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LANDMARK TRIALS IN BREAST
CANCER SURGERY PART 1
Dr Naveen Saini
First year resident
Mch surgical oncology
• Halsted’s principle that cancer spread from
the breast to the pectoralis muscles and
regional lymph nodes first and then to distant
sites.
• Investigators had begun to question this
“contiguous spread” model and suggested
instead that breast cancer was a systemic
disease.
National Surgical Adjuvant Breast and
Bowel Project B-04: Radical
Mastectomy to Total Mastectomy
• Goal- to determine whether patients who
received local-regional treatment other than
radical mastectomy had similar outcomes to
those undergoing radical mastectomy.
Time period-1971 and 1974
• 1079 patients clinically node-negative were randomized
1. Radical mastectomy (n=362)
2. Total mastectomy plus local-regional/axillary radiation
(n=352)
3. Total mastectomy alone without axillary treatment (n=365).
• And 586 clinically node-positive patients disease were
randomized to
1. Radical mastectomy (n=292) or
2. Total mastectomy and radiation (n=294).
None of the patients received systemic therapy.
• No significant differences with respect to disease-
free survival (DFS), distant-disease-free survival
(DDFS), and overall survival (OS) amongst all the
groups of patients in clinically node-negative
disease or clinically node-positive disease.
• The 25-year outcomes from the NSABP B-04 trial
(in 2002)- no significant differences between
groups with respect to any endpoint.
• But in node-negative arm, patients who underwent
total mastectomy plus radiation had a lower rate of
local-regional recurrence (LRR; 5%) than did those who
underwent radical mastectomy (9%) or total
mastectomy alone (13%) (p=0.002).
• In the node-positive arm the rate of local recurrence
was significantly different between those who
underwent radical mastectomy (8%) and those who
underwent total mastectomy plus radiation (3%);
however, no significant differences in regional
recurrence rates were found.
• 40% cN0 were actually pN1 in node negative group.
• But of the 365 only 68 (19%) subsequently developed nodal disease
and underwent axillary lymph node dissection (within 2 years).
• Overall survival between all the arms of trial was same, hence this
data suggest that routine ALND for patients with a cN0 axilla is
unnecessary and omission of this procedure until there is clinically
evident disease in the axilla will not have a significant negative
impact on OS.
• This study also showed no advantage of adding local-regional
radiation to total mastectomy.
• Most importantly, the trial supported the paradigm shift to less
radical surgery for breast cancer.
NSABP B-06: Total Mastectomy
versus Breast-Conserving Therapy
• Aim - to determine rates of ipsilateral breast
cancer recurrence, DFS, DDFS, and OS,
• 2163 patients from 1976 to 1984.
• Initial reports of the trial at 5, 8, and 12 years
included 1843 evaluable patients and showed
no significant differences for any endpoint
among the groups
• All patients underwent level I and II ALND.
• Radiation was administered to 50 Gy without
a boost to the lumpectomy bed or radiation to
the axilla.
• 20-year follow-up of data, also didn’t show
significant differences in DFS, DDFS, or OS
among groups.
• BUT ABOUT LOCAL CONTROL
• The cumulative incidence of ipsilateral breast tumor
recurrence (IBTR) in patients with tumor-free margins
was 39% in patients who underwent lumpectomy
alone and 14% in patients who underwent lumpectomy
and radiation (p<0.001).
• Radiation group had fewer late recurrences; 73% of
recurrences in the lumpectomy plus radiation group
were within 5 years while 9% occurred after 10 years
compared to the lumpectomy-only group in which 40%
of the recurrences were within 5 years and 30%
occurred after 10 years.
• CONCLUSION
• The NSABP B-06 trial was critical for establishing
the concept of breast-conserving therapy (BCT)
and confirmed the importance of radiation as a
component of such treatment.
• These results were confirmed by other
randomized clinical trials conducted by others,
including the group from the Milan Cancer
Institute
Cancer and Leukemia Group B
9343
AIM
• Radiation in Women 70 years and Older
whether radiation could be safely omitted in
selected patients in whom the absolute risk of
recurrence would be predicted to be low.
• 1994 and 1999.
• 636 women 70 years and older who had
undergone lumpectomy for stage I, ER-positive
breast cancer.
• Patients were randomized to receive tamoxifen
(n=319) or tamoxifen and radiation (n=317).
• The primary endpoints were time to local or
regional recurrence, frequency of mastectomy for
recurrence, DFS, time to distant metastasis, and
OS.
