webinar ca ovari residents

1. Abordatge
Multidisciplinari
del càncer d’ovari
avançat
Abordatge Multidisciplinari del càncer d’ovari avançat
Sessió 27 Maig
Moderadora:
▪ Ma Pilar Barretina. Oncòloga mèdica. Cap Assistencial
Servei d’Oncologia Mèdica. ICO Girona.
Ponents:
▪ Sergi Martínez. Ginecòleg. Cap de Servei de Ginecologia.
Hospital Germans Trias i Pujol. Badalona.
▪ Lydia Gaba. Oncòloga mèdica. Servei d’Oncologia Mèdica.
Hospital Clínic. Barcelona.
27 Maig 2021

2. ▪ EOC is the most common cause of death among
women with gynecologic malignancies and the
fifth leading cause of cancer death in women
▪ 75 percent of women have stage III or stage IV
disease at diagnosis
▪ Stage at diagnosis is an important prognostic
factor
Introduction
Lheureux S et al. Ca Cancer J Clin 2019;69:280–304

3. Cas clínic
▪ Dona de 78 anys
▪ A. Familiars: no antecedents d’interès
▪ A. Patològics:
▪ Fibril·lació auricular en tractament amb apixaban
▪ HTA en tractament amb hidroclorotiazida + bisoprolol
▪ Dislipèmia en tractament amb simvastatina
▪ Glaucoma en tractament tòpic amb col·liris
▪ Cirurgies prèvies: sense interès

4. Cas clínic
▪ Motiu de consulta: Palpació de tumoració engonal dreta
▪ Pèrdua de pes no quantificada
▪ Re-estrenyiment de 2 mesos de evolució
▪ Sensació de pes a hipogastri
▪ Exploració física:
▪ Exploració mamària sense troballes
▪ AC: Tons cardíacs arítmics
▪ ABD: sense troballes
▪ Adenopatia engonal dreta de 3x4 cm
▪ Analítica (ambulatori):
▪ MT: CA-153 66 U/mL (<40), CEA 5.2 ng/mL (<5.0), CA-125 159
U/mL (<40), CA-19.9 19 U/mL (<37), HE4 154.3 pmol/L (<150)

5. Pregunta 1: Quines exploracions
complementàries realitzaries?
A. TC T-A-P + FCS + Biòpsia adenopatia engonal
B. TC T-A-P + Biòpsia adenopatia engonal
C. Ecografia + Biòpsia adenopatia engonal
D. PET/TC + Biòpsia adenopatia engonal

6. Cas clínic
▪ Exploracions complementàries:
▪ Biòpsia engonal: carcinoma serós d’alt grau. IHQ: WT-
1 positiu, patró d’expressió anormal de p53, CK7
positiva, CK20 negativa
▪ TC T-A-P:
▪ Massa de parts toves a nivell femoral dret de
43x32x36mm
▪ Massa de parts toves a nivell femoral esquerra
43x28x40mm
▪ Massa de parts toves ilíaca dreta de
47x35x40mm
▪ Massa pelviana heterogènia a annexe esquerre.

7. Cas clínic

8. Pregunta 2: Realitzaries més exploracions
complementàries?
A. No, el diagnòstic està clar i l’actitud terapèutica
també
B. Sí, realitzaria una ecografia ginecològica per
completar l’estudi de la massa ovàrica
C. Sí, realitzaria un PET/TC donat que es tracta d’un
carcinoma serós d’ovari avançat
D. Sí, realitzaria una laparoscòpia exploradora

9. Cas clínic
▪ Exploracions complementàries:
▪ Ecografia ginecològica: Tumoració solido-quística
localitzada a ovari esquerra amb vascularització
doppler augmentada (score 4/4). No ascites
▪ FCS: Hemorroides internes grau II. Diverticulosis.
Fixació a nivell de sigma
▪ PET/TC:
▪ Massa pelviana solido-quística amb captació
patològica de FDG en el component sòlid (SUV màx
14.48) de probable origen annexial.
▪ No altres troballes diferents del TC

