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Survivorship, Patient Engagement & Side Effect Management

Survivorship, Patient Engagement & Side Effect Management

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Survivorship, Patient Engagement & Side Effect Management

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  1. Survivorship, Patient Engagement & Side Effect Management LLS Multiple Myeloma Conference Pewaukee, WI October 5, 2013 (updated post conference) Mike Thompson, MD, PhD @mtmdphd Medical Director Early Cancer Research Program, Patient-Centered Research Aurora Research Institute

  2. Outline • COI / Participatory Medicine • Resources • #MMSM Twitter Chat • What is a “Survivor” • Side Effects & Management

  3. Outline • COI / Participatory Medicine • Resources • #MMSM Twitter Chat • What is a “Survivor” • Side Effects & Management

  4. Potential Conflicts (or Convergence) of Interests: • Novartis – research funding (2006, Zometa) • Celgene - MDS registry advisor (2012-) • Seattle Genetics, Advisory Board (2013) • ECOG Myeloma Core Committee • NCI Myeloma Steering Committee • ASCO Cancer Research Committee (2013-16) • Aurora Health Care / ARI

  5. I WILL talk about off label use of products.

  6. Patient Advocacy / Participatory Medicine and e-Health • LLS • Stillwaters Cancer Support Group • International Cancer Advocacy Network (ICAN) • Best Doctors • HealthTap • Doximity • ASCO Connection blogger • #MMSM Twitter Chat

  7. Outline • COI / Participatory Medicine • Resources • #MMSM Twitter Chat • What is a “Survivor” • Side Effects & Management

  8. “The Internet” Is the Internet Really Making Me Stupid, Crazy, and Constantly Distracted? http://lifehacker.com/5927763/is-the-internet-really-making-me-stupid-crazy-and-constantly-distracted?utm_campaign=socialflow_lifehacker_twitter&utm_source=lifehacker_twitter&utm_medium=socialflow

  9. Resources • LLS – www.lls.org • http://www.canceradvocacy.org/toolbox/multiple-myeloma/ • http://www.mayoclinic.org/multiple-myeloma/symptoms.html • Multiple Myeloma Personal Care Assistant™ • International Myeloma Foundation • www.myeloma.org • ASCO • http://www.cancer.net/patient/Cancer+Types/Multiple+Myeloma • Side Effects http://www.cancer.net/patient/Cancer+Types/Multiple+Myeloma?sectionTitle=Side%20Effects • Cancer.Net • #mmsm – engaged patients • MPatient- http://www.mpatient.org/

  10. National Coalition for Cancer Survivorship (NCCS) • http://www.canceradvocacy.org/toolbox/multiple-myeloma/ • Cancer Survival Toolbox • Side Effects And Symptom Management 

  11. Outline • COI / Participatory Medicine • Resources • #MMSM Twitter Chat • What is a “Survivor” • Side Effects & Management

  12. Myeloma #MMSM Twitter Chat • Sunday nights, 9-10 pm • Search / follow #mmsm (multiple myeloma social media) • http://twubs.com/mmsm • Started 9/15/13 by @mtmdphd & @myelomateacher • Next 10/20/13 • Participants from Mayo, MDACC, UNC, etc

  13. Outline • COI / Participatory Medicine • Resources • #MMSM Twitter Chat • What is a “Survivor” • Side Effects & Management

  14. What is a Survivor?

  15. Survivorship DefinitionsVarious • 5 yrs after Tx / cure • "From the time of cancer diagnosis, through the balance of his or her life."  • National Coalition of Cancer Survivorship & The Office of Cancer Survivorship (NCI) & Lance Armstrong Foundation

  16. Many Cancer Survivors AACR In the US alone, there are 12 million cancer survivors http://ow.ly/6BXgg#AACR#cancerprogress AACR ‏@AACR2 Oct In 1971, one of every 69 people was a cancer survivor. Today, it's one in 23. http://ow.ly/poyUS #CancerProgress13

  17. The “C” Word • ASH 2009 • Bart Barlogie used the word “Cure” in talking about MM • Ken Anderson (DFCI) & Vincent Rajkumar (Mayo) followed his talk and didn’t disagree • Prior we usually talked about MM as an incurable disease • A paradigm shift? • “Not currently curable” – James Bond (Pt) 2012 WI LLS mtg

  18. “Curability of Multiple Myeloma” ASH 2009Delasalle et al. #3864 (MDACC study) • Conclusions: Assuming that prolonged CR for more than 10 years translatesinto potential cure, we calculated a "cure fraction" of 2% forpatients treated between 1987-1997. • Such favorable outcomewith potential cure should be more likely with current programsassociated with more frequent early intensive therapy and CR.