• After a median follow-up of 5 years.
• No significant differences between the groups in the rates
of subsequent mastectomy, distant metastases, or OS.
• The rate of local or regional recurrence
• 1% in the tamoxifen plus radiation group
• 4% in the tamoxifen alone group, statistically significant
(p<0.001).
• After a median follow-up of 10.5 years, the LRR rate:
• 9% in the tamoxifen alone group and
• 2% in the tamoxifen plus radiation group.(largely IBTR).
• DDFS, breast cancer-specific survival, OS, and the
ability to undergo breast-conserving therapy
remained comparable between the two groups.
• On the basis of these findings, the authors
concluded that lumpectomy with endocrine
therapy and without radiation is an appropriate
treatment option for women 70 years or older
with node-negative, ER-positive breast cancer.
FROM AXILLARY LYMPH NODE
DISSECTION TO SENTINEL LYMPH
NODE DISSECTION
• Women presenting with clinically node-
negative disease, the rate of nodal metastases
is only 20–35%.
• Removing healthy lymph nodes renders no
benefit; therefore, sentinel lymph node
dissection (SLND), a more selective approach
to managing the axilla was developed.
NSABP B-32
• AIM- Whether SLND renders the same
survival benefit and regional control that
ALND does but with fewer side effects in
patients with clinically node-negative disease
• 1999 and 2004
• 5611 patients and randomized
1. SLND plus ALND.
2. SLND with ALND only if the SLN was positive.
• Primary endpoints were OS, regional control, and
morbidity.
• Secondary endpoints were accuracy and technical
success
The use of systemic therapy and radiation was similar
between groups.
• Primary survival endpoints of the trial were published
in 2010.
1. OS were 97% and 95% for groups one and two,
respectively, and the 8-year estimates were 92% and 90%
respectively (p=0.12).
2. 8-year estimates of DFS were 82% in both groups.
3. Regional control were also similar.
• NSABP investigators concluded that when the SLN is
negative, SLND alone is suuficient without ALND in
clinically negative lymph nodes.
• Secondary end points
• A SLN was identified in 5379 (97%).
• The SLN was positive in 26% of patients in both groups.
• In group one, the accuracy of SLND was 97%, and the false-
negative rate was 9.8%.
• High false-negative rate was related to
1.Tumor location
2.Type of biopsy performed
3.Number of SLNs removed.
• Morbidity was greater in patients who underwent ALND.
ACOSOG Z0011 trial
AIM
To determine whether all patients with a
positive SLN need an ALND.
• Patient characteristics- cT1 or T2, N0, M0 breast cancer who
underwent BCT and and found to have one or two positive SLNs by
H&E evaluation.
Randomization
1. ALND group
2. No further surgery group.
All patients received WBI (third-field axillary irradiation was not
allowed), and recommendations for systemic adjuvant therapy were
made at the discretion of the treating oncologist .
The primary endpoint was OS and secondary endpoint was DFS.
However regional recurrences were monitored.
• Began accrual in 1999 but was closed early in 2004
because of slow accrual.
891 patients were randomized;
• 446 in the SLND alone arm and
• 445 in the SLND + ALND arm.
• Clinicopathologic characteristics were similar between
the two groups and overall reflected a population of
patients with favorable characteristics
• After a median follow-up of 6.3 years
• Only 29 local-regional recurrences were reported
in the entire population.
• The local recurrence rate was 2% in the SLND arm
and 4% in the ALND arm.
• Ipsilateral axillary recurrences were uncommon,
occurring in 4 (0.9%) patients in the SLND arm
and 2 (0.5%) patients in the ALND arm.
• No differences in DFS or OS.
• Concern for the trial -Planned sample size was not reached.
• JUSTIFICATIONS-
1. Increased acceptance of screening mammography and
improvements in systemic therapy led to an event rate
that was lower than anticipated at the time of study
design.
2. 95% CIs for the HR did not cross the predefined point at
which the treatments would not be considered equal, the
results would not be expected to change with a larger
sample size.
3. Finally, the endpoints of total local-regional recurrences,
DFS, and OS all numerically favored the SLN group.
• CONCLUSION-
ACOSOG ZOO11 showed that routine use of
ALND is not justified and may be safely omitted
in selected patients with clinically node-negative
disease who have one or two positive SLNs.
LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1.pptx
LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1.pptx
LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1.pptx
LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1.pptx

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LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1.pptx

  • 1. LANDMARK TRIALS IN BREAST CANCER SURGERY PART 1 Dr Naveen Saini First year resident Mch surgical oncology
  • 2. • Halsted’s principle that cancer spread from the breast to the pectoralis muscles and regional lymph nodes first and then to distant sites. • Investigators had begun to question this “contiguous spread” model and suggested instead that breast cancer was a systemic disease.
  • 3.
  • 4. National Surgical Adjuvant Breast and Bowel Project B-04: Radical Mastectomy to Total Mastectomy • Goal- to determine whether patients who received local-regional treatment other than radical mastectomy had similar outcomes to those undergoing radical mastectomy.
  • 5.
  • 6. Time period-1971 and 1974 • 1079 patients clinically node-negative were randomized 1. Radical mastectomy (n=362) 2. Total mastectomy plus local-regional/axillary radiation (n=352) 3. Total mastectomy alone without axillary treatment (n=365). • And 586 clinically node-positive patients disease were randomized to 1. Radical mastectomy (n=292) or 2. Total mastectomy and radiation (n=294). None of the patients received systemic therapy.
  • 7. • No significant differences with respect to disease- free survival (DFS), distant-disease-free survival (DDFS), and overall survival (OS) amongst all the groups of patients in clinically node-negative disease or clinically node-positive disease. • The 25-year outcomes from the NSABP B-04 trial (in 2002)- no significant differences between groups with respect to any endpoint.
  • 8. • But in node-negative arm, patients who underwent total mastectomy plus radiation had a lower rate of local-regional recurrence (LRR; 5%) than did those who underwent radical mastectomy (9%) or total mastectomy alone (13%) (p=0.002). • In the node-positive arm the rate of local recurrence was significantly different between those who underwent radical mastectomy (8%) and those who underwent total mastectomy plus radiation (3%); however, no significant differences in regional recurrence rates were found.
  • 9. • 40% cN0 were actually pN1 in node negative group. • But of the 365 only 68 (19%) subsequently developed nodal disease and underwent axillary lymph node dissection (within 2 years). • Overall survival between all the arms of trial was same, hence this data suggest that routine ALND for patients with a cN0 axilla is unnecessary and omission of this procedure until there is clinically evident disease in the axilla will not have a significant negative impact on OS. • This study also showed no advantage of adding local-regional radiation to total mastectomy. • Most importantly, the trial supported the paradigm shift to less radical surgery for breast cancer.
  • 10.
  • 11. NSABP B-06: Total Mastectomy versus Breast-Conserving Therapy
  • 12.
  • 13. • Aim - to determine rates of ipsilateral breast cancer recurrence, DFS, DDFS, and OS, • 2163 patients from 1976 to 1984. • Initial reports of the trial at 5, 8, and 12 years included 1843 evaluable patients and showed no significant differences for any endpoint among the groups
  • 14. • All patients underwent level I and II ALND. • Radiation was administered to 50 Gy without a boost to the lumpectomy bed or radiation to the axilla. • 20-year follow-up of data, also didn’t show significant differences in DFS, DDFS, or OS among groups.
  • 15. • BUT ABOUT LOCAL CONTROL • The cumulative incidence of ipsilateral breast tumor recurrence (IBTR) in patients with tumor-free margins was 39% in patients who underwent lumpectomy alone and 14% in patients who underwent lumpectomy and radiation (p<0.001). • Radiation group had fewer late recurrences; 73% of recurrences in the lumpectomy plus radiation group were within 5 years while 9% occurred after 10 years compared to the lumpectomy-only group in which 40% of the recurrences were within 5 years and 30% occurred after 10 years.
  • 16. • CONCLUSION • The NSABP B-06 trial was critical for establishing the concept of breast-conserving therapy (BCT) and confirmed the importance of radiation as a component of such treatment. • These results were confirmed by other randomized clinical trials conducted by others, including the group from the Milan Cancer Institute
  • 17. Cancer and Leukemia Group B 9343
  • 18. AIM • Radiation in Women 70 years and Older whether radiation could be safely omitted in selected patients in whom the absolute risk of recurrence would be predicted to be low.
  • 19. • 1994 and 1999. • 636 women 70 years and older who had undergone lumpectomy for stage I, ER-positive breast cancer. • Patients were randomized to receive tamoxifen (n=319) or tamoxifen and radiation (n=317). • The primary endpoints were time to local or regional recurrence, frequency of mastectomy for recurrence, DFS, time to distant metastasis, and OS.
