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To determine whether gastrointestinal (GI) disorder insurance claims in the year preceding a diagnosis of ovarian cancer (OC) lead to differing treatment allocations. The hypothesis is that GI disorders may be indicative of advanced OC.This retrospective study identified patients with newly diagnosed OC from January 2015 to January 2019 in the IBM® MarketScan® US commercial insurance and Medicare databases. Analysis was limited to patients with primary or interval debulking surgery or chemotherapy, with or without GI claims in the year prior to diagnosis, with commercial or Medicare coverage for ≥12 months prior and ≥1 month after the index date. Patients were compared in terms of the odds of treatment with neoadjuvant chemotherapy (NCT) or primary debulking surgery (PDS) (logistic regression analysis). Median treatment-free interval in the subset of patients with antineoplastic treatment was compared (Kaplan-Meier analysis).Of the 6286 patients, 22% had a diagnosis of ≥1 GI disorder before their OC diagnosis. Of these patients, 39% were diagnosed with a GI disorder between 6 and 12 months before OC diagnosis and 61% were diagnosed6 months prior. Women with a GI diagnosis were more likely to undergo NCT than PDS (odds ratio [OR], 1.37; P0.0001); this remained significant even when controlling for age, region, insurance plan type, and index year (OR, 1.24; P = 0.001).In this database, ≈25% of women with OC had a GI claim within the past year and were more likely treated with NCT, an indicator of more advanced disease with a worse prognosis. This suggests that OC should be considered in the differential diagnosis among women with GI complaints, which could alter treatment allocation.

Poly(ADP-ribose) polymerase (PARP) inhibitors have rapidly emerged as a new class of daily oral chemotherapeutic agents that have the potential to dramatically alter the way in which primary peritoneal, fallopian tube and ovarian cancers are treated. However, the management of nausea and vomiting, the most common toxicities incurred by these agents, remains poorly understood. The purpose of this review is to provide an overview of current guidelines, antiemetic agents and management steps for patients experiencing nausea and vomiting associated with the use of PARP inhibitors.

Objective This study aims to describe the real-world experience, including the clinical and financial burden, associated with PARP inhibitors in a large community oncology practice. Methods Retrospective chart review identified patients prescribed olaparib, niraparib or rucaparib for maintenance therapy or treatment of recurrent ovarian, primary peritoneal or fallopian tube cancer across twelve gynecologic oncologists between December 2016 and November 2018. Demographic, financial and clinical data were extracted. One PARP cycle was defined as a single 28-day period. For patients treated with more than one PARPi, each course was described separately. Results A total of 47 patients and 506 PARP cycles were identified (122 olaparib, 24%; 89 rucaparib, 18%; 294 niraparib, 58%). Incidence of grade ≥ 3 adverse events were similar to previously reported. Toxicity resulted in dose interruption, reduction and discontinuation in 69%, 63% and 29% respectively. Dose interruptions were most frequent for niraparib but resulted in fewer discontinuations (p-value 0.01). Mean duration of use was 7.46 cycles (olaparib 10.52, rucaparib 4.68, niraparib 7.34). Average cost of PARPi therapy was $8018 per cycle. A total of 711 phone calls were documented (call rate 1.4 calls/cycle) with the highest call volume required for care coordination, lab results and toxicity management. Conclusions Although the toxicity profile was similar to randomized clinical trials, this real-world experience demonstrated more dose modifications and discontinuations for toxicity management than previously reported. Furthermore, the clinical and financial burden of PARP inhibitors may be significant and future studies should assess the impact on patient outcomes.

Introduction/Background* Clinical trials consistently demonstrate the detrimental impact of progressive disease (PD) on patients’ health-related quality of life (HRQoL). Progression-free survival (PFS) is an established regulatory endpoint. However, PFS is often excluded as an efficacy endpoint on the basis that — PFS is not patient relevant — in early benefit assessment by select EU health technology agencies. The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) Phase 3 trial showed niraparib significantly prolongs median PFS vs placebo in patients with AOC responsive to 1L platinum (Pt)-based chemotherapy, (CT), regardless of biomarker status. This post-hoc analysis of PRIMA is the first study to examine the relationship between HRQoL and PD in a broad frontline AOC maintenance treatment setting. Methodology In PRIMA, patients with AOC responsive to 1L Pt CT were randomised 2:1 to once-daily, maintenance niraparib or placebo. Impact of PD on patient HRQoL, irrespective of treatment, was evaluated within the pooled ITT population by comparing HRQoL at the last on-treatment (pre-progression) visit with HRQoL at end of treatment (EOT), +4 weeks, +8w, +12w, and +24w. Assessments included FOSI, EORTC QLQ-C30, EQ-5D-VAS, and EORTC QLQ-OV28 abdominal/GI symptom scale. ANCOVA was applied with treatment as a fixed effect and HRQoL at last on-treatment visit as a continuous covariate. Mixed models for repeated measurements (MMRM) evaluated cumulative HRQoL changes. Result(s)* Significant reductions in HRQoL from pre- to post-progression were observed across all measures. Compared with pre-progression, FOSI scores (Least-squares mean [95% CI]) were lower at EOT+4w (-2.2 [-2.8, -1.6]) and EOT+24w (-1.7 [-2.3, -1.1]); each p Conclusion* These findings demonstrate HRQoL is negatively impacted by PD in AOC. Preservation of HRQoL, an important therapy goal in the maintenance setting particularly for asymptomatic patients, can be achieved with PFS prolongation. PFS is of significant relevance and clinically important for AOC patients.

Introduction/Background* Although most patients with ovarian cancer (OC) respond to first-line (1L) treatment, ≈70% experience recurrence within 3 years. Limited evidence exists on the interaction of prognostic factors and the risk of progressive disease (PD). This study assessed whether the number of risk factors (RFs) impacted time to PD in patients treated with maintenance therapy (MT) or active surveillance (AS) after completing 1L therapy. Methodology This retrospective cohort study included patients diagnosed with OC between January 1, 2011, and February 28, 2021, from the Flatiron Health electronic health record-derived de-identified US database. Patients ≥18 years old, with stage III/IV disease, who received 1L platinum-based therapy, had ECOG performance score of 0/1, and had ≥12 weeks of follow-up after 1L treatment were included. Patients were classified into 2 risk categories: moderate risk (stage III disease, no visual residual disease, primary debulking surgery, and BRCA mutant) or high risk (presence of ≥1 of the following: stage IV disease, visible residual disease, interval debulking surgery/no surgery, or BRCA wild type/unknown status). High-risk patients were further grouped by total number of RFs. Patients were followed from index date (ID), defined as end of 1L treatment. The target trial emulation method was used to account for potential selection and immortal time biases. Patients were classified as having received MT if MT was started within 120 days of ID. Result(s)* Of the 1251 patients with advanced OC evaluated, 26% (n=323) initiated 1L MT and 74% (n=928) did not. Of patients who received MT, 5% (n=16) were moderate risk and 95% (n=307) were high risk. Only 4% (n=34) of AS patients were moderate risk and 96% (n=894) were high risk. Time to next treatment (TTNT) decreased with more RFs (table 1). Notably, among patients in the high-risk category, median TTNT was longer in patients who received 1L MT than in those who received AS (table 1). Conclusion* The number of RFs impacted the risk of PD, irrespective of the type of treatment the patient received after completion of 1L treatment. For high-risk patients, greater TTNT prolongation was associated with 1L MT but not AS.

