Docetaxel and carboplatin combination chemotherapy as outpatient palliative therapy in carcinoma of unknown primary: A multicentre Hellenic Cooperative Oncology Group phase II study

Figures & data

Table I.  Patient and disease characteristics.

	Favorable n = 24	Unfavorable n = 23	All patients n = 47
Age
Median (range)	66 (43–75)	62 (38–73)	63 (38–75)
Sex
Female	15 (63)^*	11 (48)	26 (55)
Male	9 (38)	12 (52)	21 (45)
PS
0	16 (67)	13 (57)	29 (62)
1	8 (33)	7 (30)	15 (32)
2	0 (0)	3 (13)	3 (6)
Sites of disease
Nodal predominantly	16 (67)	0 (0)	16 (34)
Peritoneal	8 (33)	6 (26)	14 (30)
Visceral	0 (0)	17 (74)	17 (36)
Liver	0 (0)	9 (39)	9 (19)
Bone	0 (0)	5 (22)	5 (11)
Adrenal	0 (0)	1 (4)	1 (2)
Skin	0 (0)	1 (4)	1 (2)
Nodal	0 (0)	10 (43)	10 (21)
Other	0 (0)	3 (13)	3 (6)
Number of metastatic sites
1	16 (67)	10 (44)	26 (55)
2	5 (21)	10 (44)	15 (32)
3	3 (13)	3 (13)	6 (13)

*Figures in parentheses are percentage ratios except for age.

Table II.  Treatment and efficacy data.

	Favorable n = 24	Unfavorable n = 23	All n = 47
Cycles delivered
≤ 2	3	7	0 (21)*
3	3	3	6 (13)
4	2	4	6 (13)
5	0	0	0 (0)
> = 6	16	9	25 (53)
Total	129	92	221
Median	6	4	6
Completion of treatment	16 (67)	9 (39)	24 (51)
Never starters	0 (0)	2 (9)	2 (4)
Treatment discontinuation
Disease progression	5 (21)	5 (22)	10 (21)
Death	0 (0)	5 (22)	5 (11)
Doctor's decision	2 (8)	0 (0)	2 (4)
Patient's decision	1 (4)	1 (4)	2 (4)
Toxicity	0 (0)	1 (4)	1 (2)
Median RDI
Docetaxel	0.97	0.96	0.97
Carboplatin	0.92	0.97	0.93
GCSF use	8 (33)	5 (22)	13(28)
Number of cycles	41 (32)	18 (20)	59 (27)
Activity			95% CI
CR	5 (21)	0 (0)	11% (4–23)
PR	6 (25)	4 (17)	21% (11–36)
SD	5 (21)	3 (13)	17% (8–31)
PD	7 (29)	10 (43)	36% (26–43)
Non-evaluable	1 (4)	6 (26)
ORR	11 (46)	4 (17)	32% (19–47)
Overall survival
Median	22.6	5.3	16.2
95% CI	10–35	2.8–7.7	4.6–27.8
TTP
Median	11.5	3.1	5.5
95% CI	2.6–20.5	1.1–5	0.9–10.2

*Figures in parentheses are percentage ratios, except for 95% Confidence Intervals in Activity.

RDI: Relative dose intensity, GCSF: Granulocyte colony-stimulating factor, CR: Complete response, PR: Partial response, SD: Stable disease, PD: Progressive disease, ORR: Objective response rate.

Figure 1.  Kaplan-Meier curves for the overall survival of favourable risk (red line) and unfavourable risk (blue line) CUP patients.

Table III.  Grade 3 or 4 toxicity data.

	Favorable n = 24		Unfavorable n = 21		All n = 45
	Gr.3	Gr.4	Gr.3	Gr.4	Gr.3	Gr.4
Anemia	1 (4)	1 (4)	1 (5)	0 (0)	2 (4)	1 (2)
Neutropenia	5 (21)	3 (13)	1 (5)	3 (14)	6 (13)	6 (13)
Febrile neutropenia		2 (8)		1 (5)		3 (7)
Thrombocytopenia	1 (4)	0 (0)	0 (0)	1 (5)	1 (2)	1 (2)
Diarrhea	1 (4)	0 (0)	0 (0)	0 (0)	1 (2)	0 (0)
Fatigue	1 (4)	0 (0)	0 (0)	1 (5)	1 (2)	1 (2)
Hepatotoxicity	0 (0)	0 (0)	0 (0)	1 (5)	0 (0)	1 (2)
Myalgias	1 (4)	0 (0)	0 (0)	0 (0)	1 (2)	0 (0)

* Figures show number of patients with each side-effect, figures in parentheses are percentage ratios.

Gr: Grade.

Table IV.  Prognostic factors for patient outcome.

	Favourable			Unfavourable			All
	HR	95% CI	p	HR	95% CI	p	HR	95% CI	p
TTP
PS
0	1	–	–	1	–	–	1	–	–
1 or 2	1.6	0.6–4.3	0.3	7.2	1.9–27.8	0.004	2.4	1.2–4.8	0.01
Marker status
All normal	1	–	–	1	–	–	1	–	–
At least one abnormal	0.40	0.14–1.16	0.093	3.6	1.1–12.1	0.04	0.94	0.4–1.9	0.94
Metastatic sites
1	1	–	–	1	–	–	1	–	–
> 1	0.82	0.3–2.2	0.692	3.5	1.1–11	0.03	1.8	0.9–3.6	0.08
Overall survival (OS)
PS
0	1	–	–	1	–	–	1	–	–
1 or 2	2.8	1–7.5	0.04	6.6	1.9–23	0.002	3.8	1.9–7.2	<0.001
Marker status
All normal	1	–	–	1	–	–	1	–	–
At least one abnormal	0.97	0.3–3.2	0.9	6.0	1.3–28	0.02	1.9	0.8–4.5	0.15
Metastatic sites
1	1	–	–	1	–	–	1	–	–
> 1	0.74	0.25–2.3	0.6	4.5	1.3–16.3	0.02	2.1	1.1–4.3	0.03
Docetaxel RDI
< 0.9	1	–	–	1	–	–	1	–	–
≥ 0.9	0.14	0.03–0.6	0.01	1.3	0.3–5	0.67	0.6	0.2–1.5	0.3

HR: Hazard ratio, 95% CI: 95% Confidence Intervals, p: two-sided value, TTP: Time to Progression, PS: Performance Status, RDI: Relative Dose Intensity.