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PHASE I TRIAL OF CONCURRENT CHEMORADIOTHERAPY

PHASE I TRIAL OF CONCURRENT CHEMORADIOTHERAPY USING DOXIFLURIDINE AND PACLITAXEL IN ADVANCED BREAST CANCER. H.Hirowatari 1 , K. Karasawa 1,2 , K. Ito 1,2 , T. Takada 1 , H. Izawa 1 , T. Furuya 1,2 , S.Ozawa 1,2 ,C.Kurokawa 1,2

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PHASE I TRIAL OF CONCURRENT CHEMORADIOTHERAPY

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  1. PHASE I TRIAL OF CONCURRENT CHEMORADIOTHERAPY USING DOXIFLURIDINE AND PACLITAXEL IN ADVANCED BREAST CANCER H.Hirowatari1, K. Karasawa1,2, K. Ito1,2, T. Takada1, H. Izawa1, T. Furuya1,2, S.Ozawa 1,2,C.Kurokawa 1,2 １Department of Radiology, School of Medicine Juntendo University, 2Department of Medical Physics for Advanced Radiotherapy, Graduate School of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421 Japan

  2. Backgrounds • Radiotherapy with concurrent chemotherapy has been used to increase local control in patients with advanced tumor. • A variety of anti-cancer agents have been used, the optimal drug combinations, doses, and schedules have not yet been established. • Concurrent chemoradiotherapy for breast cancer has been not popular.

  3. Purpose We conducted phase I trial of concurrent chemoradiotherapy using Doxifluridine (5'-DFUR) and Paclitaxel (TAL) for advanced or recurrent breast cancer, which could admit the induction of d-ThdPase peculiarly only in the tumor for a radiation sensitizer.

  4. Patients Eligibility • Histologically documented cancer of the breast. • Locally advanced inoperable breast tumor or a recurrent tumor requiring localized radiotherapy. • Bone marrow function tolerance: WBC >4000/µL and <10000/µL , Plt>100000,Hb>9.5g/dl • Expected prognosis:who will live more than 3 months. • No infections. • No severe respiratory complications. • Pretreatment staging:CT or MRI of head, neck,chest abdomen and bone scintigraphy.

  5. Treatment Methods • Radiotherapy 60Gy/30f/6week • (4-MV photon beam) • 5’-DFUR 600mg/body five days/week • TAL 20-35mg/m2 twice/week • Adjuvant therapy • TAL 60mg/m2/week Mon Tue Wed Thu Fri Radiation 5’-DFUR TAL

  6. Patients Characteristics of the16 cases(2002.11-2005.5) Age 37-74y.o.(median 57) Menopausal status Pre 3 Post 13 Pathology IDC 15 ILC 1 Untreated fresh 13 Pervious chemotherapy 3

  7. Patients Status of the 16 cases(2002.11-2005.5) Unresectable advance primary tumor 13 with axillary lymph nodes (Bilateral tumor 1) Local recurrence 3 Regional lymph node recurrence 2 Chest wall recurrence 1

  8. The Dosage Level of TAL • TAL Cases • Level 1 20mg/m26 • Level 2 25mg/m24 • Level 3 30mg/m2 3 • Level 4 35mg/m2 3

  9. Adverse effects NCI CTCAEv3.0 • Hematological grade • 0123 4 • Leukocytes 4 5 61 0 • Neutrophils 7 44 1 0 • Lymphopenia 5 1 7 3 0 • Hb 3 1 0 0 0 • Platelets 16 0 0 0 0 • Others • Dermatitis 0 0 8 8 0 • Hair loss8512 0 • Neuropathy 10 0 5 1 0

  10. Case:55y.o.T4cN1M0 CR 4 months after treatment Pretherapy • TAL level:20mg/m2 • She died after 58 months because of metastatic disease from other primary, otherwise breast tumor had been controled.

  11. Treatment Responses Follow up period :10 to 53 months. (median 24) • Irradiated site CR 10 • PR 6 • OverallCR 6 • PR 9 • PD 1

  12. Local Control Rate provability 61% 50% years

  13. Overall Survival Rate provability 69% 60% years

  14. Summary • Sixteen cases of inoperable advanced breast cancer had been treated with concurrent chemoradiotherapy. • The treatment regimen consisting of TAL, 5’-DFUR and local radiotherapy. • The dose of TAL 35mg/m2 twice a week and 5'-DFUR of 600mg/body five times a week was tolerable. • The treatment response of irradiated site, CR and PR were 10 and 6 case, respectively. • Local control rates at 2 and 3 years after treatment were 61% and 50%, overall survival rates at 2 and 3 years after treatment were 69% and 60%, respectively. 14

  15. Conclusions The regimen consisting of concurrent dose of 600 mg of 5'-DFUR and doses of 35mg/m2 twice a week of TAL was tolerable and effective in the local control of advanced or recurrent breast cancer.

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