Uptodate do Tratamento de 1 0 linha do Câncer de Ovário Brasília 2012 Fernando Cotait Maluf Diretor do Serviço de Oncologia Clínica Beneficência Portuguesa

Uptodate do Tratamento de 10 linha do Câncer de Ovário

Brasília 2012

FernandoFernando Cotait Maluf Cotait MalufDiretor do Serviço de Oncologia ClínicaDiretor do Serviço de Oncologia Clínica

Beneficência PortuguesaBeneficência Portuguesa

Médico Integrante da Clínica OncovidaMédico Integrante da Clínica Oncovida

([email protected])([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

Piganta E et al, J Clin Oncol, Piganta E et al, J Clin Oncol, 20112011

Critério Inclusão:Critério Inclusão:

• Câncer de ovário Câncer de ovário epitelialepitelial

• Estádio Ic-IVEstádio Ic-IV• < 76 anos< 76 anos• ECOG 0-2ECOG 0-2

RANDOMIZAÇÃO

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

MITO-2

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

Stratification variables:• PS• Stage/debulking status BEV 15 mg/kg

15 months

Paclitaxel (P) 175 mg/m2

Carboplatin (C) AUC 6





Placebo

PlaceboBEV 15 mg/kg

Front-line: Epithelial OV, PP or FT cancer

• Stage III optimal (macroscopic)

• Stage III suboptimal• Stage IV

n=1800 (planned)

I

II

III

Arm

1:1:1

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

Characteristic

Arm ICP

(n=625)

Arm IICP + BEV

(n=625)

Arm IIICP + BEV BEV

(n=623)

Median age, years (range) 60 (25–86) 60 (24–88) 60 (22–89)

Race, n (%)

Non-Hispanic white 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)

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–PathologicCharacteristics

Characteristic, n (%)

Arm ICP

(n=625)

Arm IICP + BEV(n=625)

Arm IIICP + BEV BEV

(n=623)

Stage/residual size

III optimal (macroscopic) 218 (35) 205 (33) 216 (35)

III suboptimal 254 (41) 256 (41) 242 (39)

IV 153 (25) 164 (26) 165 (27)

Histology

Serous 543 (87) 523 (84) 525 (84)

Endometrioid 20 (3) 15 (2) 25 (4)

Clear cell 11 (2) 23 (4) 18 (3)

Mucinous 8 (1) 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 categorizationaGrade 3 includes all clear cell tumors



Arm ICP

(n=625)


Arm IIICP + BEV BEV

(n=623)

Stage/residual size


III suboptimal 254 (41) 256 (41) 242 (39)

IV 153 (25) 164 (26) 165 (27)

Histology

Serous 543 (87) 523 (84) 525 (84)

Endometrioid 20 (3) 15 (2) 25 (4)

Clear cell 11 (2) 23 (4) 18 (3)

Mucinous 8 (1) 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)





Arm ICP

(n=625)


Arm IIICP + BEV BEV

(n=623)

Stage/residual size


III suboptimal 254 (41) 256 (41) 242 (39)

IV 153 (25) 164 (26) 165 (27)

Histology

Serous 543 (87) 523 (84) 525 (84)

Endometrioid 20 (3) 15 (2) 25 (4)

Clear cell 11 (2) 23 (4) 18 (3)

Mucinous 8 (1) 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)



GOG-0218: Patient Disposition

Characteristic

Arm ICP

(n=625)


Arm IIICP + BEV BEV

(n=623)

Median (range) number BEV/placebo cycles 11 (0–22a) 12 (0–22a) 14 (0–21)

On treatment at time of analysis, n (%) 86 (14) 82 (13) 117 (19)

Completed regimen, n (%) 100 (16) 104 (17) 148 (24)

Discontinued study treatment, n (%)

Disease progression 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)

Deaths 8 (1) 7 (1) 13 (2)

Patient refusal 44 (7) 55 (9) 50 (8)

Other 19 (3) 27 (4) 37 (6)

aOne patient in each group received BEV/placebo in cycle 1Percentages may not total 100% due to rounding or categorization

Adverse event (grade when limited), n (%)