10. Paper del PET/TC en l’estadificació del càncer
d’ovari avançat: Guíes clíniques

11. Paper del PET/TC en l’estadificació del càncer
d’ovari avançat: potencials aplicacions
▪ Avaluació de la malaltia ganglionar
extra-abdominal
▪ LN metastases in ovarian cancer
are more common in advances
stages: Stage I-II: 13% (pelvic) vs
Stage III-IV: 84% para-aortic +
78% pelvic
▪ Mean size of the LN metastases
does not differ from the benign
ones (which compromise the
assessment with CT)
▪ Most common site for metastases
was supradiaphragmatic lymph
Kemppainen J, et al. Semin Nucl Med 2019; 49:484. Lee IO, et al. MC Cancer 2018; 18:1165
• OS for patients with
PET/CT IV with SdLNM
was worse than those with
stage III
• OS did not differ between
patients with PET/CT
stage IV with SdLNM and
stage IV with other
metastases
• Debulking of SdLNM
lesions did not improve OS
(P = 0.465)

12. Paper del PET/TC en l’estadificació del càncer
d’ovari avançat: potencials aplicacions
▪ Avaluació de la resposta al
tractament
▪ Patients who do not respond to
NACT are also not likely to
benefit from interval debulking
surgery
▪ Metabolic responders (20%
decrease in first cycle + 55%
after third cycle) has 15.2-19.2
months longer overall survival
compared to non-responders
▪ Metabolic tumor volume change
was associated progression-
free survival and overall survival
Kemppainen J, et al. Semin Nucl Med 2019; 49:484. Vallius T, et al. Gynecol Oncol 2016; 140:29–35
• The reduction in omental
SUVmax corresponded
with the extent of the
histopathological evidence
of treatment response
• Cut-off value of 57% for
the decrease in omental
SUVmax could
differentiate responders
from non-responders
(S89%, E88%)
Response Good Moderate Poor
PFS (years) 1.4 1.2 0.9

13. Pregunta 3: Realitzaries més exploracions
complementàries?
A. Sí, realitzaria una laparoscòpia exploradora per
valorar la possibilitat de cirurgia primària
B. Sí, realitzaria una laparoscòpia exploradora per
obtenir mostra tumoral i fer un diagnòstic
histològic correcte
C. No, el diagnòstic està clar i l’actitud terapèutica
també
D. No ho sé

14. Pregunta 4: Consideres que necessitem conèixer
altres factors abans de decidir el tractament de la
pacient?
A. No, aquesta pacient és candidata a cirurgia
citorreductora primària
B. No, aquesta pacient és candidata a tractament
amb quimioteràpia neoadjuvant
C. Sí, cal valoració per anestesiologia donada l’edat i
les comorbiditats de la pacient
D. No, es tracta d’una pacient sense opcions
terapèutiques donada l’edat i l’extensió de la
malaltia

15. ▪ All women with suspected
stage IIIC or IV EOC should
be evaluated by a
multidisciplinary and
experienced team to
determine whether they are
candidates for PCS
International guidelines

16. Experienced team
Sergio Martínez
Ginecòleg
Cap de Servei de Ginecologia
Hospital Germans Trias i Pujol, Badalona

17. Cas clínic
▪ Valoració i decisió terapèutica:
▪ Carcinoma serós d’alt grau d’origen ovàric
estadi FIGO IVB per afectació ganglionar
engonal bilateral
▪ Valorat el cas en comitè oncològic
multidisciplinari és decideix iniciar tractament
quimioteràpic neoadjuvant per elevat risc de
comorbiditat associada a limfadenectomia
engonal bilateral (limfedema d’extremitats
inferiors bilateral)

