Evidence Based Oncology

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Evidence Based Oncology

• Prof. Mahmoud M. EL-Gantiry
• Radiotherapy Dept.
• National Cancer Institute
• Cairo University

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Minutes/day (mean) spent in medical reading

• Professors 19 min.
• Lecturers 28 min.
• Ass. lecturers 43 min.
• Residents 57 min

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Median minutes/week spent reading about my
patientsSelf-reports at 17 Grand Rounds

• Medical Students 90 minutes
• House Officers (PGY1) 0 (up to 70none)
• SHOs (PGY2-4) 20 (up to 15none)
• Registrars 45 (up to 40none)
• Sr. Registrars 30 (up to 15none)
• Consultants
• Grad. Post 1975 45 (up to 30none)
• Grad. Pre 1975 30 (up to 40none)

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Introduction

• 1192 AD Fredrick II, Emperor of the Romans.
• Mid 19th century Pier Louis Bloodletting.
• After the 2nd world war Richard Doll and Archie
  Cochrane.
• 1948 MacWriter.
• 1972 Cochrane. Effectiveness and Efficiency
  Random Reflections on Health Services . A
  radical critique of the health and social
  services.

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Cochrane concluded

• Medicine is subjective, illogical with no
  scientific basis for most procedures

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Definition (mixed reaction)

• Proponents
• The conscience, explicit and judicious use of
  current best evidence in making decisions about
  the care of individual patient.
• The science of finding, evaluating and
  implementing the results of medical research can
  make patient care more objective, more logical
  and more cost effective.

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Definition (mixed reaction)

• Opponents
• The uncritical acceptance of published numerical
  data.
• The preparation of guidelines by self-appointed
  experts who are out of touch with real medicine.
• The debasement of clinical freedom by imposing
  rigid and dogmatic clinical protocols.
• The overreliance on simplistic, inappropriate,
  and often incorrect economic analysis.

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Expert opinion Evidence base

• Fast, Cheap, Unstructured.
• ? Biased.
• Sampling may be biased.
• Implicit evidence.
• Even experts disagree.
• ? Conflict of interest.
• ? Useful if evidence is weak.

• Systematic, structured, expensive, time
  consuming.
• Unbiased or available for scrutiny.
• Sampling is rigorous and explicit.
• Explicit evidence, generalizable and can be
  reproduced.

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Statements of evidence

• I Ia Evidence obtained from meta-analysis of
  randomised controlled trials.
• Ib Evidence obtained from at least one
  randomised controlled trial.
• II IIa Evidence obtained from at least one
  well-designed controlled study without
  randomisation.
• IIb Evidence obtained from at least one other
  type of well-designed quasi-experimental study.
• III Evidence obtained from well-designed
  non-experimental descriptive studies, such as
  comparative studies, correlation studies and case
  studies.
• IV Evidence obtained from expert committee
  reports or opinions and/or clinical experiences
  of respected authorities.
• Grades of Recommendations
• Systemic Review and Randomised controlled trial.
  (Evidence levels Ia, Ib)
• Well conducted non-randomised studies (levels
  IIa, IIb, III)
• Expert committee reports or opinions and/or
  clinical experiences of respected authorities.
  (Evidence level IV)

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Breast Cancer (PDQ) TreatmentHealth
Professional Version. National Health Library of
Medicine (nhlm). www.cancer.gov
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Treatment protocol of operable breast cancer in
NCI
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NCI protocol (work up and treatment)Work up

• Medical history and clinical examination.
• Laboratory Investigations (All patients)
• 1-CBC, LFTs and RFTs.
• 2-CEA CA-15.3. (Grade C Evidence)
• Radiological Investigations (All patients)
• 1-CXR.
• 2-Abd. u/s CT scan. (Grade C Evidence)
• 3-Bone scan. (Grade C Evidence)
• N.B. 23 should be done to T3, N1-2 patients and
  symptomatic T1-2, N0-1 patients.

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Treatment protocol of operable breast cancer in
NCI

• Operable Small Tumors T1-2 (lt3 cm), N0-1, M0.
• Breast conservation surgery with axillary
  clearance and radiotherapy (RT) to breast.
• OR
• Mastectomy RT.
• (Grade A Evidence)
• IMC and supraclavicular RT in medial and central
  tumors, and in all patients with pathologically
  positive axillary lymph nodes.
• (Grade B Evidence)

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Operable large tumors T2-3, NO-1, MO (T2 3-5
cm)

• Mastectomy (modified or radical) PORT.
• Chest wall RT in T3 and gt 3 positive axillary
  nodes.
• (Grade A Evidence)
• IMC and supraclavicular RT in medial quadrant and
  central tumors and positive axillary lymph nodes.
  
• (Grade B Evidence)

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Adjuvant systemic treatment

• ST GALLEN RECOMMENDATIONS, 2005 Summary
• Chemotherapy
• - All node positive patients.
• - All node negative patients except low risk
  hormone receptor ve patients.
• Hormone therapy for hormone receptor ve
  patients (Tamoxifen Ovarian ablation).
• (Grade A Evidence)

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Sequence of CTh and RT

• Adjuvant chemotherapy is to be given first for 12
  weeks (4 cycles).
• Radiotherapy.
• Rest of chemotherapy.
• (Grade B Evidence)

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Excellent NCI protocol is (almost)evidence
base Grade A
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• So
• Do we need experts?

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Do we need experts?

• Yes
• Of course!!!

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Do we need experts?

• Conducting these trials.
• Evaluating these trials.
• Choosing the proper treatment for each individual
  patient.
• Implementation of treatment.
• Adaptation of treatment to local circumstances
  e.g.
• Well executed level B treatment is better than
  poor executed level A treatment.

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Conclusions

• E B Oncology is reasonable strategy for
  management.
• However expertise is essential for its proper
  implementation.

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THANK YOU