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Table 3 Administration of induction chemotherapy

From: Phase I trial of split-dose induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1)

Induction chemotherapy parameter

Number of patients (%), N = 18

Dose level

      

0

12

(67)

    

-1

6

(33)

    

DLT

8

(44)

    

in dose level 0

7

(38)

    

in dose level -1

1

(6)

    

Number of doses* of TPF (Median, range)

6, 1 - 6

Number of patients completed maximal

level 0

level -1

all patients

number of cycles induction chemotherapy

N = 12

N = 6

N = 18

3 cycles

7

(58)

5

(83)

12

(67)

2 cycles

7

(58)

5

(83)

12

(67)

1 cycle**

5

(42)

1

(17)

6

(33)

Dose intensity***, overall (Median, range)

 

Docetaxel

333.8, 78.2 – 474

Cisplatin

375.3, 78.2 – 474

5-Fluorouracil

10020, 3211 - 11851

Dose density**** per cycle

Week 1

Week 2

Dose density, cycle 1 (Median, range)

  

Docetaxel

72.6, 45.2 – 80.5

71.3, 45 – 80

Cisplatin

73.96, 60.3 – 80.5

73, 45.3 – 80

5-Fluorouracil

3708, 3016 - 4025

3680, 3002 - 4000

Dose density, cycle 2 (Median, range)

  

Docetaxel

65.9, 45 – 79.2

65.8, 44.8 – 79.2

Cisplatin

70.8, 44.9 – 79.2

71, 44.8 – 79.2

5-Fluorouracil

3572, 2990 - 3960

3550, 2992 – 3960

Dose density, cycle 3 (Median, range)

  

Docetaxel

66.2, 46.9 – 78.6

60.1, 36.1 – 78.6

Cisplatin

71.3, 44.9 – 78.6

69.5, 45.1 – 78.6

5-Fluorouracil

3546, 2392 - 3931

3482, 2404 - 3931

Number of patients with dose reductions

4

(22)