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WRAP UP BREAST CANCER

WRAP UP BREAST CANCER. Stefania Redana Divisione Universitaria di Oncologia Medica IRCC - Candiolo. Bologna, 20 Giugno 2010. Wrap Up Breast Cancer Outline . Loco-regional treatment The role of sentinel node dissection in clinically N0 patients

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WRAP UP BREAST CANCER

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  1. WRAP UP BREAST CANCER Stefania Redana Divisione Universitaria di Oncologia Medica IRCC - Candiolo Bologna, 20 Giugno 2010

  2. Wrap Up Breast CancerOutline • Loco-regional treatment • The role of sentinel node dissection in clinically N0 patients • Radiotherapy: time for changing clinical practice? • Endocrine therapy • Chemopreservation of ovarian function • Metastatic disease • HER2 positive disease: beyond trastuzumab and lapatinib • Biopsy of metastatic sites • Multi-targeted therapies • Role of bevacizumab in first line treatment • New drugs

  3. Loco-regional treatmentThe role of sentinel node dissection • ACOSOG Z0010 A multicenter prognostic study of sentinel node (SN) and bone marrow (BM) micrometastases in women with clinical T1/T2 N0 M0 breast cancer. Abs CRA 504 SN not found ALND REGISTERED YES: enrolled in Z0011 FOLLOWED BCT, SLND, bilateral iliac crest BM aspiration cT1 or cT2 N0 M0 Consentfor Z0011 SN positive NO NO ALND and no specific axillary therapy SN negative IHC N=5210

  4. Loco-regional treatment The role of sentinel node dissection • ACOSOG Z0010: main results • 5 years overall survival: 93% among patients with H&E+ SN • The detection of IHC+ SN mets has no impact on overall survival • The detection of IHC+ bone marrow mets is predictive for a reduced overall survival • No clinical implication on daily clinical practice

  5. Loco-regional treatment The role of sentinel node dissection • ACOSOG Z0011 A radomized trial of axillary node dissection in women with clinical T1/T2 N0 M0 breast cancer who have a positive sentinel node. Abs CRA 506 FOLLOWED RANDOM Breast radiation Adjuvant Systemic therapy ALND cT1 or cT2 N0 M0 BCT, SLND with positive SN NO furhter surgery N=891 of the planned 1900

  6. Loco-regional treatment The role of sentinel node dissection • ACOSOG Z0011: main results • No difference in the rate of local recurrence between ALND and SLND (4.1% vs 2.8%, respectively) • Loco-regional recurrence rate is independent from the number of nodes removed, positive nodes or the size of nodal disease • No impact on disease free survival (83.2% vs 82.2% in SLND and ALND respectively) • No impact on overall survival (92.5% vs 91.8% in SLND and ALND respectively) • Hard to believe that 0.9% increased risk of regional recurrence and 2.8% increased risk of loco-regional recurrence might influence survival

  7. Loco-regional treatment The role of sentinel node dissection • NSABP B32 A randomized phase III clinical trial to compare sentinel node resection to axillary dissection in clinically node-negative breast cancer patients. Abs LBA 505 SLND positive SLND + ALND RANDOM SLND negative FOLLOW-UP N=1975 Clinically negative node disease SLND positive Intraop cytology and postop H&E SLND SLND negative FOLLOW-UP N=2011

  8. Loco-regional treatment The role of sentinel node dissection • NSABP B32: main results • No difference in the rate of local (2.7% vs 2.4%) and axillary recurrence (0.1% vs 0.3%) between ALND and SLND • No impact on disease free survival (HR 1.05, p=0.542), no difference even according to stratification factors (type of surgery, tumor size, age) • No impact on overall survival (HR 1.20, p=0.117), no difference even according to stratification factors (type of surgery, tumor size, age) • More morbidty was seen after ALND

  9. Loco-regional treatment Radiotherapy: time for changing clinical practice? • CALGB 9343 comparison of lumpectomy plus tamoxifen with or without irradiation in women 70 or older with stage I, ER+ breast carcinoma. Abs 507 RANDOMIZATION Age≥70 Clinically node negative Lumpectomy, negative margins Tumor size ≤2cm ER positive or indeterminate TAMOXIFEN + RADIATION THERAPY TAMOXIFEN + NO RADIATION THERAPY N=631 Median follow-up 12 years

  10. Loco-regional treatment Radiotherapy: time for changing clinical practice? • CALGB 9343: main results Breast recurrence ~7% Ultimate breast preservation NS Secondary primary NS Distant metastaes NS Breast cancer specific death (3%) NS Death from any cause (46%) NS

  11. Endocrine therapyChemopreservation of ovarian function • Role of luteinizing hormone-releasing hormone analog (LHRHa) triptorelin (T) in preserving ovarian function during chemotherapy for early breast cancer patients: Results of a multicenter phase III trial of Gruppo Italiano Mammella (GIM) group. Abs 528 CHT 133 MainResults RANDOM 281 pt Age 18-45 Stage I-III HR + or - CHT + OS 148 Absolute reduction of early menopause: ~19%

