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RARE TUMORS OF INFANCY

RAJKUMAR VENKATRAMANI, MD, MS Director, Rare Tumors Program, Texas Children’s Hospital OBJECTIVES

• Review the epidemiology and clinical presentation of in infancy.

• Discuss the classification of soft tissue sarcomas in infants based on molecular diagnostic techniques.

• Review the management of soft tissue sarcomas in infancy including targeted therapy. OUTLINE

• Epidemiology • Infantile • Rhabdoid tumor • Undifferentiated round cell INCIDENCE IN INFANTS, SEER 18, 2010-2014 Hepatic tumors Renal tumors Neuroblastoma

Soft tissue sarcomas

234 cases per million Germ cell tumors infants/ year

Leukemia Retinoblastoma

Central nervous system INCIDENCE IN INFANTS, SEER 18, 2010-2014 Hepatic tumors Renal tumors Neuroblastoma

Soft tissue sarcomas

Germ cell tumors

Leukemia Retinoblastoma

Central nervous system neoplasms SOFT TISSUE MASS IN INFANTS: DIFFERENTIAL DIAGNOSIS

BENIGN MALIGNANT

Vascular tumors Rhabdomyosarcoma Infantile hemangioma Infantile fibrosarcoma Kaposiform hemangioendothelioma Primitive myxoid mesenchymal tumor of Epithelioid hemangioendothelioma infancy (PMMTI) Malignant Rhabdoid Tumor (MRT) Fibroblastic tumors Undifferentiated sarcoma Desmoid Dermatofibrosarcoma protuberans Infantile myofibromatosis Hemangiopericytoma Fibrous hamartoma of infancy SOFT TISSUE MASS DIAGNOSTIC WORK-UP

• Presentation: History and physical exam • Diagnostic imaging: ultrasound, MRI • Biopsy (open vs. percutaneous core needle image guided) FNA • Pathology: Microscopic, H/E, IHC, molecular staining • Metastatic work up: CT chest STS INCIDENCE IN INFANTS

Age <30 days Age <1 year

RMS IFS RMS IFS

MRT MRT NOS NOS

Ferrari, Orbach et al. Seminars in fetal and neonatal medicine; 2012. INFANT STS SURVIVAL BY SUBTYPE

IFS

RMS

MRT

Survival curves according to histologic subtypes in infants (<1yr) SEER database 1973-2007 Figure adapted and modified from Ferrari, Orbach et al. Seminars in fetal and neonatal medicine; 2012. INFANTILE FIBROSARCOMA INFANTILE FIBROSARCOMA

• Occurs in first 2 years of life • 60% diagnosed before 3 months of age

Courtesy of Noah Federman MD

Coffin CM et al. Pediatr Pathol. 1994 Jan-Feb;14(1):133-50. IFS ETV6-NTRK3 FUSION

Knezvich et al. Nature Genetics, 1998., Loxooncology.com IFS: EUROPEAN EXPERIENCE

Orbach et al. J Clin Oncol 28:318-323. IFS SUGGESTED TREATMENT ALGORITHM

Vincristine/Actinomycin/ Cyclophosphamide (VAC) Vincristine, Adriamycin, Cyclophosphamide (VAdriaC) Vincristine/Actinomycin (VA) IFS: NOVEL TARGETED THERAPEUTICS

• Larotrectinib (Loxo ) Phase 1/2 study of oral TRK inhibitor larotrectinib (LOXO101) for treatment of advanced pediatric solid tumor and primary CNS tumors (Age 1mo-21yo)

(Ignyta) Phase 1/1b multicenter dose escalation study of entrectinib in patients with relapsed/refractory solid tumors (Age 2-22yo) LOXO-101 PEDIATRIC PHASE 1 SCOUT TRIAL

• Rolling-6 dose escalation trial • Ages 1-21 years in unselected refractory cancer; • As young as 1 month for infantile fibrosarcoma or congenital

Nagasubramanian R et al. Proc ASCO 2016. Abstr TPS10583. LOXO-101 PEDIATRIC PHASE 1 SCOUT TRIAL

Laetsch et al, J Clin Oncol 35, 2017 (suppl; abstr 10510). IFS: PLANNED COG PHASE 2 STUDY

ADVL1821: Larotrectinib for Newly Diagnosed TRK Fusion Positive Solid Tumors and TRK Fusion Positive Relapsed Acute Leukemias RHABDOMYOSARCOMA RHABDOMYOSARCOMA • 4% of RMS occurs in infants • 76 infants enrolled in IRS-IV, D9602 and D9803 • Median age 7.4 months (17% < 3 months) • 57% embryonal, 21% alveolar, 22% other • Lower proportion of parameningeal • Higher proportion of trunk/abdomen

Malempati et al. Cancer 2011;117:3493–501. RHABDOMYOSARCOMA 5-YEAR SURVIVAL

87% 81% 75 %

68% 76% 57%

Malempati et al. Cancer 2011;117:3493–501. RHABDOMYOSARCOMA SURVIVAL BY IRS GROUP

89%

69%

39%

Malempati et al. Cancer 2011;117:3493–501. RHABDOMYOSARCOMA GROUP III BY XRT

63%

47 % 58%

32 %

The rate of local failure for infants with Group III tumors was 42% vs 17% for all Group III patients

