Primary debulking surgery versus primary neoadjuvant chemotherapy for high grade advanced stage ovarian cancer: comparison of survivals

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Patient characteristics by treatment arm: primary debulking surgery (PDS) (N = 108) versus neoadjuvant chemotherapy (NACT) (N = 49)

Patients Characteristic	PDS (108 patients)	NACT + IDS (49 patients)	p value
Age (years)	59,3 (28 - 85)	61,2 (34 – 80)	0,197
BMI	23,8 (18,6 – 34,6)	23,8 (17 – 42,9)	0,424
Parity (number)	2 (0 – 8)	2 (0 – 5)	0,125
Age at last period (years)	50 (40 – 60)	50 (42 – 58)	0,210
preop CA125 (units/mL)	435,0 (14,0 - 21156,0)	770,0 (68,0 - 36130,0)	0,059
Menopausal status
Yes	74,1 (80)	89,8 (44)	0,033
No	25,9 (28)	10,2 (5)
ASA
1	16,7 (18)	10,2 (5)	0,559
2	53,7 (58)	61,2 (30)
3	28,7 (31)	26,5 (13)
4	0,9 (1)	2,0 (1)
Histology
serous	66,7 (72)	85,7 (42)	0,071
endometriod	25,0 (27)	12,2 (6)
mucinous	4,6 (5)	0 (0)
clear cells	3,7 (4)	2,0 (1)
FIGO STAGE
III	95.4 (103)	87.7 (43)	0,08
IIa	(8)	(1)
IIIb	(25)	(0)
IIIc	(70)	(42)
IV	4.6 (5)	12.3 (6)
Residual disease
0 mm (RD = 0)	53,7 (58)	77,6 (38)	0,020
1-10 mm (RD = 1)	17,6 (19)	8,2 (4)
> 10 mm (RD = 2)	28,7 (31)	14,3 (7)
Recurrence
Yes	79,6 (86)	87,8 (43)	0,265
No	20,4 (22)	12,2 (6)
Vital Status
Alive	35,2 (38)	22,4 (11)
Death	64,8 (70)	77,6 (38)	0,575
Length of follow-up (months)	41,7 (1,4 - 100,0)	34,5 (7,6 - 91,0)	0,21

Patient data about type of chemotherapy (neoadjuvant chemotherapy [NACT] and adjuvant chemotherapy [ACHT]) and interval time from surgery: primary debulking surgery (PDS) (N = 108) versus NACT (N = 49)

NACT + IDS group
Cycles of NACT	5 (3 – 6)
Type of NACT
Carboplatin	8,2 (4)
Carboplatin and Paclitaxel	87,8 (43)
Carboplatin and Doxorubicin	4,1 (2)
Response to NACT
Complete	20,4 (10)
Partial	79,6 (39)
Interval LPS to NACT (weeks)	3 (2 – 5)
Interval NACT to IDS (weeks)	3 (2 - 8)
All Groups	PDS (108 patients)	NACT + IDS (49 patients)	p value
Cycles of ACHT	6 (2 - 9)	3 (2 – 9)	0,000
Type of ACHT
Carboplatin	7,4 (8)	8,2 (4)
Carboplatin and Paclitaxel	88,0 (95)	87,8 (43)	1,000
Carboplatin and Doxorubicin	4,6 (5)	4,1 (2)
Interval PDS to ACTH and IDS to ACTH	4 (3 - 10)	4 (2 - 7)	0,147
Second line ACHT
Yes	78,9 (56)	79,1 (34)	0,588
No	21,1 (15)	20,9 (9)

Patient intra-operative and post-operative data by treatment arm: primary debulking surgery (PDS) (N = 108) versus neoadjuvant chemotherapy (NACT) (N = 49)

Variables	PDS (108 patients)	NACT + IDS (49 patients)	p value
LPS explorative	47,2 (51)	100 (49)
Blood Loss (ml)	500,0 (100 - 5000)	400,0 (50 – 2000)	0,0001
EC units	2 (1 – 23) 44 patients	2 (2-3) 12 patients	0,019
Transfusion
Yes	40,7 (44)	24,5 (12)	0,035
No	59,3 (64)	75,5 (37)
Hospitalization Lenght	15 (7 - 62)	12 (5 -38)	0,003
Post-op complications
No/Grade I-II	77,8 (84)	93,9 (46)	0,009
Grade III-IV	22,2 (24)	6,1 (3)
Reoperation for recurrence
Yes	18,6 (16)	25,6 (11)	0,174
No	81,4 (70)	74,4 (32)

