Table 2.

No. of Cycles Received and Off Treatment Reason by Arm

Parameter	Treatment
	GEM (n = 275)		GEM FDR (n = 277)		GEMOX (n = 272)
	No.	%	No.	%	No.	%
Mean No. of total cycles*	3		3		5
Standard deviation	3		4		6
Median	2		3		4
Range	0-21		0-18		0-32
Mean duration on treatment, days	87		99		79
Standard deviation	94		105		88
Median	43		63		43
Range	0-607		0-883		0-434
Off treatment reason
Disease progression/symptom deterioration	161	59	157	57	131	48
Toxicity/adverse effects/complications	42	15	52	19	70	26
Death ≤ 4 weeks after beginning protocol therapy	19	7	18	7	17	6
Physician/patient withdrawal	26	10	33	12	42	15
Alternative therapy/other complicating disease/treatment delay or cancelled/other/unknown	27	10	17	6	12	4

NOTE. GEM: first cycle 8 weeks; subsequent cycles 4 weeks. GEM FDR: 4-week cycles. GEMOX: 2-week cycles.

Abbreviations: GEM, gemcitabine; GEM FDR, gemcitabine fixed-dose rate; GEMOX, gemcitabine 1,000 mg/m²/100 minutes/day 1 plus oxaliplatin 100 mg/m²/day 2 every 14 days.