Transcript Slide 1

Uptodate do Tratamento de 10 linha do
Câncer de Ovário
Brasília 2012
Fernando Cotait Maluf
Diretor do Serviço de Oncologia Clínica
Beneficência Portuguesa
Médico Integrante da Clínica Oncovida
([email protected])
Uptodate do Tratamento de 10 linha do
Câncer de Ovário
Enfoque:
- esquemas de 10 linha
- MITO-2: CD vs CP
-esquemas de 10 linha com BEV
- GOG 218 e ICON 7: CP-BEV vs CP
MITO-2
Critério Inclusão:
• Câncer de ovário
epitelial
• Estádio Ic-IV
• < 76 anos
• ECOG 0-2
R
A
N
D
O
M
I
Z
A
Ç
Ã
O
Carboplatina AUC 5 EV + Paclitaxel 175
mg/m2 IV 3
cada 21 d x 6 ciclos
Carboplatin AUC 5 EV + Doxo
Lipossomal 30 mg/m2 IV 1 h
cada 21 d x 6 ciclos
Piganta E et al, J Clin Oncol, 2011
Sobrevida Livre de Progressão
Sobrevida Global
Análise de Subgrupo (SG)
Toxicidade
Carboplatina/doxorrubicina lipossomal: menos alopecia e neuropatia
Carboplatina/paclitaxel: menos mielosupressão
Phase III Trial of Bevacizumab in the Primary
Treatment of Advanced Epithelial Ovarian,
Primary Peritoneal, or Fallopian Tube Cancer:
A Gynecologic Oncology Group (GOG) Study
R.A. Burger,1 M.F. Brady,2 M.A. Bookman,3
J.L. Walker,4 H.D. Homesley,5 J. Fowler,6
B.J. Monk,7 B.E. Greer,8 M. Boente,9 S.X. Liang10
1Fox
Chase Cancer Center, Philadelphia, PA; 2Gynecologic Oncology Group Statistical
and Data Center, Roswell Park Cancer Institute, Buffalo, NY; 3University of Arizona
Cancer Center, Tucson, AZ; 4University of Oklahoma Health Sciences Center,
Oklahoma City, OK; 5Brody School of Medicine, Greenville, NC; 6James Cancer
Hospital at the Ohio State University, Hilliard, OH; 7University of California, Irvine
Medical Center, Orange, CA; 8Seattle Cancer Care Alliance, Seattle, WA; 9Minnesota
Oncology and Hematology, Minneapolis, MN; 10State University of New York at Stony
Brook, Stony Brook, NY, USA
GOG-0218: Schema
Arm
Carboplatin (C) AUC 6
Front-line:
Epithelial OV, PP
or FT cancer
• Stage III optimal
(macroscopic)
• Stage III
suboptimal
• Stage IV
n=1800 (planned)
Paclitaxel (P) 175 mg/m2
R
A
N
D
O
M
I
Z
E
I
Placebo
Carboplatin (C) AUC 6
1:1:1
Stratification variables:
• PS
• Stage/debulking status
Paclitaxel (P) 175 mg/m2
BEV 15 mg/kg
II
Placebo
Carboplatin (C) AUC 6
Paclitaxel (P) 175 mg/m2
III
BEV 15 mg/kg
15 months
GOG-0218: Analysis Plan
• Primary analysis
– Compare investigator-determined progression-free survival (PFS) for
each BEV arm (CP + BEV; CP + BEV  BEV) vs control (CP)
• If both results positive, compare CP + BEV  BEV vs CP + BEV
– Disease progression based on: RECIST, global clinical deterioration, or
CA-1251
– Planned sample size of 1800 based on:
• 90% power to detect PFS hazard ratio (HR) 0.77
– Median PFS shift: 14.0 months  18.2 months
• Secondary analyses: Overall survival (OS), safety, quality of
life; correlative laboratory studies
1. Gynecologic Cancer Intergroup Criteria - Rustin et al. J Natl Cancer Inst 2004
GOG-0218: Key Eligibility Criteria
• Histologic diagnosis of epithelial OV, PP, or FT cancer
• Following maximal debulking surgery: stage III optimal
(macroscopic residual disease 1 cm) or suboptimal (>1 cm),
or stage IV
