Feasibility of cisplatin/5-fluorouracil and panitumumab in Japanese patients with squamous cell carcinoma of the head and neck.
OBJECTIVE
In Japan, cisplatin/5-fluorouracil 80/800 (cisplatin 80 mg/m2, 5-fluorouracil 800 mg/m2) is widely used to treat recurrent/metastatic squamous cell carcinoma of the head and neck, whereas cisplatin/5-fluorouracil 100/1000 (1000 mg/m2/24 h by continuous intravenous infusion on Days 1-4 plus cisplatin 100 mg/m2 on Day 1 in 3-week cycles) is the standard treatment in Europe and North America.


METHODS
We prospectively evaluated the feasibility of cisplatin/5-fluorouracil 100/1000 in Japanese patients enrolled in the global Phase 3 study of panitumumab 9 mg/kg combined with cisplatin/5-fluorouracil 100/1000 (Arm 1) versus cisplatin/5-fluorouracil 100/1000 alone (Arm 2).


RESULTS
Twenty Japanese patients were enrolled and received treatment (Arm 1, n=13; Arm 2, n=7). Grade 3/4 adverse events included neutropenia, hypomagnesemia, stomatitis, hyponatremia, paronychia, febrile neutropenia, decreased appetite and hypokalemia. There were no fatal adverse events. Median overall survival was not estimable in Arm 1 and 15.4 months in Arm 2. Median progression-free survival was 6.9 months in Arm 1 and 5.7 months in Arm 2. The median number of infusions (cycles) of cisplatin was 5 in Arm 1 and 4 in Arm 2; the median number of infusions (cycles) of 5-fluorouracil was 6 in both arms. The mean administered dose for cisplatin was 93.6 mg/m2 in Arm 1 and 97.2 mg/m2 in Arm 2, and 3732.6 and 3880 mg/m2 in Arm 1 and Arm 2, respectively, for 5-fluorouracil.


CONCLUSIONS
These results suggested that cisplatin/5-fluorouracil 100/1000 was feasible for recurrent/metastatic squamous cell carcinoma of the head and neck in Japanese patients.
Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba matahara@east.ncc.go.jp.
Makoto
M
Tahara
Shizuoka Cancer Center, Shizuoka.
Yusuke
Y
Onozawa
Jichi Medical University Hospital, Tochigi.
Hirofumi
H
Fujii
National Hospital Organization Shikoku Cancer Center, Ehime.
Nobuya
N
Monden
Takeda Bio Development Center, Ltd., Tokyo.
Ikuo
I
Yana
Takeda Bio Development Center, Ltd., Tokyo.
Satoru
S
Otani
Aichi Cancer Center Hospital, Aichi, Japan.
Yasuhisa
Y
Hasegawa
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People / Q000706:statistics & numerical data; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000453:epidemiology; D000077544:Panitumumab; D011446:Prospective Studies; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000077544:Panitumumab; D002945:Cisplatin; D005472:Fluorouracil
Japanese subgroup analysis; cisplatin/5-fluorouracil-100/1000; head and neck