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

5082^ General Poster Session (Board #23B), Sun, 8:00 AM-12:00 PM
Final results of a phase II trial of weekly nab-paclitaxel with GM-CSF as
chemoimmunotherapy for platinum-resistant epithelial ovarian cancer.
Presenting Author: Ron E. Swensen, Loma Linda University, Loma Linda,
CA
Background: Ovarian cancer patients with an anti-tumor immune response
have a prolonged survival, suggesting that augmenting anti-tumor immunity
may be therapeutic. We hypothesized that weekly nab paclitaxel (nabP)
followed by GM-CSF may enhance anti tumor immunity and prolong time to
progression (TTP). Methods: Eligible subjects had platinum resistant
ovarian, primary peritoneal or fallopian tube cancer, and an elevated
CA125. Conditional power estimate after 11 subjects showed 22 subjects
had 80% power to show a response rate (RR) �21% if the true study RR is
35%. Study end points were RR and TTP. Progression (DP) was doubling of
CA125 above the nadir. Complete response (CR) was a decline of CA125
below institutional normal. Partial response (PR) was a decline of �50%
from baseline. Stable disease (SD) was all other scenarios. Subjects
received nabP, 100mg/m2 days 1,8,15 followed by GM-CSF 250mcg days
16-26 of a 28 day cycle until progression or 6 cycles were complete.
Responding subjects received up to 6 more cycles of GM-CSF on days
14-28. Results: 21 subjects received at least one dose of study medications.
Median age was 61 (30-91) and had a median of 3 (1-13) prior
regimens. Among those completing the study, the median TTP was 132
days vs. 272 days on the prior platinum regimen. 9/21 (43%) had a PR and
4/21 (19%) had a CR. Subjects with a response had a median TTP of 140
days. Assay of serial T-lymphocyte counts against CEA, MUC1, CA125 and
tt and influenza controls are planned. Conclusions: Weekly nabP with
GM-CSF had manageable toxicity and induced a high response rate (62%
by CA125) in patients with platinum resistant ovarian cancer, however this
regimen did not prolong the TTP beyond the TTP observed in the prior
platinum regimen.
5084 General Poster Session (Board #23D), Sun, 8:00 AM-12:00 PM
Prevalence of high-risk human papillomavirus in uterine cervical lesions
among older Japanese women. Presenting Author: Kazuhiro Takehara,
National Hospital Organization Kure Medical Center/Chugoku Cancer
Center, Hiroshima, Japan
Background: To estimate the prevalence and genotypes of high-risk human
papillomavirus (HPV) among older Japanese women, using liquid-based
cytology (LBC). Methods: ThinPrep LBC specimens were collected from
11,039 Japanese women (age range, 14-98 years). After classifying
cytodiagnosis, specimens were analyzed for HPV DNA using the multiplex
polymerase chain reaction method. Cervical smear specimens from 1,302
women showed positive results. To examine the prevalence of HPV in
women defined as negative for intraepithelial lesion or malignancy (NILM),
2,563 samples were randomly selected from the remaining 9,737 women.
Comparisons were made between women �50 years of age (older age
group) and women �50 years of age (younger age group). Written informed
consent was obtained from all patients. In this study, the high-risk HPV
genotypes encountered were 16, 18, 31, 33, 35, 45, 52, and 58. Results:
In the older age group with abnormal smear findings, HPV genotypes were
detected in 49.7% (148/298), including high-risk HPV genotypes in
40.9% (122/298). In the younger age group with abnormal smear findings,
HPV genotypes were detected in 71.7% (720/1004), including high-risk
HPV genotypes in 58.1% (583/1,004). In NILM, HPV-positive rates were
4.5% (39/873) in the older age group and 11.8% (199/1,690) in the
younger age group. In high-grade squamous intraepithelial lesion (HSIL) or
more severe cytological findings, HPV genotypes of each group (older age
group/younger age group) were detected in 61.7%/83.1%, and high-risk
HPV genotypes were detected in 56.4%/74.7% of women. In positive
cervical smears, HPV 16 was the most frequently detected (28.5%) in the
younger age group, while HPV 52 (31.3%) and 58 (27.2%) were detected
more frequently than HPV 16 (18.4%) in the older age group. Conclusions:
In Japan, although HPV infection as a cause of abnormal cervical cytology
is more frequent among younger age groups than in older age groups,
high-risk HPV infection was more highly associated with older individuals
(older age group/younger age group: abnormal smear findings, 82.4%/
81.0%; HSIL or more severe cytological findings, 91.3%/89.9%). In older
age groups, HPV 52 and 58 were more frequent than HPV 16.
