TABLE 2.

Univariate analysis for DFS, PFS, and OS for the follow-up period of 30 months.

	Disease-free survival (DFS)					Progression-free survival (PFS)
	Adjuvant					First-line
	N° events/Total		Median (95% CI)		p-value**	N° events/Total		Median (95% CI)		p-value **
PMA-ZEO treat. group overall	22/46		39.1 (15.3–62.9)		0.6	49/56		15.5 (11.9–19.0)		0.9
	Placebo	PMA-ZEO	Placebo	PMA-ZEO		Placebo	PMA-ZEO	Placebo	PMA-ZEO
	9/22	13/24	n.e.	38.6 (25.2–57.1)		23/28	26/28	15.7 (5.7–25.7)	14.9 (12.7–7.0)
Overall survival (OS)
	Adjuvant					First-line
	N° events/Total		Median (95% CI)		p-value**	N° events/Total		Median (95% CI)		p-value **
PMA-ZEO treat. group overall	14/46		58.6 (54.7–62.6)			39/56		30.2 (22.6–37.9)
	Placebo	PMA-ZEO	Placebo	PMA-ZEO		Placebo	PMA-ZEO	Placebo	PMA-ZEO
	7/22	7/24	56.7 (n.e.)	58.7 (31.5–85.8)	0.8	22/28	17/28	26.3 (16.6–36.1)	37.1 (31.1–43.1)	0.1
Age
<60 years	2/7	3/12	56.7 (n.e)	n.e.	0.9	8/7	8/14	16.5 (0.01–39.1)	37.1 (23.4–50.8)	0.09
61–65 years	1/4	1/1	35.0 (n.e.)	4.5 (n.e.)	0.05	3/5	1/2	40.6 (0.01–90.1)	15.5 (n.e.)	0.7
66–70 years	3/7	1/7	n.e.	n.e.	0.3	3/6	4/6	59.9 (n.e.)	17.8 (0.01–37.7)	0.3
>70 years	1/4	2/4	n.e.	58.7 (n.e.)	0.7	9/9	4/6	21.8 (15.2–28.3)	39.7 (3.1–76.3)	0.06
Sex
Male	4/12	5/15	56.7 (32.4–80.9)	n.e.	0.9	13/17	8/10	25.0 (3.3–46.7)	26.3 (3.6–48.9)	0.7
Female	3/10	2/9	n.r.	58.7 (n.e.)	0.8	9/11	9/18	28.5 (17.8–39.1)	37.1 (30.1–44.1)	0.3
N° of cycles
<9 cycles	2/9	1/6	n.e.	n.e.	0.6	8/10	2/6	10.7 (0.9–20.4)	n.e.	0.06
≥9 cycles	5/13	6/18	56.7 (39.9–73.4)	58.7 (n.e.)	0.9	14/18	15/22	30.2 (26.7–33.6)	37.1 (16.7–57.2)	0.8
Dose reduction
No	4/10	5/9	56.8 (n.e.)	30.6 (16.7–44.5)	0.2	12/16	6/12	21.8 (4.3–39.3)	37.5 (24.6–50.5)	0.2
Yes	3/10	2/15	n.e.	58.7 (n.e.)	0.3	10/12	11/16	26.4 (18.9–33.9)	37.2 (16.2–58.1)	0.6
Comorbidity
No	3/7	4/14	56.7 (24.5–88.9)	58.7 (n.e.)	0.8	10/11	8/14	25.0 (2.8–47.1)	37.1 (14.4–59.8)	0.1
Yes	4/15	3/10	n.e.	n.e.	0.9	12/17	9/14	28.5 (12.2–44.7)	33.9 (16.7–51.0)	0.7

**Log-rank test.