Introduction/Background* This systematic literature review evaluated the relationship between progression-free survival (PFS) and overall survival (OS) in adult patients with ovarian cancer following primary debulking or interval debulking surgery. Methodology MEDLINE®, Embase® and Cochrane Central were searched between 1 January 2011 and 7 July 2020 to identify eligible clinical trials or observational studies conducted in the target population. Gray literature, bibliographies and conference proceedings were also searched. Weighted linear regression analysis was used to evaluate the correlation between PFS and OS in patients with ovarian cancer by residual disease (RD) status. Result(s)* Forty-seven observational studies and three randomized controlled trials were eligible for inclusion, with sample size ranging between 203 and 8,652 patients. There was a strong positive association between PFS and OS, irrespective of RD status (median OS = 4.49 + [2.27 x median PFS]; adjusted R2 = 0.84). Similarly, there was a strong positive association between the log hazard ratios (logHR) for PFS and OS (logHR OS = 0.03 + [1.01 x logHR PFS]); adjusted R2 = 0.86) across RD categories. Conclusion* Among patients with ovarian cancer who had received frontline treatment (primary debulking or interval debulking surgery), there is a positive correlation between PFS and OS. This meta-analysis expands on the growing body of evidence showing that ovarian cancer treatments effective in delaying disease progression can meaningfully extend OS.

Persistent human papillomavirus (HPV) infection is the vital factor driving cervical carcinogenesis; however, other features of the local cervicovaginal microenvironment (CVM) may play a critical role in development of precancerous cervical dysplasia and progression to invasive cervical carcinoma (ICC). Here we investigated relationships between locally secreted cancer biomarkers and features of the local CVM to better understand the complex interplay between host, virus and vaginal microbiota (VMB). We enrolled women with ICC, high- and low-grade squamous intraepithelial lesions, as well as, HPV-positive and healthy HPV-negative controls. A broad range of cancer biomarkers was present in the local CVM and specifically elevated in ICC patients. The majority of cancer biomarkers were positively correlated to other biomarkers and linked to genital inflammation. Several cancer biomarkers were also negatively correlated to Lactobacillus abundance and positively correlated with abnormal vaginal pH. Finally, a hierarchical clustering analysis of cancer biomarkers and immune mediators revealed three patient clusters, which varied in levels of cancer biomarkers, genital inflammation, vaginal pH and VMB composition. Specific cancer biomarkers discriminated patients with features of the CVM, such as high genital inflammation, elevated vaginal pH and dysbiotic non-Lactobacillus-dominant VMB, that have been associated with HPV persistence, dysplasia and progression to ICC.

Introduction/Background Although most patients with ovarian cancer (OC) respond to first line (1L) treatment, 70% of women experience disease progression (PD) within 3 years. Identifying prognostic factors that impact survival is crucial to identify patients who may benefit from new treatment regimens such as maintenance therapies. The objective of this study was to assess the association between visible residual disease (VRD) following interval (IDS) or primary debulking surgery (PDS) and other clinical factors, and the risk of PD or death in patients with advanced OC in a real-world setting. Methodology This retrospective cohort study included patients diagnosed with invasive ovarian cancer between January 1, 2011 and February 29, 2020, from the Flatiron Health electronic health record-derived de-identified US database (most OC patients (87%) originate from community oncology practices). Inclusion/exclusion criteria are shown in table 1. The index date (ID) was defined as the last date of 1L treatment. Multivariate Cox regression models were used to identify demographic and clinical factors associated with time to next treatment (TTNT,a proxy for PD), defined as time from ID to start date of second line treatment, death, or last confirmed structured activity. Overall survival (OS) was defined as time from ID to death or last confirmed structured activity. Kaplan Meier analysis was used to assess median TTNT and OS. Results A total of 1,920 advanced OC patients with a median (25th, 75th percentile) age of 67.0 (58.0, 75.0) years were included. Most patients were white (74%) and originated from a community oncology practice (88%). While 67% of patients had evidence of a BRCA biomarker test, only 5% had evidence of a homologous recombination deficient (HRD) test. Results are shown in table 2. Statistically significant predictors of OS were VRD, age, BRCA status, Eastern Cooperative Oncology Group (ECOG) score, extent of debulking, histology, stage of disease, and therapy modality. Statistically significant predictors of TTNT included: VRD, BRCA status, extent of debulking, histology, practice type, race, stage of disease, and therapy modality. Conclusion VRD was a key predictor of TTNT and mortality in patients with advanced OC. Among biomarkers, BRCA status was a key predictor of OC outcomes; HRD could not be assessed due to lack of data. A key strength of this study is that it presents outcomes from community practices primarily, whereas most retrospective studies contain a higher proportion of academic practices. Disclosures Dr. Chase reports speakers’ bureau fees from GSK. Dr. Gonzalez-Martin reports personal fees and non-financial support from AstraZeneca; Grant and personal fees from GSK, Clovis Oncology, Roche Holding AG, Merck & Co., Inc., Genmab, INMUNOGEN, Pharma Mar, S.A., and Oncoinvent AS. Drs. Kalilani, Perhanidis, Sansbury, Woodward and Gupta are employees of GlaxoSmithKline.

