Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?

BMC Cancer

Table 5 Univariate and multivariate predictors of overall survival

		Univariate model			Multivariable model (stepwise)
Variables		Median OS (days)	95% CI	p-value (Log-rank)	Hazard ratio	95% CI	p-value
Gender	Female	365	276-501	0.05
	Male	270	204-346
Age	< 65 years	325	271-400	0.81
	≥ 65 years	297	210-398
Albumin	≥ 35 g/L	325	271-365	0.02
	< 35 g/L	54	42-408
LDH	Normal	366	320-501	0.001
	Elevated	210	147-276		1.75	1.24-2.46	0.001
No. of metastatic sites	≤ 2	358	299-446	0.0001
	> 2	210	136-290		1.68	1.18-2.40	0.004
ECOG Performance Status	0	366	302-464	0.02
	> 0	270	158-325		1.42	1.00-1.99	0.05
Hemoglobin	≥ 12 g/dL	350	273-412	0.09
	< 12 g/dL	276	185-346
WBC	≤ 10.5 × 10⁹/L	345	276-398	0.07
	> 10.5 × 10⁹/L	236	103-352
Platelets	≤ 400 × 10⁹/L	329	273-398	0.23
	> 400 × 10⁹/L	261	137-352
Lymphocytes	≥ 0.7 × 10⁹/L	346	290-400	0.04
	< 0.7 × 10⁹/L	166	99-315
Lung metastases	No	338	271-414	0.58
	Yes	302	223-365
Liver metastases	No	366	297-501	0.01
	Yes	250	191-329
Bone metastases	No	329	276-365	0.32
	Yes	261	135-433
Brain	No	320	270-358	0.47
	Yes	269.5	40-499
Peritoneal Mets	No	325	250-365	0.99
	Yes	315	257-474
No. of prior treatments	< 3	302	266-365	0.76
	≥ 3	320	227-400

Abbreviations: LDH = lactate dehydrogenase; No. = number; ECOG = Eastern Cooperative Oncology Group; WBC = white blood cells; OS = overall survival; CI = confidence interval

ISSN: 1471-2407