Evidence Based Oncology Prof. Mahmoud M. EL-Gantiry Radiotherapy Dept. National Cancer Institute Cairo University
نفر أورام سوهاج نفر أورام شبرا نفر أورام قومى
Minutes/day (mean) spent in medical reading • Professors: 19 min. • Lecturers: 28 min. • Ass. lecturers: 43 min. • Residents: 57 min
Median minutes/week spent reading about my patients:Self-reports at 17 Grand Rounds: • Medical Students: 90 minutes • House Officers (PGY1): 0 (up to 70%=none) • SHOs (PGY2-4): 20 (up to 15%=none) • Registrars: 45 (up to 40%=none) • Sr. Registrars 30 (up to 15%=none) • Consultants: • Grad. Post 1975: 45 (up to 30%=none) • Grad. Pre 1975: 30 (up to 40%=none)
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 andEfficiency: Random Reflections on Health Services” . A radical critique of the health and social services.
Cochrane concluded : “Medicine is subjective, illogical with no scientific basis for most procedures”
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”.
Definition: (mixed reaction) Opponents: • “The uncritical acceptance of published numerical data”. • “The preparation of guidelines by self-appointed expertswho 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”.
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. Expert opinion Evidence base
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)
Breast Cancer (PDQ®): TreatmentHealth Professional Version. National Health Library of Medicine (nhlm). www.cancer.gov
NCI protocol (work up and treatment)Work up • Medical history and clinical examination. • Laboratory Investigations: (All patients) 1-CBC, LFT’s and RFT’s. 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. 2&3 should be done to T3, N1-2 patients and symptomatic T1-2, N0-1 patients.
Treatment protocol of operable breast cancer in NCI: Operable Small Tumors:T1-2 (<3 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)
Operable large tumorsT2-3, NO-1, MO (T2: 3-5 cm): Mastectomy (modified or radical) + PORT. • Chest wall RT in T3 and > 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)
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)
Sequence of CTh and RT • Adjuvant chemotherapy is to be given first for 12 weeks (4 cycles). • Radiotherapy. • Rest of chemotherapy. (Grade B Evidence)
So Do we need experts?
Do we need experts? Yes Of course!!!
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.
Conclusions • E B Oncology is reasonable strategy for management. • However expertise is essential for its proper implementation.