Background Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor that is approved for use in heavily pretreated pts and as maintenance treatment of pts with newly diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy (CT). Here we report PROs in pts receiving niraparib and placebo (PBO) in the PRIMA/ENGOT-OV26/GOG-3012 trial. Methods This double-blind, PBO-controlled, phase 3 study randomised 733 pts with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response (CR or PR) to first-line (1L) platinum-based CT. Pts received niraparib or PBO once daily for 36 months or until disease progression. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review. PROs, a secondary endpoint, were collected every 8 weeks for 56 weeks, then every 12 weeks thereafter while treatment was ongoing. Once a pt discontinued treatment, PRO evaluations were performed at the time of treatment discontinuation and then at 4, 8, 12, and 24 weeks (±1 week for each time point) after the end of treatment, regardless of the status of subsequent treatment. The validated PRO instruments utilised were FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28. Results Compliance rates were high for all of the PRO instruments used in the study. PRO analysis of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 did not indicate a difference in health-related quality of life scores of pts treated with niraparib vs placebo. Mean scores between niraparib and placebo arms were similar at each time point. Overall, the health utility index showed a slight improvement trend in pts who received niraparib vs placebo. Conclusion Consistent with PRO results in the NOVA study, pts receiving niraparib in the PRIMA trial did not experience a decrease in quality of life compared with those receiving placebo. Disclosures Sponsor: GlaxoSmithKline, Waltham, MA, USA NCT number: NCT02655016 Encore statement: This data is presented on behalf of the original authors with their permission. Presented at the European Society for Medical Oncology (ESMO) Annual Meeting, September 19–21, 2020, Virtual. Dr. Maenpaa reports Honoraria from Tesaro, AstraZeneca, Clovis, Roche, MSD and OrionPharma Dr. Pothuri reports grants, personal fees and non-financial support from GSK; Advisory Board fees from AstraZeneca and Clovis Oncology. Dr. Chase reports speakers’ bureau fees from GSK. Dr. Gonzalez-Martin reports personal fees and non-financial support from AstraZeneca; Grant and personal fees from GSK, Clovis Oncology, Roche Holding AG, Merck & Co., Inc., Genmab, INMUNOGEN, Pharma Mar, S.A., and Oncoinvent AS. Dr. Monk reports consulting and advisory role at Merck, GSK, Roche/Genentech, AstraZeneca, Advaxiz, Cerulean Pharma, Amgen, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Perthera, Abbvie, Myriad Pharmaceuticals, Incyte, VBL Therapeutics, Takeda, Samumed, Oncomed, OncoSec, ChemoID, Geistlich Pharma, Eisai and Chemocare; Speakers’ bureau at Roche/Genentech, AstraZeneca, Janssen, Clovis Oncology and GSK; Honoraria from Merck, GSK, Roche/Genentech, AstraZeneca, Advaxis, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Pethera, Abbvie, Myriad Pharmaceuticals, Incyte, Janssen, Amgen, Genmab, Samumed, Takeda, VBL Therapeutics, Puma Biotechnology, Immunomedics, Conjupro Biotherapeutics, Agenus, OncoQuest, ChemoID, Geistlich Pharma, Eisai and Chemocare; and Research funding from Novartis, Amgen, Genentech, Lilly, Janssen, Array BioPharma, GSK, Morphotek, Pfizer, Advaxis, AstraZeneca, Immunogen, Regeneron, and Nucana. Drs. Han, Bender, and Follana have nothing to disclose. Drs. Bacque and Li are employees of GlaxoSmithKline.

Introduction Niraparib is a poly(ADP-ribose) polymerase inhibitor approved for treatment in heavily pretreated patients and maintenance of patients with newly diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. Here we report safety and patient-reported outcomes (PROs) in the overall population and subgroups from PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016). Methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients. Patients received a 300-mg QD fixed starting dose (FSD) of niraparib or placebo for 36 months or until progression/toxicity. A protocol amendment introduced an individualized starting dose (ISD): 200 mg in patients with body weight Results In the overall population, the most common grade ≥3 treatment-emergent adverse events (TEAEs) were hematologic (table 1). In patients receiving ISD, these TEAEs decreased. No treatment-related deaths occurred. PRO analysis showed no difference in niraparib-treated patients versus placebo in the overall population or in the homologous recombination deficient, homologous recombination proficient, FSD, and ISD subgroups. Conclusions ISD incorporation improved the safety profile of niraparib without compromising efficacy. Niraparib was well tolerated, with similar PRO scores across the treatment period. Hematologic toxicities were manageable through implementation of dose interruptions and reductions. Funding GlaxoSmithKline NCT: NCT02655016

IntroductionTo describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.MethodsSummarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.ResultsOf the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.DiscussionPatients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.

Inflammatory myofibroblastic tumors (IMTs) are spindle cell neoplasms of intermediate (borderline) biologic potential with tendency for local recurrence but low risk of metastasis. They affect children more than adults. The most common sites of involvement are the lung, soft tissue, peritoneum, bladder, and less commonly the gynecologic tract. IMTs are characterized by spindle to epithelioid cells with myofibroblastic differentiation, some degree of smooth muscle differentiation, myxoid stroma and usually associated with brisk lymphoplasmacytic infiltrates. In about half of the cases, IMTs are associated with rearrangements of the anaplastic lymphoma kinase (ALK) gene located at chromosome 2p23. The ALK rearrangement can be detected by immunohistochemistry for ALK protein expression (mostly cytoplasmic with or without perinuclear accentuation) or by fluorescent in situ hybridization (FISH) using dual-color break-apart probes for which the typical pattern is seen as split 3' end (red) and 5' end (green) probe signals in addition to single normal, unsplit red-green signal pair (yellow). Herein we describe a case of uterine IMT initially misdiagnosed intraoperatively as leiomyoma which showed sparse lymphocytic infiltrates, positive ALK expression by immunohistochemistry, a predominantly atypical FISH signal pattern (1 yellow and 1 red signal only) and few typical signal patterns (1 yellow, 1 red, and 1 green signal) in a smaller population of tumor cells. The RNA sequencing showed a recently described DES-ALK fusion transcript in the tumor cells, suggesting an intrachromosomal inversion and deletion as the likely underlying mechanism for the atypical FISH pattern. Familiarity with the unusual morphology and atypical FISH pattern is crucial given that this tumor has an activating ALK rearrangement and may benefit from targeted tyrosine kinase inhibitors in the future.

Introduction: In 2008, we published on the application of supportive care to ovarian cancer patients which involves caring for a patient’s symptoms during and/or after treatment with an objective of providing these women with an improved quality of life (QoL). This complex, multi-dimensional field involves all body systems and collaboration among multiple medical specialties.Areas Covered: In this updated review, we have incorporated new data investigating QoL and supportive care in ovarian cancer, maintaining our format of analyzing the data by separating it into two categories: tumor-related and treatment-related morbidities. The main themes within these categories include nausea and vomiting, abdominal pain, anxiety and depression, fatigue and anemia, small bowel obstruction, sexual dysfunction, and peripheral neuropathy, to name a few.Expert Commentary: While all of these components are challenging to manage, the oncologist must act as a facilitator who either addresses these needs or send the...

