Faith Davies - UK Myeloma Forum

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Transcript Faith Davies - UK Myeloma Forum

in partnership with

The Role of Cytogenetics in Elderly patients with Myeloma

Dr Faith Davies Cancer Research UK Senior Cancer Fellow Centre for Myeloma Research Divisions of Molecular Pathology, Cancer Therapeutics and Clinical Studies Royal Marsden Hospital and The Institute of Cancer Research London Making the discoveries that defeat cancer

Stages of Disease

clinically and biologically Morgan, Walker & Davies

Nat Rev Cancer

2012

12

:335

Advances in technology have led to an increasing knowledge of myeloma genetics

Translocations of C14 G band FISH 1995

Conventional Cytogenetics

G-banding Wikipedia et al !!

Chromosome 14 FISH - translocation

14q32 region Immunoglobulin heavy chain locus Dual, Break Apart probe Centromere Constant seg Variable segments Telomere c. 250 kb IGH 3’ Flanking Probe c. 900 kb IGHV Probe

Kindly provided by Dr Fiona Ross, Wessex Regional Cytogenetics Laboratory

Molecular classification of myeloma

Early events • Translocations – t(4;14) – t(11;14) – t(6;14) – t(14;16) – t(16;20)

Translocations

• Chromosome gain – 3, 5, 7, 9, 11, 15, 19, 21

Hyperdiploidy

Kuehl & Bergsagel 2005

Normal Isotype Switching on Chromosome 14q32

telomer e VDJ  

switch region = 1-3kb long, tandem pentameric repeats)

   2  centromere  2 VDJ S  C  S 2 C 2 VDJ C 2

- Intervening DNA deleted - Hybrid switch formed

S  S 2

Illegitimate switch recombination in Myeloma

VDJ      2   2 VDJ C 2 Gene X Gene Y VDJ Gene X Gene Y C 2

Translocations into 14q32

• Various partner chromosomes are linked to 14q32, in cell line studies. Some have also been identified in patients. • Up to 70% of patients have a translocation - thought to be a primary event.

• • • • t(11;14)(q13;q32) t(4;14)(p16:q32) t(6;14)(p25;q32) t(14;16)(q32;q23) 30% 15% 4% 5% cyclin D1 FGFR3 and MMSET cyclin D3 and IRF4 cMAF (and WWOX) • • many other regions may be involved often the partner is not identified .

Advances in technology have led to an increasing knowledge of myeloma genetics

Translocations of C14 G band FISH Gene expression arrays TC classification Global mapping methylation miRNA NGS Normal MGU S MM Translocations t(4;14) t(11;14) t(6;14) t(14;16) Translocations Hyperdiploid Chromosome gain 3, 5, 7, 9, 11, 15, 19, 21 1995 2000 2005 2010 2015

Hyperdiploidy 1 2 3 7 8 9 10 4 11 5

• Gain of chromosomes (between 48-74) 11 • Mostly odd numbered chromosomes • 3, 5, 7, 9, 11, 15, 19, 21 • gain of chromosomes 15, 9 and 19 are most frequent • mechanism of gain not understood

12 6 13 19 14 15 20 16 17 21 18 22 X

Walker

et al.

Blood 2006

Myeloma specific copy number variation

Deletion -Deletion 1p (30%)

CDKN2C, FAF1

,

FAM46C

- Deletion 6q (33%) -Deletion 8p (25%) - Deletion 13 (45%)

RB1

,

DIS3

- Deletion 11q (7%)

BIRC2/BIRC3

- Deletion 14q (38%)

TRAF3

- Deletion 16q (35%) W

WOX, CYLD

- Deletion 17p (8%)

TP53

- Deletion 20 (12%) - Deletion 22 (18%) - Deletion X (28%) Gain Gain 1q (40%)

CKS1B, ANP32E

Gain 12p

LTBR

Gain 17p T

ACI

Gain 17q

NIK

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 202122 X

Boyd KD, et al. Leukemia. 2012;26:349-355. Walker BA, et al. Blood. 2010;116:e56-e65.

