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Table: 975PD Continued
AMG 386 +
paclitaxel and carboplatin (n = 27)
Parasthesia 4 (29) 0 (0) 1 (8) 0 (0)
Vomiting 2 (14) 0 (0) 3 (23) 0 (0)
Musculoskeletal pain 2 (14) 0 (0) 3 (23) 0 (0)
Anemia 3 (21) 0 (0) 3 (23) 1 (8)
Mucosal
3 (21) 0 (0) 1 (8) 0 (0)
inflammation
Myalgia 3 (21) 0 (0) 1 (8) 0 (0)
Dizziness 3 (21) 0 (0) 2 (15) 0 (0)
Dysgeusia
Of specific interest
Edema
3 (21) 0 (0) 1 (8) 0 (0)
Generalized 2 (14) 0 (0) 0 (0) 0 (0)
Lymphedema 2 (14) 1 (7) 1 (8) 0 (0)
Female genital tract
fistula
0 (0) 0 (0) 1 (8) 0 (0)
Wound 0 (0) 0 (0) 1 (8) 0 (0)
*Grade 4 AEs were neutropenia (n = 3).
** Grade 4 AEs were neutropenia (n = 1) and thrombocytopenia (n = 1).
Conclusions: Interim results from this Phase 1b study of ovarian cancer patients
undergoing PDS or IDS suggest that AMG 386 at 15 mg/kg IV QW plus paclitaxel
and carboplatin was tolerable. No PK interactions were observed between AMG 386
and paclitaxel or carboplatin.
Disclosure: I.B. Vergote: As is relevant for the current drug, I am an advisory board
member for and received funding from Amgen. However, I am also an advisory board
member and received funding from other companies. J. Baurain: Corporate-sponsored
research: Academic clinical trial run with an Amgen product in squamous skin cancer.
X. Yang: Stock ownership: Amgen I am an employee with Amgen. B. Wu: Stock
ownership: Amgen I am an employee at Amgen. Z. Zhong: Stock ownership: Amgen I
am an employee at Amgen. M. Puhlmann: Stock ownership: Amgen I am an employee
at Amgen. All other authors have declared no conflicts of interest.
976P A SEMI-PROSPECTIVE TRIAL TO DETERMINE THE OUTCOME
OF BORDERLINE OVARIAN TUMOR PATIENTS. RESULTS OF
ROBOT, A STUDY OF THE AGO STUDY GROUP
H. Lueck 1 , N. Ewald-Riegler 2 , N. De Gregorio 3 , A. Reuss 4 , S. Mahner 5 ,
C. Fotopoulou 6 , F. Kommoss 7 , B. Schmalfeldt 8 , S. Hauptmann 9 ,
A. Du Bois 10
1 Gyn Oncol, Gynäkologisch-Onkologische Schwerpunktpraxis Hannover,
Hannover, GERMANY, 2 Klinik für Gynäkologie U. Gynäkologische Onkologie,
HSK Wiesbaden, Wiesbaden, GERMANY, 3 Frauenklinik, Universitätsklinikum Ulm,
Ulm, GERMANY, 4 Studienzentren, Koordinierungszentrum für Klinische Studien,
Marburg, GERMANY, 5 Dept of Gynecology and Gynecologic Oncology,
University Medical Center Hamburg-Eppendorf, Hamburg, GERMANY,
6 Frauenklinik, Charité, Campus Virchow Klinikum, Berlin, GERMANY, 7 Gyn
Tumors, Institut für Pathologie, Mannheim, GERMANY, 8 Frauen- und Poliklinik,
Klinikum rechts der Isar der Technischen Universität, München, GERMANY, 9 Gyn
Tumors, Institut für Pathologie Allgäu-Oberschwaben, Wangen, GERMANY,
10 Klinik für Gynäkologische Onkologie, Kliniken Essen-Mitte, Essen, GERMANY
Background: Borderline ovarian tumors (BOT) are a rare entity, current standard of
care is based on the available data of predominantly small retrospective trials.
