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Radiation Breast Oncology Highlights of SABC 2006 Alison Bevan, MD PhD UCSF Radiation Oncology January, 2007. Topics. I. Updates a. Evaluating the impact of adjuvant radiation in older women with ER+ ESBC on Tamoxifen (# 11) b. Who needs a boost? Defining radiation dose (#10)

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  1. Radiation Breast Oncology Highlights of SABC 2006Alison Bevan, MD PhD UCSF Radiation OncologyJanuary, 2007

  2. Topics I. Updates a. Evaluating the impact of adjuvant radiation in older women with ER+ ESBC on Tamoxifen (# 11) b. Who needs a boost? Defining radiation dose (#10) c. MammoSite TM (ASTRO #52) II. New a. DCIS: Who can avoid RT (#29) b. EBCTCG Meta-Analysis (ASTRO #4, SABC #40) ) IV. Conclusions • Ongoing • Conclusions

  3. Radiation dose: who needs a boost to decrease LRR? • Whole breast radiotherapy is delivered over 5 to 6 weeks. • Boost is delivered over the last 5-8 days to the tumor bed • Cost from patient’s point of view: time and toxicity • Prior to EORTC trial, no guidelines

  4. EORTC Boost TrialBartelink, H., et al. NEJM, 2001 • >5500 patients with stage I&II • 50Gy (5 weeks) ± 16Gy boost (8 days) after complete excision • Systemic therapy decreased LRR (HR .75) but disappeared in multivariate analysis

  5. EORTC Boost TrialBartelink, H., et al. NEJM, 2001 • Benefit was age-related, particularly important for those younger than 50 years • No difference in DM, OS

  6. Randomized trial evaluating 10 Gy boost (Lyon Trial)Romestaing, P et al, JCO 1997 • 1024 women with tumors <3cm with negative margins

  7. Impact of boost on LRR, cosmesis & survival10 year results Bartelink H et al., EORTC 22881-10882 Abstract #10 • No difference in OS (82%, p.93) • Fibrosis increased with boost 4.4% v 1.6% p<.0001 • Cumulative LRR 10% v 6% • All statistically significant

  8. Impact of boost on LRR, cosmesis & survival10 year results Bartelink H et al., EORTC 22881-10882 Abstract #10 • Benefit in all ages • Despite some poor boost techniques • Is absolute benefit of 3% critical?

  9. Impact of boost on LRR, cosmesis & survival10 year results Bartelink, H et al., EORTC 22881-10882 Abstract #10 • The boost is very important for young patients <35y and less important with increasing age • Also incomplete excision arm consisting of 255pts randomized to 10Gy v 26Gy with increased local control (NS) & severe fibrosis • New studies: microarrays to distinguish pathological features

  10. Early Breast Cancer Trialists Collaborative Group (EBCTCG) Meta-analysis 1995 Post-operative radiation significantly reduced breast cancer deaths but increased non-breast cancer deaths resulting in no significant improvement survival. 2000 Significant reduction isolated local recurrence and breast cancer mortality with radiation but increase in non-breast cancer deaths with a non-significant benefit overall survival at 20 years.

  11. Effects of radiotherapy and differences in the extent of surgery for early breast cancer on local recurrence and 15 year survival: An overview of the randomized trials Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) Lancet 366: 2087-2106, 2005 ASTRO abstract #4, 2006 SABC abstract #40, 2006

  12. EBCTCG: local therapies No. TrialsNo. women Total (by 1995) 78 42,080 CS +/- RT10 7,311 Mastectomy +/- RT 36 16,177 Mastectomy vs. CS +/- RT 11 6,615 Nodal surgery vs. RT 9 4,550 Nodal surgery vs. none 8 2,502 RM vs. MRM 4 4,925

  13. EBCTCG: endpoints for trial comparison • 5 year isolated LRR (75% occurred within 5 years) • 15 year breast cancer mortality • 15 year all cause mortality

  14. EBCTCG: breast cancer specific survival benefit at 15 years Trials with <10% absolute difference in 5 year isolated local-regional recurrence 15 year breast cancer mortality benefit 1% (M±RT N-, MRM v RM, M v CS+R) Trials with 10-20% absolute difference 15 year breast cancer mortality benefit 4.5% (CS±R n-, M ±R n+, axillary dissection v no axillary treatment) Trials with >20% absolute difference 15 year breast cancer mortality benefit 6% (CS ±R n+, M without axilllary dissection ±R n+)

  15. EBCTCG: BCS trials • Radiotherapy After BCS, 10 trials with 7311 women Overall mortality reduction 5.3%

  16. EBCTCG: BCS & RT 15y absolute survival benefit LRR 5% N0 16% 7% N+ 30% (Mastectomy N+ 5%)

  17. EBCTCG: local therapy comparisons For the women who received adjuvant systemic therapy: 5y isolated LRR No Systemic therapy 28% Systemic therapy 8% 15y reduction breast ca mortality 6% Better local treatment adds to the effects of systemic therapy on LR and breast cancer mortality

  18. EBCTCG: local therapy comparisons

  19. EBCTCG: toxicity & OS Radiotherapy was associated with a significant increase in contralateral breast cancer at 15 years (7.5% vs. 9.3%) Radiotherapy was associated with a significant increase in non-breast cancer deaths at 15 years (14.6% vs. 15.9%) The excess mortality was primarily from heart disease and lung cancer

