TY - JOUR
T1 - A phase i trial combining oral cisplatin (CP Ethypharm) with radiotherapy in patients with locally advanced head and neck squamous cell carcinoma
AU - Tao, Yungan
AU - Rezaï, Keyvan
AU - Brain, Etienne
AU - Etessami, Atoussa
AU - Lusinchi, Antoine
AU - Temam, Stephane
AU - Urien, Saik
AU - Van, Marie Louise Vo
AU - Vauzelle-Kervroedan, Françoise
AU - Lokiec, François
AU - Daly-Schveitzer, Nicolas
AU - Bourhis, Jean
PY - 2011/1/1
Y1 - 2011/1/1
N2 - Purpose: To determine the maximum tolerated dose (MTD) of oral cisplatin (CP Ethypharm®) in combination with radiotherapy in head and neck squamous cell carcinoma (HNSCC) and the recommended dose for phase II trials. Patients and methods: Phase I, multicenter, open-labelled, non-comparative and dose escalating trial. CP Ethypharm® was administered on five consecutive days every other week for 7 weeks (4 treatment cycles) in combination with radiotherapy. Eighteen patients with locally advanced HNSCC were allocated to four cisplatin dose levels: 10 mg/m 2/day: 4 patients; 15 mg/m 2/day: 4, 20 mg/m 2/day: 5 and 25 mg/m 2/day: 5. The inclusion of patients was dictated by occurrence of dose limiting toxicities (DLTs) at each dosing level. Results: The most frequently experienced AEs were gastrointestinal (GI) disorders. Five DLTs were observed, including three at 25 mg/m 2 level (two grade 2 renal toxicities, one grade 3 GI and renal toxicities), one at 20 mg/m 2 level (grade 3 GI disorders), one at 10 mg/m 2 level (grade 4 mucositis). PK analysis showed no significant difference of C max values between day 1 and day 5 of treatment at each dose level (total & ultrafilterable platinum). Conclusion: Due to 3 DLTs experienced at 25 mg/m 2/day, MTD was reached and the recommended dose for phase II studies was determined as 20 mg/m 2/day.
AB - Purpose: To determine the maximum tolerated dose (MTD) of oral cisplatin (CP Ethypharm®) in combination with radiotherapy in head and neck squamous cell carcinoma (HNSCC) and the recommended dose for phase II trials. Patients and methods: Phase I, multicenter, open-labelled, non-comparative and dose escalating trial. CP Ethypharm® was administered on five consecutive days every other week for 7 weeks (4 treatment cycles) in combination with radiotherapy. Eighteen patients with locally advanced HNSCC were allocated to four cisplatin dose levels: 10 mg/m 2/day: 4 patients; 15 mg/m 2/day: 4, 20 mg/m 2/day: 5 and 25 mg/m 2/day: 5. The inclusion of patients was dictated by occurrence of dose limiting toxicities (DLTs) at each dosing level. Results: The most frequently experienced AEs were gastrointestinal (GI) disorders. Five DLTs were observed, including three at 25 mg/m 2 level (two grade 2 renal toxicities, one grade 3 GI and renal toxicities), one at 20 mg/m 2 level (grade 3 GI disorders), one at 10 mg/m 2 level (grade 4 mucositis). PK analysis showed no significant difference of C max values between day 1 and day 5 of treatment at each dose level (total & ultrafilterable platinum). Conclusion: Due to 3 DLTs experienced at 25 mg/m 2/day, MTD was reached and the recommended dose for phase II studies was determined as 20 mg/m 2/day.
KW - Chemotherapy
KW - Head and neck cancer
KW - Oral cisplatin
KW - Phase I
KW - Radiotherapy
UR - http://www.scopus.com/inward/record.url?scp=78651355624&partnerID=8YFLogxK
U2 - 10.1016/j.radonc.2010.11.008
DO - 10.1016/j.radonc.2010.11.008
M3 - Article
C2 - 21176985
AN - SCOPUS:78651355624
SN - 0167-8140
VL - 98
SP - 42
EP - 47
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
IS - 1
ER -