• No prior chemotherapy
• 1–12 weeks after initial surgery
• GOG PS 0–2
• No history of significant vascular events
• No evidence of intestinal obstruction requiring parenteral support
• Written informed consent
GOG-0218: Baseline Clinical
Characteristics
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
60 (25–86)
60 (24–88)
60 (22–89)
526 (84)
519 (83)
521 (84)
Asian
41 (7)
37 (6)
39 (6)
Non-Hispanic black
25 (4)
28 (5)
27 (4)
Hispanic
21 (3)
28 (5)
25 (4)
Characteristic
Median age, years (range)
Race, n (%)
Non-Hispanic white
Other, specified
8 (1)
5 (<1)
4 (<1)
GOG PS, n (%)
0
311 (50)
315 (50)
305 (49)
1
272 (44)
270 (43)
267 (43)
2
42 (7)
40 (6)
51 (8)
Percentages may not total 100% due to rounding or categorization
GOG-0218: Baseline Surgical–Pathologic
Characteristics
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
III optimal (macroscopic)
218 (35)
205 (33)
216 (35)
III suboptimal
254 (41)
256 (41)
242 (39)
IV
153 (25)
164 (26)
165 (27)
543 (87)
523 (84)
525 (84)
Endometrioid
20 (3)
15 (2)
25 (4)
Clear cell
11 (2)
23 (4)
18 (3)
Mucinous
8 (1)
Characteristic, n (%)
Stage/residual size
Histology
Serous
5 (<1)
8 (1)
Tumor grade
3a
412 (66)
435 (70)
430 (69)
2
94 (15)
77 (12)
92 (15)
1
33 (5)
28 (4)
16 (3)
Not specified/pending
86 (14)
85 (14)
85 (14)
Percentages may not total 100% due to rounding or categorization
aGrade 3 includes all clear cell tumors
GOG-0218: Baseline Surgical–Pathologic
Characteristics
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
III optimal (macroscopic)
218 (35)
205 (33)
216 (35)
III suboptimal
254 (41)
256 (41)
242 (39)
IV
153 (25)
164 (26)
165 (27)
543 (87)
523 (84)
525 (84)
Endometrioid
20 (3)
15 (2)
25 (4)
Clear cell
11 (2)
23 (4)
18 (3)
Mucinous
8 (1)
Characteristic, n (%)
Stage/residual size
Histology
Serous
5 (<1)
8 (1)
Tumor grade
3a
412 (66)
435 (70)
430 (69)
2
94 (15)
77 (12)
92 (15)
1
33 (5)
28 (4)
16 (3)
Not specified/pending
86 (14)
85 (14)
85 (14)
Percentages may not total 100% due to rounding or categorization
aGrade 3 includes all clear cell tumors
GOG-0218: Baseline Surgical–Pathologic
Characteristics
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
III optimal (macroscopic)
218 (35)
205 (33)
216 (35)
III suboptimal
254 (41)
256 (41)
242 (39)
IV
153 (25)
164 (26)
165 (27)
543 (87)
523 (84)
525 (84)
Endometrioid
20 (3)
15 (2)
25 (4)
Clear cell
11 (2)
23 (4)
18 (3)
Mucinous
8 (1)
Characteristic, n (%)
Stage/residual size
Histology
Serous
5 (<1)
8 (1)
Tumor grade
3a
412 (66)
435 (70)
430 (69)
2
94 (15)
77 (12)
92 (15)
1
33 (5)
28 (4)
16 (3)
Not specified/pending
86 (14)
85 (14)
85 (14)
Percentages may not total 100% due to rounding or categorization
aGrade 3 includes all clear cell tumors
GOG-0218: Patient Disposition
Characteristic
Median (range) number BEV/placebo cycles
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
11 (0–22a)
12 (0–22a)
14 (0–21)
On treatment at time of analysis, n (%)
86 (14)
82 (13)
117 (19)
100 (16)
104 (17)
148 (24)
299 (48)
264 (42)
164 (26)
Adverse events
69 (11)
86 (14)
94 (15)
Cycles 1–6
57 (9)
73 (12)
59 (9)
Cycle ≥7
12 (2)
13 (2)
35 (6)