Overall survival and progression free survival in patients who underwent primary debulking surgery (PDS) (N = 108) and neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) (N = 49); NACT stratified by residual disease (all sample)

	PFS		OS
	Median (months)	95% CI (months)	Median (months)	95% CI (months)
PDS
0 mm (RD = 0)	20,7	13,2 - 28,3	54,7	40,6 - 68,7
1-9 mm (RD = 1)	11,2	10,2 - 12,2	34,7	0,00 - 71,1
> 10 mm (RD = 2)	13,3	10,0 - 16,5	31,3	15,6 - 47,0
General	17,3	15,0- 19,5	41,3	31,2 - 51,3
NACT + IDS
0 mm (RD = 0)	19,9	16,1 - 23,7	36,3	27,7 - 44,8
1-9 mm (RD = 1)	14,5	2,7 - 26,3	25,6	3,9 - 47,2
> 10 mm (RD = 2)	8,0	6,0 - 9,9	16,1	8,1 - 24,0
General	18,3	14,9 - 21,8	34,5	26,6 - 42,4

Univariate and multivariate hazard ratios (HRs) and 95% confidence intervals (CIs) associated with selected variables, all sample and stratified by treatment group

Variables	Univariate HR (95% CI)	p	Multivariate HR (95% CI)	p
All sample (157)
Treatment group
PDS	1.00 (reference)
NACT + IDS	1,34 (0,90 – 1,99)	0,14	1,45 (0,87 – 2,42)	0,14
Residual Disease
0 mm (RD = 0)	1.00 (reference)
1-9 mm (RD = 1)	1,51 (0,88 - 2,60)	0,13	1,66 (0,96 – 2,82)	0,06
> 10 mm (RD = 2)	2,29 (1,49- 3,53)	0,0001	2,82 (1,79 – 4,46)	0,0001
Age
< 60	1.00 (reference)
≥ 60	1,33 (0,91 - 1,95)	0,13	0,91 (0,61 – 1,38)	0,68
ASA
I - II	1.00 (reference)
III - IV	2,29 (1,53 – 3,41)	0,0001	2,21 (1,44 – 3,40)	0,0001
ACHT cycles	0,94 (0,82 – 1,08)	0,42	0,99 (0,85 – 1,16)	0,96
PDS group
Residual Disease
0 mm (RD = 0)	1.00 (reference)
1-9 mm (RD = 1)	1,70 (0,89 – 3,26)	0,10	2,12 (1,08 – 4,15)	0,028
> 10 mm (RD = 2)	2,37 (1,40 – 4,0)	0,001	3,12 (1,80 – 5,41)	0,00005
Age
< 60	1.00 (reference)
≥ 60	1,49 (0,93 – 2,39)	0,09	0,81 (0,48 – 1,37)	0,44
ASA
I - II	1.00 (reference)
III - IV	3,44 (2,08 – 5,68)	0,001	4,40 (2,50 – 7,75)	0,0001
ACHT cycles	0,77 (0,51 – 1,16)	0,22	0,70 (0,53 – 0,93)	0,015
NACT + IDS group
Residual Disease
0 mm (RD = 0)	1.00 (reference)
1-9 mm (RD = 1)	1,38 (0,47 – 3,98)	0,55	1,53 (0,52 – 4,52)	0,43
> 10 mm (RD = 2)	4,92 (2,04 – 11, 88)	0,0001	6,67 (2,43 -18,33)	0,0001
Age
< 60
≥ 60	0,95 (0,50 – 1,81)	0,88	0,71 (0,35 – 1,47)	0,36
ASA
I - II
III - IV	0,99 (0,48 – 2,01)	0,97	0,77 (0,35 – 1,69)	0,52
ACHT cycles	1,01 (0,85 – 1,19)	0,89	1,03 (0,86 – 1,23)	0,70