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The role and side effects of ovarian
suppression: Who need it?
Dr Ajeet Kumar Gandhi
MD (AIIMS); DNB; UICCF (MSKCC, USA)
Assistant professor, Radiation oncology
Dr RMLIMS, Lucknow
1882: Thomas William
Nunn suggested
regression of breast
cancer with
menopause
The father of endocrine ablation in
cancer management: George Thomas
Beatson
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
 6/100 node-negative women and 12/100 node-positive
women have survival advantage at 15 years follow up
Evolution of OFS trials
• 1950s: OFS with RT/Surgery
• 1960s: Chemotherapy
• 1990s: OFS vs. CT [ZEBRA study; Zoladex vs CMF]
• Not included Tamoxifen
• 2000s: OFS with Tamoxifen/AIs
• SOFT; TEXT; ABCSG12; ECOG; ABC etc
Introduction
 Adjuvant TAM for 5-10 years is recommended for
pre-menopausal women with hormone receptor
positive disease
 The value of therapeutic suppression of ovarian
estrogen production in premenopausal women who
receive TAM was uncertain recently
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
OFS in breast cancer
 Benefits of OFS in the era of adjuvant
chemotherapy/hormone therapy
 Which patients would benefit?
 Optimum method of OFS?
 Duration of OFS?
 QOL and adverse effects of OFS?
Benefits of OFS in the era of
adjuvant chemotherapy/hormone
therapy
The SOFT trial
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Summary – SOFT Trial
SOFT Tamoxifen-
OFS
Tamoxifen P value
5-yr DFS 86.6% 84.7% 0.10
5-yr OS 96.7% 95.1% 0.13
5-yr BC
freedom rate
88.4% 86.4% 0.09
949 premenopausal women (>40 years of age, small,
node-negative tumors, low to intermediate
Grade)
Freedom from recurrence > 95% at 5 years with TAM
alone
 Most recurrences of
breast cancer were in
patients who remained
premenopausal after
receiving chemo.
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
TEXT-SOFT combined
analysis
Tamoxifen-
OFS
Exemestane-
OFS
P-value
5-yr DFS 87.3% 91.1% P<0.001
5-yr BC free interval 88.8% 92.8% P<0.001
Freedom from
recurrence of breast
cancer at a distant site
92% 93.8% P=0.02
5-yr OS 95.9% 96.9% p=0.37
• Median follow-up : 68 months
Among patients who received chemotherapy, the absolute improvement in the 5-
year BC-free rate with Exemestane-OFS as compared with tamoxifen- OFS was
5.5% in TEXT and 3.9% in SOFT.
 Absolute improvement in breast cancer-free interval (BCFI)
based on a continuous, composite measure of recurrence
risk.
 Absolute improvement in 5-year BCFI:
 5-15% for intermediate to high composite risk
 Patient with lowest composite risk: No benefit
19 (July 2016)
2221-2231
Age <35 years
Those who remained premenopausal after chemotherapy
Large/ node-positive tumors, higher-grade tumour features.
Optimum method of OFS
 Pharmacotherapy
 Most commonly used in the current trials
 Cost
 Reversibility
 Incomplete suppression and adverse events
 Permanent ablative techniques [16% SOFT/TEXT]:
 Irradiation: 20 Gray/10#; 15 Gray/5#
 Surgical oophorectomy
 Cost effective, irreversible, fertility preservation not an
issue, GnRH analogues contraindicated
Which pharmacotherapy??
 Triptorelin pamoate/acetate (GnRH analogue):
3.75 mg q 4 weekly [SOFT/TEXT trials]
 Goserelin (LHRH analogue): 3.6 mg monthly
 Leuprolide depot (LHRH analogue): 3.75 mg
monthly
 3 monthly schedule could be used [ASCO
guideline 2016]
 Optimum duration: Not known (5 years)
 Used in majority trials
 St Gallen recommendations
 ASCO recommendations
Optimum combination for OFS
 LHRH analogue alone: Inferior results; Improve
recurrence (12%) and death fro recurrence (15%) in
combination with TAM/CT
[Klijn et al. JCO 2001 Meta-Analysis
EBCTCG meta-analysis; Lancet 2007]
 TEXT trial showed superiority of Exemestane over
Tamoxifen
 ABCSG-12 showed no difference between TAM and
AI; albeit an inferior outcome with AIs
 Issues with AIs: poor adherence, incomplete
suppression (7-10%; TABLE and SOFT-Substudy),
genetic polymorphism (CYP191A)
 Either of Tamoxifen or AIs could be used [ASCO
recommendation 2016]
Optimum timing of LHRH analogue
 Concurrent in TEXT and sequential in SOFT
 No beneficial/detrimental effect seen
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Optimum timing of LHRH analogue
Prefer to give sequentially!!!