8 (1)
7 (1)
13 (2)
Patient refusal
44 (7)
55 (9)
50 (8)
Other
19 (3)
27 (4)
37 (6)
Completed regimen, n (%)
Discontinued study treatment, n (%)
Disease progression
Deaths
aOne
patient in each group received BEV/placebo in cycle 1
Percentages may not total 100% due to rounding or categorization
GOG-0218: Select Adverse Events
Onset between cycle 2 and 30 days after date of last treatment
GI eventsa (grade ≥2)
Arm I
CP
(n=601)
7 (1.2)
Arm II
CP + BEV
(n=607)
17 (2.8)
Arm III
CP + BEV  BEV
(n=608)
16 (2.6)
Hypertension (grade ≥2)
43 (7.2)b
100 (16.5)b
139 (22.9)b
4 (0.7)
4 (0.7)
10 (1.6)
Pain (grade ≥2)
250 (41.7)
252 (41.5)
286 (47.1)
Neutropenia (grade ≥4)
347 (57.7)
384 (63.3)
385 (63.3)
Febrile neutropenia
21 (3.5)
30 (4.9)
26 (4.3)
Venous thromboembolic event
35 (5.8)
32 (5.3)
41 (6.7)
Arterial thromboembolic event
5 (0.8)
4 (0.7)
4 (0.7)
CNS bleeding
0
0
2 (0.3)
Non-CNS bleeding (grade ≥3)
5 (0.8)
8 (1.3)
13 (2.1)
RPLS
0
1 (0.2)
1 (0.2)
Adverse event (grade when limited), n (%)
Proteinuria (grade ≥3)
RPLS = reversible posterior leukoencephalopathy syndrome
aPerforation/fistula/necrosis/leak
bp<0.05
GOG-0218: Investigator-Assessed PFS
Proportion surviving progression free
1.0
0.9
Patients with event, n (%)
0.8
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
423
(67.7)
418
(66.9)
360
(57.8)
10.3
11.2
14.1
Median PFS, months
0.7
Stratified analysis HR
(95% CI)
0.6
One-sided p-value (log rank)
0.908
0.717
(0.759–1.040) (0.625–0.824)
0.080a
<0.0001a
0.5
0.4
0.3
0.2
CP (Arm I)
+ BEV (Arm II)
0.1
+ BEV → BEV maintenance (Arm III)
0
0
12
24
Months since randomization
36
ap-value
boundary = 0.0116
GOG-0218: subgroup analyses of PFS
Risk factor
Cancer stage and residual lesion size
III, macroscopic ≤1cm
Arm II vs Arm I
Arm III vs Arm I
III, >1cm
Arm II vs Arm I
Arm III vs Arm I
IV
Arm II vs Arm I
Arm III vs Arm I
Histologic type
Serous
Arm II vs Arm I
Arm III vs Arm I
Nonserous
Arm II vs Arm I
Arm III vs Arm I
Tumour grade
1 or 2
Arm II vs Arm I
Arm III vs Arm I
3
Arm II vs Arm I
Arm III vs Arm I
Total no. of patients
Hazard ratio for Avastin (95% CI)
423
434
0.780
0.618
510
496
0.981
0.763
317
318
0.923
0.698
1,066
1,068
0.913
0.701
184
180
0.893
0.713
232
235
1.039
0.578
847
842
0.891
0.700
0.33
0.50
0.67
bevacizumab better
1.00
1.50
2.00
3.00
Control better
Burger et al. NEJM 2011;365 (26):2473–83
© Massachusetts Medical Society
GOG-0218: subgroup analyses of PFS (cont’d)
Risk factor
Total no. of patients
Hazard ratio for Avastin (95% CI)
GOG performance status score
0
Arm II vs Arm I
Arm III vs Arm I
626
616
0.877
0.710
1 or 2
Arm II vs Arm I
Arm III vs Arm I
624
632
0.961
0.690
<60 years
Arm II vs Arm I
Arm III vs Arm I
616
630
0.976
0.680
60–69 years
Arm II vs Arm I
Arm III vs Arm I
414
408
0.892
0.763
≥70 years
Arm II vs Arm I
Arm III vs Arm I
220
210
Age
0.33
0.50
0.67
bevacizumab better
1.00
1.50
2.00
Control better
3.00
0.841
0.678
Burger et al. NEJM 2011;365 (26):2473–83
© Massachusetts Medical Society
GOG-0218: Overall Survival (OS)
Outcome
Deaths, n (%)
1-year survival, %
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