  12. Metastatic diseaseHER2 positive breast cancer • A phase Ib/II trial of trastuzumab-DM1 (TDM-1) with pertuzumab for women with HER2 positive locally advanced or metastatic breast cancer who were previously treated with trastuzumab. Abs 1012

  13. Metastatic diseaseHER2 positive breast cancer Efficacyresults Safety Results 1 grade 5 event 2 grade 4 evets (4.5%) Most common grade 3 events were: fatigue (13.6%), thrombocytopenia (6.8%), increase of AST (6.8%), nausea and vomiting (4.5% each)

  14. Metastatic diseaseBiopsy of metastatic sites • Tissue confirmation of disease recurrence in patients with breast cancer: pooled analysis of two large prospective studies. Abs 1007 Recurrence or progression • DESTINY STUDY • Single institution study (Canada) • ER/PgR determined according to ASCO guidelines with IHC • HER2  FISH • Re analysis of primary • BRITS STUDY • Multicentric study (UK) • ER/PgR determined with IHC according to Allred score • HER2  FISH • Re analysis of primary • N=271 patients Written informed consent Oncologist post-biopsy questionnaire BIOPSY Central revision of ER/PgR/HER2 Oncologist post-biopsy questionnaire

  15. Metastatic diseaseBiopsy of metastatic sites • Should liver metastases of breast cancer be biopsied to improve treatment choice? Abs CRA 1008 • TRIAL DESIGN: retrospective analysis on 255 liver biopsy performed on metastatic recurrent breast cancer at a single institution • AIM: quantify discordance of ER, PgR and HER2 expression between primary tumor and metastases from breast cancer • Discordance in hormone receptor status in breast cancer during tumor progression. Abs 1009 • TRIAL DESIGN: retrospective analysis of 486 patients for whom assessment of ER and PgR was available on both primary tumor and mets • AIM: determine if hormone receptors (ER and PgR) change between the primary tumor and recurrence

  16. Metastatic diseaseBiopsy of metastatic sites Amir: less discordance among triple negative tumors (6.8%) Karlsson: correlation between ER status in relapse and OS

  17. Metastatic disease Multi-targeted therapies • SUN 1064. Sunitinib (SU) in combintion with docetaxel (D) versusD alone for the first-line treatment of advanced breast cancer (ABC). Abs LBA 1010 • SUN 1099. Phase III trial of Sunitinib (SU) in cmbination with capecitabine (C) versus C alone in previously treated advanced breast cancer (ABC). Abs LBA 1011 SUN 1064 Measurable or non measurable disease Prior neo/adjuvant anthracyclines and taxanes 1-2 prior CHT for ABC SUN 1099 Measurable or non measurable disease ≥12 months from neo/adjuvant taxanes No CHT for ABC RANDOM C + SUN RANDOM D + SUN C D Primary End Point: PFS Secondary: ORR, OS,safety

  18. Metastatic disease Multi-targeted therapies • Efficacy results • Safety results • Most grade 3-4 AE were registered in the experimental arms • More frequent AE were: neutropenia, thrombocytopenia, asthenia/fatigue, diarrhea, HFS, nausea and vomiting

  19. Metastatic diseaseRole of bevacizumab in first line therapy • A meta-analysis of overall survival data from three randomized trials of bevacizumab (BV) and first-line chemotherapy for treatment of patients with metastatic breast cancer(MBC). Abs 1005 E2100 Paclitaxel RANDOMIZE CT + NO BV Previously untreated MBC Optional 2nd line with BV AVADO Docetaxel Treat untill PD CT + BV RIBBON-1 Capecitabine, anthracyclines or taxanes PRIMARY END POINT: PFS

  20. Metastatic diseaseRole of bevacizumab in first line therapy • Main results * Only patients with measurable disease

  21. Metastatic diseaseNew drugs • A Phase III study (EMBRACE) of eribulin mesylate versus treatment of physician's choice in patients with locally recurrent • or metastatic breast cancer previously treated with an anthracycline and a taxane. Abs CRA1004^

  22. Metastatic diseaseNew drugs Efficacyresults Safetyresults

  23. Take home messagesEarly Breast Cancer • Patients with early breast cancer clinically N0 should not undergo ALND but only SLND • Patients with clinically N0 but positive SLND could safely be spared ALND without an increased risk of progression or death • Old women with HR+, cN0, free margins after lumpectomy could be spared RT if given hormonal therapy • Young women should be offered OS during adjuvant chemotherapy either they are HR+ or not

  24. Take home messagesMetastatic disease • TDM-1 + Pertuzumab is a reasonable option for patients with HER2+ disease progressing after trastuzumab and lapatinib • Biopsy of metastatic sites could be changing practice • Sunitinib should not be considered for the treatment of ABC • 1st line bevacizumab increases PFS and ORR but has no effect on OS (hard to see in 1st line treatments) • Eribulin increases OS in heavily pre-treated metastatic breast cancer patients (new drugs can impact OS in further lines of therapy)

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