Phase II trial of carboplatin/docetaxel in patients with resected NSCLC

Table 1 Patient characteristics

Characteristic	n = 61
Gender
Male	43
Female	18
Age, yr	66 (42-79)
Histology
Adenocarcinoma	45
Squamous cell carcinoma	13
Pleomorphic carcinoma	2
Giant cell carcinoma	1
Lesion site
Right	42
Left	19
Lesion location
Upper	38
Middle	1
Lower	22
Pathological stage (7th)
IB	17
IIA	14
IIB	8
IIIA	22
Surgical procedure
Sublobar resection	2
Lobectomy	58
Pneumonectomy	1

Table 2 Drug delivery n (%)

Number of cycles delivered
1	61 (100)
2	58 (95)
3	51 (84)
Total	170
Median	3
Number of patients who required dose reduction of
CBDCA	43 (70)
DTX	43 (70)
Mean dose intensity (% planned)
CBDCA	4.3 AUC (86.7)
DTX	51.8 mg/m2 (86.3)
Median dose intensity (% planned)
CBDCA	4.3 AUC (86.7)
DTX	53.3 mg/m2 (88.8)

CBDCA: Carboplatin; DTX: Docetaxel; AUC: Area under the curve.

Table 3 Worst adverse events that occurred in the present study n (%)

Toxicity	Grade 3	Grade 4
Hematological events
Neutropenia	15 (25)	40 (66)
Febrile neutropenia	4 (7)	0 (0)
Non-hematological events
Anorexia	41 (7)	0 (0)
Nausea	21 (3)	0 (0)
General fatigue	2 (3)	0 (0)
GI disorder2		1 (2)
Diarrhea	1 (2)

¹Two patients had both anorexia and nausea;

²Intra-abdominal abscess from ileocecal diverticulitis. GI: Gastrointestinal.

Table 4 The pathological stages and types of recurrence n (%)

Pathological stage (7th)	No. of cases	Local	Systemic
IB	17	0	1
IIA	14	2	2
IIB	8	0	3
IIIA	22	7	10
Total	61	9 (15)	16 (26)

Five patients had both local and systemic recurrent tumors.