Paclitaxel, cisplatin and 5-fluorouracil in recurrent squamous cell carcinoma of the head and neck: A phase II trial from an Italian cooperative group

Figures & data

Table I.  Patient characteristics

Gender
Male	41
Female	6
Age
Median (range)	60 (41–76)
ECOG PS
0, 1	43
2	4
Histology
SCC	46
Undiff ca	1
Site of primary
Oral cavity	12
Oropharynx	13
Hypopharynx	2
Larynx	18
Nasal cavity and paranasal sinuses	2
Disease status
Locoregional	28
Metastatic	5
Locoregional and metastatic	14
Pretreatment
None	6
Surgery	5
Radiotherapy	6
Surgery and radiotherapy	30
Chemotherapy	0

Table II.  Toxicity (46 evaluable patients).

	WHO grade
	1 (%)	2 (%)	3 (%)	4 (%)
Leukopenia	1 (24)	6 (13)	11 (24)	3 (7)
Neutropenia	6 (13)	5 (11)	13 (28)	9 (20)
Thrombocytopenia	16 (35)	3 (7)	2 (4)	1 (2)
Anemia	33 (72)	10 (22)	2 (4)	–
Diarrhea	2 (4)	1 (2)	1 (2)	–
Mucositis	5 (11)	2 (4)	–	1 (2)
Nausea/Vomiting	10 (22)	1 (2)	2 (4)	–
Arthralgia/Myalgia	4 (9)	1 (2)	1 (2)	–
Neurotox sensory	7 (15)	1 (2)	–	–
Neurotox motor	–	–	1 (2)	–
Alopecia	3 (6)	15 (33)	12 (26)	5 (11)
Fever without infection	1 (2)	1 (2)	–	–

Table III.  Overall Response Rates (ORR) and median survival (mSURV) according to disease status

	Overall (45 pts)	Locoregional relapse only (27 pts)	Metastatic disease (18 pts)
ORR	31.1%	25.9%	p = n.s. 39%
mSURV	7.9 months (95% C.I.: 4.9–11.1)	9.4 months (95% C.I.: 5.8–11.1)	p = n.s. 4.9 months (95% C.I.: 3.3–18.7)

Table IV.  Trials on combinations of Cisplatin, 5Fluorouracil and Paclitaxel.

	DISEASE STATUS	PHASE	N	DRUGS	CR%	ORR%	mSURV
Benasso	recurrent	II	47	P, DDP, 5FU bolus	13	31	7.9
Hussain [18]	recurrent	II	19	P, DDP, 5FU c.i.	21	58	6
Worden [19]	recurrent	II	65	P, DDP, 5FU c.i	5	37	9
Hitt [20]	recurrent	II	24	P, DDP, 5FU c.i., LLV	46	83	17
Hitt [21]	local. adv.	II	70	P, DDP, 5FU c.i	59	88	n.s.
Hitt [22]	local. adv.	III	192	P, DDP, 5FU c.i.	33*	86	n.s.
			192	DDP, 5FU c.i.	14*	75	n.s.

P: paclitaxel, DDP: cisplatin, 5FU: 5-flurouracil; CR: complete response; ORR: overall response rate; n.s.: not stated; *: p = 0.000.

Table V.  Trials on combinations of Cisplatin, 5Fluorouracil and Docetaxel.

	DISEASE STATUS	PHASE	N	DRUGS	CR%	ORR%
Posner [25]	local. adv.	II	43	D, DDP, 5FU c.i.	40	93
Colevas [26]	local. adv.	II	34	D, DDP, 5FU c.i., LLV	44	94
Schrijvers [27]	local. adv.	II	48	D, DDP, 5FU c.i.	0	64–78
Vermorken [28]	local. adv.	III	177	D, DDP, 5FU c.i.	n.s.	68*
			181	DDP, 5FU c.i.	n.s.	54*

DDP: cisplatin, 5FU: 5-flurouracile, D: docetaxel; CR: complete response; ORR: overall response rate; *: p = 0.016.

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