Results: 13 patients (7.2%) had documented ONJ e 12 while receiving intravenous bisphosphonate and 1 while receiving denosumab after switching from a bisphosphonate. 6 had postcodes belonging to the 40% most deprived areas in Scotland [4]. Management post-diagnosis was variable e 6 patients continued on the same bisphosphonate, 1 switched type of bisphosphonate, 1 switched to denosumab and 4 discontinued bisphosphonate. The patient who developed ONJ on denosumab had this temporarily withheld and restarted when the ONJ was quiescent. Only 2% of patient electronic records contained documentation about dental health or advice regarding dental assessment prior to starting bisphosphonate. Conclusion: The incidence of BONJ in GGC is higher than reported in the literature. It is important to counsel patients about good dental health and document advice given to patients regarding dental pre-assessment. A dental referral and assessment form has been introduced in GGC for this purpose. References [1] Vahtsevanos K, Kyrgidis A, Verrou E, et al. Longitudinal cohort study of risk factors in cancer patients of bisphosphonate-related osteonecrosis of the jaw. J Clin Oncol 2009;27(32):5356e5362. [2] Wang EP, Kaban LB, Strewler GJ, Raje N, Troulis MJ. Incidence of osteonecrosis of the jaw in patients with multiple myeloma and breast or prostate cancer on intravenous bisphosphonate therapy. J Oral Maxillofacial Surg 2007;65(7):1328e1331. [3] Quispe D, Shi R, Burton G. Osteonecrosis of the jaw in patients with metastatic breast cancer: ethnic and socio-economic aspects. Breast J 2011;17(5):510e513. [4] Scottish Government. The Scottish Index of Multiple Deprivation. Available at: http://www.gov.scot/Topics/Statistics/SIMD (accessed 26 September 2016).
Abstracts / Clinical Oncology 29 (2017) e95ee104
early breast who had undergone an EndoPredict (EPclin) assay were identified. The policy at this time was to test postmenopausal cases fit enough for chemotherapy and to test premenopausal patients only in exceptional cases; also to consider chemotherapy in all patients with N1 disease. The clinicopathological features and EPclin score were recorded. For 5 patients with micrometastases only, EPclin assays were calculated for both stage N1 and N0. The absolute percentage increase in breast cancer-specific survival from chemotherapy at 10 years above endocrine therapy was calculated using the ‘PREDICT!’ online algorithm, with N1mi patients assigned as such on PREDICT! v2.0. An absolute benefit of 3% was used as the threshold to offer chemotherapy (‘high risk’ by ‘PREDICT’ if 3%). Results: 22 patients were identified, 20 postmenopausal. The median age was 62.5, range 36e73. 7/22 (32%) had an EPclin score <3.4/low risk (N1mi assigned as N1); of these, 1/7 (14%) received chemotherapy. 8/22 (36%) were estimated ‘low risk’ by ‘PREDICT!’ and 3/8 (38%) received chemotherapy. Of the 15 patients assigned to high risk by EPClin (68%), 9/15 (60%) received chemotherapy and 7/14 (50%) assigned high risk by ‘PREDICT!’ received chemotherapy. Conclusion: About one-third of patients were classified as low risk by ‘PREDICT!’ and by EPclin. In this small cohort, chemotherapy prescribing appeared more in keeping with EPClin score than ‘PREDICT!’ estimates of risk but patients did not always receive chemotherapy in accordance with either clinical or EPClin risk assessment.