Myeloma Abnormalities

• Number of common abnormalities

– Deletions • 13q (45%) and 17p (8%) • Other regions – 1p, 1q (40%), 16q – Translocations – Hyperdiploidy • odd number chromosomes (3,7,9,11,17)

The Incidence of Abnormality Changes With Disease Progression

14

Abnormality

t(11;14) t(14;16) t(14;20) del(13q) del(17p) 1q+ del(CDKN2C)

MGUS (%)

10 3 5 24 3 22 4

SMM (%)

16 3 <1 37 1 39 10

MM (%)

14 3 1.5

45 8 41 15

Ross et al. Haematologica 2010 95:1221 Leone et al. Clinical Cancer Research 2008 14:6033 Lopez-Corral et al. Clinical Cancer Research 2011 17:1692

Myeloma Disease Progression and Genetic Events

15 Morgan, Walker & Davies

Nat Rev Cancer

2012

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:335

Inter relationship of abnormalities t(4;14) t(11;14) 6 16 20?

No Data HRD 16 HRD+t(#;14) None All t(4;14) have del(13) 17p evenly distributed Boyd KD, et al. Leukemia. 2012;26:349-355. Walker BA, et al. Blood. 2010;116:e56-e65.

Inter relationship of abnormalities t(4;14) t(11;14) 6 16 20?

No Data HRD 17 HRD+t(#;14) None All t(4;14) have del(13) 17p evenly distributed Boyd KD, et al. Leukemia. 2012;26:349-355. Walker BA, et al. Blood. 2010;116:e56-e65.

Myeloma IX trial: del(13) by FISH not associated with poor survival outcome* 18 100

Survival according to del(13) by FISH

No del(13) del(13) 100 80

Survival according to del(13) with “bad” IgH and del(17)(p53) removed

No del(13) del(13) only Bad IgH or del(17p) 80 60 n = 568 ms 48.3 months 60 n = 283; ms not reached 40 20 0 0 p = 0.024

10 20 30 40 n = 478 ms 40.9 months

Survival (months)

50 60 40 n = 568 ms 48.3 months 70 20 n = 191 ms 27.7 months 0 0 p < 0.001

10 20 30 40

Survival (months)

50 60 70 * In the absence of other adverse prognostic features.

19

Inter-relationship of Adverse Lesions

Genetic abnormalities are not solitary events and can occur together Strong positive association with adverse IGH and 1q+ -72% of IGH translocations with 1q+ Implications i. In order to understand the prognosis of any lesion need to know if other lesions are present.

ii. Lesions may collaborate to mediate prognosis.

Boyd et al. Leukemia 2011

Frequency in the Elderly

Frequency of abnormalities with age

N = 228 Ross et al Leukemia 2006

Frequency of abnormalities with age

N = 1890, median age 72, range 66-94 Avet Loiseau et al 2013 JCO

Clinical and prognostic significance in the Elderly

Myeloma IX trial: effect of “bad” IgH translocations on survival

100 80 60 40 20 0 0 p < 0.001

10

Combined “bad” IgH translocations

No “bad” IgH translocations Any “bad” IgH translocation n = 858 ms 49.6 months 20 30 40

Survival (months)

ms 25.8 months 50 n = 170 60 70

Intensive arm

100 80 60 40 20 0 0 p < 0.001

10 20 30 40

Survival (months)

ms not reached ms 36 months 50 n = 495 n = 170 60 70 100 80 60 40 20 0 0 p < 0.001

10 ms = median survival.

Non-intensive arm

“Bad” IgH Rest n = 363 ms 33.4 months 20 30 40

Survival (months)

n = 63 ms 13.1 months 50 60

Myeloma IX trial: effect of deletion 17p53 on survival

100 80 60 40 20 0 0 p < 0.001

10

Survival of patients with del(17)(p53)

No del(17)(p53) del(17)(p53) n = 929 ms 45.8 months 20 30 40

Survival (months)

50 n = 87 ms 22.2 months 60 70

del(17)(p53): intensive arm

100 80 60 40 20 0 0 p = 0.004

10 20 30 40

Survival (months)

50 n = 545 ms not reached n = 48 ms 40.9 months 60 70 del(17p) Rest 100 80 60 40 20 0 0 p = 0.017

10

del(17)(p53): non-intensive arm

20 30 40

Survival (months)

n = 384 ms 32.6 months n = 39 ms 19.2 months 50 60

Prognostic Impact of Lesions

26 N = 1890, median age 72, range 66-94

Avet Loiseau et al JCO 2013

100 80 60 40 20 0 0

Myeloma IX trial: effect of combined deletion 17p53 and “bad” IgH on survival

Any bad IgH translocation + del(17)(p53)

p < 0.001

n = 754 n = 214 500 1,000

Survival (days)

1,500 n = 18 2,000 Bad IgH translocation Bad IgH translocation + del(17p) Rest

Impact of Combined Lesions

The number of adverse markers has an additive effect on overall survival 28 60 months 40 months 23.4 months 9.1 months

Boyd et al. Leukemia 2011

Defining high risk according to the ISS: “bad” IgH and del(17p)

Myeloma IX trial: effect of adverse prognostic features on survival ISS + any bad IgH translocation + del(17)(p53)

1 = 1 excluding bad IgH or del(17)(p53) 2 = ditto + 1 including, etc.