Therefore we performed a pattern of care study including central pathology review.
Methods: All consecutive patients diagnosed with BOT 1998-2008 in 24 German
institutions were included. Tumor samples were sent for central histopathological
review to experienced pathologists, clinical data were collected and patient follow-up
was updated.
Results: Pathological review was obtained in 1,042 of 1,236 pts resulting in 950
confirmed BOT cases analyzed here. Under- and overdiagnosis occurred in 5.0% and
6.2% of cases. Median age was 49 years; 82% of patients had FIGO stage I disease;
serous type (S-BOT) was diagnosed in 68% and mucinous type (M-BOT) in 31%.
Primary/re-staging surgery led to complete debulking in 92% of pts (residual disease
1.3%, unknown 6.4%). Adjuvant chemotherapy was given to 33 (3.5%) pts only. 166
(17%) underwent fertility preserving surgery and 31 (19%) of these patients had
documented pregnancies thereafter. Overall, 74 (7.8%) pts experienced relapse and 43
(4.5%) died, transformation to invasive carcinoma occurred in 30% of the relapses.
Inadequate surgical staging, residual tumor, fertility sparing surgery and higher FIGO
stage were associated with shorter progression-free survival. No differences were observed
for laparatomy vs. laparoscopy as initial surgical approach or adjuvant chemotherapy.
Conclusions: To this day, this is the largest data set available for this entity.
Prognosis of BOT is good even without adjuvant therapy if correct surgical staging is
performed. Both tumor characteristics and treatment variables had a significant
impact on relapse rate and outcome. In contrast to previous data, transformation to
invasive carcinoma occurred in a significant amount of relapse cases.
Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology
977P PROGNOSTIC FACTORS AFTER CONSERVATIVE TREATMENT
OF A LARGE SERIES OF "STAGE I" SEROUS BORDERLINE
OVARIAN TUMORS
P. Morice 1 , A. Kane 1 , E. Muller 1 , R. Fauvet 2 , S. Gouy 1 , P. Pautier 3 , C. Lhomme 3 ,
E. Darai 4 , P. Duvillard 1 , C. Uzan 1
1 Surgery, Institut Gustave Roussy, Villejuif, FRANCE, 2 Obstetrics Gynecology,
CHU, Amiens, FRANCE, 3 Consultation de Gyn, Institut de Canc, Villejuif Cedex,
FRANCE, 4 Obstetrics & Gynecology, Hopital Tenon, Paris, FRANCE
Objectives: The aim of this study was to evaluate the prognostic factors of recurrence
after conservative treatment of a large series of “apparent” stage I serous borderline
ovarian tumors (SBOT).
Methods: A review of 119 patients treated conservatively between 2000 and 2010
with data on the follow-up. All pathological slides were reviewed by the same expert
pathologist. Prognostic factors of recurrences were studied (age, histologic subtypes,
surgical procedures used … ).
Results: Conservative procedures were: unilateral cystectomy/UC (n = 43; 36%);
unilateral salpingo-oophorectomy/USO (n = 50; 42%); bilateral cystectomy (n = 11;
9%) and USO + CC (n = 15; 13%). Fourteen patients underwent complete peritoneal
staging. Stages distributions were: IA (n = 80; 67%); IB (n = 18; 15%) & IC (n = 21;
18%). Twenty-six patients had bilateral tumors. Respectively 21 (18%) & 13 (11%)
had stromal microinvasion and/or micropapillary pattern. With a median follow-up
of 45 months, 40 (33%) patients recurred (in whom 10 had peritoneal recurrence
under the form of non invasive implants during the 1 st recurrence). Two of these 40
recurrent patients had evolution in the form of invasive recurrence (during the 2 nd or
3 rd recurrence): 1 in remaining ovary & 1 in the peritoneum. None patient died from
disease. Only 2 prognostic factors of recurrence were identified in multivariate
analysis: the young age of the patients (< 30 years old) & the bilaterality of the
tumours. None of the others factors studied had impact on the rate of recurrence.
