Functional Assessment Of Cancer Therapy-Ovarian Research Articles

Hyperthermic intraperitoneal chemotherapy (HIPEC) vs. postoperative intraperitoneal (IP) chemotherapy – Impact on health-related quality of life in primary ovarian cancer patients after cytoreductive surgery

PurposeTo compare health-related quality of life (HRQL) in primary ovarian cancer (OC) patients with peritoneal metastases (PM) after undergoing upfront cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) as part of a phase 2 trial (NCT-02124421). MethodsPatients with stage III/IV high-grade serous OC were randomized (1:1) to either CRS/HIPEC with carboplatin followed by 6 cycles of adjuvant systemic chemotherapy (carboplatin/paclitaxel) or CRS followed by 6 cycles of combination intraperitoneal/intravenous chemotherapy (cisplatin/paclitaxel). The trial outcome index (TOI) of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire was used to assess HRQL. The FACT-O was administered at randomization and postoperatively at 6 weeks and 6, 12, and 24 months, or until disease recurrence/death. HRQL was analyzed using a linear mixed model. ResultsSixteen patients were enrolled in each group. All (32/32) patients completed questionnaires at baseline and 53.1 % (17/32) at 24 months. Reasons for missing scores were similar between groups. Average TOI was similar between treatment arms at each time point. In both arms, mean TOI was below baseline at 6 weeks (p = 0.798) and 6 months (p = 0.821) after CRS, but recovered at 12 months (p = 0.518). No significant differences were found in FACT-O total score or FACT-O individual dimensions over time between groups. ConclusionsNo long-term HRQL impairment was observed when HIPEC was added to CRS in primary OC. Access to CRS/HIPEC as primary treatment of PM in OC should not be solely limited by concerns for patient HRQL. SynopsisHealth-related quality of life (HRQL) was evaluated in primary ovarian cancer patients participating in a phase 2 trial comparing cytoreductive surgery (CRS)/HIPEC vs CRS + intraperitoneal (IP) chemotherapy. No differences between groups or long-term HRQL impairment were observed.

HIPEC after neoadjuvant chemotherapy is associated with acceptable toxicity and favorable quality of life in newly diagnosed advanced ovarian cancer patients

ObjectiveTo evaluate toxicity, quality of life and PFS in patients with advanced ovarian cancer who underwent neoadjuvant chemotherapy (NAC) followed by CRS and HIPEC with carboplatin. MethodsPatients with stage IIIC or IVA epithelial ovarian cancer, who were not candidates for primary CRS, were enrolled in this phase two trial. Patients received 3–6 cycles of NAC with an IV carboplatin doublet followed by CRS with HIPEC (carboplatin 800 mg/m2 for 90 min). They were followed for at least 12 months to assess for adverse events, quality of life (QOL) and disease progression. QOL was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaires prior to CRS and post-operatively at 6 weeks, 3 months, and 6 months after CRS. ResultsTwenty patients were enrolled. HIPEC was completed successfully in all twenty patients, and there was no peri-operative mortality. Twelve (70.6%) patients experienced a grade 3 or 4 toxicity; most commonly anemia (59%), thrombocytopenia (29%), and hypokalemia (24%). There was no significant change between the pre-operative and postoperative 6 weeks, 3 month, and 6 month FACT-O, NTX, and AD scores. Nine (45%) patients have experienced disease recurrence to date. The median progression free survival in this cohort is 11.2 months (2.5–23.7 months). ConclusionThe addition of HIPEC with carboplatin to interval CRS was well tolerated in patient population. Myelosuppression was the most common adverse event. CRS with HIPEC did not adversely impact these patients' QOL indices. The efficacy of this regimen should be further evaluated in a larger clinical trial.