Arm ICP

(n=601)


Arm IIICP + BEV BEV

(n=608)

GI eventsa (grade ≥2) 7 (1.2) 17 (2.8) 16 (2.6)

Hypertension (grade ≥2) 43 (7.2)b 100 (16.5)b 139 (22.9)b

Proteinuria (grade ≥3) 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)

GOG-0218: Select Adverse EventsOnset between cycle 2 and 30 days after date of last treatment

RPLS = reversible posterior leukoencephalopathy syndromeaPerforation/fistula/necrosis/leak

bp<0.05

GOG-0218: Investigator-Assessed PFSArm I

CP (n=625)


Patients with event, n (%)423

(67.7)418

(66.9)

Median PFS, months 10.3 11.2

Stratified analysis HR (95% CI)

0.908(0.759–1.040)

One-sided p-value (log rank) 0.080a

+ BEV (Arm II)CP (Arm I)

ap-value boundary = 0.0116

+ BEV → BEV maintenance (Arm III)Pro

po

rtio

n s

urv

ivin

g p

rog

ress

ion

fre

e

Months since randomization

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

00 12 24 36

Arm IIICP + BEV BEV

(n=623)

360 (57.8)

14.1

0.717 (0.625–0.824)

<0.0001a

Burger et al. NEJM 2011;365 (26):2473–83© Massachusetts Medical Society

GOG-0218: subgroup analyses of PFSRisk factor Total no. of patients Hazard ratio for Avastin (95% CI)

Cancer stage and residual lesion size III, macroscopic ≤1cm Arm II vs Arm I Arm III vs Arm I

423 434

0.7800.618

III, >1cm Arm II vs Arm I Arm III vs Arm I

510 496

0.9810.763

IV Arm II vs Arm I Arm III vs Arm I

317 318

0.9230.698

Histologic type

Serous Arm II vs Arm I Arm III vs Arm I

1,0661,068

0.9130.701

Nonserous Arm II vs Arm I Arm III vs Arm I

184 180

0.8930.713

Tumour grade

1 or 2 Arm II vs Arm I Arm III vs Arm I

232 235

1.0390.578

3 Arm II vs Arm I Arm III vs Arm I

847 842

0.8910.700

0.33 0.50 0.67 1.00 1.50 2.00 3.00

bevacizumab better 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

626616

0.8770.710

1 or 2 Arm II vs Arm I Arm III vs Arm I

624632

0.9610.690

Age

<60 years Arm II vs Arm I Arm III vs Arm I

616630

0.9760.680

60–69 years Arm II vs Arm I Arm III vs Arm I

414408

0.8920.763

≥70 years Arm II vs Arm I Arm III vs Arm I

220210

0.8410.678

0.33 0.50 0.67 1.00 1.50 2.00 3.00

bevacizumab better Control better

GOG-0218: Overall Survival (OS)

• 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

OutcomeArm I

CP(n=625)


Arm IIICP + BEV BEV

(n=623)

Deaths, n (%)156

(25.0)150

(24.0)138

(22.2)

1-year survival, % 90.6 90.4 91.3

GOG-0218: Overall Survival Analysis At time of final PFS analysis (January 2010)

Arm ICP

(n=625)


Arm IIICP + BEV BEV

(n=623)

Patients with events, n (%)

156 (25.0)

150 (24.0)

138 (22.2)

Median, months 39.3 38.7 39.7

HRa

(95% CI)1.036

(0.827–1.297)0.915

(0.727–1.152)

One-sided p-value 0.361 0.252

Pro

po

rtio

n a

live

Months since randomization

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

00 12 24 36 48

aStratified analysis

625/625/623 442/432/437 173/162/171 46/39/40No. at risk

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 cancerTim 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)

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

28

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

Stratification variables:• Stage & extent of debulking: I–

III debulked ≤1cm vs stage I–III debulked >1 cm vs stage IV and inoperable stage III

• Timing of intended treatment start≤4 vs >4 weeks after surgery

• GCIG group

Schema

Academic-led, industry-supported trial to investigate use of bevacizumab and to support licensing