Malempati et al. Cancer 2011;117:3493–501. SPINDLE CELL RHABDOMYOSARCOMA

t(8;11) NCOA2-TEAD1 FUSION SPINDLE CELL RHABDOMYOSARCOMA

< 1 year old (n=11) > 1 year old (n=15) • VGLL2 rearrangements in 7 • MYOD1L122R in 10 (VGLL2-CITED2, VGLL2-NCOA2) • Sclerosing variants had coexisting • NCOA2 gene fusions in 3 PIK3CA mutations

• All localized tumors • Fatal outcome in all

• Long term survivors

Alaggio et al. Am J Surg Pathol 2016;40:224–235 NEONATAL ALVEOLAR RHABDOMYOSARCOMA

Neonatal period Alveolar Multiple skin and subcutaneous metastases Early development of brain metastases Poor outcome

Rodriguez-Galindo et al. Cancer, 92: 1613–1620. RHABDOID TUMOR RHABDOID TUMOR • Sites: , non-renal soft tissue, CNS

• Bi-allelic deletion of SMARCB1/INI1 gene

• Treatment: surgical resection, and radiation

NWTS 1-5 age distribution

Tomlinson et al. J Clin Oncol 23:7641-7645. RHABDOID TUMOR SURVIVAL: EpSSG NRSTS 2005

40.1% 39.3%

13% 8.7%

VDCy alternating with CyCE x 10 cycles

Brennan et al. European Journal of Cancer 60 (2016) 69e82 RHABDOID TUMOR: HIGH DOSE CHEMOTHERAPY • Study of 58 patients with rhabdoid tumor of kidney

• 31 patients without events at 90 days

• No difference in prognosis between those who got high dose chemo and those who did not.

Futwangler et al. Pediatr Blood Cancer. 2017;e26746 RHABDOID TUMOR: LOWER SURVIVAL IN INFANTS

Tomlinson et al. J Clin Oncol 23:7641-7645. van den Heuvel-Eibrink. Pediatr Blood Cancer, 56: 733–737. RHABODID TUMOR OUTCOMES

Stage NWTS 1-3 NWTS 1-5 NWTS-5 AREN0321 (number (number of (number of (number of of pts.) pts.) pts.) pts.)

I 50% (6) 33.3% (15) 50.0% (2) 100%(2)

II 44% (9) 46.9% (25) 33.3% (3) 100%(5)

III 22% (37) 21.8% (58) 33.3% (9) 26.1%(23)

IV 0% (18) 8.4% (41) 21.4% (14) 11.1%(9) TAZEMETOSTAT (EPZ-6438): EZH2 INHIBITOR

Novel Structure, Potent Target Inhibition Selective for EZH2

Ki <2.5 nM PRMTs Selectivity >20,000-fold (100-fold for EZH1) PKMTs

Antitumor Activity in Xenograft Model of INI1-negative MRT (G401)

Knutson 2013 TAZEMETOSTAT RESPONSE IN ADULT PHASE I STUDY

75% *

50%

*

25% *

0%

-25% % change from from baseline change %

-50% INI1-negative SMARCA4-negative

-75% Other solid tumor** * Patients censored at time of progression 34 ** Four additional other solid tumor patients with pending disease evaluation UNDIFFERENTIATED ROUND CELL SARCOMA URCS IN INFANTS

5 months female 4 months female 2 months male

CCSK PMMTI URCS URCS- CCSK

• Median age of diagnosis between 2-3 years • Approximately 4% of all kidney tumors in children • May metastasize to bone, lungs and brain • Addition of doxorubicin and XRT has improved outcomes

R. Furtwangler et al. / European Journal of Cancer 49 (2013) 3497–3506 URCS- CCSK AREN0321 OUTCOMES

Stage Treatment n 4-year EFS % 4-year OS%

I DD4A, no XRT 8 80 100

II Regimen I 28 87 96

III Regimen I 43 77 95

IV Regimen UH1 3 1/3 with relapse/death

Preliminary data. Slide courtesy of Jeff Dome URCS- CCSK t(10;17)(q22;p13) YWHAE-NUTM2B BCOR ITD

O’Meara et al. J Pathol. 2012 May;227(1):72-80. Roy et al. Nat Commun. 2015 Nov 17;6:8891 Ueno-Yokohata et al. Nat Genet. 2015 Aug;47(8):861-3. URCS- PMMTI

Initially classified as infantile 16 cases reported in literature Locally aggressive Sites: trunk, extremities, head and neck Local recurrence Treatment: surgery Poor response to chemotherapy

Alaggio et al. Am J Surg Pathol 2006 Foster et al. Pediatric developmetal pathology 2016 URCS- PMMTI

• BCOR ITD testing by PCR and RNA sequencing • 6/7 positive

Kao et al. Am J Surg Pathol 2016 URCS BCOR MUTATED SARCOMA

YWHAE-NUTM2B in 2 (9%) BCOR ITD in 9 (41%) Clinical features and treatment not well defined

Kao et al. Am J Surg Pathol 2016 URCS BCOR MUTATED SARCOMA TREATMENT

• Complete surgical resection • Ifosfamide/doxorubicin • VDC/IE Ewings regimen • ?CCSK regimen

J Natl Compr Canc Netw 2017;15(7):868–871 BCOR-MUTATED SARCOMA REGISTRY

[email protected] STS IN INFANTS

• Infantile fibrosarcoma, rhabdomyosarcoma and malignant rhabdoid tumor are the most common soft tissue sarcomas in infants. • In general, infants with STS have worse outcomes when compared to older children. • Molecular studies have resulted in accurate diagnosis and classification. • Newer targeted therapies are likely to improve the prognosis of infants with STS in the near future. THANK YOU