18. Pregunta 5: Quin esquema de tractament
utilitzaries?
A. Quimioteràpia amb Carboplatí + Paclitaxel x 3-4
cicles seguit de cirurgia d’interval
B. Quimioteràpia amb Carboplatí + Paclitaxel x 6
cicles seguit de cirurgia al final de quimioterapia
C. Quimioteràpia amb Carboplatí + Paclitaxel +
Bevacizumab x 3-4 cicles seguit de cirurgia
d’interval
D. Quimioteràpia amb Carboplatí + Paclitaxel x 3-4
cicles seguit de cirurgia d’interval + HIPEC

19. ▪ Objectives:
▪ Increase the likelihood of a complete resection at the time
of surgery
▪ Reduce perioperative morbidity and mortality
▪ Assessment of the effectiveness of chemotherapy or new
therapeutic agents
Neoadjuvant chemotherapy rationale:
The oncologist point of view

20. ▪ Randomized trials
Neoadjuvant chemotherapy: looking for the
evidence

21. EORTC 55971 trial (no inferiority design)
Vergote I et al. N Engl J Med 2010;363:943-53
Neoadjuvant
Chemotherapy (N=334)
≥3 cycles x Platinum-
based chemotherapy
Interval Debulking
Surgery (if no PD)
Ovarian, Tuba o Peritoneal Cancer
Stage IIIC/IV (n=670)
Primary Debulking
Surgery (N=336)
≥6 cycles x Platinum-
based chemotherapy
Randomization - Centre
- Tumor stage
- Largest tumor size
3 cycles x Platinum-
based chemotherapy
Primary Debulking
Surgery
If RD no R0 at PDS, IDS was
permitted after 3 cycles of ChT
(if no PD) (19%)
Primary endpoint: Overall Survival
Secondary endpoints:
- Progression Free Survival
- Quality of Life
- Complications
< 6 weeks
< 6 weeks
≤ 5 cm 94 (28.0%) 164 (28.4%)
> 5cm 242 (72.0%) 239 (71.5%)
>6 cycles:
28%

22. Characteristics
PDS
(N=310)
IDS
(N=322)
Size of residual tumor
No RD
1 – 10 mm
11 – 20 mm
>20 mm
Missing
61 (19.4%)
70 (22.2%)
37 (11.7%)
130 (41.3%)
17 (5.4%)
151 (51.2%)
87 (29.5%)
17 (5.8%)
35 (11.9%)
5 (1.7%)
Median operative time
Total (range)
No residual
1 -10 mm residual
> 10 mm residual
165 (10-720)
312
190
120
180 (30-560)
194
179
120
EORTC 55971 trial: Surgery Results
41.6
%
80.7%
Vergote I et al. N Engl J Med 2010;363:943-53
Peri- and postoperative Aes
PDS
(N = 310)
IDS
(N = 322)
Postoperative death (<28 days) 8 (2.5%) 2 (0.7%)
Hemorrhage
Grade 3
Grade 4
17 (5.5%)
6 (1.9%)
11 (3.8%)
1 (0.3%)
Venous
Grade 3
Grade 4
5 (1.5%)
3 (1.0%)
-
-
Infection
Grade 3
Grade 4
20 (6.5%)
5 (1.5%)
3 (1.0%)
2 (0.7%)
Gastrointestinal fistula 3 (1.0%) 1 (0.3%)
Urinary fistula 1 (0.3%) 1 (0.3%)
• Perioperative and postoperative morbidity and mortality
were less common in NACT arm (but noy significant)
• NACT reduced the tumor load and improved the rate of
optimal debulking surgeries (RD ≤1 cm)

23. EORTC 55971 trial: Survival
PDS 29 months vs NACT 30 months
HR 0.98 (90% CI: 0.84-1.13);
(P=0.01 for noninferiority)
Intention-to-treat
analyses
NACT followed by IDS was not inferior to PDS followed by CT as a
treatment option for patients with bulky stage IIIC or IV
Complete resection of all macroscopic disease at PDS or
after NACT, remains the main objective
45 months
32 months
26 months
38 months
27 months
25 months
Vergote I et al. N Engl J Med 2010;363:943-53