  19. MM Curability?(or chronic disease) • Kathy Giusti • Founder and CEO of the MM Research Foundation (MMRF) • 15 year multiple myeloma patient (2011) http://www.themmrf.org/about-the-mmrf/powerful-news/press-releases/kathy-giusti-and-mmrf-featured-in-harvard-business-review.html

  20. Mayo MM Survival

  21. MM Survivors • Survival/Prognostic tables based on “old” data. • We are not curing everyone (yet), but… • New drugs & treatment approaches are changing MM. • MM “Survivors” will increase in number and need/demand new treatments and supportive care

  22. “I Will Survive”

  23. OutlineSide Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  24. Side Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  25. Steroid S/E(Steroids = backbone of MM Tx) • Mental • “chemo brain” • irritability • mood swings • depression • Insomnia • General • weight gain • increased appetite • general body swelling • flushing, and sweating • muscle cramping • GI - heartburn, gas, and taste changes • changes in sexual function • and a “letdown” effect when steroids are stopped suddenly • paradoxical fatigue

  26. Diabetes Mellitus • Avoid (relatively) the following: • Dex • Thal/Dex • Len/Dex • Bortezomib/Dex • Bortezomib - hypoglycemia

  27. Sleep-shopping (or "Oops, I purchased what???") Once per week, I take 20 mg of dexamethasone, which is a steroid. As a result, I won't sleep at all if I don't take Ambien twice a week-- on the day I take dex and the day after. When I take Ambien, I mostly don't remember what I've done. Which means texting and phone calls can be comical. But last week, I encountered something potentially not comical. After an Ambien night, I woke up the next day, checked my email, and discovered that I went shopping in the middle of the night and bought things that I didn't want or need.I mean, they're kind of cool, but it was a big "I did what?" moment. So my shipments have arrived and here's what I ended up with: 7/25/13 - http://lizzysmilez.blogspot.com/2013/07/night-shopping-or-oops-i-purchased-what.html

  28. OutlineSide Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  29. Bone Disease • 80% MM Pts with “bone disease” – depends on how you look • A major source of • pain • complications • death

  30. Bone • Low bone mass – osteopenia or osteoporosis • Lytic bone lesions • Pain • Pathologic fractures • ONJ – osteonecrosis of the jaw from bisphosphonate (or d-mab) Rx

  31. Bone - Zoledronic Acid in MMUK MRC Myeloma IX Data • N = ~ 2000 MM Pts • Zoledronic acid (Zometa) IV vs. oral (and less potent) cladronate (not avail in US) • RESULTS – Favored Zometa • 50% fewer SRE • Improved OS 16% (incr med OS by 5.5 mon) • Increase PFS 12% (incr med PFS by 2.0 mon) Lancet Oncology (2011;12:743-751) Lancet 2010;376:1989-99

  32. Bone - Zoledronic Acid in MMUK MRC Myeloma IX Data • “Previously people with no bone lesions weren't considered for treatment with these agents, but I think we have shown convincingly that you can reduce the rates of SREs in patients even in patients who don't have bone disease at baseline,” Dr. Morgan said. • “That's important, because if patients start out without bone lesions they don't get bone pain, but once they do have an SRE there is a chance it will impair their quality of life.” Lancet Oncology (2011;12:743-751) Lancet 2010;376:1989-99 Oncology Times: 10 September 2011 - Volume 33 - Issue 17 - pp 13,16

  33. NCCN UpdatesVersion 1.2012 Adjunctive treatment: The panel now recommends bisphosphonate therapy for all patients receiving primary myeloma therapy. Previously it was recommended in all myeloma patients with documented bone disease. For treatment of hypercalcemia, if bisphosphonates is chosen, the panel prefers using zoledronic acid.

