Clinical results of BNCT for Head and Neck melanoma J. Hiratsuka, N.Kamitani, N.Morita T.Aihara, A.Maruhashi * and K.Ono * Kawasaki Medical School *Research.

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Clinical results of BNCT for Head and Neck melanoma J. Hiratsuka, N.Kamitani, N.Morita T.Aihara, A.Maruhashi * and K.Ono * Kawasaki Medical School *Research Reactor Institute, Kyoto University 16 th International Congress on Neutron Capture Therapy (2014)

BNCT using BPA made it possible to cure skin malignant melanoma without severe skin damage.

89 Skin Mm32 H & N tumor55 Mm12 non-Mm43 Other2 Case distribution of BNCT （ 1987 ～ 2013 ）

CaseNCT-no.AgeSexi-StageBNCT site Primary/Meta at BNCT site Previous Tx Tumor size （ cm ） Tumor distance from skin surface (cm) 1NCT-3355 Ｍ T2N0M0Nasal cavityPrimaryOp + Chemsuperficial3 2NCT-3874 Ｆ T2N0M0Nasal cavityMetaOp + chemsuperficial4 3NCT-3966MT1N2bM0NeckMetaOp2.5 * NCT-4074MT1N0M0Nasal cavityPrimary ＿ superficial2.5 5NCT-4271 Ｆ T4N0M0Nasal cavityPrimaryOp + Chem3.0 * NCT-4364MT2N0M0Nasal cavityPrimaryOp + Chem1.5 * NCT-4469MT4N0M0Nasal cavityPrimaryOp + Chem4.0 * NCT-4774 Ｆ T1N0M0Nasal cavityPrimaryOp + Chemsuperficial2 9NCT-5369MT1N0M0Nasal cavityPrimaryOp + Chem1.0 * NCT-5572MTxN2aM0NeckPrimary ＿ 2.0 * NCT-6859 Ｆ T1N0M0NeckMetaOp + Chem10.0 * NCT-7937MT1N0M0NeckMetaChem21.0 * Head & Neck Melanoma cases ( )

CaseNCT-no.AgeSexi-StageBNCT site Primary/Meta at BNCT site Previous Tx Tumor size （ cm ） Tumor distance from skin surface (cm) 1NCT-3355 Ｍ T2N0M0Nasal cavityPrimaryOp + Chemsuperficial3 2NCT-3874 Ｆ T2N0M0Nasal cavityMetaOp + chemsuperficial4 3NCT-3966MT1N2bM0NeckMetaOp2.5 * NCT-4074MT1N0M0Nasal cavityPrimary ＿ superficial2.5 5NCT-4271 Ｆ T4N0M0Nasal cavityPrimaryOp + Chem3.0 * NCT-4364MT2N0M0Nasal cavityPrimaryOp + Chem1.5 * NCT-4469MT4N0M0Nasal cavityPrimaryOp + Chem4.0 * NCT-4774 Ｆ T1N0M0Nasal cavityPrimaryOp + Chemsuperficial2 9NCT-5369MT1N0M0Nasal cavityPrimaryOp + Chem1.0 * NCT-5572MTxN2aM0NeckPrimary ＿ 2.0 * NCT-6859 Ｆ T1N0M0NeckMetaOp + Chem10.0 * NCT-7937MT1N0M0NeckMetaChem21.0 * Head & Neck Melanoma cases ( )

CaseNCT-no.AgeSexi-StageBNCT site Primary/Meta at BNCT site Previous Tx Tumor size （ cm ） Tumor distance from skin surface (cm) 1NCT-3355 Ｍ T2N0M0Nasal cavityPrimaryOp + Chemsuperficial3 2NCT-3874 Ｆ T2N0M0Nasal cavityMetaOp + chemsuperficial4 3NCT-3966MT1N2bM0NeckMetaOp2.5 * NCT-4074MT1N0M0Nasal cavityPrimary ＿ superficial2.5 5NCT-4271 Ｆ T4N0M0Nasal cavityPrimaryOp + Chem3.0 * NCT-4364MT2N0M0Nasal cavityPrimaryOp + Chem1.5 * NCT-4469MT4N0M0Nasal cavityPrimaryOp + Chem4.0 * NCT-4774 Ｆ T1N0M0Nasal cavityPrimaryOp + Chemsuperficial2 9NCT-5369MT1N0M0Nasal cavityPrimaryOp + Chem1.0 * NCT-5572MTxN2aM0NeckPrimary ＿ 2.0 * NCT-6859 Ｆ T1N0M0NeckMetaOp + Chem10.0 * NCT-7937MT1N0M0NeckMetaChem21.0 * Head & Neck Melanoma cases ( )

CaseNCT-no.AgeSexi-StageBNCT site Primary/Meta at BNCT site Previous Tx Tumor size （ cm ） Tumor distance from skin surface (cm) 1NCT-3355 Ｍ T2N0M0Nasal cavityPrimaryOp + Chemsuperficial3 2NCT-3874 Ｆ T2N0M0Nasal cavityMetaOp + chemsuperficial4 3NCT-3966MT1N2bM0NeckMetaOp2.5 * NCT-4074MT1N0M0Nasal cavityPrimary ＿ superficial2.5 5NCT-4271 Ｆ T4N0M0Nasal cavityPrimaryOp + Chem3.0 * NCT-4364MT2N0M0Nasal cavityPrimaryOp + Chem1.5 * NCT-4469MT4N0M0Nasal cavityPrimaryOp + Chem4.0 * NCT-4774 Ｆ T1N0M0Nasal cavityPrimaryOp + Chemsuperficial2 9NCT-5369MT1N0M0Nasal cavityPrimaryOp + Chem1.0 * NCT-5572MTxN2aM0NeckPrimary ＿ 2.0 * NCT-6859 Ｆ T1N0M0NeckMetaOp + Chem10.0 * NCT-7937MT1N0M0NeckMetaChem21.0 * Head & Neck Melanoma cases ( )

