Local Control for Intermediate Risk Rhabdomyosarcoma: Results from D9803 according to Histology, Group, Site and Size A Report from the Children’s.

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Local Control for Intermediate Risk Rhabdomyosarcoma: Results from D9803 according to Histology, Group, Site and Size A Report from the Children’s Oncology Group Suzanne Wolden, Elizabeth Lyden, Carola Arndt, Douglas Hawkins, James Anderson, David Rodeberg, Ken Brown, Sarah Donaldson

D9803 background Intermediate risk RMS 1999-2005 Phase III: VAC vs VAC/VTC 617 eligible patients enrolled Local control analysis limited to nonmetastatic, centrally confirmed alveolar or embryonal RMS Soft Tissue Sarcoma

Patients 423 eligible for local failure analysis Alveolar histology, Group I/II 41 Embryonal histology, Group III 280 Alveolar histology, Group III 102 Local failure defined as local progression as 1st event (+/- regional or distant failure) Median follow-up 6.6 years Soft Tissue Sarcoma

Local failure: Alveolar Group I-II 10% local failure, n=41 All events at 5 years: 31% Soft Tissue Sarcoma

EFS and local failure: Group III 5-yr EFS: 70% Overall failure rate 30% 5-yr local failure: 19% 63% of all failures are local Soft Tissue Sarcoma

Local failure: Group III by histology ERMS 20% ARMS 17% p=0.97 Soft Tissue Sarcoma

Local failure: Group III by primary site Retroperitoneal 33% Parameningeal 19% Everything else 14% Soft Tissue Sarcoma

Local failure: Only tumors >5cm Retroperitoneal 33% Retroperitoneal 30% Parameningeal 24% Parameningeal 19% Extremity, B/P 19% Everything else 14% Soft Tissue Sarcoma

Local failure: Group III by size >= 5 cm 25% < 5 cm 10% p=0.0004 Soft Tissue Sarcoma

Local failure: Group III by nodal status Soft Tissue Sarcoma

Comparison to IRS III & IV Patient subsets IRS-III IRS-IV D9803 All patients 19% 13% Embryonal histology 20% Alveolar histology (+ UDS for IRS-III) 17% Parameningeal 16% Extremity 7% 15% Bladder/prostate 14% N0 N1 32% < 5 cm 10% 5+ cm 21% 25% Soft Tissue Sarcoma

Summary Local control was excellent (90%) for Group I/II ARMS representing only 32% of all failures with strategy of postoperative RT Local failure accounted for 63% of all failures in Group III patients & did not vary by histology or nodal status Local failure was highest for RP primary tumors (33%) compared to all other sites (14-19%) Local failure higher for tumors > 5cm (25% vs 10%) Results are similar to IRS III Soft Tissue Sarcoma

Future directions Suggestions for next COG Intermediate Risk RMS study: RT boost to 55.8 Gy (from 50.4) for tumors arising in retroperitoneal & parameningeal sites and all tumors >5cm. Limit pre-chemotherapy volume to 30.6 Gy (from 36 Gy). Reduce total dose for complete response or resection at week 12 to 30.6 Gy. Study PET response related to local failure Soft Tissue Sarcoma