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Statistics and Medicine – Friends or Foes?
Monika Krzyzanowska MD MPHMedical Oncologist, Princess Margaret Cancer CentreAssociate Professor of Medicine, University of Toronto
Case
• 61 year old male tailor• Presented with iron deficiency anemia• Colonoscopy: tumour in colon• Sent to general surgeon who removed the
primary cancer from the colon• The surgeon has referred the patient to you
(medical oncologist) for an opinion regarding what to do next?
What do you need to know to advise the patient on next steps?
• How serious is the cancer?• What are the “treatment” options?• What are the benefits of treatment?• What are the risks?
What do you need to know to advise the patient on next steps?
• How serious is the cancer?• What are the “treatment” options?• What are the benefits of treatment?• What are the risks?
How serious is the cancer?
PROGNOSIS
Colorectal Cancer Stages
TNM Staging System
• T: depth of invasion into bowel wall– T1 Invasion of submucosa– T2 Invasion into muscularis propria– T3 Invasion through muscularis into serosa– T4 Invasion of other organs +/- perforation
• N: regional nodes– N0 No nodal mets– N1 Mets to 1-3 lymph nodes– N2 Mets in 4 nodes
• M: distant metastases
TNM Staging System
TNM Classification Dukes’ Survival (no tx)
Stage I T1N0M0T2N0M0
A > 90%
Stage II IIAIIB
T3N0M0T4N0M0
B 60-85%
Stage III IIIAIIIBIIIC
T1-2N1M0T3-4N1M0anyTN2M0
C 25-65%
Stage IV anyTanyNM1 D 5%
Case Revisited• CT scans – no spread of disease• Pathology
– Adenocarcinoma – invading through the muscularis into serosa– 7/15 LN involved with tumour
Stage: pT3N2M0 (Stage 3)
TNM Staging
TNM Classification Dukes’ Survival (no tx)
Stage I T1N0M0T2N0M0
A > 90%
Stage II IIAIIB
T3N0M0T4N0M0
B 60-85%
Stage III IIIAIIIBIIIC
T1-2N1M0T3-4N1M0anyTN2M0
C 25-65%
Stage IV anyTanyNM1 D 5%
Adjuvant! Online
https://www.newadjuvant.com/default2.aspx
What do you need to know to advise the patient on next steps?
• How serious is the cancer?• What are the “treatment” options?• What are the benefits of treatment?• What are the risks?
What are the treatment options?
• Do nothing• Surveillance• Chemotherapy
http://www.psmag.com/health/evidence-of-a-need-for-change-4241/
Adjuvant Therapy
Treatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation therapy, hormone therapy, or biological therapy.
What do you need to know to advise the patient on next steps?
• How serious is the cancer?• What are the “treatment” options?• What are the benefits of treatment?• What are the risks?
Chemotherapy Options for St 3 Colon Cancer in 2013
• Drug A -- 5-fluorouracil (5-FU)
• Drug B – capecitabine
• Combination therapy (Drug A or B plus other drugs)
Drug A vs No Treatment
MOSAIC Trial
St II & III colon
n = 2,246
RANDOMIZATION
Combination
Drug A – 5FU
Andre NEJM 2004
Adjuvant! Online
https://www.newadjuvant.com/default2.aspx
What do you need to know to advise the patient on next steps?
• How serious is the cancer?• What are the “treatment” options?• What are the benefits of treatment?• What are the risks?
MOSAIC Trial: Serious Toxicity
Toxicity 5FU FOLFOX
Neuropathy 0.2 12.4
Neutropenia 4.7 41.1
Diarrhea 6.6 10.7
Vomiting 1.4 5.8
Febrile neutropenia 0.2 1.8
Death 0.5 0.5
MOSAIC Trial: Serious Toxicity
Toxicity 5FU FOLFOX
Neuropathy 0.2 12.4
Neutropenia 4.7 41.1
Diarrhea 6.6 10.7
Vomiting 1.4 5.8
Febrile neutropenia 0.2 1.8
Death 0.5 0.5
Back to the Case
• 61 year old male tailor• Stage 3 colon cancer
What would you recommend?a. Do nothingb. Surveillance
c. Chemotherapy
Evidence Based Medicine
Guidelines
https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=14002
Guideline Concordance
Statistics & Medicine• Explain & describe disease
– Natural history– Risk factors– Causes
• Evaluate treatments– Benefit– Risk
• Communicate with patient • Assess quality of care
Friends or Foes?