Tumor distance from skin surface (cm)

CaseNCT-no.AgeSexi-StageBNCT site Primary/Meta at BNCT site Previous Tx Tumor size （ cm ） Tumor distance from skin surface (cm) 1NCT-3355 Ｍ T2N0M0Nasal cavityPrimaryOp + Chemsuperficial3 2NCT-3874 Ｆ T2N0M0Nasal cavityMetaOp + chemsuperficial4 3NCT-3966MT1N2bM0NeckMetaOp2.5 * NCT-4074MT1N0M0Nasal cavityPrimary ＿ superficial2.5 5NCT-4271 Ｆ T4N0M0Nasal cavityPrimaryOp + Chem3.0 * NCT-4364MT2N0M0Nasal cavityPrimaryOp + Chem1.5 * NCT-4469MT4N0M0Nasal cavityPrimaryOp + Chem4.0 * NCT-4774 Ｆ T1N0M0Nasal cavityPrimaryOp + Chemsuperficial2 9NCT-5369MT1N0M0Nasal cavityPrimaryOp + Chem1.0 * NCT-5572MTxN2aM0NeckPrimary ＿ 2.0 * NCT-6859 Ｆ T1N0M0NeckMetaOp + Chem10.0 * NCT-7937MT1N0M0NeckMetaChem21.0 * Head & Neck Melanoma cases ( )

CaseBoron (blood)BPA-PET T/N （Ｂ） Tumor size （ cm ） Tumor dose (Min.) (Gy-eq) Skin dose (Max.) (Gy-eq) Local responsealive / death 125ppm ＿ 3Superficial2311.9CRalive 2 32 ｐｐｍ＿ 3Superficial26.211CRdeath 3 32 ｐｐｍ ○3 ≦ 5cm CRdeath 425ppm ＿ 3Superficial PRdeath 5 24 ｐｐｍ ○3 ≦ 5cm 1915CRdeath 625ppm○2.7 ≦ 5cm PDdeath 7 27 ｐｐｍ ○3.7 ≦ 5cm PDdeath 827ppm ＿ 3Superficial CRdeath 9 29 ｐｐｍ ○2.5 ≦ 5cm CRdeath ｐｐｍ ○3.1 ≦ 5cm PRdeath ｐｐｍ ○5 5cm ≦ 372.9CRalive 1225ppm○6.9 5cm ≦ PDdeath

Overall survival rate （ n=12) ( years ) 5-year : 25%

Local relapse - free survival rate (n=12) ( years ) 5-year : 54%

( years ) ≧ 25Gy-eq (6) ≦ 25Gy-eq (6) Local relapse - free survival rate according to min. tumor dose

Tumor distance from skin surface 10 cm 5 cm Minimum tumor dose ( Gy-eq ) Non-CRCR

Tumor depth from skin surface 10 cm 5 cm Minimum tumor dose ( Gy-eq ) Non-CRCR

Relapse findings ５５ years old ( male ) Malignant melanoma of the nasal cavity Relapse occurred 3 months after resection and chemotherapy The T/N ratio was 3.0. October 2005: BNCT Salvage BNCT --- NCT-33 septum

Irradiation time ： 42 minutes Tumor doses ＝ 23-35Gy-eq Mucosal doses ＝ 13Gy-eq JRR-4

3 months after BNCT 11 months after BNCT CR for 8 years Prior to BNCT

Tumor depth from skin surface 10 cm 5 cm Minimum tumor dose ( Gy-eq ) Non-CRCR

Pre- BNCT 2 m later NCT-44 Local response : PD Dead of Mm 1 year later 3 m later5 m later T/B= Gy-eq ≦ Tumor dose

Tumor depth from skin surface 10 cm 5 cm Minimum tumor dose ( Gy-eq ) Non-CRCR

Salvage BNCT--- 59Yo. Female Local LN recurrent malignant melanoma after operation (TxN1bM0, Stage Ⅲ B, amelanotic melanoma) melanoma(?) resection LN recurrence resection recurrence rapid growth NCT-68

T/N= years old （ Female ） Malignant melanoma （ before BNCT ） 37Gy-eq ≦ Tumor dose

8 m. later11 m.13 m.18 m.

Dose distribution in Tumor （ Gy-eq )

Before BNCT 18 m. later

Before BNCT18 m. later

18 months after BNCT

（ 2.5 y after BNCT )

Tumor depth from skin surface 10 cm 5 cm Minimum tumor dose ( Gy-eq ) Non-CRCR

Summary We presented the latest clinical results of 12 patients with H & N melanoma treated by BNCT. Almost all patients have been dead of local failure and distant metastases. In spite of continuous CR, some patients have been dead of systemic metastases. Patients irradiated more than 25Gy-eq as minimum tumor dose tended to show good response ---- no statistically significant difference! There is a strong possibility to achieve CR, if melanoma is irradiated more than 25Gy-eq and the tumor distance is less than 5cm.

Thank you for your attention. Seto Inland Sea, OKAYAMA, Japan.