HIPEC after neoadjuvant chemotherapy is associated with acceptable toxicity and favorable quality of life in newly diagnosed advanced ovarian cancer patients (509)

HIPEC after neoadjuvant chemotherapy is associated with acceptable toxicity and favorable quality of life in newly diagnosed advanced ovarian cancer patients (509)

H.O.P.E. & Healing: a randomized pilot study of structured palliative care referrals in recurrent ovarian cancer

<h3>Objectives:</h3> The inclusion of palliative care (PC) across the cancer continuum has been identified as a marker of high-quality cancer care. With limited PC specialists, integrated approaches may be necessary with the primary oncologist providing this care. However, recurrent ovarian cancer patients often have significant physical and/or emotional needs that may be best addressed by PC specialists. Our primary objective was to test the effect of a structured PC intervention on quality of life (QOL) for patients with recurrent ovarian cancer. Secondary objective was to assess the effect of the structured PC approach on overall survival. <h3>Methods:</h3> This was an IRB approved prospective randomized controlled trial at 2 academic institutions and was registered with clinicaltrials.gov (NCT02090582). Eligible patients included those with platinum resistant ovarian cancer or platinum sensitive cancer with a sentinel clinical event (recent bowel obstruction, liver metastases, pleural effusion or ascites). Subjects were randomized 1:1 to usual care versus a structured palliative care intervention (see Figure 1). Quality of life was assessed using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL) at baseline and 12-week intervals. Wilcoxon tests were used to detect differences between arms. Overall survival was analyzed using Kaplan-Meyer curves. <h3>Results:</h3> A total of 54 subjects were enrolled from 5/2014-4/2016; 26 in the intervention arm and 28 in the control arm. Median follow up was 6.5 months (Range: 2-12months). Median age of subjects was 63 with an ECOG performance status of 1. The majority of patients were Caucasian (44; 81.5%) and had platinum resistant disease (37; 68.5%). Most patients had received between 1-3 prior lines of chemotherapy (34/54; 63%); 5 patients (9.2%) had received ≥6 lines of therapy. There was no difference in overall or subset QOL in patients receiving usual care compared to those in the structured PC arm (p=0.14). There were no differences in hospital admissions (p=0.96), days from last chemo to hospice admission (p=1.0), days from hospice admission to death (p=0.41), place of death (p=0.68) or number of PC appointments (p=0.30) between the two arms. Patients enrolled in the 2nd half of the cohort were more likely to die at home rather than in the hospital or inpatient hospice (p=0.01) compared to subjects enrolled early in the study period. 81% of subjects randomized to the intervention arm completed at least 1 QDACT assessment (range 1-17). Similarly, there was no overall survival difference between the 2 arms (9.3m vs 10.1m; p=0.21). <h3>Conclusions:</h3> Structured integrated approaches between gynecologic oncology providers and PC specialists are feasible. The QDACT tool may be an effective, standardized measure to assess cancer symptom burden over time in this population. Further study is needed to identify interventions and collaborations that may have the greatest impact on QOL for recurrent ovarian cancer patients.

PCN222 Health Related Quality of Life (HRQoL) Review in Patients with Ovarian Cancer: A Systematic Literature Review (SLR)

HRQoL estimates are essential components of an effectiveness analysis for a new treatment. The purpose of this research was to review the HRQoL measures used in understanding ovarian cancer (OC) treated with poly(ADP) ribose polymerase inhibitors (PARPi). A SLR was conducted using the Population, Intervention, Comparator, Outcome, Study Design (PICOS) model. Cochrane Library, Medline via Embase, and PubMed were searched for articles in English (2012-July 2020) that addressed HRQoL measured by patient reported outcomes in recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers in treatment with PARPis. All countries were included. Six studies met the final criteria for inclusion. Three PARPis (olaparib, niraparib, and rucaparib) were identified that assessed HRQoL. Instruments used were EuroQoL five-dimension scale (EQ-5D), Functional Assessment of Cancer Therapy-Ovarian (FACT-O), Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI), Trial Outcomes Index (TOI), and Quality-Adjusted Progression-Free Survival (QAPFS). Niraparib was comparable to placebo when measured via EQ-5D; niraparib and olaparib were comparable to placebo via FOSI; olaparib was comparable to placebo via FACT-O; olaparib was comparable to placebo via TOI. Olaparib (in 2 studies) and rucaparib had longer QAPFS than placebo. There was no single tool or result common across all assessed interventions. Across all indices, olaparib, niraparib, and rucaparib showed mixed results in terms of HRQoL outcomes compared to placebo. Although patients showed improvement in QAPFS with two PARPis their HRQoL did not seem to improve. This could be due to the drugs’ side-effects or method used to measure HRQoL in these studies. To better understand HRQoL and address the unmet needs in recurrent OC patients, additional research using more advanced methodology is needed.