24. CHORUS trial (no inferiority design)
≤ 5 cm 79 (28.6%) 78 (28.5%) 157 (28.6%)
> 5 cm 197 (71.4%) 196 (71.5%) 393 (71.5%)
Neoadjuvant
Chemotherapy (N=274)
3 cycles x carboplatinum-
based chemotherapy
Interval Debulking
Surgery (if no PD)
Ovarian, Tuba o Peritoneal Cancer
Stage III/IV (n=550)
Primary Debulking
Surgery (N=276)
6 cycles x carboplatinum-
based chemotherapy
Randomization
3 cycles x Platinum-
based chemotherapy
Primary Debulking
Surgery
Primary endpoint: Overall Survival
Secondary endponts:
- Progression Free Survival
- Quality of Life
- Complications
< 6 weeks
< 6 weeks
- Centre
-Tumor stage
- Largest tumor size
Kehoe S et al. Lancet 2015; 386: 249–57

25. ▪ NACT improved the rate of optimal surgeries (RD
≤1 cm)
▪ 93% of patients were discharged within 14 days
from surgery in NACT, compared with 80% in PDS
group
CHORUS trial: Surgery Results
Kehoe S et al. Lancet 2015; 386: 249–57
41% 73%
41%
42%
76%
66%
p=.007
p=.001

26. ▪ The volume of residual disease was prognostic
in both the primary-surgery and primary-
chemotherapy groups
CHORUS trial: Survival
Kehoe S et al. Lancet 2015; 386: 249–57
PDS 22.6 months vs NACT 24.1
months
46.9 vs 36.8 vs 15.5 monts
47.3 vs 23.2 vs 14.7 monts

27. ▪ Starting treatment with chemotherapy allowed more patients
to undergo optimal tumor debulking during the subsequent
operation
▪ Neoadjuvant chemotherapy followed by interval debulking
surgery was not inferior to primary debulking surgery
followed by chemotherapy
▪ Complete resection of all macroscopic disease, whether
performed as primary treatment or after neoadjuvant
EORTC 55971 + CHORUS trial: Conclusions

28. SCORPION: Superiority
trial design
Fagotti A, et al. Int J Gynecol Cancer 2020;30:1657–1664
• Randomized Phase III trial
(N=171)
• 1ary endpoint: PFS and safety
PDS 14 vs NACT 15 months
PDS 41 months vs
NACT 43 months

29. Presented By Takashi Onda at 2018 ASCO Annual Meeting
• No diagnostic
laparoscopy or
laparotomy
• Tumor marker criteria
to rule out other
malignancies (CA125
>200 U/ml + CEA <20
ng/ml)
• Pelvic and aortic
lymphadenectomies
were not mandatory
• 1ary endpoint: OS
N=301
JCOG0602: Inferiority trial design

30. Negative trial
Initial Statistical Considerations:
Non-inferiority margin = 5% in 3y OS (25% vs 30.3%
Corresponding HR of 1.161 (IC HR > non-inferiority limit) Presented By Takashi Onda at 2018 ASCO Annual Meeting
Better Outcomes if complete
surgery at PDS or IDS
JCOG0602: Inferiority trial design

31. All that glitters is not gold!
Caution should be used in
adopting NACT
approach
No differences in outcomes between PDS vs
NACT + IDS… but,

32. ▪ Lower overall survival according to the scientific literature in PDS arms
Considerations about survival
EORTC 55971 (PDS) CHORUS (PDS)
29 months 23 months
45 months 47 months
32 months 37 months
26 months 16 months
GOG-182
OS study population 44.1 months
OS microscopic 68 months
OS if RD ≤ 1cm 40 months
OS if RD > 1 cm 33 months
Bookman MA et al. J Clin Oncol. 2009 Mar 20;27(9):1419-25
Other first line trials