156
(25.0)
150
(24.0)
138
(22.2)
90.6
90.4
91.3
• Events observed in 24% of patients at time of data lock
• After primary endpoint changed from OS to PFS
– Unblinding to treatment assignment allowed at time of disease
progression
GOG-0218: Overall Survival Analysis
At time of final PFS analysis (January 2010)
1.0
0.9
Proportion alive
0.8
0.7
0.6
0.5
0.4
Patients with
events, n (%)
0.3
Median, months
0.2
HRa
0.1
One-sided p-value
Arm I
CP
(n=625)
Arm II
CP + BEV
(n=625)
Arm III
CP + BEV  BEV
(n=623)
156
(25.0)
150
(24.0)
138
(22.2)
39.3
38.7
39.7
1.036
0.915
(0.827–1.297)
(0.727–1.152)
0.361
0.252
(95% CI)
0
No. at
risk
0
12
24
36
Months since randomization
625/625/623
442/432/437
173/162/171
48
46/39/40
aStratified
analysis
ICON7: A phase III Gynaecologic
Cancer InterGroup (GCIG) trial of
adding bevacizumab to standard
chemotherapy in women with newly
diagnosed epithelial ovarian, primary
peritoneal or fallopian tube cancer
Tim Perren, Ann Marie Swart, Jacobus Pfisterer,
Jonathan Ledermann, Alain Lortholary, Gunnar Kristensen,
Mark Carey, Philip Beale, Andreas Cervantes, Amit Oza
on behalf of GCIG ICON7 collaborators
(MRC/NCRI, AGO-OVAR, GINECO, NSGO, ANZGOG, GEICO, NCIC-CTG)
28
Patient population
• Histologically confirmed epithelial ovarian cancer,
primary peritoneal cancer or fallopian tube cancer
• Prior surgical debulking with the aim of maximal
surgical cytoreduction undertaken AND no planned
further surgical debulking before disease progression
• FIGO stage
• I–IIA if high risk: Grade 3 or clear cell histology (10%)
• IIB–IV: All grades and histological subtypes
• Patients with inoperable stage III/IV disease eligible after
biopsy only if no further surgery planned
• ECOG performance status 0–2
29
Schema
Academic-led, industry-supported trial to investigate use of
bevacizumab and to support licensing
1:1
Carboplatin AUC6
Stratification variables:
Paclitaxel 175 mg/m2
• Stage & extent of debulking:
I–III debulked ≤1cm vs stage
I–III debulked >1 cm vs stage IV
and inoperable stage III
R
Carboplatin AUC6
n=1528*
Paclitaxel 175 mg/m2
• Timing of intended treatment
start
≤4 vs >4 weeks after surgery
• GCIG group
Bevacizumab 7.5 mg/kg q3w
18 cycles
*Dec 2006 to Feb 2009
Year 1
Years 2–3
Years 4–5
CT
Baseline; after cycles 3 & 6; at 9 & 12 months
Every 6 months
As indicated
CA-125/clinical
assessment
Every chemotherapy cycle; every 6 weeks
during maintenance phase
Every 3 months
Every 6 months
30
Study endpoints
• Primary endpoint: Progression-free survival (PFS)
• Disease progression defined by RECIST guidelines on
radiological, clinical or symptomatic progression
• CA-125 elevation alone not defined as disease progression
• 1520 patients randomised over 2 years (684 events) →
5% significance level, 90% power to detect:
• PFS hazard ratio (HR) of 0.78
• Increase of median PFS from 18 to 23 months
• Secondary endpoints: Overall survival (due 2012),
response rate, toxicity
• Substudies: Quality of life, health economics,
translational research
31
Baseline
characteristics (1)
Control
(n=764)
Research
(n=764)
57 (18–81)
57 (24–82)