Conclusions: In this series (representing the largest series reported of conservative
management of stage I SBOT), the risk of recurrence is not related to the histologic
patterns of the tumor (micropapillary, stromal microinvasion) nor to the surgical
procedures used (type of conservative approach, the use of staging surgery, the use of
laparoscopic approach). The rate of invasive recurrence is very rare in stage I SBOT (2
cases in this series). Young age (< 30 years old) and bilaterality of the tumors are risk
factors of recurrence suggesting that improvement of the fertility management (before
potential recurrence) should be improved particularly in theses subgroup of patients.
Disclosure: All authors have declared no conflicts of interest.
978P ROSIA: A SINGLE-ARM STUDY IN MORE THAN 1000
PATIENTS (PTS) RECEIVING FRONT-LINE BEVACIZUMAB
(BEV) + CHEMOTHERAPY (CT) FOR OVARIAN CANCER (OC)
C. Mendiola 1 , I. Davidenko 2 , N. Colombo 3 , J. Korach 4 , F. Selle 5 , P. Gocze 6 ,
E. Chmielowska 7 , P. Pautier 8 , D. Bollag 9 , A.M. Oza 10
1 Medical Oncology Service, University Hosptial 12 De Octubre Medical
Oncology, Madrid, SPAIN, 2 Oncology Dispensary, Krasnodar Regional Clinical
Oncology Center, Krasnodar, RUSSIAN FEDERATION, 3 Gynecologic Oncology
Division, European Institute of Oncology, Milan, ITALY, 4 Gynecology Oncology,
The Chaim Sheba Medical Center, Tel Hashomer, ISRAEL, 5 Medical Oncology,
Hôpital Tenon, Paris, FRANCE, 6 Department of Obstetrics and Gynaecology,
University of Pecs, Pecs, HUNGARY, 7 Oddzial Onkologii, SPZOZ Centrum
Onkologii im. Prof.Lukaszczyka, Bydgoszcz, NAP, POLAND, 8 Hopital de Jour de
Medecine, Institut Gustave Roussy, Villejuif, FRANCE, 9 GPS, F. Hoffmann- La
Roche AG, Basel, SWITZERLAND, 10 Dept. of Medicine, Princess Margaret
Hospital, Toronto, ON, CANADA
Background: BEV significantly improved the efficacy of front-line CT for OC in the
ICON7 and GOG-0218 phase III trials. The global single-arm ROSiA study was
designed to assess the safety of BEV-containing therapy, given until progression or
for up to 36 cycles, in the context of routine oncology practice.
Methods: Eligible pts have FIGO stage IIb–IV or grade 3 stage I–IIa epithelial
ovarian, fallopian tube or primary peritoneal carcinoma, have received no prior
post-surgical therapy for OC, are aged ≥18 years and have ECOG PS 0–2. Prior
neoadjuvant CT is permitted. Pts with uncontrolled hypertension, clinical signs/
symptoms of GI obstruction, or a history of abdominal fistula, GI perforation or
intra-abdominal abscess within the preceding 6 months are ineligible. After definitive
surgery, pts receive BEV 15 mg/kg q3w (or 7.5 mg/kg at the investigator’s discretion)
in combination with 4–8 cycles of CT (paclitaxel [175 mg/m 2 d1 q3w or 80 mg/m 2
qw) + q3w carboplatin [AUC 5 or 6]). BEV is continued at the same dose as a single
agent until disease progression (PD), unacceptable toxicity or for up to 36 cycles.
The primary objective is to assess safety (CTCAE v4.03). Secondary endpoints
include progression-free survival, overall response rate by RECIST and/or CA-125
response criteria, duration of response and overall survival. The study includes
exploration of potential correlations of plasma, tumour and genetic biomarkers with
BEV efficacy and toxicity.
ix322 | Abstracts Volume 23 | Supplement 9 | September 2012