Olaparib is a poly(ADP-ribose) polymerase inhibitor that received accelerated approval from the US Food and Drug Administration as monotherapy for patients with germline BRCA mutations and ovarian cancer treated with three or more prior lines of chemotherapy. This article summarizes the mechanism of poly(ADP-ribose) polymerase inhibition, therapeutic profile and uses of olaparib, and current and ongoing literature pertaining to olaparib in advanced ovarian cancer.

While high-risk human papillomavirus (HPV) infection is a well-established risk factor for cervical cancer, there are likely other factors within the local microenvironment that contribute to cervical carcinogenesis. Here we investigated relationships between HPV, vaginal pH, vaginal microbiota (VMB) composition, level of genital immune mediators and severity of cervical neoplasm. We enrolled women with low- and high-grade cervical dysplasia (LGD, HGD), invasive cervical carcinoma (ICC), and healthy controls. HPV16, HPV45, HPV58, and HPV31 were the most prevalent in our cohort with HPV16 and HPV31 genotypes more prevalent in Hispanics. Vaginal pH was associated with ethnicity and severity of cervical neoplasm. Lactobacillus dominance decreased with the severity of cervical neoplasm, which correlated with elevated vaginal pH. Hispanic ethnicity was also associated with decreased Lactobacillus dominance. Furthermore, Sneathia was enriched in all precancerous groups, ICC, abnormal pH and Hispanic origin. Patients with ICC, but not LGD and HGD, exhibited increased genital inflammatory scores and elevated specific immune mediators. Notably, IL-36γ was significantly associated with ICC. Our study revealed local, host immune and microbial signatures associated with cervical carcinogenesis and provides an initial step to understanding the complex interplay between mucosal inflammation, HPV persistence and the VMB.

Objectives: The 2-item Patient Health Questionnaire (PHQ-2) is a short self-reported questionnaire used to screen for depression. Currently, no studies have evaluated the use of this tool among gynecology oncology patients. The objective of this study was to evaluate the sensitivity of the PHQ-2 in a gynaecologic oncology patient population compared with patient reported symptoms, medical history, and treatment for depression. Risk factors for depressive symptoms and treatment effect of antidepressants were also evaluated.Methods: Consecutive 12-month new patient visits attending a gynaecologic oncology clinic completed the PHQ-2 and written intake form. Each new patient was verbally administered the PHQ-2, and then administered a written health questionnaire which gathers information about current symptoms of depression (ROS, within the past week), current diagnosis of depression, and medications with a treatment indication of depression. Additional clinical data was abstracted from patient charts and entered into a database.Results: A total of 439 patients completed the PHQ-2 and written intake form. The average age was 53 years old (SD=15). The majority were White (67%), primarily spoke English (92%) and 54% did not have current diagnosis of cancer at their initial visit. Sixty-one patients screened positive on the PHQ-2, while 121 had a positive history, 92 had positive review of systems, and 79 indicated medications prescribed for depression. The sensitivity of the PHQ-2 for identifying patients meeting any criteria for depression on the written questionnaire was 18.7% with a specificity of 87.9%. The sensitivity and specificity of the PHQ-2 to identify patients reporting a current diagnosis of depression was 56.3% and 97.4% respectively, 28.8% and 89.5% respectively for the intake form, and 20.4% and 87.8% for patients on medications. Among the variables, pain correlated positively to PHQ-2 (r=0.13, p

Background Measuring QoL is essential to the field of gynecologic oncology but there seems to be limited standardized data regarding collecting QoL assessments throughout a patient’s cancer treatment especially in non-clinical trial patients. The aim of this study is to explore patient characteristics that may be associated with poor quality of life (QoL) in women with gynecologic cancers at two University of Arizona Cancer Center (UACC) sites. Methods A cross-sectional survey was conducted among English speaking women with gynecologic malignancies at the University of Arizona Cancer Centers in Phoenix and Tucson from April 2012 to July 2015. The survey was a paper packet of questions that was distributed to cancer patients at the time of their clinic visit. The packet contained questions on demographic information, treatment, lifestyle characteristics, pelvic pain and Health-related quality of life (HRQoL). Measures included the generic and cancer-specific scores on the Functional Assessment of Cancer Therapy–General (FACT-G) and the Female Genitourinary Pain Index (GUPI). The total scores and subdomains were compared with descriptive variables (age, body mass index (BMI), diet, exercise, disease status, treatment and support group attendance) using Cronbach alpha (α), Spearman rank correlations (ρ), and Holm’s Bonferroni method. Results One–hundred and forty-nine women completed the survey; 55% (N = 81) were older than 60 years, 38% (N = 45) were obese (BMI > 30), 46% (N = 66) exercised daily, and 84% (N = 111) ate one or more daily serving of fruit and vegetables. Women in remission, those who exercised daily and ate fruits/vegetables were less likely to have their symptoms impact their QoL. Younger women were more likely to report genitourinary issues (p = − 0.22) and overall problems with QoL (p = − 0.29) than older women. Among FACT-G support group responses, we found those that did not attend support groups had a significantly higher emotional wellbeing (p = 0.05). Conclusions This study identified potential areas of clinical focus, which aid in understanding our approach to caring for gynecologic cancer patients and improvement of their HRQoL. We identified that age, pelvic pain, and lifestyle characteristics have indicators to poor QoL in women with gynecologic cancers. In this population, younger women and those with pelvic pain complaints, poor diet and exercise habits should be targeted early for supportive care interventions to improve QoL throughout both treatment and survivorship.