Biochemical Monitoring
Optimal method to measure plasma concentration is
debated
High sensitivity assays not widely available
Measurement of estradiol levels in patients on
exemestane unreliable due to cross-reactions
Serial biochemical monitoring every 3 to 6 months
during treatment, especially for patients younger than 50
years
QOL and Adverse events
Adverse events: SOFT trial
The events of grade 3 or 4 that were reported most frequently were hot flushes,
musculoskeletal symptoms, and hypertension.
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
Role  and Side effects of Ovarian Function Suppression in Breast Cancer
 Short follow up: 5 years in 15 years disease
 Endpoints: DFS vs. OS
 Late switch to AI after 5 years of TAM vs.
OFS+AI [Improved DFS in MA.17]
 Therapy after 5 years of OFS+AI unknown
Questions unanswered??
 Role of OFS in patients receiving 10 years of TAM or TAM+AIs
 Role of OFS versus Chemotherapy
 Should all patients who remain premenopausal after adjuvant
chemotherapy receive OFS?
Adjuvant Ovarian Suppression plus AI
or Tamoxifen (ASPAIT)
Sun yat sen University (Recruiting)
Neoadjuvant Aromatase Inhibitor(AI)
With Ovarian Suppression Versus
Chemotherapy in Premenopausal
Breast Cancer Patients (COMPETE)
Li Zhu, Rujin Hospital (China)
Evaluating the Role of the Addition of
Ovarian Function Suppression (OFS) to
Tamoxifen in Young Women (ASTRRA)
Korean breast cancer study group
Take home message!!
 OFS benefits patients with high risk of
relapse (patient selection evolving)
 LHRH/GnRH analogues with TAM/AI for 5
years along with biochemical monitoring
 QOL and adverse events should be kept in
mind before embarking on the routine use of
OFS
 Time has not yet come to recommend it to all
premenopausal women of hormone receptor
positive breast cancer
Thank youfor your kind
attention

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Role and Side effects of Ovarian Function Suppression in Breast Cancer

  • 1. The role and side effects of ovarian suppression: Who need it? Dr Ajeet Kumar Gandhi MD (AIIMS); DNB; UICCF (MSKCC, USA) Assistant professor, Radiation oncology Dr RMLIMS, Lucknow
  • 2. 1882: Thomas William Nunn suggested regression of breast cancer with menopause
  • 3. The father of endocrine ablation in cancer management: George Thomas Beatson
  • 5.  6/100 node-negative women and 12/100 node-positive women have survival advantage at 15 years follow up
  • 6. Evolution of OFS trials • 1950s: OFS with RT/Surgery • 1960s: Chemotherapy • 1990s: OFS vs. CT [ZEBRA study; Zoladex vs CMF] • Not included Tamoxifen • 2000s: OFS with Tamoxifen/AIs • SOFT; TEXT; ABCSG12; ECOG; ABC etc
  • 7. Introduction  Adjuvant TAM for 5-10 years is recommended for pre-menopausal women with hormone receptor positive disease  The value of therapeutic suppression of ovarian estrogen production in premenopausal women who receive TAM was uncertain recently
  • 10. OFS in breast cancer  Benefits of OFS in the era of adjuvant chemotherapy/hormone therapy  Which patients would benefit?  Optimum method of OFS?  Duration of OFS?  QOL and adverse effects of OFS?
  • 11. Benefits of OFS in the era of adjuvant chemotherapy/hormone therapy
  • 14. Summary – SOFT Trial SOFT Tamoxifen- OFS Tamoxifen P value 5-yr DFS 86.6% 84.7% 0.10 5-yr OS 96.7% 95.1% 0.13 5-yr BC freedom rate 88.4% 86.4% 0.09 949 premenopausal women (>40 years of age, small, node-negative tumors, low to intermediate Grade) Freedom from recurrence > 95% at 5 years with TAM alone
  • 15.  Most recurrences of breast cancer were in patients who remained premenopausal after receiving chemo.