33. ▪ Short survival results may reflect the
characteristics of participants:
▪ Older median age (65 years)
▪ Poorer performance status:
▪ ECOG PS 2-3: 19%
▪ 25% patients received single-agent
carboplatin instead of a platinum-
based doublet in both arms
▪ Higher stage tumors
▪ Stage IV: 16%-24%
▪ 61.6% had metastatic lesions >10 cm
▪ 74.5% had lesions >5 cm
Considerations about patient selection bias

34. ▪ Low rate of patients who achieved optimal resection at PDS
▪ EORTC 42% and CHORUS 41%
Considerations about surgical outcomes
EORTC: 23%
CHORUS: 16%
EORTC: 62
CHORUS: 65
EORTC: 42%
CHORUS: 41%
Optimal cytoreduction: 69%
N=4312
Bookman MA et al. J Clin Oncol. 2009 Mar 20;27(9):1419-25

35. ▪ Standard procedures such as
hysterectomy and BSO were not
performed)
Considerations about surgical procedures
CHORUS (not performed) PDS IDS
Hysterectomy 67 (27%) 25 (12%)
Bilateral salpingo-oophorectomy 61 (24%) 22 (10%)
Omentectomy 36 (14%) 11 (5%)
Upper abdominal surgery 213 (88%) 164 (83%)
EORTC 55971 (not performed) PDS IDS
Hysterectomy 100 (32%) 74 (22%)
Bilateral salpingo-oophorectomy 80 (25%) 67 (20%)
Omentectomy 79 (25%) 94 (28%)
Upper abdominal surgery 283 (91%) 320 (96%)
Median surgery time (min) PDS IDS
EORTC 165 (10-720) 180 (30-560)
CHORUS 120 (12–450) 120 (30–330)
Median surgery time
(min)
320
(115–
750)
230
(85–
480)
150
(60–
534)
Eisenhauer EL et al. Gynecologic Oncology 103 (2006) 1083–1090
Standard
surgical
techniques
alone
>1 cm residual
disease after an
attempted
cytoreduction
Patients who
required more
extensive
surgery

36. ▪ Retrospective studies have shown that
NACT was associated with:
▪ Higher risk of platinum-resistant
relapse, even when IDS resulted in
complete macroscopic resection
▪ Lower response rates to a platinum
combination in case of platinum-
sensitive progression
Considerations about platinum free interval
PDS NACT
Recurrence at 6 months (platinum
resistance disease)
103
(31.2%)
42 (44.2%) P=0.01
Progression during 2nd platinum (in
case PS recurrence)
14 (12.3%) 7 (19.4%) P=0.3
Recurrence at 6 months of 2nd
platinum (in case PSrecurrence)
62 (55.3%) 32 (88.8%) P=0.001
Rauh-Hain et al. Gynecol Oncol (2013) 63–68
EORTC 55971 CHORUS
▪ EORTC + CHORUS have not
shown PFS differences, but:
▪ PFS is calculated from
date of randomization
▪ Patients in the NACT
group finished the
platinum therapy later
than PDS
▪ pTFI is not reported

37. ▪ Subgroup analysis
▪ PDS is better in:
▪ Patients with
metastatic tumors <5
cm: HR 0.64 (95%CI:
0.45 to 0.93)
▪ IDS is better in:
▪ Patients with stage IV:
▪ NACT: 5y OS 22%
▪ PDS: 5y OS 5%
Patient selection: Stage considerations
Vergote I et al. N Engl J Med 2010;363:943-53. van Meurs Hs et al. Eur J Cancer 2013; 49:3191-3201

38. ▪ Objectives:
▪ Increase the likelihood of a complete resection at the time of surgery
▪ (But it is not associated with better outcomes)
▪ Reduce perioperative morbidity and mortality
▪ Assessment of the effectiveness of chemotherapy or new
therapeutic agents
Neoadjuvant chemotherapy rationale

