Annual Meeting Proceedings Part 1 - American Society of Clinical ...

340s Gynecologic Cancer
5054 General Poster Session (Board #19F), Sun, 8:00 AM-12:00 PM
An updated safety analysis of OCEANS, a randomized, double-blind, phase
III trial of gemcitabine (G) and carboplatin (C) with bevacizumab (BV) or
placebo (PL) followed by BV or PL to disease progression (PD) in patients
with platinum-sensitive (Plat-S) recurrent ovarian cancer. Presenting
Author: Carol Aghajanian, Memorial Sloan-Kettering Cancer Center, New
York, NY
Background: OCEANS met its primary end point with a statistically
significant and clinically meaningful hazard ratio for progression-free
survival (PFS) of 0.484. Secondary end points included objective response
rate, overall survival, and safety. Eleven additional months of safety data
were collected after the data cut-off date for the final PFS analysis event
and updated safety analyses were performed. Methods: Eligible patients
(pts) were randomized to arm A: GC (G [1000 mg/m 2 days 1 and 8] and C
[AUC 4, day 1], q21d for 6–10 cycles) � concurrent PL (q21d), followed
by PL until PD or unacceptable toxicity; or arm B: GC � concurrent BV (15
mg/kg q21d), followed by BV until PD or unacceptable toxicity. All adverse
events (AE) were recorded and graded per NCI-CTCAE v3.0. Results: The
incidence of any grade AE was 100% in both arms and of SAEs was 25.3%
(PL arm) and 35.6% (BV arm). The rates of proteinuria, hypertension
(HTN), reversible posterior leukoencephalopathy syndrome (RPLS), thrombocytopenia
and epistaxis were higher in the BV arm. More pts in the BV
arm (20.6%) than in the PL arm (4.7%) experienced an AE that led to
discontinuation of study drug, in the BV arm most commonly due to HTN
(4%), proteinuria (2.8%), epistaxis (1.2%), thrombocytopenia (1.6%) and
RPLS (0.8%). Median number of BV cycles in pts with G �3 proteinuria
was 22.5 and the AE resolved in 91.7% of pts. Among the pts with G �3
HTN, the median number of BV cycles was 16.5 and the AE resolved in
72.7% of pts. Conclusions: The overall safety profile was similar to that seen
at the time of the final PFS analysis. Higher incidences of proteinuria and
HTN were possibly related to longer BV treatment duration and resolved in
the majority of pts.
Adverse event, n (%)
GC � PL
(n�233)
GC � BV
(n�247)
Bleeding (non-CNS), all G 64 (27.5) 158 (64)
Bleeding (non-CNS), G >3 2 (0.9) 14 (5.7)
Epistaxis, G >3 1 (0.4) 12 (4.9)
HTN, all G 20 (8.6) 107 (43.3)
HTN, G >3 1 (0.4) 44 (17.8)
Fistula/abscess, all G 1 (0.4) 4 (1.6)
GIP, all G 0 (0) 0 (0)
Proteinuria, G >3 2 (0.9) 24 (9.7)
RPLS, all G 0 (0) 2 (0.8)
Thrombocytopenia, G >3 79 (34) 99 (40)
5056 General Poster Session (Board #19H), Sun, 8:00 AM-12:00 PM
The impact of interval cytoreduction and age in advanced-stage ovarian
cancer: A GOG ancillary study. Presenting Author: Stuart M. Lichtman,
Memorial Sloan-Kettering Cancer Center, New York, NY
Background: To determine if an age group exists for which interval
cytoreductive surgery (ICS) in patients with suboptimal residual disease at
primary surgery influences progression free survival (PFS) and overall
survival (OS) among women with advanced ovarian cancer treated on GOG
182. Methods: GOG 182 was a prospective, randomized trial of first-line
chemotherapy in patients with advanced ovarian cancer. Patients with both
optimal and suboptimal residual disease were included, and those with
suboptimal residual were considered for ICS, with intent registered and
stratified prior to randomization. Patients were randomized to one of five
chemotherapy arms, employing combinations of either two or three agents
delivered intravenously, with a control arm of paclitaxel and carboplatin. A
retrospective analysis was approved by the GOG Ancillary Study Committee
to investigate the influence of age on treatment and outcomes. In that
analysis, Cox regression was used to identify independent prognostic
factors and estimate their covariate effects on the adjusted PFS and OS of
patients with suboptimal residual disease. Statistical significance was set
at p�0.05. Results: Among the entire eligible study population, 28%
(n�1,042) were registered with suboptimal residual disease (� 1 cm) and
109 of these patients elected to undergo ICS. Hazard ratios (HR) were
determined for patients undergoing ICS with reference to patients with
suboptimal disease not undergoing ICS. Based on the most current
follow-up data, the HR for progression or death was not statistically
different between the groups, but the HR of death alone was significant at
0.72 (95% CI: 0.57–0.92, p�0.008). There was no significant association
of age with ICS in either the PFS or the OS model. Conclusions: In this
trial, a patient’s age did not influence the effect of ICS on PFS or OS. There
is no demonstrable benefit in PFS associated with ICS, but there was a
statistically significant improvement in OS. To elucidate this finding,
further study is warranted, likely in the form of a meta-analysis incorporating
data from other prospective trials.