Paclitaxel 175 mg/m2

Carboplatin AUC6

Carboplatin AUC6

Paclitaxel 175 mg/m2

18 cycles

R

n=1528*

Bevacizumab 7.5 mg/kg q3w

29

1:1

*Dec 2006 to Feb 2009*Dec 2006 to Feb 2009

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

30

Baseline characteristics (1)

CharacteristicControl (n=764)

Research (n=764)

Median age (range) 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 (87)29 (4)56 (7)12 (2)

673 (88)27 (4)50 (6)14 (2)

Histology Serous Clear cell Endometrioid Mucinous Mixed/other

529 (69)60 (8)57 (7)15 (2)

103 (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

31

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)

32

*Stratification variable

Selected adverse events (all grades)

6.2

2.5 2.1 1.3 0.4

11.6

4.11.5 0.4 0

29.1

2.0

9.2

25.9

4.4 5.0

1.7 1.3

39.6

6.73.6

0.4 0

28.3

2.8

12.5

0

5

10

15

20

25

30

35

40

45Control (n=753)

Research (n=745)

ATE = arterial thromboembolism; CHF = congestive heart failure; RPLS = reversible posterior leucoencephalopathy syndrome; VTE = venous thromboembolism

Pati

ents

(%

)Pati

ents

(%

)

33

2.10.1 0.4

0.90.4 0.3

1.7 1.3 0.4 0

15.1

2.0 2.0

18.3

0.5 1.3 0.8 1.3 1.2

4.32.7

0.3 0

16.5

2.6 3.5

0

5

10

15

20

25

30

35

40

45Control (n=753)

Research (n=745)

ATE = arterial thromboembolism; CHF = congestive heart failure; RPLS = reversible posterior leucoencephalopathy syndrome; VTE = venous thromboembolism

Pati

ents

(%

)Pati

ents

(%

)

34

Selected grade ≥3 adverse events

(gra

de ≥

2)

Number at riskControl 764 723 693 556 464 307 216 143 91 50 25Research 764 748 715 647 585 399 263 144 73 36 19

Number at riskControl 764 723 693 556 464 307 216 143 91 50 25Research 764 748 715 647 585 399 263 144 73 36 19

Progression-free survival

1.00

0.75

0.50

0.25

0

1.00

0.75

0.50

0.25

0

Pro

port

ion a

live w

ithout

pro

gre

ssio

nPro

port

ion a

live w

ithout

pro

gre

ssio

n

Time (months)Time (months)0 3 6 9 12 15 18 21 24 27 300 3 6 9 12 15 18 21 24 27 30

Control ResearchEvents, n (%) 392 (51) 367 (48)Median, months 17.3 19.0Log-rank test p=0.0041

HR (95% CI) 0.81 (0.70–0.94)

17.3 19.0

ControlResearch

Academic analysis

35

Number at riskControl 234 205 98 36 14 2Research 231 213 159 56 10 1

Number at riskControl 234 205 98 36 14 2Research 231 213 159 56 10 1

PFS: FIGO stage III suboptimal and FIGO stage IV with debulking

1.00

0.75

0.50

0.25

0

1.00

0.75

0.50

0.25

0

Pro

port

ion a

live w

ithout

pro

gre

ssio

nPro

port

ion a

live w

ithout

pro

gre

ssio

n

Time (months)Time (months)0 3 6 9 12 15 18 21 24 27 300 3 6 9 12 15 18 21 24 27 30

Control(n=234)

Research (n=231)

Events, n (%) 173 (74) 158 (68)

Median, months 10.5 15.9Log-rank test p<0.001

Hazard ratio (95% CI) 0.68 (0.55–0.85)

Restricted mean 13.3 16.5

10.5 15.9

ControlResearch

37

No. of events/no. of patients

Origin of cancerCP + Av7.5

Av7.5CP HR

Age <60 202/449 210/450 0.84

60–69 134/242 142/237 0.76

≥70 31/73 40/77 0.82

ECOG PS 0 154/334 145/358 1.01

1 175/366 210/354 0.66

2 27/45 31/43 0.78

Histology Serous 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

Hazard ratio (fixed)