  • 18. TEXT-SOFT combined analysis Tamoxifen- OFS Exemestane- OFS P-value 5-yr DFS 87.3% 91.1% P<0.001 5-yr BC free interval 88.8% 92.8% P<0.001 Freedom from recurrence of breast cancer at a distant site 92% 93.8% P=0.02 5-yr OS 95.9% 96.9% p=0.37 • Median follow-up : 68 months Among patients who received chemotherapy, the absolute improvement in the 5- year BC-free rate with Exemestane-OFS as compared with tamoxifen- OFS was 5.5% in TEXT and 3.9% in SOFT.
  • 19.  Absolute improvement in breast cancer-free interval (BCFI) based on a continuous, composite measure of recurrence risk.  Absolute improvement in 5-year BCFI:  5-15% for intermediate to high composite risk  Patient with lowest composite risk: No benefit 19 (July 2016) 2221-2231
  • 20. Age <35 years Those who remained premenopausal after chemotherapy Large/ node-positive tumors, higher-grade tumour features.
  • 21. Optimum method of OFS  Pharmacotherapy  Most commonly used in the current trials  Cost  Reversibility  Incomplete suppression and adverse events  Permanent ablative techniques [16% SOFT/TEXT]:  Irradiation: 20 Gray/10#; 15 Gray/5#  Surgical oophorectomy  Cost effective, irreversible, fertility preservation not an issue, GnRH analogues contraindicated
  • 22. Which pharmacotherapy??  Triptorelin pamoate/acetate (GnRH analogue): 3.75 mg q 4 weekly [SOFT/TEXT trials]  Goserelin (LHRH analogue): 3.6 mg monthly  Leuprolide depot (LHRH analogue): 3.75 mg monthly  3 monthly schedule could be used [ASCO guideline 2016]  Optimum duration: Not known (5 years)  Used in majority trials  St Gallen recommendations  ASCO recommendations
  • 23. Optimum combination for OFS  LHRH analogue alone: Inferior results; Improve recurrence (12%) and death fro recurrence (15%) in combination with TAM/CT [Klijn et al. JCO 2001 Meta-Analysis EBCTCG meta-analysis; Lancet 2007]  TEXT trial showed superiority of Exemestane over Tamoxifen  ABCSG-12 showed no difference between TAM and AI; albeit an inferior outcome with AIs  Issues with AIs: poor adherence, incomplete suppression (7-10%; TABLE and SOFT-Substudy), genetic polymorphism (CYP191A)  Either of Tamoxifen or AIs could be used [ASCO recommendation 2016]
  • 24. Optimum timing of LHRH analogue  Concurrent in TEXT and sequential in SOFT  No beneficial/detrimental effect seen
  • 26. Optimum timing of LHRH analogue Prefer to give sequentially!!!
  • 28. Optimal method to measure plasma concentration is debated High sensitivity assays not widely available Measurement of estradiol levels in patients on exemestane unreliable due to cross-reactions Serial biochemical monitoring every 3 to 6 months during treatment, especially for patients younger than 50 years
  • 29. QOL and Adverse events
  • 31. The events of grade 3 or 4 that were reported most frequently were hot flushes, musculoskeletal symptoms, and hypertension.
  • 35.  Short follow up: 5 years in 15 years disease  Endpoints: DFS vs. OS  Late switch to AI after 5 years of TAM vs. OFS+AI [Improved DFS in MA.17]  Therapy after 5 years of OFS+AI unknown
  • 36. Questions unanswered??  Role of OFS in patients receiving 10 years of TAM or TAM+AIs  Role of OFS versus Chemotherapy  Should all patients who remain premenopausal after adjuvant chemotherapy receive OFS? Adjuvant Ovarian Suppression plus AI or Tamoxifen (ASPAIT) Sun yat sen University (Recruiting) Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients (COMPETE) Li Zhu, Rujin Hospital (China) Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women (ASTRRA) Korean breast cancer study group
  • 37. Take home message!!  OFS benefits patients with high risk of relapse (patient selection evolving)  LHRH/GnRH analogues with TAM/AI for 5 years along with biochemical monitoring  QOL and adverse events should be kept in mind before embarking on the routine use of OFS  Time has not yet come to recommend it to all premenopausal women of hormone receptor positive breast cancer
  • 38. Thank youfor your kind attention