39. The neoadjuvant design may be
useful to test new therapies in a
faster way and with fewer patients
than is required for large adjuvant
trials
NACT: window of opportunity
HGSOC
diagnosis
Initial sensitive
(85%)
pCR (10-20%)
Residual
disease
(80-90%)
Relapse
Primary resistant
(15%)
Progression
NACT
IDS
No IDS
Evaluate
mechanisms
of primary
resistance
Evaluate
mechanisms
of adquired
resistance
Poor prognosis
More effective therapies needed
for primary refractory HGSOC
Good prognosis
pCR as an endpoint to test new
therapies???
Evaluate
mechanisms
of high
sensitivity
Translational research
opportunity

40. ▪ Phase 2 multicenter randomized trial
NACT: window of opportunity
Bevacizumab: GEICO 12-05 (NOVA) trial
• Newly diagnosed
HGSOC or eOC
• FIGO stage III/IV
• ECOG PS 0–2
• Planned NACT +
IDS (unresectable
disease)
• No intestinal
occlusion or BEV
contraindication
C: AUC 6
4 q3w IV cycles
S
U
R
G
E
R
Y
P: 175 mg/m2
C: AUC 6
P: 175 mg/m2
BEV: 15 mg/kg
3 q3w IV cycles
Single-agent BEV for 15 months
R
• Primary endpoint: Complete macroscopic response rate (PCI=0) at IDS
• Assuming 40% rate in PDS (30% increase in NACT)
• Secondary endpoints: Safety, surgical feasibility, optimal cytoreduction rate,
response rate, PFS
Garcia Garcia Y, et al. Int J Gynecol Cancer, 2019;29(6):1050-1056

41. GEICO 12-05 (NOVA) trial
N=68
Characteristic CP alone
(n=33)
CP + BEV
(n=35)
Median age, years (range) 57 (36–82) 63 (33–78)
ECOG PS 0
1
2
5 (15)
21 (64)
7 (21)
8 (23)
24 (69)
3 (9)
Origin of
cancer
Ovary
Primary peritoneal
Fallopian tube
25 (76)
7 (21)
1 (3)
31 (89)
4 (11)
0
FIGO
stage
IIIC
IV
22 (67)
11 (33)
23 (66)
12 (34)
Histologica
l subtype
Serous
Adenocarcinoma
Endometrioid/other
26 (79)
5 (15)
2 (6)
27 (77)
7 (20)
1 (3)
• Primary objective:
• Complete macroscopic response rate (PCI=0)
at IDS (surgeon)
• pCR + CGR with μRD (AP)
Suregry:
8.3% vs 6.5%
ITT
6.1% vs 5.7%
The addition of BEV to
NACT did not improve the
complete macroscopic
response rate at IDS, which
was <10% in both arms
Garcia Garcia Y, et al. Int J Gynecol Cancer, 2019;29(6):1050-1056

42. GEICO 12-05 (NOVA) trial
No. of patients (%)
CP alone
(n=33)
CP +
BEV
(n=35)
p-
value
IDS surgical feasibility (IDS performed) 22 (67) 31 (89) 0.029a
Surgical
outcome
Complete resection/optimal
surgery
Suboptimal
Unresectable
No surgery
c
21 (64)
1 (3)
2 (6)
9 (27)
23 (66)
8 (23)
0
4 (11)
0.858a
0.028b
0.232b
0.097a
Best
response
(RECIST)
(n=32)
22 (69)
(n=32)
28 (88) 0.175a
Grade ≥3 AEs, n
(%)
CP
(n=33)
CP +
BEV
(n=35)
p-value
At any time 26 (79) 19 (54) p=0.033a
During NACT 20 (61) 10 (29) p=0.008a
≤1 month after
surgery
2/23 (9) 5/31 (16) p=0.685b
Although NACT + BEV improved
surgical feasibility at IDS, neither
the rate of optimal cytoreduction
nor PFS was improved
Adding BEV to NACT did not increase
the overall rate of grade ≥3 AEs
Garcia Garcia Y, et al. Int J Gynecol Cancer, 2019;29(6):1050-1056

