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

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Radiology and Oncology

Volume 52 (2018): Issue 3 (September 2018)

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Article Category: Research Article

Published Online: Sep 11, 2018

Page range: 307 - 319

Received: Mar 28, 2018

Accepted: Jul 23, 2018

DOI: https://doi.org/10.2478/raon-2018-0030

© 2018 Borut Kobal, Marco Noventa, Branko Cvjeticanin, Matija Barbic, Leon Meglic, Marusa Herzog, Giulia Bordi, Amerigo Vitagliano, Carlo Saccardi, Erik Skof, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

(A) Overall survival by treatment arm: primary debulking surgery (PDS) (N = 108) versus neoadjuvant chemotherapy (NACT) (N = 49). (B) Progression free survival by treatment arm: primary debulking surgery (PDS) (N = 108) versus neoadjuvant chemotherapy (NACT) (N = 49).

(A) Overall survival according the neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) with residual disease = 0 versus primary debulking surgery (PDS) with residual disease = 0 and PDS with residual disease = 1. (B) Progression free survival according the neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) with residual disease = 0 versus primary debulking surgery (PDS) with residual disease = 0 and primary debulking surgery PDS with residual disease = 1.

(A) Overall survival by treatment excluding endometriod and mucinous histotype. (B) Progression free survival by treatment excluding endometriod and mucinous histotype.

(A) Overall survival according the neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) with residual disease = 0 versus primary debulking surgery (PDS) with residual disease = 0 and PDS with residual disease = 1 (excluding endometriod and mucinous histotype). (B) Progression free survival according the neoadjuvant chemotherapy (NACT) + interval debulking surgery (IDS) with residual disease = 0 versus primary debulking surgery (PDS) with residual disease = 0 and PDS with residual disease = 1 (excluding endometriod and mucinous histotype).

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)	0,033

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)	0,265

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)	0,588

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)	0,035
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)	0,009

Reoperation for recurrence

Yes	18,6 (16)	25,6 (11)	0,174
No	81,4 (70)	74,4 (32)	0,174

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

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