Objective Genetic predisposition to ovarian cancer is well documented. With the advent of next generation sequencing, hereditary panel testing provides an efficient method for evaluating multiple genes simultaneously. Therefore, we sought to investigate the contribution of 19 genes identified in the literature as increasing the risk of hereditary breast and ovarian cancer (HBOC) in a BRCA1 and BRCA2 negative population of patients with a personal history of breast and/or ovarian cancer by means of a hereditary cancer panel. Methods Subjects were referred for multi-gene panel testing between February 2012 and March 2014. Clinical data was ascertained from requisition forms. The incidence of pathogenic mutations (including likely pathogenic), and variant of unknown significance were then calculated for each gene and/or patient cohort. Results In this cohort of 911 subjects, panel testing identified 67 mutations. With 7.4% of subjects harboring a mutation on this multi-gene panel, the diagnostic yield was increased, compared to testing for BRCA1 and BRCA2 mutations alone. In the ovarian cancer probands, the most frequently mutated genes were BRIP1 (n=8; 1.72%) and MSH6 (n=6; 1.29%). In the breast cancer probands, mutations were most commonly observed in CHEK2 (n=9; 2.54%), ATM (n=3; 0.85%), and TP53 (n=3; 0.85%). Conclusions Although further studies are needed to clarify the exact management of patients with a mutation in each gene, this study highlights information that can be captured with panel testing and provides support for incorporation of panel testing into clinical practice.

e18195 Background: Ovarian cancer (OC) has a very poor clinical prognosis, with an average 5-year survival rate of < 50%. Symptoms indicating OC are often nonspecific and overlap with gastrointestinal (GI) diagnosis (eg, gastroesophageal reflux disease [GERD], diverticulosis, irritable bowel syndrome [IBS]). Thus, OC diagnosis can be difficult, with most cases diagnosed at an advanced stage. This study examined whether women with a prior GI diagnosis are more likely to undergo neoadjuvant chemotherapy (CT) as their initial OC treatment modality compared to those without a prior GI diagnosis who may be likely candidates for primary debulking surgery (PDS). Methods: This retrospective study identified patients with newly diagnosed OC in the United States from January 2014–July 2018 using MarketScan Commercial and Medicare Supplemental Databases. Analysis was limited to women with commercial or Medicare coverage for ≥12 months before and ≥1 month after the index date (defined as the earliest date of an OC diagnosis or surgery) who underwent CT or PDS. Patients with GI symptoms were identified by diagnosis codes from claims in the year before the OC index date. Logistic regression analysis was used to test the hypothesis that women with a prior GI diagnosis are diagnosed with more advanced OC as signaled by their initial OC treatment (CT vs PDS) compared to women without a prior GI diagnosis. Results: Of the 5865 patients with OC identified, 23% had a diagnosis of ≥1 of the following GI disorders before their OC diagnosis: IBS, inflammatory bowel disease, diverticulosis, and GERD. Of these patients, 40% and 60% had GI disorders that occurred 6–12 months before and < 6 months before their OC diagnosis, respectively. Women with a GI diagnosis were more likely to undergo CT versus PDS as their first OC treatment (odds ratio [OR], 1.37; P < 0.0001), even when controlled for age, region, insurance plan type, and index year (OR, 1.23; P = 0.0021). Conclusions: In this administrative claims database, nearly one-quarter of women with OC had a prior GI diagnosis within the past year and were at greater odds of being diagnosed with more advanced disease requiring CT prior to surgical intervention.

Bevacizumab is the first antiangiogenic agent to have demonstrated benefit as first-line and maintenance therapy in epithelial ovarian cancer (EOC), with the Gynecologic Oncology Group 218 and ICON 7 phase III trials revealing significantly prolonged progression-free survival (PFS) for carboplatin/paclitaxel plus bevacizumab followed by bevacizumab maintenance versus carboplatin/paclitaxel alone. Results are forthcoming from several phase III maintenance trials of investigational antiangiogenic agents, each evaluating PFS as the primary endpoint: AGO-OVAR12/LUME-Ovar1 (nintedanib [BIBF 1120]), AGO-OVAR16 (pazopanib), and TRINOVA-1, -2, and -3 (AMG 386). Here we review available data and ongoing clinical trials of investigational antiangiogenic agents as maintenance therapy for EOC. Current controversies, including uncertainties regarding the (1) most appropriate clinical trial endpoints, (2) optimal dosing, duration, and timing of therapy (e.g., with first-line chemotherapy and/or as maintenance monotherapy), and (3) feasibility, tolerability, and cost of adding these agents to platinum/taxane regimens are also highlighted.

Objectives To present responses to sexual function items contained within the quality of life (QOL) survey of the Gynecologic Oncology Group LAP2 study, to investigate associations between sexual function and other factors (such as relationship quality and body image), and to explore patterns of response in patients with endometrial cancer. Methods Participants enrolled in the LAP2 QOL study arm completed a self-report QOL survey, which contained sexual function items, before surgery, and at 1, 3, and 6 weeks and 6 months after surgery. Responses to sexual function questions were classified into 3 patterns—responder, intermittent responder, and nonresponder—based on whether the sexual function items were answered when the QOL survey was completed. Results Of 752 patients who completed the QOL survey, 225 completed the sexual function items within the QOL survey, 224 responded intermittently, and 303 did not respond at all. No significant differences of sexual function were found between the patients randomized to laparoscopy compared to laparotomy. Among those who responded completely or intermittently, sexual function scores declined after surgery and recovered to presurgery levels at 6 months. Sexual function was positively associated with better quality of relationship (P Conclusion Our findings suggest that younger patients, those who were married, and those who had quality relationships were more likely to answer the sexual function items and have better quality of sexual function. Factors such as age, relationship quality, body image, and pain may place women with endometrial cancer at risk for sexual difficulties in the immediate recovery period; however, sexual function improved by 6 months postoperatively in our cohort of patients with early-stage endometrial cancer.

Background After platinum and taxane chemotherapy, with or without bevacizumab, active regimens for advanced or recurrent cervical cancer are lacking. Our objective was to review a single institution experience in treating recurrent, refractory cervical cancer with nano-particle albumin bound (NAB) paclitaxel with or without bevacizumab. Methods This retrospective case series was conducted in accordance with the regulations set forth by the Institutional Review Board at St. Joseph’s Hospital and Medical center. The chemotherapy log at the outpatient infusion center at the University of Arizona Cancer Center was reviewed to identify all advanced cervical cancer patients treated with NAB-paclitaxel from November 2011 until February 2015. The following data points were extracted from patient charts: demographic information, number of cycles, progression free survival (PFS), overall survival (OS), dose reductions and dose-limiting toxicities. In addition the average number of treatment cycles and age at recurrence were calculated. Results A total of 12 subjects were identified as receiving treatment with NAB-paclitaxel. Mean age at time of recurrence was 47.2 years (36–55). Nine subjects had squamous cell histology and three subjects had adenocarcinoma histology. All subjects had failed treatment with platinum and taxane, or platinum and topotecan chemotherapy. Two subjects were lost to follow up. The Median number of cycles of NAB-paclitaxel was 6.5 (2–19). The total number of cycles of NAB-paclitaxel in the study population was 65. Seven subjects were treated in combination with bevacizumab. Of these, three subjects are still alive and one subject is currently receiving active treatment with NAB-paclitaxel. The median PFS and OS for all subjects that met mortality endpoint was 4.8 months and 8.9 months (n = 7), respectively. One subject discontinued NAB-paclitaxel secondary to peripheral neuropathy, and one subject developed a vesicovaginal fistula while obtaining combination NAB-paclitaxel and bevacizumab therapy. Conclusions NAB-paclitaxel with or without bevacizumab is tolerable and potentially active in treating recurrent cervical cancer after failing platinum-taxane or topotecan chemotherapy. This small case series deserves confirmation through prospective clinical trials.