43. NACT: window of opportunity
Bevacizumab: ANTHALYA trial
1:2
1ary endpoint:
Benefit of neoadjuvant
bevacizumab +
chemotherapy assessed
by the complete resection
rate at IDS
Rouzier R. et al. Eur J Cancer. 2017 Jan;70:133-142
Multicenter, open-
label, non-comparative
phase II study

44. No. of patients (%)
CP alone
(n=37)
CP + BEV
(n=58)
IDS surgical feasibility 22 (60%) 40 (69%)
Surgical
outcome
Complete resection/optimal surgery 19 (51.4%) 34 (58.6%)
Suboptimal/Unresectable 3 (8.1%) 6 (10.3%)
No surgery 15 (41%) 18 (31%)
BEV increases surgical chances
Inefficacy
Primary Endpoint
achieved
ANTHALYA trial

45. Eficacia de Bevacizumab en neoadyuvància
Indirect data of possible benefit of bevacizumab post-NACT
(independent of residual disease)
EORTC CHORUS
Median PFS 12 months 12 months
% R0 Surgeries 50% 39%
NOVA ANTHALYA
20 months 21 months
64% 51%
Without bevacizumab after IDS With bevacizumab after IDS

46. ▪ OVHIPEC Study: randomized trail of
hyperthermic intraperitoneal chemotherapy
(HIPEC) plus interval cytoreductive surgery (CRS)
vs interval CRS for stage III EOC
SD or PR
At time of surgery if
≤ R1 is anticipated
Center (8 sites)
Previous sergery Yes vs No
Nº regions involved 0-5 vs 6-8
CA-125 every 3m x 3y -> 6m (5y)
TC 1, 6, 12 and 24 mos
RFS: RECIST or CA-125
Ineligible for
primary
cytoreduction
Eficacia de HIPEC a la IDS

47. OVIHIPEC: Efficacy (median follow-up of 4.7 years)
RFS OS
HIPEC 14.2 vs
no-HIPEC 10.7 months
HIPEC 45.7 vs
no-HIPEC 33.9 months
The addition of HIPEC resulted in +3.5 months in RFS and +11.8 months in OS
Immature but provocative overall survival data

48. OVIHIPEC: Toxicity concerns
+63%
+5%
+166%
+44%
+200%
+10
+23%
+56%
+50%

49. OVHIPEC is a positive trail, but there are a lot of concerns in the
scientific community
Recruitment
“Not suitable” for PDS (no criteria defined)
NACT could be started in another hospital
No information about surgeons’ qualifications
Inclusion criteria
Too low accrual (3 patients / center / year)
Hyperselection of patients
Timing of randomization
Knowing whether the patient will get HIPEC or not before or at
the start of surgery might influence the surgeon and induce
bias
Small size trial
Only 15 events death difference
13 unfavorable non-HGSOC in no-HIPEC (vs only 3)
Toxicity
Differences between treatment arms
(not statistically but clinically significant)
(from +23% in fatigue to +200% in TE events)

50. ▪ Evaluation of patients with advanced EOC should be done in specialized
centers
▪ PDS versus NACT + IDS is a matter of selection:
▪ Selection of the appropriate patient based on operability,
resectability… and biology
▪ If surgery with R0 (no macroscopic residual disease) is feasible, PDS
should be considered
▪ When NACT is indicated, carboplatin + paclitaxel is the standard therapy
▪ Other therapies might be considered a window of opportunity and
should be investigated
▪ More evidence is needed to confirm the role of bevacizumab during
and after NACT and the use of HIPEC in the IDS
Conclusions

51. Moltes gràcies
per la vostra
atenció!!
lgaba@clinic.cat