1. Dr Dylan Narinesingh and Team Presenters : Dr P.Sylvester and Dr N.Bhim

2. Palliative setting InpatientOutpatient

3. Inpatient setting  Assess and treat symptomatically  Family meeting concerning options for home care vs hospice care  Home care not feasible  referral to Hospice  Family advised to visit place to meet health care providers at the Hospice  Then patient is transported from SFGH  Hospice

4. Outpatient setting Clinic ZometaXeloda Paliative care clinic DHF

5. Zometa  Intravenous bisphosphonate  Indicated for Rx with metastatic bone disease  Multiple Myeloma  Prevents SRE and relieves bone pain  Administered every 4 to 5 weeks Zsuzsanna Nagy : Zoledronic acid (ZOMETA) : a significant improvement in the treatment of Bone metastases. Pathology and Oncology Research Vol 11, No 3, 2005.

6. Initial clinic visit for Zometa  Counselling  side effects  Calcium supplements  Monthly blood tests to review prior to administering (RFT’s and Ca 2+ )  Informing physician on dental procedures  Severity of Bone pain  Pain management according to the WHO Analgesic ladder  Palliative radiotherapy @ NRC http://www.zometa.com/dosing-and-administration/dosing-for-solid-tumours-and-multiple myeloma/treat-every-3-to-4-weeks.jsp

7. Palliative Radiotherapy  Patients referred to be assessed at National Radiotherapy Centre on Tuesdays  Clinical mark-up planning  Radiation dose of 8Gy x 1 Fraction or 20Gy x 5 Fractions (administered to the area that gives the patient the most pain) Chow E, Harris K, Fan G : Journal of Clinical Oncology, Vol 25, No 11 (April 10), 2007: pp. 1423-1436

8. Palliative Xeloda clinic  Indicated in Metastatic Colorectal Cancer 1 and Breast Cancer 2  Initial visit  Counseling patient on side effects and how to manage them  Blood test to review before prescribing ( CBC, RFT, LFT)  Vitamin B6 to be taken daily  Patients seen every 3/52  Reassessment after 3 cycles 1. http://www.xeloda.com/about/prescribed-for/mcrc 2. Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999;17(2):485-493.

9. District Health Facilities  Princes Town / Couva / Siparia  Providing best supportive care  Team effort comprising Physicians, Nurses and counselors  Provide education and counseling of Patient and relatives

10. Paliative Care clinic  Situated at SFGH outpatient Oncology Clinic every 2/52  Dr S. Chamely  Palliative care physician  Patients receiving home care

11. Hospice care in South Trinidad  Soon to be established at Petrotrin Medical Centre

13. Overview  Audit period 10/7 (October 4 th, 2011 to October 19 th, 2011)  Inclusion Criteria  Metastatic bone disease  Duration of treatment with Zometa >3mths  Total population approx. 100 patients

14. Demographics  Sample size 34 patients: 28 males and 6 females  Age Distribution: Age Group <5050-5960-6970-79>80 No. of Patients 0611152 %017.632.444.15.9

15. Primary site of cancer Prostate Breast Other

17.  Date:_____________ Record No._____________  Name:__________________________________________________________________  DOB (age): / / _____yrs  Gender: M F  Ethnicity: Black Asian East Indian Caucasian Mixed_____________  Address:________________________________________________________________________________________________  Cancer Type: Breast Prostate Lung Colon/Rectum Kidney Lymphoma (HL/NHL) Malignant Melanoma Brain Head & Neck Gastric Esophagus  Pancreatic Liver Cervix Endometrial Ovarian CUP  Other______________________________  Histology:________________________________________________________________________________  Date Diagnosed with Cancer:___________________________  Date Diagnosed with Bony Metastases:_________________________  Imaging Modality used for diagnosis: X-rays Bone Scan MRI CT  Site of Bony Metastates: Pelvis Spine (Cervical Thoracic Lumbar Sacral) Rib Cage Skull Scapula Clavicle Femur Humerus Other____________________  Spinal Cord Compression (at time of diagnosis): Y N  RT administered for SCC: Y N

18.  Bone Pains: Y N  Site of Bone Pains: ___________________________________________  RT administered for Bone Pain: Y N  Receiving Palliative Chemotherapy/Hormonal Therapy: Y N  Date Zoledronic Acid started:________________________________________________  Baseline Creatinine and Calcium levels:_______________________________________  Duration of Treatment (months):_____________________________________________  Date Zoledronic Acid Discontinued:__________________________________________  Reason for discontinuation: Renal Failure Hypocalcaemia Osteonecrosis of Jaw Atypical Fracture Other__________________  Did patient experience any adverse skeletal-related event (SRE) or hypercalcemia of malignancy (resulting in admission) whilst receiving Zoledronic Acid: Y N  Specify:_________________________________________________________________  Dose Reduction of Zometa: Y N  Reason for Dose Reduction: Renal Impairment Other_________________________

