Improved efficacy of mitoxantrone in patients with castration-resistant prostate cancer after vaccination with GM-CSF-transduced allogeneic prostate cancer cells

Figures & data

Table 1. Baseline characteristics at start chemotherapy of patients treated in the phase I dose-escalation trial studying the combination of ipilimumab with the whole-cell vaccine GVAX.

	Docetaxel	Mitoxantrone
	(n = 23)	(n = 13)
Mean age in years (range)	67.3 (45.5–80.9)	70.7 (55.5–83.0)
ECOG Performance Score
- Not mentioned	0	1
− 0	4	3
− 1	16	6
− 2	2	3
− 3	1	0
Median PSA (µg/L)	298 (84–2633)	1286 (16–7861)
Median lactate dehydrogenase (U/L)	255 (162–840)	242 (198–808)
Median alkaline phosphatase (U/L)	298 (84–1395)	299(57–893)
Median hemoglobin (mmol/L)	7.1 (4.8–8.2)	7.0 (5.3–8.9)

Abbreviations: ECOG = Eastern Cooperative Oncology Group

Table 2. Baseline characteristics of study subjects in the Vital 1 or Vital 2 study at start of chemotherapy.

	Docetaxel	GVAX^+	GVAX^–	Mitoxan-trone	GVAX^+	GVAX^–
	(n = 21)	(n = 9)	(n = 12)	(n = 14)	(n = 7)	(n = 7)
Mean age in years (range)	67.5	66	68.6	67.3	63.4	68.6
	(58.1–80.6)	(58.7–80.6)	(58.1–76.0)	(59.9–80.1)	(60.6–80.1)	(59.9–77.0)
ECOG PS
- Not mentioned	2	1	1	1	0	1
- 0	6	3	3	2	1	1
- 1	11	4	7	8	4	4
- 2	2	1	1	2	1	1
- 3	0	0	0	1	1	0
Median PSA (µg/L)	184.9	184.9	220.9	332	376	173
	(5.7–3885.5)	(5.7–3885.5)	(14.9–3364.3)	(14–2822)	(14–1263)	(51–2822)
Median lactate dehydro- genase (U/L)	254	214	264	290	290	288
	(146–616)	(159–322)	(146–616)	(161–531)	(179–521) (2 missing)	(161–531)
Median alkaline phosphatase (U/L)	366	373	274	207	202	212
	(59–2413)	(59–1470)	(126–2413)	(79–1826)	(119–1826)	(79–790)
Median hemoglobin (mmol/L)	7.4	7.9	7.3	6.8	6.6	6.9
	(4.2–8.8)	(4.2–8.6)	(6.1–8.8)	(5.6–8.6)	(5.6–8.6)	(6.0–7.6)

Abbreviations: ECOG PS = Eastern Cooperative Oncology Group Performance Score, GVAX⁺ = Patients who were treated with GVAX, GVAX^– = Patients who received placebo-treatment

Figure 1. Kaplan–Meier curves of progression-free survival after docetaxel and mitoxantrone of study subjects from the VITAL1 or VITAL2 study. Kaplan–Meier curves of progression-free survival (PFS) after docetaxel (A) and mitoxantrone (B) treatment for subjects with (solid line) or without (dotted line) prior prostate GVAX treatment. Number of patients and corresponding median PFS for each group is given. Statistical significance of the survival distribution was analyzed by log-rank testing..

Figure 2. High Tact/Treg ratios after prostate GVAX/ipilimumab therapy are associated with significantly longer PFS following mitoxantrone. Kaplan–Meier curves of progression-free survival (PFS) following (A) mitoxantrone or (B) docetaxel treatment for prostate GVAX/ipilimumab-treated patients with high vs. low CD8⁺ICOS⁺/Treg ratios. Number of patients and corresponding median PFS for each group is given. Statistical significance of the survival distribution was analyzed by log-rank testing.