0 1 20.5 1.5

CP + Bev7.5 Bev 7.5 better CP better

Age: Trend p=0.69, interaction p=0.83 ECOG: Trend p=0.027, interaction p=0.022Histology: Interaction test p=0.085

Perren et al. NEJM 2011;365 (26):2482–2496© Massachusetts Medical Society

Subgroup analysis of PFS (1)

FIGO: Trend p=0.71, interaction p=0.91Residual disease: Trend p=0.10Grade: Trend p=0.76, interaction p=0.95


Subgroup analysis of PFS (2)

No. of events/no. of patients

Origin of cancerCP + Av7.5

Av7.5CP HR

FIGO 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

Residual disease

Optimal (≤1cm) 226/559 233/552 0.87

Suboptimal (>1cm) 131/192 145/195 0.68

Grade Grade 1 10/41 16/56 0.76

Grade 2 86/175 77/142 0.77

Grade 3 267/538 294/556 0.81

Hazard ratio (fixed)

0 1 20.5 1.5

CP + Bev7.5 Bev7.5 better CP better


Interim OS analysis, full population (regulatory request)

1.00

0.75

0.50

0.25

0

1.00

0.75

0.50

0.25

0

Pro

por

tion

aliv

eP

rop

ortio

n al

ive

Time (months)Time (months)0 3 6 9 12 15 18 21 24 27 30 33 36 390 3 6 9 12 15 18 21 24 27 30 33 36 39

Number at riskCP 764 741 724 703 672 646 623 542 421 304 212 132 71 26CP + Av7.5 764 753 737 717 702 680 657 592 459 329 228 129 69 19 Av7.5

Number at riskCP 764 741 724 703 672 646 623 542 421 304 212 132 71 26CP + Av7.5 764 753 737 717 702 680 657 592 459 329 228 129 69 19 Av7.5

CPCP + Av7.5 Av7.5

Deaths, n (%) 200 (26) 178 (23)

Median, months Not yet reached

Log-rank test p=0.11

HR (95% CI) 0.85 (0.69–1.04)

1-year OS rate (%) 92 95

Number at riskCP 234 219 194 166 107 46 15CP + Av7.5 231 222 208 186 134 65 18 Av7.5

Number at riskCP 234 219 194 166 107 46 15CP + Av7.5 231 222 208 186 134 65 18 Av7.5

High-risk subgroup

CP (n=234)

CP + Av7.5 Av7.5 (n=231)

Deaths, n (%) 109 (47) 79 (34)

Median, months 28.8 36.6


HR (95% CI) 0.64 (0.48–0.85)

1-year OS rate (%) 86 92


OS: high-risk patients (FIGO stage III suboptimal and FIGO stage IV with debulking)

1.00

0.75

0.50

0.25

0

1.00

0.75

0.50

0.25

0

Time (months)Time (months)0 3 6 9 12 15 18 21 24 27 30 33 36 390 3 6 9 12 15 18 21 24 27 30 33 36 39

Pro

por

tion

aliv

eP

rop

ortio

n al

ive

Data cut-off date: November 30, 2010Perren et al. NEJM 2011;365 (26):2482–2496

© Massachusetts Medical Society

Updated PFS

CP

CP + Av7.5 Av7.5

Events, n (%) 464 (61) 470 (62)

Median, months 17.4 19.8


HR (95% CI) 0.87 (0.77–0.99)

Pro

por

tion

aliv

e w

ithou

t pr

ogre

ssio

nP

rop

ortio

n al

ive

with

out

prog

ress

ion

Time (months)Time (months)

17.4 19.8

764764

693716

474599

350430

221229

114107

3927

Number at riskCPCP + Av7.5 Av7.5

Number at riskCPCP + Av7.5 Av7.5

0 3 6 9 12 15 18 21 24 27 30 33 360 3 6 9 12 15 18 21 24 27 30 33 36

1.00

0.75

0.50

0.25

0

1.00

0.75

0.50

0.25

0

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]

Documents

Uptodate do Tratamento de 1 0 linha do Câncer de Ovário Brasília 2012 Fernando Cotait Maluf Diretor do Serviço de Oncologia Clínica Beneficência Portuguesa