19.  Objective Improvement in Quality of Life  Compare Before and After Zoledronic Acid administered:  Describe in patient’s (and/or caregiver’s) own words: _______________________________________________________________________  Objective improvement in mobility:  ECOG/Karnofsky/Lansky Performance Status Before Zoledronic Acid:______________  ECOG/Karnofsky/Lansky Performance Status After Zoledronic Acid:________________  Number of Doses/Cycles given before improvement noticed:_______________________  Objective improvement in bone pain (see NIPC rating scales):  Numeric Rating Scale Before Zoledronic Acid: _________________________________  Verbal Pain Intensity Scale Before Zoledronic Acid:______________________________  Numeric Rating Scale After Zoledronic Acid: __________________________________  Verbal Pain Intensity Scale After Zoledronic Acid:_______________________________  Number of doses/cycles of Zoledronic Acid given before improvement noticed:________

20. KARNOFSKY PERFORMANCE STATUS SCALE DEFINITIONS RATING (%) CRITERIA Able to carry on normal activity and to work; no special care needed. 100 Normal no complaints; no evidence of disease. 90Able to carry on normal activity; minor signs or symptoms of disease. 80Normal activity with effort; some signs or symptoms of disease. Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed. 70Cares for self; unable to carry on normal activity or to do active work. 60 Requires occasional assistance, but is able to care for most of his personal needs. 50Requires considerable assistance and frequent medical care. Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly. 40Disabled; requires special care and assistance. 30 Severely disabled; hospital admission is indicated although death not imminent. 20 Very sick; hospital admission necessary; active supportive treatment necessary. 10Moribund; fatal processes progressing rapidly. 0Dead

21. ECOG PERFORMANCE STATUS GradeECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 Dead

22. 0–10 Numeric Pain Rating Scale

23. Duration of Treatment

24. Dose reduction

25. Spinal Cord Compression

26. Bone Pain

27. Improvement in pain scores

28. Improvement in pain  Average no. of doses before decrease in pain noticed 2.5 doses  Average decrease in numeric pain rating: approximately 3.5pts

29. Improvement in mobility

30.  Average no. of doses before change noticed: 2months  Average increase in performance status by ECOG Scale approximately 2pts  Average increase in performance status by Karnofsky Scale approximately 20pts

31. Skeletal Related Events

33. What is Zometa?  Zometa (Zoledronic acid) belongs to a class of drugs known as bisphosphonates.  Zometa fights against skeletal destruction in advanced tumours and multiple myeloma

34. Mechanism of action

35.  In addition to being a potent inhibitor of bone resorption, Zometa also possesses anticancer properties that could contribute to its overall efficacy in the treatment of metastatic bone disease  Zometa is administered as an IV infusion every 3-4 weeks in MM and advanced solid tumours

36. SRE  Skeletal Related events can shorten the survival in patients with advanced prostate and breast CA

37. Prostate CA  49% of patients with advanced prostate Ca and bone metastases will experience a SRE within the first 2yrs  Average time to first SRE is 10.7mths  Average frequency of SRE was approximately every 8 mths

38. Breast CA  68% of patients with advanced breast Ca and bone metastases will suffer a SRE within 2yrs  The average length of time to first time SRE was 7mths  The frequency of SREs occur approximately every 3mths

39.  In view, of data collected in audit thus far.  At a cost of $2400.00TT per dose of Zometa vs an average $1100.00TT per hospital bed per night.  How cost effective is the use of Zometa in Palliative care in our setting?

40. References  1. Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treatment Rev. 2001;27:165-176.  2. Lipton A, Theriault RL, Hortobagyi GN, et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000;88:1082-1090.  3. Saad F, Lipton A, Cook R, Chen Y-M, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer. 2007;110:1860-1867.  4. ZOMETA Summary of Product Characteristics. Novartis Pharma AG.  5. Andre F, Slimane K, Bachelot T, et al. Breast cancer with synchronous metastases: trends in survival during a 14-year period. J Clin Oncol. 2004;22:3302-3308.  6. Rosen LS, Gordon D, Kaminski M, et al; Zoledronic Acid Breast Cancer and Multiple Myeloma Study Group. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003;98:1735-1744.  7. Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2005;23:3314-3321.  8. Aapro M, Abrahamsson PA, Body JJ, et al. Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel. Ann Oncol. 2008;19:420-432.  9. Van Poznak CH, Temin S, Yee GC, et al. American Society of Clinical Oncology executive summary of the Clinical Practice Guideline update on the role of bone-modifying agents in metastatic breast cancer. J Clin Oncol. 2011;29:1221-1227.