ECOG PS, n (%)
0
1
2
358 (47)
354 (47)
43 (6)
334 (45)
366 (49)
45 (6)
Origin of cancer, n (%)
Ovary (epithelial)
Fallopian tube
Primary peritoneal
Multiple sites
667
29
56
12
(87)
(4)
(7)
(2)
673
27
50
14
Histology
Serous
Clear cell
Endometrioid
Mucinous
Mixed/other
529
60
57
15
103
(69)
(8)
(7)
(2)
(13)
525 (69)
67 (9)
60 (8)
19 (2)
93 (12)
Grade, n (%)
1
2
3
Unknown
56 (7)
142 (19)
556 (74)
10
41 (5)
175 (23)
538 (71)
10
Characteristic
Median age (range)
(88)
(4)
(6)
(2)
32
Baseline
characteristics (2)
Characteristic, n (%)
Control
(n=764)
Research
(n=764)
FIGO stage, n (%)
I/IIA
IIB–IIIB
IIIC/IV
75 (10)
160 (21)
529 (69)
67 (9)
155 (20)
542 (71)
Debulking surgery/residuum
Optimal surgery (≤1 cm)
Suboptimal surgery (>1 cm)
No surgery
552 (74)
195 (26)
17 (2)
559 (74)
192 (26)
13 (2)
FIGO stage and residuum*
Stage I–III (≤1 cm)
Stage I–III (>1 cm)
Stage III (inoperable)/IV
508 (66)
150 (20)
106 (14)
518 (68)
140 (18)
106 (14)
Intent to start chemotherapy*
≤4 weeks from surgery
>4 weeks from surgery
328 (43)
436 (57)
326 (43)
438 (57)
*Stratification
variable
33
Selected adverse
events (all grades)
45
Control (n=753)
39.6
40
Research (n=745)
Patients (%)
35
30
29.1 28.3
25.9
25
20
15
10
5
0
12.5
11.6
6.2
5.0
4.4
2.5
2.1
1.31.7 0.41.3
6.7
4.1
9.2
3.6
1.5
0.4 0.4 0
0
2.8
2.0
ATE = arterial thromboembolism; CHF = congestive heart failure; RPLS = reversible posterior
leucoencephalopathy syndrome; VTE = venous thromboembolism
34
Selected grade ≥3
adverse events
45
Control (n=753)
40
Research (n=745)
Patients (%)
35
30
25
20
18.3
15.1
15
16.5
10
5
0
2.1
4.3
2.7
1.3
1.3
1.7
0.9
1.3
0.8 0.4
0.4 0.3 0
0.3 1.2
0.10.5 0.4
0
2.6
3.5
2.0
2.0
ATE = arterial thromboembolism; CHF = congestive heart failure; RPLS = reversible posterior
leucoencephalopathy syndrome; VTE = venous thromboembolism
35
Progression-free
survival
Academic analysis
Proportion alive without progression
1.00
Control
Research
392 (51)
367 (48)
17.3
19.0
p=0.0041
0.81 (0.70–0.94)
Events, n (%)
Median, months
0.75
Log-rank test
HR (95% CI)
0.50
0.25
Control
Research
17.3
0
0
Number at risk
Control
764
Research
764
3
6
9
723
748
693
715
556
647
19.0
12
15
18
Time (months)
464
585
307
399
216
263
21
24
27
30
143
144
91
73
50
36
25
19
37
PFS: FIGO stage III suboptimal
and FIGO stage IV with debulking
Control
(n=234)
Proportion alive without progression
1.00
Events, n (%)
Median, months
Log-rank test
0.75
Hazard ratio (95% CI)
Restricted mean
Research
(n=231)
173 (74)
158 (68)
10.5
15.9
p<0.001
0.68 (0.55–0.85)
13.3
16.5
0.50
0.25
Control
Research
10.5
0
0
Number at risk
Control
234
Research
231
3
6
205
213
9
15.9
12
15
18
Time (months)
98
159
36
56
21
24
14
10
27
30
2
1
Subgroup analysis of PFS (1)
Origin of cancer
Age
Histology
HR
Hazard ratio (fixed)
<60
202/449
210/450
0.84
60–69
134/242
142/237
0.76
31/73
40/77
0.82
0
154/334
145/358
1.01
1
175/366
210/354
0.66
2
27/45
31/43
0.78
274/525
278/529
0.85
Mucinous
12/19
10/15
0.77
Endometroid
26/60
25/57
0.81
Clear cell
22/67
22/60
0.90
≥70
ECOG PS
No. of events/no. of patients
CP + Av7.5 
CP
Av7.5
Serous
0
0.5
1
CP + Bev7.5  Bev 7.5 better