  34. NCCN v 2.013 • Zoledronic acid (category 1 EBM) • SMM • consider Zometa in clinical trial • Yearly bone XR survey • Monitor renal fn & ONJ • Trial – Zometa vs. denosumab (NCT01345019)

  35. Bone • OsteoCLASTs - bone-destroying cells • OsteoBLASTs - bone-forming cells • Treatments for bone disease include: • Drugs • Radiation • Vertebro- or kyphoplasty • Surgery (less common now)

  36. Bone • Bisphosphonates • inhibit the activity and formation of bone-destroying cells. • pamidronate (Aredia) - less effective • zoledronic acid (Zometa) • RANK Ligand Inhibitor • Xgeva (denosumab, Amgen) • Bortezomib (Velcade) • Transient rather than permanent new bone formation • Parathyroid hormone (PTH, teriparatide, Forteo, Lilly) – a drug used to treat some patients with osteoporosis has a benefit in mice and may be safe for patients with myeloma • New drugs – Not approved • DKK-1 inhibitors • BHQ880 (Novartis) - antibody • Activin A inhibitor • ACE-011 (Sotatercept, Acceleron/Celgene) [& anemia Tx?] • bone morphogenetic protein receptor type 1A (BMPR1A) inhibitor • ACE-661 (Acceleron)

  37. Side Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  38. Infection • MM results (usually) in the expansion in one (mono-) type “clone” (-clone) = monoclonal (M-spike) of Ig • Other Ig’s can be reduced • Tx can reduce immunity • Most common cause of MM death is infection

  39. Infection • IVIg considered • Vax – PVX, Influenza • lower Ab response, but still advised • Px for high dose Dex • PCP, herpes, antifungal • Px for bortezomib (or MM in general) • Herpes zoster px

  40. Side Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  41. Fatigue • “The most common symptom of multiple myeloma is fatigue, found in 70 percent of patients at diagnosis.” – Mayo • http://www.mayoclinic.org/multiple-myeloma/symptoms.html (?) • Anemia – consider Epo (VTE risk), RBC Tx • Poor sleep • Decr caffeine • Good sleep hygiene • Pain control • Exercise

  42. OutlineSide Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  43. Sexual Side Effects • Danish researchers recently found that patients who underwent SCTfrequently experienced sexual dysfunction, sometimes for extended periods of time after transplantation.  • Reduced sexual function -> lower quality of life (QOL) • Decreases in: • sexual activity (38%) • ability to have sex (36%) • pleasure from sex (31%) • interest in sex (28%) Thygesen et al. The impact of hematopoietic stem cell transplantation on sexuality: a systematic review of the literature. Bone Marrow Transplantation , (29 August 2011) Myeloma Beacon - http://www.myelomabeacon.com/news/2011/09/19/researchers-find-high-rates-of-sexual-dysfunction-after-stem-cell-transplantation/

  44. OutlineSide Effects • Steroid SE • Bone • Infection • Fatigue • Sexual • Neuropathy • Financial toxicity • Digestive / GI • Cardiovascular • Renal • 2nd malignancies

  45. Neuropathy • Tingling and pain in the hands, arms, feet, and legs (known as peripheral neuropathy, PN). • Treatments for myeloma can make this neuropathy worse • Combinations of drugs associated with PN can greatly increase the risk (VTD). • However, other combinations may decrease the risk of PN (Hsp90 or HDACi)

  46. Neuropathy • MM (before Tx) • Tx related • Thalidomide • Much less with other IMiDs • Bortezomib • Less with SQ or qWK dosing • not used much now • Vincristine • Platinums

  47. NeuropathyMechanism (Thalidomide) Thalidomide • Researchers looked at MM pts (n=27 MM & 30 ctrls) treated with thalidomide • clinical and electrophysiological assessment of peripheral sensory nerves • axonal and demyelinatingabnormalities • Clinically: • arm and heat-pain detection thresholds were elevated • threshold for skin cooling was decreased Bilińska M et al. Pol Merkur Lekarski. 2011 Aug;31(182):86-91.

  48. Neuropathy Bortezomib Dosing • FDA approved • 1.3 mg/m2 IV d1,8,11 q21d • PN 36% total ; Gr 3 7%, Gr 4 <1% • Weekly • 1.6 mg/m2 IV weekly • REF: Greco et al. ASCO 2006 #7547 • N=37 (26 evaluated) • PN 0% • Subcutaneous (SQ) • 1.3 mg/m2 SQ d1,4,8,11 q21 • REF: Moreau et al. Lancet Oncol 12(5):431-440 • N=222 (145 SQ, 77 IV) ; 3 RCT • PN: SQ 38% vs. IV 53% (total) • PN >=gr3 – SQ 57% vs. IV 70% NOTE: No data for SQ qWEEK. SQ may be good for home. Weekly decr PN

  49. Neuropathy • 2011 -- No randomized controlled trials (RCTs) published of any drug or supplement in myeloma patients looking to prevent or treat peripheral neuropathy • Vitamin B6 and nutritional supplements with amino acids, pain medicines, • anti-depressants, NSAIDs (watch kidneys!) • Neuropathy meds – anti-seizure drugs • Duloxetine (Cymbalta) ?