100 80 p < 0.001

1 2 3 4 60 Group 1 ISS1 Group 2 ISS2 Group 3 ISS3 Group 4 40 bad IgH or del(17p) 20 bad IgH or del(17p) 0 0 ie having something bad doesn’t always mean it is! n = 125 n = 244 n = 269 n = 76 500 1,000

Survival (days)

1,500 2,000

Boyd et al. Leukemia 2011

Non-intensive pathway – chemotherapy regimens Baseline assessment C

yclophosphamide

T

halidomide

D

examethasone a ttenuated 500 mg po 50 - 200 mg po 20 mg po Every 28 Days to maximal response. 6 - 9 cycles

M

elphalan

P

rednisolone 7 mg/m 2 od po 40 mg od po Every 28 Days to maximal response. 6 - 9 cycles Days 1, 8, 15, 22 Daily Days 1- 4, 15- 18 Days 1 - 4 Days 1 - 4 Primary endpoints: PFS and OS Secondary endpoints: Response, QoL and toxicity

Response assessment

Maximal response Morgan et al Blood 2011

Summary of patient characteristics at trial entry Age (years) Gender (N (%)) ISS (N (%)) β2M (mg/l) Median Range Male Female I II III Missing Data Median Range MP (N=423) 73 57 – 89 231 (54.6) 192 (45.4) 64 (15.1) 156 (36.9) 165 (39.0) 38 (9.0) 4.9

0.3-40.4

CTDa (N=426) 73 58 – 87 242 (56.8) 184 (43.2) 46 (10.8) 156 (36.6) 168 (39.4) 56 (13.1) 5.0

0.4

–64.0

Summary of cytogenetics at trial entry Trans location Favour able Adverse MP 125 90 % CTDa % Total % 58.1

129 41.9

96 57.3

254 57.7

42.7

186 42.3

Adverse group includes t(4;14), t(14;20) t(14,16), gain 1q and del 17p Morgan et al Blood 2011

PFS and OS according to cytogenetics

Favourable Adverse

PFS

14 months 95% CI 12-17 range 0-65 12 months 95% CI 10-13 range 0-67

OS

37 months 95% CI 22-44 range 0-69 24 months 95% CI 20-28 range 0-68 Morgan et al Blood 2011

OS according to treatment group in patients with favorable cytogenetics

P=0.1041

MP CTDa Morgan et al Blood 2011

OS in favorable cytogenetics according to treatment; landmark at 1.5 years

CTDa median not reached MP 42 months CTDa not reached vs 42 months Morgan et al Blood 2011

Influence of cytogenetics on survival among patients achieving a CR

Favourable Adverse Morgan et al Blood 2011

NGS results inform myeloma biology

• No single mutation responsible for myeloma – hundreds of mutations identified.

• Deregulation of pathways is an important molecular mechanism.

• Including NF-κB pathway, histone modifying enzymes and RNA processing.

Morgan GJ, Walker BA and Davies FE. Nature Reviews Cancer. Vol 12 May 335-348, 2012,

Mutational landscape of myeloma

Hallmarks Of Myeloma •

Acute leukaemia

– 8 non-synonymous variants per sample •

Myeloma

– 35 non-synonymous variants per sample •

Solid tumours

– 540 non-synonymous variants per sample Morgan G, et al. Nat Rev Cancer. 2012;12:335-48.

Comparative analysis of cancer evolutionary trees

Comparison across disease states and curability

Paediatric ALL Myeloma Solid cancer

Linear and branching models for myeloma evolution

40 Morgan, Walker and Davies Nature Reviews Cancer 2012

Linear and branching models for myeloma evolution

41 Morgan, Walker and Davies Nature Reviews Cancer 2012

“Nothing in biology makes sense except in the light of evolution”

Theodosius Dobzhansky, 1973

“Nothing in biology makes sense except in the light of evolution”

Theodosius Dobzhansky, 1973 Adaption and survival of the fittest

Charles Darwin

“Applying the ideas developed initially by Darwin, to explain the origin of the species, can inform us of how cancer develops and how best to treat it”

Clonal evolution of myeloma

Ecosystem 1

Selective pressures

Ecosystem 2 Ecosystem 3 EMM Diffuse

Treatment

Ecosystem 5 Single founder cell (stem or progenitor) Focal Ecosystem 4 MGUS MM PCL

Adaption and survival of the fittest

Subclones with unique genotype/”driver” mutations Adapted from Greaves MF, Malley CC. Nature. 2012;481:306-13.