Age: Trend p=0.69, interaction p=0.83
ECOG: Trend p=0.027, interaction p=0.022
Histology: Interaction test p=0.085
1.5
2
CP better
Perren et al. NEJM 2011;365 (26):2482–2496
© Massachusetts Medical Society
Subgroup analysis of PFS (2)
Origin of cancer
FIGO
Residual
disease
Grade
No. of events/no. of patients
CP + Av7.5 
CP
Av7.5
HR
Hazard ratio (fixed)
I
6/54
9/65
0.73
II
14/83
19/80
0.72
III
277/523
290/522
0.79
IV
70/104
74/97
0.69
Optimal (≤1cm)
226/559
233/552
0.87
Suboptimal (>1cm)
131/192
145/195
0.68
Grade 1
10/41
16/56
0.76
Grade 2
86/175
77/142
0.77
Grade 3
267/538
294/556
0.81
0
0.5
1
CP + Bev7.5  Bev7.5 better
FIGO: Trend p=0.71, interaction p=0.91
Residual disease: Trend p=0.10
Grade: Trend p=0.76, interaction p=0.95
1.5
2
CP better
Perren et al. NEJM 2011;365 (26):2482–2496
© Massachusetts Medical Society
Interim OS analysis, full population
(regulatory request)
1.00
Proportion alive
0.75
CP
CP + Av7.5
 Av7.5
200 (26)
178 (23)
0.50
Deaths, n (%)
Not yet reached
Median, months
0.25
0
Number at risk
CP
CP + Av7.5
 Av7.5
Log-rank test
p=0.11
HR (95% CI)
0.85 (0.69–1.04)
1-year OS rate (%)
92
0
3
6
9
12
15
764
764
741
753
724
737
703
717
672
702
646
680
95
18
21
24
Time (months)
623
657
542
592
421
459
27
30
33
36
39
304
329
212
228
132
129
71
69
26
19
Perren et al. NEJM 2011;365 (26):2482–2496
© Massachusetts Medical Society
OS: high-risk patients (FIGO stage III
suboptimal and FIGO stage IV with debulking)
1.00
Proportion alive
0.75
0.50
High-risk
subgroup
CP
(n=234)
CP + Av7.5
 Av7.5
(n=231)
Deaths, n (%)
109 (47)
79 (34)
28.8
36.6
Median, months
0.25
Log-rank test
p=0.002
HR (95% CI)
0.64 (0.48–0.85)
1-year OS rate (%)
86
92
0
0
Number at risk
CP
CP + Av7.5
 Av7.5
234
231
3
6
219
222
9
12
194
208
15
18
21
24
Time (months)
166
186
107
134
27
30
46
65
33
36
39
15
18
Perren et al. NEJM 2011;365 (26):2482–2496
© Massachusetts Medical Society
Updated PFS
Proportion alive without progression
1.00
Events, n (%)
0.75
CP
CP +
Av7.5 
Av7.5
464 (61)
470 (62)
17.4
19.8
Median, months
Log-rank test
p=0.04
HR (95% CI)
0.87 (0.77–0.99)
0.50
0.25
17.4
19.8
0
0
Number at risk
CP
764
CP + Av7.5
764
 Av7.5
3
6
693
716
Data cut-off date: November 30, 2010
9
12
15
18
21
Time (months)
24
474
599
350
430
221
229
27
30
114
107
33
36
39
27
Perren et al. NEJM 2011;365 (26):2482–2496
© Massachusetts Medical Society
Conclusions
 Bevacizumab combined with chemotherapy and
continued alone (7.5 mg/kg for 12 months) vs
chemotherapy demonstrates
 Continued improvement in PFS with no crossing of
curves
 Trend for improved OS continues in the total
population
 Final analysis of OS is due in 2013
 Treatment effect is greater in patients at high risk of
recurrence, which may be of clinical relevance
Perren, et al. NEJM 2011
Take Home Messages
1) MITO-2: carboplatina/doxil: considerado um
esquema padrão de 1o linha alternativo para
pacientes com neuropatia e para aqueles que
querem evitar alopécia
2) GOG 218 e ICON 7:
carboplatina/paclitaxel/bevacizumabe (indução e
manutenção) considerado uma opção de 1o linha
em pacientes selecionadas
Obrigado
[email protected]