Gynecologic Cancer
347s
5083 General Poster Session (Board #23C), Sun, 8:00 AM-12:00 PM
Prospective multicenter study evaluating the survival of patients with
locally advanced cervical cancer (LACC) and negative positron emission
tomography with computerized tomography (PET-CT) in the para-aortic
area undergoing laparoscopic para-aortic (PA) lymphadenectomy before
chemoradiation therapy. Presenting Author: Sebastien Gouy, Institut
Gustave Roussy, Villejuif, France
Background: In three comprehensive cancer centers, patients with LACC
were systematically staged using conventional and PET-CT imaging before
chemoradiotherapy. If patients had no uptake in the PA area, laparoscopic
extraperitoneal PA surgery was then performed to define radiation field
limits more accurately. The aim of this study was to evaluate the
therapeutic impact of this management. Methods: A prospective multicenter
series of 237 patients treated from 2004 to 2011 for LACC with a
negative PET-CT of the PA area and undergoing laparoscopic PA lymphadenectomy.
Radiation fields were extended to PA area when PA nodes were
involved. Chemoradiotherapy modalities were homogeneous between Institutions.
Patients with a poor prognosis histologic subtype, peritoneal
carcinomatosis or ovarian metastasis were excluded. Results: Clinical
stages were IB2 (n�79), IIA (n�10), IIB (n�120), III (n�23), IVA (n�5).
The histologic types were squamous carcinoma (n�197), adenocarcinoma
(n�34) and others (n�6). Twenty-nine (11%) patients had nodal involvement
(false negative PET-CT results): 16 with PA nodal metastasis
measuring � 5 mm and 13 � 5 mm. With a median follow-up of 18 (range,
0-67) months, disease-free survival (DFS) at 2 years in patients without
and with PA involvement was respectively 76% (68%-83%) and 61%
(37%-80%)(p�.007). DFS at 2 years in patients without PA involvement
or with PA metastasis measuring � or � 5 mm was respectively 76%
(68%-83%), 89% (57%-98%) and 38% (14%-68%)(p�.0006).
Conclusions: This is the largest series of patients reported undergoing such
strategy. We obtained a similar survival rate for patients with PA nodal
metastasis � 5 mm and patients without PA lymph node involvement
suggesting that this strategy is highly efficient in such patients. Conversely,
the survival of patients with PA nodal involvement � 5 mm remained poor,
despite no extrapelvic disease at PET-CT imaging in this subgroup. Other
treatment modalities should be evaluated for these patients.
5085 General Poster Session (Board #23E), Sun, 8:00 AM-12:00 PM
Nuclear Y-box binding protein-1 expression as a prognostic marker and
correlation with epidermal growth factor receptor expression in cervical
cancer. Presenting Author: Shin Nishio, Kurume University School of
Medicine, Kurume, Japan
Background: Y-box binding protein-1 (YB-1) is a member of the cold shock
protein family and functions in transcription and translation. Many reports
indicate that YB-1 is highly expressed in tumor cells and is a marker of
tumor aggressiveness and clinical prognosis. Overexpression of epidermal
growth factor receptor (EGFR) has been associated with poor outcomes in
cervical cancer (CC). Clinical trials have shown that EGFR inhibitors are
effective against CC (JCO 2011). Nuclear YB-1 expression correlates with
EGFR expression in various types of cancer. Methods: Nuclear YB-1
expression was immunohistochemically analyzed in tissue specimens
obtained from 204 CC patients who underwent surgery. Associations of
nuclear YB-1 expression with clinicopathological factors such as survival
and EGFR (HER1 and HER2) expression were investigated. Results:
Nuclear YB-1 expression was observed in 41 (20%) of 204 cases and
correlated with stage, tumor diameter, stromal invasion, and lymph-node
metastasis. Nuclear YB-1 expression also correlated with both HER1
expression (p�0.0114) and HER2 expression (p�0.0053). Kaplan-Meier
survival analysis showed that nuclear YB-1 expression was significantly
associated with poor outcomes in terms of progression-free survival
(p�0.0033) and overall survival (p�0.0003). On multivariate analysis,
stromal invasion, parametrial invasion, and nuclear YB-1 expression were
independent predictors of survival. Conclusions: Nuclear YB-1 expression is
a prognostic marker and correlates with EGFR expression in CC.
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