A Review of the Safe Introduction of Everolimus in York and Harrogate A. Stansfeld *, A. Proctor *, J. Joseph y * York Hospital, York, UK y Harrogate Hospital, Harrogate, UK
Purpose: To review the prescription, tolerance and toxicity profile of everolimus and exemestane and to compare with outcomes from the published data (BOLERO-2, BRAWO) [1,2]. Methods: A prospective database was maintained from February 2013 and reviewed in July 2016. Data were collected from online patient records and the chemotherapy prescribing software. Results: 34 patients were included. 4 patients are still on treatment. 23 patients stopped treatment due to progressive disease. 7 patients stopped due to toxicity. Of the 7 patients who stopped due to toxicity, 4 had a dose reduction before stopping. In total, 276 cycles were prescribed. 32/34 patients started on everolimus at 10 mg, 2/34 started on 5 mg. Of cycles prescribed, 63% were at 10 mg, 10% at 7.5 mg, 12% at 5 mg and 15% of cycles were prescribed without everolimus. 9 patients (26%) had 10 mg continuously before developing progressive disease. Reported toxicities included stomatitis (63%), dermatological conditions (53%), nausea (29%), pneumonitis (26%) and hyperlipidaemia (24%). 18% of patients developed evidence of transaminitis leading to a treatment break or cessation. The mean number of cycles prescribed per patient was 8 (range 1e24). Conclusion: Of the 7 patients who stopped treatment due to toxicity, 5 had 3 cycles. This suggests that severe toxicity is usually idiosyncratic rather than cumulative. This analysis will enable the breast oncology team to educate both patients and other members of the healthcare team about expectations of toxicity and treatment duration. An improved understanding of the anticipated side-effects will enable early intervention and management of toxicities. As the first drug approved for endocrine resistance, the safe introduction of everolimus can act as a model for incorporation of similar therapies in the future (PALOMA-2, MONALEESA-2) [3,4]. References [1] Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366:520e529. [2] Luefter D, Schuetz F, Grischke E, et al. Breast cancer treatment with everolimus and exemestane for ERþ women: results of the first interim
analysis of the noninterventional trial BRAWO. J Clin Oncol 2014;32:5s (abstract 578). [3] Finn R, Martin M, Rugo H, et al. PALOMA-2: primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ERþ/HER2e advanced breast cancer (ABC). J Clin Oncol 2016;34(Suppl):abstract 507. [4] Clinicaltrials.gov [Internet]. 2013 Dec e ongoing. Identifier NCT01958021. A randomized double-blind, placebo-controlled study of LEE011 (ribociclib) in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2 negative, advanced breast cancer who received no prior therapy for advanced disease.
Bisphosphonate-associated Osteonecrosis of the Jaw (BONJ) in Metastatic Breast Cancer Patients in Greater Glasgow and Clyde Y. Tan, S. Barrett Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Glasgow, UK
Purpose: Osteonecrosis of the jaw (ONJ) is an uncommon complication of bisphosphonate treatment for bone metastases, with dental extractions being a precipitating factor [1]. The incidence of bisphosphonate-associated osteonecrosis of the jaw (BONJ) in metastatic breast cancer patients is estimated at 2.5e3.1% in the literature [1,2], with higher rates quoted in populations of lower socio-economic status [3]. This audit served to study the incidence of BONJ in Greater Glasgow & Clyde (GGC), the management of bisphosphonate treatment post-diagnosis of BONJ as there is currently no consensus of practice, and documentation of dental assessment prior to bisphosphonate initiation. Methods: 181 metastatic breast cancer patients in GGC who received more than one dose of bisphosphonate via electronic prescription in 2009e2011 were included. Patient electronic records were reviewed for information on demographic and clinical characteristics, documentation of dental preassessment, subsequent diagnoses of BONJ after at least 4 years of follow-up, and management post-diagnosis. Results: 13 patients (7.2%) had documented ONJ e 12 while receiving intravenous bisphosphonate and 1 while receiving denosumab after switching from a bisphosphonate. 6 had postcodes belonging to the 40% most deprived areas in Scotland [4]. Management post-diagnosis was variable e 6 patients continued on the same bisphosphonate, 1 switched type of bisphosphonate, 1 switched to denosumab and 4 discontinued bisphosphonate. The patient who developed ONJ on denosumab had this temporarily withheld and restarted when the ONJ was quiescent. Only 2% of patient electronic records contained documentation about dental health or advice regarding dental assessment prior to starting bisphosphonate. Conclusion: The incidence of BONJ in GGC is higher than reported in the literature. It is important to counsel patients about good dental health and document advice given to patients regarding dental pre-assessment. A dental referral and assessment form has been introduced in GGC for this purpose. References [1] Vahtsevanos K, Kyrgidis A, Verrou E, et al. Longitudinal cohort study of risk factors in cancer patients of bisphosphonate-related osteonecrosis of the jaw. J Clin Oncol 2009;27(32):5356e5362. [2] Wang EP, Kaban LB, Strewler GJ, Raje N, Troulis MJ. Incidence of osteonecrosis of the jaw in patients with multiple myeloma and breast or prostate cancer on intravenous bisphosphonate therapy. J Oral Maxillofacial Surg 2007;65(7):1328e1331. [3] Quispe D, Shi R, Burton G. Osteonecrosis of the jaw in patients with metastatic breast cancer: ethnic and socio-economic aspects. Breast J 2011;17(5):510e513. [4] Scottish Government. The Scottish Index of Multiple Deprivation. Available at: http://www.gov.scot/Topics/Statistics/SIMD (accessed 26 September 2016).