  20. EBCTCG: local therapy comparisons Rule of 4 Proportional relationship between effects on local control and breast cancer mortality: “One breast cancer death (in the absence of any other causes of death) would be avoided for every 4 local recurrences prevented.” 4:1 local recurrence benefit/breast cancer survival benefit

  21. EBCTCG: local therapy comparisons Rule of 4 For example: LRR without RT 26% LRR with RT 10% Absolute benefit = 16% at 5 years then survival benefit 4% at 15 years

  22. Lumpectomy + Tamoxifen with & without XRT for Women ≥70 years with Early Stage Breast CancerHughes, KS et al. CALGB 9343, RTOG, ECOG Abstract #11 • 8.2 year follow-up (5yr NEJM, 2004) • About 200pts in each group had no axillary exploration ≥70 years ≤2cm, cN0, ER+ Lumpectomy (631pts) TamRT Tam

  23. Lumpectomy + Tamoxifen with & without XRT for Women ≥70 years with Early Stage Breast CancerHughes, KS et al. CALGB 9343, NEJM, 2005

  24. Lumpectomy + Tamoxifen with & without XRT for Women ≥70 years with Early Stage Breast CancerHughes, KS et al. CALGB 9343, RTOG, ECOG Abstract #11

  25. Lumpectomy + Tamoxifen with & without XRT for Women ≥70 years with Early Stage Breast CancerHughes, KS et al. CALGB 9343, RTOG, ECOG Abstract #11 • Absolute LRR difference of 5-6% • No statistical difference in mastectomy rate, distant metastases, BSS, OS • Cosmesis inferior in TamRT arm • No thromboembolic events • Conclusion: reasonable option for some patients

  26. Lumpectomy + Tamoxifen with & without XRT for Women ≥50 years with Early Stage Breast CancerFyles, AW et al, NEJM 2004 & ASTRO abstract #8 2006 (PMH) • T1/T2N0 ER+ • Median age 68y • No association with age • ER+ T1 had 9.9% versus 4.4% (≥60y: 7% v 3.7% p=.02) • Tumors ≤1cm, 6.7% v 3%

  27. Comparison of Trials

  28. Considerations • Age • Hormone Receptor + • Toxicity of Tamoxifen • Co-morbidities • Life expectancy • Patient preference

  29. MammoSiteTM : multi-institutional 2 year experience with ESBCCuttino, LW, et al ASTRO abstract #52 • 9 institutions, 2000-2004 • 483 patients with stage 0, I, II • In-breast failure in 6 pts, 4 outside lumpectomy site • Closed cavity placement reduced risk of infection from 9% to 4.8% • Infection related to overall cosmesis being fair to poor • Cosmesis good/excellent in 91%

  30. Lumpectomy alone for low risk DCIS5 year results of intergroup trial E5194Hughes, L et al., ECOG, NCCTG Abstract #29 • 711 patients with DCIS enrolled from 1997-2002 (29 ineligible) • Median age 60 years (range 28-88) • Median f/u was 4.96 years • Adjuvant Tamoxifen allowed in 2000 (ER status testing routine) • All pathology reviewed at Vanderbilt University • 89% acceptable for study after central review (excluded size <3mm)

  31. Lumpectomy alone for low risk DCIS5 year results of intergroup trial E5194Hughes, L et al., ECOG, NCCTG Abstract #29 DCIS Lumpectomy (711 pts) Group II Group I High grade <1cm Low/int grade <2.5cm Post-op mammogram clear for calcifications Margins>3mm Observation 30% Tamoxifen

  32. Low-Int grade(580 pts) •median tumor size 6mm •18% >1cm. •median margin 5-10mm. •31% declared intention for TAM High grade (102 pts) •median tumor size 7mm •Median margin 5-10mm •30% declared intention to take TAM Lumpectomy alone for low risk DCIS5 year results of intergroup trial E5194Hughes, L et al., ECOG, NCCTG Abstract #29 Ipsi breast events 6.8% 13.7% 50% DCIS and 50% Invasive Contralateral events 3.5% & 4.2%

  33. Lumpectomy alone for low risk DCIS5 year results of intergroup trial E5194Hughes, L et al, ECOG, NCCTG Abstract #29 • Observation is acceptable for rigorously evaluated and selected patients with low to intermediate grade DCIS of the breast • For high grade lesions (Grade 3), excision is inadequate • Early data, need longer f/u • Who got Tam, LRR with grade, age and margins status?

  34. Prospective Study of Wide Excision Alone for DCIS of the BreastDana Farber/Brigham and Woman’s CC • 158 pts, median age 51 • ≥1cm margins, Grade 1/2 (50/50), ≤2.5cm by mammo • No Tamoxifen • Rate of ipsi recurrence was 2.4% per year • 5 year rate of 12% • Closed early--met stopping rules • 84% re-excision, 6% multiple re-excisions ?younger, larger tumors, no Tamoxifen? Wong, J et al. JCO, 2005

  35. Conclusions • Boost: benefit in all age groups • Tamoxifen without radiation after local excision for some ≥ 70 years women with ER+ ESBC may be acceptable • EBCTCG: local control benefits breast cancer survival at 15 years • Low-risk DCIS: no adjuvant radiation may be needed for small tumors with wide margins • MammoSiteTM trials are immature; closed technique superior in reducing infection

  36. DCIS Collaborative GroupCS+RT in 1003 pts

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