A Model of MM Disease Progression

A model based on the random acquisition of genetic hits and Darwinian selection

Initiation Progression Germinal centre Post-GC B cell Bone marrow MGUS Inherited variants Primary genetic events

IgH translocations Hyperdiploidy

Smouldering myeloma Myeloma Peripheral blood Plasma cell leukaemia COMPETITION AND SELECTIVE PRESSURE Secondary genetic events

Copy number abnormalities DNA hypomethylation Acquired mutations

MIGRATION AND FOUNDER EFFECT

Clonal advantage Myeloma progenitor cell

T UMOUR CELL DIVERSITY G ENETIC LESIONS

Morgan G, et al.

Nat Rev Cancer

. 2012;12:335-48.

A Darwinian View of Induction, maintenance and relapse Clones can be eradicated - cured Morgan GJ, Walker BA, Davies F.

Nature Reviews Cancer,

2012

A Darwinian view of induction, maintenance and relapse Clones can be eradicated - cured

Post treatment

Myeloma progenitor cell Evolutionary / Treatment Bottleneck Morgan GJ, Walker BA, Davies F.

Nature Reviews Cancer,

2012

Intraclonal heterogeneity and targeted treatment

Clones with a distinct pattern of mutations

Target

Intraclonal heterogeneity and targeted treatment

Clones with a distinct pattern of mutations

Suboptimal response at 30%

A Darwinian View of Induction, maintenance and relapse Clones can be eradicated - cured Morgan GJ, Walker BA, Davies F.

Nature Reviews Cancer,

2012

A Darwinian view of induction, maintenance and relapse Clones can be eradicated - cured

Post treatment

Myeloma progenitor cell Evolutionary / Treatment Bottleneck Morgan GJ, Walker BA, Davies F.

Nature Reviews Cancer,

2012

Clonal Tides During Myeloma Treatment

Relapse can come from any one of a number of clones

Relapse

Original clone – treatment resistant Myeloma progenitor cell Differential sensitivity to treatment treatment sensitive Morgan GJ, Walker BA, Davies F.

Nature Reviews Cancer,

2012

Clonal dynamics over multiple relapses

Clinical evidence supports this a t(4;14) case Keats JJ, et al. Blood. 2012;120:1067-76.

Conclusions

• Myeloma is biologically and genetically diverse. • Genetic complexity develops early before clinical symptoms develop.

• Linking biological data to clinical data is beginning to identify clinically distinct subgroups with different disease characteristics and outcomes.

• The frequency of the different subgroups differs with age, but the prognostic significance remains • Darwinian style processes can describe the multistep pathogenesis of myeloma. • The impact of clonal heterogeneity needs to be considered when making treatment choices

Conclusion

• Knowledge of the patients genetic sub group is important regardless of the patients age • This has been incorporated into the UKMF/BCSH guidelines • C14 translocation, 17p, HRD, C1

in partnership with

Centre for Myeloma Research, ICR Davies Lab

Mike Bright

Chief Investigators

Lei Zhang Lauren Aronson JA Child Jade Strover Jackie Fok GJ Morgan GH Jackson Daniel Izthak NH Russell

Morgan Lab

Brian Walker Chris Wardell David Johnson Li Ni David Gonzalez Ping Wu Fabio Mirabella Lorenzo Melchor AnnaMaria Brioli Charlotte Pawlyn Elileen Boyle Matthew Jenner Kevin Boyd Martin Kaiser

CTRU, Leeds

K Cocks W Gregory A Szubert S Bell N Navarro Coy F Heatley P Best J Carder M Matouk D Emsell A Davies D Phillips

Leeds

RG Owen AC Rawstron R de Tute M Dewar S Denman G Cook S Feyler D Bowen

Birmingham

MT Drayson K Walker A Adkins N Newnham

Salisbury

F Ross L Chieccio MRC Leukaemia Trial Steering Committee MRC Leukaemia Data Monitoring and Ethics Committee NCRI Haematological Oncology Clinical Studies Group UK Myeloma Forum Clinical Trials Committee Myeloma UK

Funding

Medical Research Council Pharmion Novartis Chugai Pharma Bayer Schering Pharma OrthoBiotech Celgene Kay Kendall Leukaemia Fund