5055 General Poster Session (Board #19G), Sun, 8:00 AM-12:00 PM
The impact of obesity on time to recurrence in ovarian cancer: A
retrospective study. Presenting Author: Karina E Hew, Mercy Medical
Center, Baltimore, MD
Background: There has been conflicting data regarding the relationship
between obesity and progression free survival in patients with ovarian
cancer. There has been some evidence to suggest that obesity results in
altered tumor biology and a poorer prognosis in these patients. The aim of
this study was to examine whether obesity is a risk factor for time to
recurrence in primary epithelial ovarian cancer. Methods: A multicenter
retrospective chart review was performed at Mercy Medical Center and
University of Michigan Medical Center. 591 patients were diagnosed with
primary epithelial ovarian cancer between 2004-2009. However, 221
patients were excluded from the analysis because of persistent or progressive
disease, treatment with neoadjuvant chemotherapy, presence of
synchronous tumors or incomplete follow-up data. 370 patients were
eligible for analysis. Data collected included: height and weight at the time
of surgery, age, race, medical co-morbid illnesses, tumor stage, grade and
histology. Treatment related data such as number of cycles of adjuvant
chemotherapy; and optimal versus suboptimal tumor debulking was also
collected. Body mass index (BMI) was defined according to WHO 2004
criteria. Women with a BMI greater than 30 were categorized as obese. The
diagnosis of recurrence was made by positive radiological or pathological
diagnosis of cancer recurrence after patient had surgery, received adjuvant
chemotherapy and had no clinical, radiological or serological evidence of
recurrence during this time. The time to recurrence was then quantified in
terms of months from the initial surgery. Survival analyses were performed
with the Kaplan-Meier method and compared using log-rank testing. Time
to recurrence was analyzed using Mann-Whitney U and Wilcox W tests.
Results: 130 (35%) obese patients were compared with 240 (65%) non
obese patients. A recurrence was documented in 125 (47.9%) non obese
patients and 49 (37.7%) obese patients. Time to recurrence between both
BMI groups was found to be identical, at 15 months (p�1.0). The
progression free survival was similar in both obese and non obese subjects
(p�0.118). Conclusions: Obesity does not impact the time to recurrence in
patients with primary ovarian cancer.
5057 General Poster Session (Board #20A), Sun, 8:00 AM-12:00 PM
The impact of interval from surgery to chemotherapy and age in advancedstage
ovarian cancer: A GOG ancillary study. Presenting Author: Andrew
Menzin, North Shore University Hospital, Manhasset, NY
Background: To determine if an age group exists for which the interval from
surgery to the initiation of chemotherapy influences progression free
survival (PFS) and overall survival (OS) among women with advanced
ovarian cancer treated on GOG 182. Methods: GOG 182 was a prospective,
randomized trial of first-line chemotherapy in patients with advanced
ovarian cancer, including those with optimal and suboptimal residual
disease. Patients were randomized to one of five chemotherapy arms,
employing combinations of either two or three agents delivered intravenously,
with a control arm of paclitaxel and carboplatin. Chemotherapy was
to be initiated within 12 weeks of primary surgery. A retrospective analysis
was approved by the GOG Ancillary Study Committee to investigate the
influence of age on treatment and outcomes. In that analysis, Cox
regression was used to identify independent prognostic factors and estimate
their covariate effects on the adjusted PFS and OS of the study
population. Statistical significance was set at p�0.05. Results: The primary
analysis of GOG 182 showed no differences in PFS or OS for any of the
experimental arms when compared to the control regimen, and it was felt
that the data from all arms could be aggregated for this analysis. Data for all
regimens was pooled, and the time interval from surgery to chemotherapy
was examined as a prognostic factor of survival. The interval had no
statistically significant association with PFS (p�0.105). In the OS model,
though, the functional form of the log interval was both significantly linear
and nonlinear (p�0.001). After being flat until about 20 days (21.2 days;
95% CI, 15.0–28.2 days), the plot of log interval against log hazard
increases, suggesting a changepoint time after which the associated risk of
death increases. Conclusions: In this study, time interval from surgery to
chemotherapy had no impact on PFS, but there was evidence of a potential
time-dependent relationship with OS, which might be elucidated with a
meta-analysis incorporating data from other prospective trials. Our observations
did not appear to be influenced by patient age. Overall, these findings
can reassure patients who are recuperating from extensive cancer surgery.
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