  • 20. • After a median follow-up of 5 years. • No significant differences between the groups in the rates of subsequent mastectomy, distant metastases, or OS. • The rate of local or regional recurrence • 1% in the tamoxifen plus radiation group • 4% in the tamoxifen alone group, statistically significant (p<0.001). • After a median follow-up of 10.5 years, the LRR rate: • 9% in the tamoxifen alone group and • 2% in the tamoxifen plus radiation group.(largely IBTR).
  • 21. • DDFS, breast cancer-specific survival, OS, and the ability to undergo breast-conserving therapy remained comparable between the two groups. • On the basis of these findings, the authors concluded that lumpectomy with endocrine therapy and without radiation is an appropriate treatment option for women 70 years or older with node-negative, ER-positive breast cancer.
  • 22. FROM AXILLARY LYMPH NODE DISSECTION TO SENTINEL LYMPH NODE DISSECTION
  • 23. • Women presenting with clinically node- negative disease, the rate of nodal metastases is only 20–35%. • Removing healthy lymph nodes renders no benefit; therefore, sentinel lymph node dissection (SLND), a more selective approach to managing the axilla was developed.
  • 24. NSABP B-32 • AIM- Whether SLND renders the same survival benefit and regional control that ALND does but with fewer side effects in patients with clinically node-negative disease
  • 25. • 1999 and 2004 • 5611 patients and randomized 1. SLND plus ALND. 2. SLND with ALND only if the SLN was positive. • Primary endpoints were OS, regional control, and morbidity. • Secondary endpoints were accuracy and technical success The use of systemic therapy and radiation was similar between groups.
  • 26. • Primary survival endpoints of the trial were published in 2010. 1. OS were 97% and 95% for groups one and two, respectively, and the 8-year estimates were 92% and 90% respectively (p=0.12). 2. 8-year estimates of DFS were 82% in both groups. 3. Regional control were also similar. • NSABP investigators concluded that when the SLN is negative, SLND alone is suuficient without ALND in clinically negative lymph nodes.
  • 27. • Secondary end points • A SLN was identified in 5379 (97%). • The SLN was positive in 26% of patients in both groups. • In group one, the accuracy of SLND was 97%, and the false- negative rate was 9.8%. • High false-negative rate was related to 1.Tumor location 2.Type of biopsy performed 3.Number of SLNs removed. • Morbidity was greater in patients who underwent ALND.
  • 28. ACOSOG Z0011 trial AIM To determine whether all patients with a positive SLN need an ALND.
  • 29. • Patient characteristics- cT1 or T2, N0, M0 breast cancer who underwent BCT and and found to have one or two positive SLNs by H&E evaluation. Randomization 1. ALND group 2. No further surgery group. All patients received WBI (third-field axillary irradiation was not allowed), and recommendations for systemic adjuvant therapy were made at the discretion of the treating oncologist . The primary endpoint was OS and secondary endpoint was DFS. However regional recurrences were monitored.
  • 30. • Began accrual in 1999 but was closed early in 2004 because of slow accrual. 891 patients were randomized; • 446 in the SLND alone arm and • 445 in the SLND + ALND arm. • Clinicopathologic characteristics were similar between the two groups and overall reflected a population of patients with favorable characteristics
  • 31. • After a median follow-up of 6.3 years • Only 29 local-regional recurrences were reported in the entire population. • The local recurrence rate was 2% in the SLND arm and 4% in the ALND arm. • Ipsilateral axillary recurrences were uncommon, occurring in 4 (0.9%) patients in the SLND arm and 2 (0.5%) patients in the ALND arm. • No differences in DFS or OS.
  • 32. • Concern for the trial -Planned sample size was not reached. • JUSTIFICATIONS- 1. Increased acceptance of screening mammography and improvements in systemic therapy led to an event rate that was lower than anticipated at the time of study design. 2. 95% CIs for the HR did not cross the predefined point at which the treatments would not be considered equal, the results would not be expected to change with a larger sample size. 3. Finally, the endpoints of total local-regional recurrences, DFS, and OS all numerically favored the SLN group.
  • 33. • CONCLUSION- ACOSOG ZOO11 showed that routine use of ALND is not justified and may be safely omitted in selected patients with clinically node-negative disease who have one or two positive SLNs.