The rising number and increasing longevity of the elderly population calls for improvements and potentially a more personalized approach to the treatment of cancer in this group. Elderly patients frequently present with a number of comorbidities, complicating surgery and chemotherapy tolerability. In the case of ovarian cancer, elderly women present with more advanced disease, making the issue of providing adequate treatment without significant morbidity critical. Most studies support the application of standard of care treatment to elderly women with ovarian cancer, yet it seems to be offered less frequently in the elderly. The objective of this review is to examine the application and outcome of standard of care treatment in elderly women with ovarian cancer. The aim is to ultimately improve the approach to treatment in this group.

Despite improvements in our understanding of the progression of cervical intraepithelial neoplasia (CIN) to invasive cancer, cervical cancer is the leading cause of cancer deaths in women of developing nations [1–3]. Although the overall incidence in the United States has decreased dramatically over the years, patients who belong to a certain minority and/or low-income populations remain at high risk for cervical cancer. This may be due to a lack of access to health care and/or a lack of compliance once access has been granted. Disparities are known to exist among the US population in relation to incidence rates of cervical cancer, including racial and ethnic disparities [1, 4], especially in African American and Latina women [5]; age [6]; and socioeconomic status such as income, health care access, and education level [7, 8]. There are also discrepancies in prevention, screening, and treatment [1, 9]. Thus, an effort should be made to design and implement effective intervention strategies to improve compliance among high-risk patients. Originating from a high-risk human papillomavirus (HPV) infection, invasive cervical cancer may take years to tens of years to progress, with potential opportunities to identify and treat CIN accordingly [10]. For women with persistently abnormal Pap test results, follow-up is based on the American Society for Colposcopy and Cervical Pathology (ASCCP) 2006 Consensus Guidelines, including screening via Pap test, then colposcopy-directed biopsy and/or elimination of cancer precursors through excisional procedures and continued surveillance and follow-up of care [11, 12]. This requires multiple visits to the doctor to avoid missed disease. Thus, noncompliance with any of these procedures may increase the risk of advanced CIN and/or the development of invasive cervical cancer [13–15]. Although research has revealed that progression to invasive cervical cancer or even the most severe CIN (CIN 3) does not occur in most HPV-infected women owing to regression of the infection [16–18], visits to the gynecologist are still necessary to detect advanced CIN and/or changes in cervical cells. It is likely that uninsured patients who do go on to develop a preventable disease like cervical cancer cause significant drain of public resources. This could include such expenses as radical surgery/chemoradiation (if curable) or possibly multiple emergency room visits, imaging, and palliative therapies (if incurable). Funding colposcopy clinics in areas of high-risk patients (i.e., areas of patients with low socioeconomic status) may help to offset the cost of caring for even one patient that develops advanced disease that would otherwise have been preventable. Furthermore, even though one may argue that most cases of CIN 1 and CIN 2 regress spontaneously, ultimately, some develop a worse preinvasive disease necessitating excisional procedures that may affect a patient's fertility and pregnancy outcomes, which are also likely impacting cost [19]. Thus, the objective of this study was to describe non-compliance with triage of abnormal Pap smear results and colposcopy in an inner-city, primarily government-funded program. Through exploration of risk factors associated with better follow-up, the goal was to be able to better define the patients at highest risk for noncompliance.

Objective To explore feasibility of measuring tumor blood flow as marker for antiangiogenic activity using DCE-MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging) in women with recurrent EOC/PPC treated with bevacizumab. Methods In a phase II study, 62 patients with recurrent/persistent EOC/PPC were treated with bevacizumab (15mg/kg IV q21days) until disease progression. DCE-MRI was performed pre-cycle 1 and 4 of bevacizumab. Images were analyzed retrospectively by a single experienced blinded radiologist. Tumor and muscle contrast enhancement was measured by region of interest signal intensity within the same DCE-MRI images. Flow rates were obtained with concentration of dye as a function of time. Relative blood flow (RBF) was calculated as a ratio of average blood flow into tumor to muscle tissue. Associations between RBF and characteristics/outcomes were explored. Results Sixty-two patients were eligible for study. Unfortunately, only 14 (23%) patients had imaging data available for analysis at baseline and 13 of those same patients (21%) had imaging data available for analysis pre-cycle 4. The RBF distribution was similar from pre-cycle 1 to 4. RBF remained stable for the majority of the cases (median change -0.21). Baseline RBF was not significantly associated with being progression-free at 6months, microvessel density, 17month overall survival, tumor response, or platinum sensitivity. However, increases in blood flow rates were associated with likelihood to be progression-free at 6months. Conclusion Functional imaging of tumor blood flow is a potential research endpoint that may be explored further. Consideration should be given to timing of endpoint and standardizing the technique.

article i nfo Purpose. To determine associations between pretreatment health-related quality of life subscales with progression-free (PFS) and overall survival (OS) in advanced and recurrent cervical cancer. Patients and Methods. Patients included those participating in Gynecologic Oncology Group advanced or recurrent cervical cancer phase III treatment trials who completed the Functional Assessment of Cancer Ther- apy for patients with cervical cancer (FACT-Cx) and a single-item pain scale at study entry. The FACT-Cx in- cludes five domains: physical (PWB), emotional (EWB), social (SWB), functional well being (FWB), and cervix cancer subscale (CCS). A high quality of life (QoL) score reflects better QoL. After stratifying by protocol and adjusting for patient and disease characteristics, a Cox proportional hazards model was fitted for each subscale as a continuous variable. If statistically significant, (pb0.05), an analysis on mean item scores (MIS) was performed. Results. Nine-hundred-ninety-one patients were enrolled from 1997 to 2007. The majority (87%) had re- current disease. After adjustment for covariates and predictors, only the PWB domain (better physical QoL) was associated with improved OS (HR 0.96 95% CI 0.95-0.98; pb0.001). When classifying patients based on the MIS of each subscale, the patients with the lowest risk of death were likely to report less compromised QoL (MIS>3) for PWB (HR 0.44 (0.33-0.58) Pb0.001), FWB (0.49 (0.38-0.62) Pb0.001), and CCS (0.48 (0.38-0.61) Pb0.001). Conclusion. The pretreatment patient-reported PWB as measured by the PWB subscale of the FACT-Cx, is significantly associated with survival in advanced cervical cancer trials, even after controlling for known prognostic factors.

