Beyond the Guidelines: Clinical Investigators Provide Their Perspectives on Current Strategies and...

Beyond the Guidelines: Clinical Investigators Provide Their Perspectives on Current Strategies and Ongoing Research in

the Management of Breast Cancer

Wednesday, December 11, 20137:30 PM – 9:30 PMSan Antonio, Texas

Faculty Lisa A Carey, MDClifford Hudis, MDHope S Rugo, MD

George W Sledge Jr, MDSunil Verma, MD, MSEd

ModeratorNeil Love, MD

Survey Faculty

Kathy S Albain, MD

Kimberly L Blackwell, MD

Howard A Burris III, MD

Harold J Burstein, MD, PhD

Lisa A Carey, MD

Rowan T Chlebowski, MD, PhD

Javier Cortes, MD, PhD

Kevin R Fox, MD

Julie R Gralow, MD

Daniel F Hayes, MD

Clifford Hudis, MD

Sara A Hurvitz, MD

Ian E Krop, MD, PhD

Hannah M Linden, MD

John Mackey, MD

Kathy D Miller, MD

Hyman B Muss, MD

Ruth O’Regan, MD

Joyce O’Shaughnessy, MD

Hope S Rugo, MD

Andrew D Seidman, MD

George W Sledge Jr, MD

Ian E Smith, MD

Joseph A Sparano, MD

Sunil Verma, MD, MSEd

Eric P Winer, MD

Module 1

Adjuvant Rx: ER-neg, HER2+Age: 40T: 1.5 cmN: 1+

AC-TH AC-TH 1616

TCH TCH

OtherOther

Adjuvant Rx: ER-neg, HER2+Age: 40T: 1.5 cmN: 0

TCH TCH 1212

Pac/TrasPac/Tras

AC-TH AC-TH

Other Other

Rx: ER-neg, HER2+Age: 40T: 0.8 cmN: 0

Pac/TrasPac/Tras 1212

TCH TCH

AC-TH AC-TH

Doc/Cyc/TrasDoc/Cyc/Tras

Neoadjuvant Rx: ER-neg, HER2+Age: 40T: 4 cmTumor shrinkage needed for BCS

Trastuzumab/pertuzumab

22TrastuzumabTrastuzumab

Anti-HER2 Treatment (with Chemo)Anti-HER2 Treatment (with Chemo)

Choice of ChemotherapyChoice of Chemotherapy

Taxane and anthracycline

1010TaxaneTaxane

Neoadjuvant Rx: ER-neg, HER2+Age: 40T: 2 cm

Trastuzumab/pertuzumab/

55Trastuzumab/

chemo Trastuzumab/

Anti-HER2 TreatmentAnti-HER2 Treatment

Choice of ChemotherapyChoice of Chemotherapy

Taxane Taxane 1515

Taxane and anthracycline

Other* Other*

* N-: taxane-based or N+: taxane + anthracycline-based* N-: taxane-based or N+: taxane + anthracycline-based

Adjuvant Rx: ER-neg, HER2+Age: 75T: 1.5 cmN: 1+

TCH TCH 1313

Pac/TrasPac/Tras

AC-TH AC-TH

OtherOther 11

Pac/TrasPac/Tras 1313

TCH TCH

Other* Other*

*Dose-dense AC-TH; no systemic therapy*Dose-dense AC-TH; no systemic therapy

Pac/TrasPac/Tras1818

NoneNone

33Other Other

TCH TCH

Module 2

Would you order 21-gene Recurrence Score® (RS)? (ER+, HER2-neg)Age: 40T: 1.5 cm N: 0

YesYes 2323

33NoNo

Would you order 21-gene RS? (ER+, HER2-neg)Age: 40T: 1.5 cm N: 1+

YesYes 99

1717NoNo

Would you order 21-gene RS? (ER+, HER2-neg)Age: 75T: 1.5 cm N: 0

YesYes 1111

1515NoNo

Would you order 21-gene RS? (ER+, HER2-neg)Age: 75T: 1.5 cm N: 1+

YesYes 1414

1212NoNo

Do the following assays predict benefit from adjuvant chemotherapy?

