Dr RA Badwe

Dr R A Badwe
Professor & Head Breast Service &
Director, Tata Memorial Centre
Mumbai , India

� Easily Implementable Practices
� Clinical Classification
� Quality Control
� Adequacy of surgery (mastectomy, wide excision and axillary
dissection)
� Adopting Technology
� Sentinel Node Biopsy
� Mammography (Diagnosis, screening, surgical planning and
follow up)
� New Knowledge
� Cost-effective, easily implementable

� Clinical Classification
� Operable Breast Cancer (OBC:T1-T2/N0-1)
Sx + Adj
� Large OBC (LOBC:T3/N0-1)
Sx+Adj or NeoAdj + Sx+Adj
� Locally Advanced Breast Cancer (LABC:T4 any
N / Any T N2-3) Neoadj + Sx + Adj
� Metastatic Breast cancer (M1) (Palliation)

� Breast Conservation Surgery
� Clear margins / No Tunneling /
� Mammogram solitary lesion without calcification
� Modified Radical Mastectomy
� Mammogram : Extensive micro-calcification
� NACT followed by Surgery
� Margins – not reported or positive
� Tunneling
� Mammogram not done
� Larger tumour/breast ratio

21.5% of the Patients referred to us have undergone some
form of surgical intervention.
Half of these have undergone MRM (N=148).

Optimizing quality in Breast cancer surgery
Quality Control
Adequacy of surgery
Axillary dissection
� Predicting adequacy in negative axilla
� Predicting adequacy (R0) in positive axilla

Predicting Axillary Lymph Node Status
� Sentinel Node Biopsy (SNB)
� Axillary Sampling

Optimizing Quality in Breast Cancer Surgery
Adopting Technology
SNB Meta-analysis* SN(TMH) AS(TMH)
N 8059 474 473
LN found (%) 89% 93.2% 100%
False -ve (%) 8.4% 27.5% 8.8%
* Ref.: Kim T et al. Cancer Jan 1, 2006;106(1):4-16 , (71 publications, 1970-2003)

LEVEL I,II
AXILLARY NODE
STATUS
Evolution of Surgery for Breast Cancer
Incomplete Surgery for Axilla
OPERABLE LESIONS-
PRIMARY SURGERY
NODE NEG. 0.2% 0%
1-3 NODES 4.3% 10%
4-9 NODES 32.1% 48%
>9 NODES 61% 85%
OVERALL 8.8% 21%
LABC- POST
CHEMOTHERAPY
SURGERY

� Creating New Easily Implementable Knowledge

PI: Dr R A Badwe
Co-Investigators
Hawaldar RW, Parmar V, Nadkarni MS, Shet T,
Desai S, Gupta S, Jalali R, Vanmali V, Mittra I

Primary Progesterone for Operable Breast Cancer
Estrogen / Progesterone levels during Menstrual Cycle
Ovulation
0 28 2 4 6 8 10 12 14 16 18 20 22 24 26 28 2 4
Days of menstrual cycle
Progesterone
( ng / ml)
20
16
12
8
4
0
500
400
300
200
100
0
Estrogen ( ng / ml)
(E 2)

� Luteal Phase 1943 / 6482
� Follicular Phase 1330 / 3994
� Odds Ratio (CI) : 0.85 [ 0.78 – 0.93)
� 15% reduction in mortality when surgery
performed during luteal phase
� Test for overall effect z= 3.61 (p= 0.0003)
� Test of Heterogeneity p

Primary Progesterone for Operable Breast Cancer
To test the effect of artificially induced
luteal phase at the time of surgery on DFS
and OS in women with operable breast
cancer

Primary Progesterone for Operable Breast Cancer
Sample Size
Baseline survival : 65%
Expected improvement in disease-free survival : 10%
α = 0.05, 1- β = 80%
N = 660
To allow a subset analysis in lymph node positive
patients, one interim analysis and for 5% lost to follow-up,
sample size was increased to
N = 1000

OBC
Menopausal
Status (Pre ,
Post)
Primary Progesterone for Operable Breast Cancer
R
Stratification
Trial Schema
Tumor Size
(5)
Inj. Hydroxy-
Progesterone
500 mg IM
(day -4 to -14)
Control
Sx
Adj Rx

Menopausal
Status
Pre
Post
Control
N (%)
275 (50.6)
225 (49.3)
Treatment
N (%)
269 (49.4)
231 (50.7)
Age (Mean) 47 47.5
cT Size
Mean (Median) 3.21 (3.0) 3.28 (3.0)
Total
544
456
Clinical
Tumor Size
5 21 (51.2) 20 (49.8) 41

Surgery (%)
MRM
BCT
Control Treatment Total
176 (50.3)
310 (49.8)
177 (49.7)
313 (50.2)
pTsize
Mean (Median) 2.98 (3.0) 3.02 (3.0)
ER/PgR (%)
Positive
Negative
NK
Lymph Node (%)
Negative
Positive
NK
252 (51.4)
215 (49.1)
19 (39.6)
245 (50.9)
232 (49.3)
9 (37.5)
238 (48.6)
223 (50.9)
29 (60.4)
236 (49.1)
239 (50.7)
15 (62.5)
353
623
490
438
48
481
471
24

Chemotherapy *
Control
N (%)
Treatment
N (%)
Anthracycline-based 285 (58.6) 278 (56.7)
CMF 102 (20.9) 97 (19.8)
Radiotherapy 335 (68.9) 339 (69.2)
Hormone 380 (78.1) 350 (71.4)
* Dose intensity was similar in both the arms

At Risk C 486 452 400 366 322 249 179
T 490 444 409 374 345 267 184
3.7%
N=490
N=486

Primary Progesterone for Operable Breast Cancer
DFS : Women with Lymph Node Positive Disease
N = 471
At Risk C 232 215 179 156 133 102 78
T 239 224 198 172 158 124 88
N=239
10.6%
N=232
10.6%

Primary Progesterone for Operable Breast Cancer
Overall Survival N = 976
At risk C 486 463 437 398 347 273 196
T 490 450 432 400 368 289 203
N=486
N=490 1.8%
N=232
N=229
1.8%

At Risk C 232 222 204 178 150 116 85
T 239 225 215 190 171 136 97
8.9%
8.9%
N = 239

1: ER/PgR+,Treatment (73.1%)
2: ER/PgR+, Control (74.6%)
3: ER/PgR-, Treatment (74.0%)
4: ER/PgR-, Control (65.1%)

Exploratory subset analysis