Although the incidence of ovarian cancer is less than that of other female cancers, the morbidity and mortality associated with the disease course is high. Because treatment involves radical surgery and intense courses of chemotherapy, health-related quality of life (HRQOL) is often compromised. Most patients recur post-first-line therapy and undergo multiple rounds of chemotherapy. Thus, HRQOL is further disrupted. As the ongoing search for optimal therapies in both the first-line and recurrent setting continues, much attention is paid towards clinical trial design and implementation. Over the last decade, patient-reported outcomes and HRQOL measurement have become an integral part of these trials. HRQOL data are valued in examining the extent of treatment benefit and therefore can aid in decision-making during active treatment and palliative care. HRQOL and patient-reported outcome measurement is also useful in determining symptom prevalence, severity and management. This article highlights the state of the science of HRQOL measurement in clinical trial design and outcomes. In addition, symptom management in ovarian cancer and its ability to modulate quality of life will be explored.

In the design of randomized clinical trials, quality of life (QOL) has become an important component across multiple cancer types. QOL includes the measurement of patient-reported outcomes, mostly described as the physical, social, emotional and functional wellbeing of the patient. These realms of wellbeing are reported by the patient themself and are thought to be a subjective measurement of response to treatment and/or treatment outcomes. Therapeutic interventions such as chemotherapy and/or radiation can thus be monitored from a patient perspective. In addition, while researchers and oncologists may recognize the futility of advanced and/or recurrent cancer therapy in the setting of reduced QOL, patients may have difficulty with discontinuing therapy. QOL research adds to the literature by introducing a patient perspective into the decision to treat aggressively. Specifically, in gynecologic cancers, there is a wide range of outcomes and patient characteristics to be considered. All three cancer settings – endometrial, cervical and ovarian – are remarkable in the QOL literature as this is a relatively new field with room to create interventions targeted towards improving QOL in often challenging clinical and life situations.

TPS5600Background: Patients with recurrent and metastatic cervical carcinoma experience modest survival benefit with first-line platinum-based chemotherapy with or without bevacizumab. Those with p...

Objective.: To identify patient characteristics which predict receipt of neoadjuvant chemotherapy (NCT) versus standard therapy (ST) in metastatic ovarian cancer. Methods.: A retrospective matched case control study was conducted of 52 women treated with NCT compared to 104 women who received standard treatment from 1996 to 2007. The t test was used for comparison of means between the groups, and the χ2test was used for categorical data. Multivariable analysis was performed with logistic regression models and only two-tailed analyses with a P value < 0.05 were considered statistically significant. Results.: Age, employment and marital status, and insurance alone did not affect treatment allocation (P = NS). However, non-Hispanic White (NHW) patients were more as likely to receive ST (P < 0.05). When insurance was stratified by ethnicity, NHW patients were twice as likely to have private insurance (OR = 2.29, CI = 1.16-4.53). Furthermore, medically compromised (MC) patients who were NHW were almost three times more likely to receive ST (OR = 2.72, CI = 1.02-5.00). In multivariate analysis, only MC and publically funded women were more likely to receive NCT (OR 3.83 CI = 1.35-11.11); P = 0.01). During surgery, patients receiving NCT were found to have smaller tumors and less ascites, and were more likely to be optimally debulked with lower estimated blood loss and shorter hospital stays. The median survival for ST was 55.8 months versus 26 months for NCT (P < 0.001). Conclusions.: Non-clinical factors such as publically funded status and non-Hispanic White race may influence the allocation of NCT for women with metastatic ovarian cancer. © 2009 Elsevier Inc. All rights reserved.

The rates of cervical cancer in the United States are low in comparison with developing nations. Whereas the Papanicolaou smear has performed well in terms of dectecting both precursors of squamous cell carcinoma and squamous cell carcinoma of the cervix, this test has been less successful at identifying those women with the highest-risk premalignant disease. The use of human papillomavirus testing has also contributed to the improved sensitivity of screening for cervical cancer. In light of this, the colposcopy clinic retains high referral rates yet has poor diagnostic accuracy. Unfortunately, patients are triaged to follow-up for abnormal Papanicolaou smears based on algorithms that rely on the less evidence-based techniques of colposcopy. Therefore, the need to improve the specificity of colposcopic-guided biopsy remains. The colposcopic procedure is highlighted in this review and evaluated in terms of current literature on technique, the colposcopic impression, cervical biopsy, and methods proposed to enhance appreciation of the highest-risk lesions. By outlining certain flaws in technique and discussing the proposal of new tests to supplement the current standard of care, this review aimed to highlight the need for future research to maintain sensitivity but improve the specificity of colposcopy.

ObjectiveThis study aimed to describe pretreatment patient characteristics and baseline quality-of-life scores as they relate to the development of grade 3 or 4 toxicity in patients receiving chemotherapy for advanced/recurrent cervical cancer.MethodsThe study sample was drawn from Gynecologic Oncology Group protocols 179 and 204. Grade 3 or 4 toxicities were considered in 4 specified categories as follows: peripheral neuropathy, fatigue, hematological, and gastrointestinal (GI). The data variables explored included age, stage, pretreatment radiation, performance status (PS) at treatment initiation, and baseline Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) score. A logistic regression model was developed with various adverse events as binary (0/1) outcomes.ResultsSix hundred seventy-three patient-reported questionnaires were used in the analyses. At baseline, pain was the most severe patient-reported symptom. Baseline line-item patient concerns did demonstrate specific correlations with the development of individual toxicities. In 401 patients who were enrolled on Gynecologic Oncology Group 204 (fatigue not measured on 179), a worse PS predicted the development of grade 3 or 4 fatigue (odds ratio, 2.78; 95% confidence interval, 1.66–4.68). Exposure to previous radiation, treatment regimen, and a worse FACT-Cx score were associated with the reporting of both grade 3 or 4 leukopenia (P< 0.05) and anemia (P< 0.0005). Performance status and treatment regimen (P< 0.05) were associated with the development of grade 3 or 4 thrombocytopenia. Age and treatment regimen (P< 0.05) were associated with the development of grade 3 or 4 neutropenia. The FACT-Cx score (P= 0.0016) predicted grade 3 or 4 GI toxicity.ConclusionsThe development of fatigue, hematological, and GI toxicity might be predictable based on factors other than treatment assignment such as age, PS, and patient-reported quality-of-life measurement.