Oncotype DX®Oncotype DX® 2525

MammaPrint®MammaPrint®

IHC4IHC4

PAM50 PAM50

EPclinEPclin

60 yo patient4.0-cm, ER+++, HER2-neg IDC requiring tumor shrinkage for BCS

21-gene RS?

It’s a good idea It’s a good idea 1111

It’s not a good ideaIt’s not a

good idea

OtherOther

Continuation of endocrine treatment at 5 yearsAge: 40 Original tumor: 1.5 cm, node-negRx: Tamoxifen

Continue tamoxifen

Stop tamoxifen (no further ET) Stop tamoxifen (no further ET)

OtherOther

Continuation of endocrine treatment at 5 yearsAge: 40 Original tumor T: 1.5 cm; N: 2+Rx: Tamoxifen

Continue tamoxifen

Switch to OS/A + AI Switch to OS/A + AI

Stop tamoxifen (no further ET) Stop tamoxifen (no further ET)

Continuation of endocrine treatment at 5 yearsAge: 75Original tumor T: 1.5 cm; N: 0Rx: AI

Stop anastrozole (no further ET)

22Continue

anastrozole Continue

anastrozole

Continuation of endocrine treatment at 5 yearsAge: 75Original tumor T: 1.5 cm; N: 2+Rx: AI

Continue anastrozole

1111Stop anastrozole (no further ET)

Stop anastrozole (no further ET)

Module 3

ER-neg, HER2+ mBC (no prior systemic Rx)Usual 1st-line Rx

taxane

11Trastuzumab/

taxane Trastuzumab/

taxane

Choice of TaxaneChoice of Taxane

Paclitaxel Paclitaxel 1717

88Docetaxel Docetaxel

11Nab paclitaxel Nab paclitaxel

ER-neg, HER2+ mBC (adj TCH 12 mo ago)Usual 1st-line Rx

taxane

Choice of TaxaneChoice of Taxane

Paclitaxel Paclitaxel 1414

55Docetaxel Docetaxel

22Nab paclitaxel Nab paclitaxel

* Trastuzumab/pertuzumab/eribulin * Trastuzumab/pertuzumab/eribulin

T-DM1 T-DM1

Other* Other*

ER-neg, HER2+ mBCUsual 2nd-line Rx

T-DM1 T-DM1 2222

Trastuzumab/lapatinib

Capecitabine/lapatinib

22OtherOther

ER+, HER2+ mBCAge 45, premenopausalMinimally symptomatic, liver mets

Trastuzumab + pertuzumab +

taxane

Trastuzumab + pertuzumab +

taxane

22Other* Other*

* ET + trastuzumab; trastuzumab + pertuzumab + ET* ET + trastuzumab; trastuzumab + pertuzumab + ET

ER+, HER2+ mBCAge 45, premenopausalAsymptomaticLow disease burden bone mets

ET + TrasET + Tras 1010

Tras/Pert/taxane

Other* Other*

* Trastuzumab/pertuzumab/ET x 2; trastuzumab + taxane; ET + lapatinib + trastuzumab* Trastuzumab/pertuzumab/ET x 2; trastuzumab + taxane; ET + lapatinib + trastuzumab

ER+, HER2+Age 75, postmenopausalAsymptomaticLow disease burden bone mets

ET + TrasET + Tras 1414

Tras + Pert + ET Tras + Pert + ET

Other* Other*

* Nab paclitaxel + trastuzumab + pertuzumab; ET + trastuzumab + lapatinib; letrozole + lapatinib * Nab paclitaxel + trastuzumab + pertuzumab; ET + trastuzumab + lapatinib; letrozole + lapatinib

ER+, HER2+Age 75, postmenopausalSomewhat symptomatic, liver mets

Tras+ Pert + taxane

ET + TrasET + Tras

Other* Other*

*ET; nab paclitaxel + trastuzumab + pertuzumab; letrozole + lapatinib

T-DM1 with pertuzumab outside of a trial?

