WHAT ARE THE MOST SERIOUS ADVERSE EVENTS DURING

  • Slides: 14
Download presentation
WHAT ARE THE MOST SERIOUS ADVERSE EVENTS DURING AND AFTER RADIATION THERAPY? Bhadrasain Vikram,

WHAT ARE THE MOST SERIOUS ADVERSE EVENTS DURING AND AFTER RADIATION THERAPY? Bhadrasain Vikram, MD

GLIOBLASTOMA Stupp, NEJM 352: 987 -96, 2005. • >Grade 3 non-heme toxicity in 31%.

GLIOBLASTOMA Stupp, NEJM 352: 987 -96, 2005. • >Grade 3 non-heme toxicity in 31%. Most common: – Fatigue & other constitutional symptoms – Rashes & other skin effects – Infection – Effects on vision – Nausea & Vomiting

HEAD & NECK Bonner, NEJM 354: 567 -78, 2006. • >Grade 3 toxicity: –Mucosal

HEAD & NECK Bonner, NEJM 354: 567 -78, 2006. • >Grade 3 toxicity: –Mucosal 56% –Dysphagia 26% –Dermatitis 23% –Weight loss 11%

SMALL CELL LUNG - LD Turrisi, NEJM 340: 265 -71, 1999. • >Grade 3

SMALL CELL LUNG - LD Turrisi, NEJM 340: 265 -71, 1999. • >Grade 3 non-heme toxicity: – Esophagitis in 32% – Infection – Fever – Vomiting – Pulmonary effects – Weight loss

ESOPHAGUS Minsky, JCO 20: 1167 -74, 2002. • >Grade 3 acute toxicity in 71%.

ESOPHAGUS Minsky, JCO 20: 1167 -74, 2002. • >Grade 3 acute toxicity in 71%. • >Grade 3 late toxicity in 37%. –Esophageal strictures, perforations, bleeding.

BREAST: POST-LUMPECTOMY Fyles, NEJM 351: 963 -970, 2004. • >Grade 3 toxicity: –Fatigue 1%

BREAST: POST-LUMPECTOMY Fyles, NEJM 351: 963 -970, 2004. • >Grade 3 toxicity: –Fatigue 1% –Skin erythema 1%

BREAST: POST-MASTECTOMY Ragaz, JNCI 97: 116 -1126, 2005. • >Grade 3 late toxicity @

BREAST: POST-MASTECTOMY Ragaz, JNCI 97: 116 -1126, 2005. • >Grade 3 late toxicity @ 20 years: – Cardiac 1% – Arm edema 6% – Symptomatic pneumonitis 0. 6%

PANCREAS: POST-OP Regine, JAMA 299: 1019 -1026, 2008. • >Grade 3 non-heme toxicity in

PANCREAS: POST-OP Regine, JAMA 299: 1019 -1026, 2008. • >Grade 3 non-heme toxicity in 58%. Most common: – Diarrhea – Stomatitis – Nausea & Vomiting

PROSTATE: LOW-RISK Lawton, IJROBP 67: 39 -47, 2007. • >Grade 3 acute toxicity: –

PROSTATE: LOW-RISK Lawton, IJROBP 67: 39 -47, 2007. • >Grade 3 acute toxicity: – GU bleeding/toxicity 8% • >Grade 3 late toxicity: – Erectile dysfunction 9% – GU obstruction/retention 2%

PROSTATE: HIGH-RISK Bolla, Lancet 360: 103 -108, 2002. • >Grade 3 toxicity: –Erectile dysfunction

PROSTATE: HIGH-RISK Bolla, Lancet 360: 103 -108, 2002. • >Grade 3 toxicity: –Erectile dysfunction 68% –GI/GU toxicity 3. 7%

CERVIX Morris, NEJM 340: 1137 -1143, 1999. • >Grade 3 acute non-heme toxicity in

CERVIX Morris, NEJM 340: 1137 -1143, 1999. • >Grade 3 acute non-heme toxicity in 11%. Most common: – Nausea & vomiting – Diarrhea • >Grade 3 late toxicity in 12%. Most common: – Bowel & Urinary toxicity

RECTUM Sauer, NEJM 351: 1731 -1740, 2004. • >Grade 3 non-heme acute toxicity in

RECTUM Sauer, NEJM 351: 1731 -1740, 2004. • >Grade 3 non-heme acute toxicity in 27%. Most common: – Diarrhea – Dermatitis • >Grade 3 late toxicity in 14%. Most common: – Diarrhea – Bowel obstruction/strictures – Bladder problems

ANAL Ajani, JAMA 299: 1914 -1921, 2008. • >Grade 3 non-heme acute toxicity in

ANAL Ajani, JAMA 299: 1914 -1921, 2008. • >Grade 3 non-heme acute toxicity in 74%. Most common: – Skin toxicity – Bowel toxicity • >Grade 3 late toxicity in 11%. Most common: – Bowel toxicity – Skin & Subcutaneous

SUMMARY • Serious adverse events frequently occur during and after radiation therapy in many

SUMMARY • Serious adverse events frequently occur during and after radiation therapy in many common cancers. • The impact of advanced technologies (IMRT, Protons, etc. ) in that regard has until now been quite modest.

Adverse Events and Serious Adverse Events Jodie RileyAdverse Events and Serious Adverse Events Jodie Riley
Serious Adverse Events and Payment Nancy Foster SeriousSerious Adverse Events and Payment Nancy Foster Serious
Adverse Events Following Immunization AEFI Adverse Events FollowingAdverse Events Following Immunization AEFI Adverse Events Following
Adverse Selection What Is Adverse Selection Adverse selectionAdverse Selection What Is Adverse Selection Adverse selection
COOL Study Adverse Event AE and Serious AdverseCOOL Study Adverse Event AE and Serious Adverse
Serious Games From Serious Fun to Serious ImpactSerious Games From Serious Fun to Serious Impact
Educational Spotlight Adverse Event Reporting Adverse Events keyEducational Spotlight Adverse Event Reporting Adverse Events key
REPORTING SERIOUS ADVERSE EVENTS AND COMPLETING THE REPORTREPORTING SERIOUS ADVERSE EVENTS AND COMPLETING THE REPORT
Prevention of Serious Adverse Events Following Angiography PRESERVEPrevention of Serious Adverse Events Following Angiography PRESERVE
GCP Workshop Ethics Committee Members Serious Adverse EventsGCP Workshop Ethics Committee Members Serious Adverse Events
Cohort Study of Serious Adverse Events with SodiumGlucoseCohort Study of Serious Adverse Events with SodiumGlucose
Reporting Serious Adverse Events Karasha Moodley Zanele MunyaiReporting Serious Adverse Events Karasha Moodley Zanele Munyai
Most Frequently Cited Serious Violations Construction 2000 MostMost Frequently Cited Serious Violations Construction 2000 Most