Malignant eccrine spiradenoma is a rare skin tumor of sweat gland origin. We present the first reported case of this tumor in the female genitalia. Due to the rarity of this tumor, there has yet to be an established standard of care. The present case is that of a 41-year-old woman with malignant eccrine spiradenoma of the periclitoral region. She had an 18-month history of a recurrent, painful mass adjacent to the clitoris. Her diagnosis was made after excision of the cystic tumor. The patient then underwent a partial radical vulvectomy with bilateral sentinel lymph node sampling. As malignant eccrine spiradenoma is a rare tumor, no standard care exists for treatment and postoperative management. Based on our review of the literature, wide local excision appears to be the preferred initial treatment. Furthermore, adjuvant chemotherapy and/or radiation does not seem to improve survival in patients with advanced or recurrent cancer. Although lymph node sampling and/or lymphadenectomy is frequently reported in the treatment of this tumor, hematogenous metastasis can also occur. Therefore, these patients require close postoperative follow-up for recurrent disease.

Most women with ovarian cancer will suffer a recurrence. Unfortunately, although initial treatment can lead to undetectable disease, recurrent disease is often more challenging to control. As curative intent is less common after relapse, patients and doctors argue for improving quality-of-life (QoL) outcomes when therapies are selected. The article reviewed here discusses the QoL results of a trial in platinum-sensitive recurrent ovarian cancer where over 900 patients were randomized to the standard treatment (carboplatin and paclitaxel) versus carboplatin and pegylated liposomal doxorubicin. In the paper under evaluation, the standard of care is challenged based on a favorable clinical outcome in addition to QoL results in the experimental arm.

To describe characteristics associated with neurotoxicity (NT) in advanced ovarian cancer patients treated on Gynecologic Oncology Group 218 and examine effect of substituting docetaxel for paclitaxel in these patients.The development of NT was defined as Common Toxicity Criteria grade (G)≥1. The association between substitution with docetaxel and NT improvement was explored with generalized estimating equations adjusting for treatment cycle and NT grading at previous cycle.Of 1864 evaluable patients, 1329 (71%) developed G≥1 NT during the study. Nearly half appeared within the first two cycles of chemotherapy, with 31% experiencing G≥2. Older patients or those with worse quality of life (QoL) scores at baseline (p0.05) were more likely to experience NT. One-hundred-six patients received docetaxel as substitute for paclitaxel. Of them, 47 patients started with docetaxel at cycle one due to reaction to paclitaxel (n=32), fear of NT (n=4), and other reasons (n=11), whereas 59 patients switched to docetaxel during cycle 2-6 due to NT (n=32), reaction to paclitaxel (n=19), and other reasons (n=8). Although the protocol instructed otherwise, the majority continued paclitaxel despite G≥2 NT symptoms. There was no evidence that substitution with docetaxel improved NT (Odds Ratio: 1.57; 95% CI 0.98-2.54; p0.05). Of 59 patients who switched to docetaxel, only seven (12%) discontinued taxane prior to chemotherapy completion. A roughly equal chance of worsening NT was reported on paclitaxel (6%) as on docetaxel (5%).Age and worse QoL at baseline are associated with NT. Substitution of docetaxel did not improve NT symptoms.

Background To determine the protein expression profile (PEP) of primary and recurrent ovarian cancer patients in order to predict therapeutic targets for chemotherapy. Methods Tissue samples were submitted for PEP in two formats, including formalin-fixed paraffin-embedded tissue for immunohistochemistry (IHC) and fresh frozen tissue for oligonucleotide microarray (MA) gene expression assays. Specimens were analyzed for 18 protein markers and 88 MA genes. A series of Generalized Linear Models (GLM) was used to predict the proportion of positive results by histology for each biomarker. Results Four hundred and twenty-eight specimens were analyzed for IHC and 67 specimens for MA analysis. The majority of specimens, 82%, were serous histology and 35.3% of specimens were poorly differentiated. Sixty percent of specimens were advanced stage, 62% were from a primary diagnosis, and 53% were obtained from a metastatic site. BCRP, ER, MGMT, and RRM1 proteins were overexpressed in 85%, 47%, 93%, and 47% of serous carcinomas, respectively. The MGMT and RRM1 biomarkers were significantly overexpressed in serous (p

© 2014 Elsevier Inc. All rights reserved. Introduction The purpose of this study is to identify factors that are associated with poor quality of life (QOL) among cervical cancer survivors.Methods Patients identified through the California Cancer Registry were recruited to participate in a randomized counseling intervention. Patient-reported outcomes (PROs) were collected at study baseline (9-30 months post-diagnosis) and subsequent to the intervention. Multivariable linear models were used to identify independent factors associated with poor baseline QOL.Results Non-Hispanic (N = 121) and Hispanic (N = 83) women aged 22-73 completed baseline measures. Approximately 50% of participants received radiation therapy with or without chemotherapy. Compared to the US population, cervical cancer patients reported lower QOL and significantly higher levels of depression and anxiety (26% and 28% > 1 SD above the general population means, respectively). Among those in the lowest quartile for QOL, 63% had depression levels > 1 SD above the mean. In addition, treatment with radiation ± chemotherapy (p = 0.014), and self-reported comorbidities predating the cancer diagnosis (p < 0.001) were associated with lower QOL. Sociodemographic characteristics explained only a small portion of variance in QOL (r2= 0.23). Persistent gynecologic problems, low social support, depression, somatization, less adaptive coping, comorbidities, sleep problems and low education were all independently associated with low QOL in multivariate analysis (r2= 0.74).Conclusion We have identified key psychological and physical health factors that contribute significantly to poor quality of life subsequent to definitive cancer treatment. The majority of these factors are amenable to supportive care interventions and should be evaluated at the time of primary treatment.

Gynecologic cancer patients frequently desire alternative and/or complementary interventions or medicines to aid in relief of both cancer-related and treatment-related side effects. Furthermore, women also seek treatment to aid in superior outcomes and cure rates. Unfortunately, evidence suggests that the use of complementary and/or alternative medicine (CAM) is underreported or not discussed with physicians providing cancer care. In gynecologic cancer literature, there is a lack of scientific evidence either supporting or negating CAM. Because of the lack of information available, health care providers do not have good information regarding safety, efficacy, and dose of CAM. This leads to miscommunication or absence of communication between providers and patients. Because patients do use CAM to improve quality of life (QOL) during and after treatment, it would be educational for providers to know the specific QOL deficits among patients that require attention. Thus, with the ultimate goal of improving QOL for gynecologic cancer patients, providers should be pushed to investigate CAM and determine an honest support or rejection of these therapies.