1. Journal club Mohammed Al-Garni, MD, FEBO,ABO,SBO
Assistant Professor and
Consultant otolaryngology
Head and neck surgery
King Saud Bin Abduaziz University-HS, KAMC-Jeddah
Princess Norah oncology center

2. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer Anil K. D’Cruz, M.S., D.N.B., Richa Vaish, M.S., Neeti Kapre, M.S., D.N.B., Mitali Dandekar, M.S., D.N.B., Sudeep Gupta, M.D., D.M., Rohini Hawaldar, B.Sc., D.C.M., Jai Prakash Agarwal, M.D., Gouri Pantvaidya, M.S., D.N.B., Devendra Chaukar, M.S., D.N.B., Anuja Deshmukh, M.S., D.L.O., D.O.R.L., Shubhada Kane, M.D., Supreeta Arya, M.D., D.N.B., D.M.R.D., Sarbani Ghosh-Laskar, M.D., D.N.B., Pankaj Chaturvedi, M.S., F.A.I.S., Prathamesh Pai, M.S., D.N.B., D.O.R.L., Sudhir Nair, M.S., M.Ch., Deepa Nair, M.S., D.N.B., D.O.R.L., and Rajendra Badwe, M.S., for the Head and Neck Disease Management Group

4. Introduction Neck dissection morbidity
Watchful waiting may result I in development of metastases
Prospective studies has conflicting result

5. This study was designed to address two issues.
First, in patients with early-stage, clinically node-negative oral cancer, is there a survival difference between elective neck dissection and therapeutic neck dissection?

6. Second, in the approach to such patients, does ultrasonography have a role in early detection of nodal metastases during follow-up?

7. Study Patients
Ages of 18 and 75 years were histopathologically proven, invasive squamous-cell carcinoma of the oral cavity
Stage 1 and 2 only

8. Trial
Patients were randomly assigned to undergo either elective or therapeutic neck dissection in a 1:1 ratio with the use of a prepared computerized block design.

9. Study Procedures Surgery
Elective group
Therapeutic group

10. Radiotherapy
All patients who had positive nodes, a primary-tumor depth of invasion of 10 mm or more, or a positive resection margin received adjuvant radiation.

11. Follow-up
Patients were followed once every 4 weeks for first 6 months. After that, they were followed every 6 weeks for the next 6 months, every 8 weeks for next 12 months, and every 12 weeks thereafter.

17. 1. Were the following clearly stated: ·
Patients
Intervention
Comparison Intervention
Outcome(s)

18. P: Patients with early-stage, clinically node-negative oral cancer.
I: Elective neck dissection.
C: Therapeutic neck dissection
O: survival difference

19. P: Patients with early-stage, clinically node-negative oral cancer.
I: Ultrasonography.
C: Physical examination.
O: Early detection of nodal metastases
during follow-up.

20. 2. Was the assignment of patients to treatments randomized. 3
2. Was the assignment of patients to treatments randomized? 3. Was the randomization list concealed? Can you tell?

22. 4. Were all subjects who entered the trial accounted for at it’s conclusion? 5. Were they analyzed in the groups to which they were randomized, i.e. intention-to-treat analysis

24. 6. Were subjects and clinicians ‘blind’ to which treatment was being received, i.e. could they tell? 7. Aside from the experimental treatment, were the groups treated equally?

26. 8. Were the groups similar at the start of the trial?

28. 9. How large was the treatment effect
9. How large was the treatment effect? Consider · How were the results expressed (RRR, NNT, etc).

29. • Experimental Event Rate (EER)= 50/243= 0.21
Total
Outcome
Group
survival
Death
243
193 50
Elective neck dissection
253
174 79
Therapeutic neck dissection
• Experimental Event Rate (EER)= 50/243= 0.21
• Control Event Rate (CER)= 79/253 = 0.31
• Absolute Risk Reduction (ARR)= =0.1
• Relative Risk (RR)= EER/CER= 0.21/0.31= 0.68
• Relative Risk Reduction (RRR)= 1-RR = 0.32
NNT = 1 / Absolute Risk Reduction (1/ARR) = 1/0.1 = 10

30. • Experimental Event Rate (EER)= 81/243= 0.33
Total
Outcome
Group
No recurrence
Recurrence
243
162 81
Elective neck dissection
253
107
146
Therapeutic neck dissection
• Experimental Event Rate (EER)= 81/243= 0.33
• Control Event Rate (CER)= 146/153 = 0.58
• Absolute Risk Reduction (ARR)= =0.25
• Relative Risk (RR)= EER/CER= 0.33/0.58= 0.57
• Relative Risk Reduction (RRR)= 1-RR = 0.75
NNT = 1 / Absolute Risk Reduction (1/ARR) = 1/0.25=4

31. 10. Do these results apply to my patient?
Is my patient so different from those in the trial that the results don’t apply?
How great would the benefit of therapy be for my particular patient?
11. Are my patient’s values and preferences satisfied by the intervention offered?
Do I have a clear assessment of my patient’s values and preferences?
Are they met by this regimen and its potential consequences?

32. Thank you