NoNo 2525

11YesYes

Module 4

60 yo womanER-neg, HER2-neg IDCPostlumpectomy local recurrence 2 years after AC T

None None 44

TC or CMF TC or CMF

Gemcitabine + platinum

CapecitabineCapecitabine

Other chemoOther chemo

60 yo womanER+, HER2+ IDCPostlumpectomy local recurrence while on anastrozole 2 years after AC TH

ET + anti-HER2 ET + anti-HER2 88

ET alone ET alone

Chemo + anti-HER2 plus or

followed by ET

Chemo + anti-HER2 plus or

followed by ET

Chemo + anti-HER2

60 yo womanER-neg, HER2+ IDCPostlumpectomy local recurrence 2 years after AC TH

None None 55

TCH TCH

THPTHP

Other chemo + trastuzumab

Trastuzumab ± lapatinib

44Other Other

ER/PR/HER2-neg mBC (BRCA+) Do PARP inhibitors demonstrate efficacy?

Yes, both w and w/o chemo

Yes, both w and w/o chemo 1414

Yes, without chemo

I don’t know I don’t know

ER/PR/HER2-neg mBC (BRCA-neg) Do PARP inhibitors demonstrate efficacy?

NoNo 1313

Yes, with chemo Yes, with chemo

ER/PR/HER2-neg mBCRelative efficacy of capecitabine versus eribulin?

Eribulin is more efficacious

Eribulin is more efficacious 1111

About the same About the same

Capecitabine is more efficacious

ER+, HER2-neg mBC resistant to ETEfficacy of capecitabine versus eribulin?

About the sameAbout the same 1818

Capecitabine more efficacious

Eribulin more efficacious

I don’t knowI don’t know

Consider the last patient in your practice who died of breast cancerHow long did the patient live with (triple-negative) mBC?

<12 months<12 months 55

12-24 months 12-24 months

>24 months >24 months

Median = 17 monthsMedian = 17 months

Was she referred for hospice care?

Median duration was 4 weeks.Median duration was 4 weeks.

11 55 1010 1515 2020

Patient #Patient #

Time between last dose of chemotherapy for triple-negative mBC and patient’s death?

Patient #Patient #Median = 8 weeksMedian = 8 weeks

11 55 1010 1515 2020 2525

Most common systemic agents administered

Eribulin Eribulin 2121

Platinum Platinum

Capecitabine Capecitabine

Gemcitabine Gemcitabine

Taxane Taxane

Module 5

ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone metsAfter 4 years adjuvant anastrozole

Fulvestrant Fulvestrant 1414

Exemestane/everolimus

Other*Other*

*Tamoxifen x 2; exemestane; fulvestrant + AI*Tamoxifen x 2; exemestane; fulvestrant + AI

ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone and liver metsAfter 4 years adjuvant anastrozole

FulvestrantFulvestrant 1212

TamoxifenTamoxifen

OtherOther

Preemptive antimucositis measures in patients receiving everolimus?

YesYes 1515

1111NoNo

ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone metsAfter 1 year adjuvant anastrozole

*Exemestane; fulvestrant + AI*Exemestane; fulvestrant + AI

Fulvestrant Fulvestrant 1313

TamoxifenTamoxifen

Other*Other*

ER+, HER2-neg mBCAge 65, postmenopausalAsymptomaticLow disease burden bone and liver metsAfter 1 year adjuvant anastrozole

Exemestane/everolimus 1212

Fulvestrant Fulvestrant

Other*Other*

*Fulvestrant + AI; capecitabine; tamoxifen*Fulvestrant + AI; capecitabine; tamoxifen

ER+, HER2-neg mBCRelapse after 4 years of nonsteroidal AIEfficacy of high-dose fulvestrant versus everolimus/exemestane?

I don’t knowI don’t know 1111

Exemestane/everolimus more

efficacious

Exemestane/everolimus more

efficacious

About the same About the same

Beyond the Guidelines: Clinical Investigators Provide Their Perspectives on Current Strategies and...

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