Disparities in health-related quality of life in women undergoing treatment for advanced ovarian cancer: the role of individual-level and contextual social determinants.

Social determinants may influence health-related quality of life (HRQOL) among women with ovarian cancer, potentially creating disparities in clinical outcomes. We investigated the relationship between HRQOL and social determinants of health, including travel distance to access cancer care and health insurance type, among women participating in a randomized trial of primary adjuvant treatment for advanced ovarian cancer. The Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire captured HRQOL (physical well-being, functional well-being, ovarian-specific, and trial outcome index [TOI]) prior to chemotherapy (baseline), during the trial, and 84weeks after initiation of chemotherapy for women with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. We constructed bivariate and multivariable linear mixed effects models examining the associations of social determinants of health (individual-level and contextual factors) with HRQOL scores at 84weeks, clustering participants (n = 993) within treatment centers, and Census regions and controlling for baseline HRQOL. Most individual-level (race, age, cancer stage, adverse events) and contextual (travel distance to treatment center, community socioeconomic status) factors were not statistically significantly associated with HRQOL. Compared to participants with private health insurance, other participants had lower mean HRQOL (physical well-being: public insurance, - 1.00 (standard error[SE] = 0.49) points, uninsured, - 1.93 (SE = 0.63) points; functional well-being: public, - 1.29 (SE = 0.59), uninsured, - 1.98 (SE = 0.76); ovarian cancer-specific: public, - 1.60 (SE = 0.59), uninsured, - 1.66 (SE = 0.75); TOI: public, - 3.81 (SE = 1.46), uninsured, - 5.51 (SE = 1.86); all p < .05). Private health insurance was associated with improved HRQOL at the completion of treatment for advanced stage ovarian cancer. Implications of health insurance on HRQOL should be further investigated, particularly among women with ovarian cancer who receive standard of care treatment.

Estimating health-state utility values for patients with recurrent ovarian cancer using Functional Assessment of Cancer Therapy - General mapping algorithms.

ObjectivesIn the absence of EuroQol 5D data, mapping algorithms can be used to predict health-state utility values (HSUVs) for use in economic evaluation. In a placebo-controlled Phase II study of olaparib maintenance therapy (NCT00753545), health-related quality of life was measured using the Functional Assessment of Cancer Therapy – Ovarian (FACT-O) questionnaire. Our objective was to generate HSUVs from the FACT-O data using published mapping algorithms.Materials and methodsAlgorithms were identified from a review of the literature. Goodness-of-fit and patient characteristics were compared to select the best-performing algorithm, and this was used to generate base-case HSUVs for the intention-to-treat population of the olaparib study and for patients with breast cancer antigen mutations.ResultsFour FACT – General (the core component of FACT-O) mapping algorithms were identified and compared. Under the preferred algorithm, treatment-related adverse events had no statistically significant effect on HSU (P>0.05). Discontinuation of the study treatment and breast cancer antigen mutation status were both associated with a reduction in HSUVs (–0.06, P=0.0009; and –0.03, P=0.0511, respectively). The mean HSUV recorded at assessment visits was 0.786.ConclusionFACT – General mapping generated credible HSUVs for an economic evaluation of olaparib. As reported in other studies, different algorithms may produce significantly different estimates of HSUV. For this reason, it is important to test whether the choice of a specific algorithm changes the conclusions of an economic evaluation.

885PD - Health-Related Quality of Life (Hrqol) During Olaparib Maintenance Therapy in Patients with Platinum-Sensitive Relapsed Serous Ovarian Cancer (Psr Soc) and a Brca Mutation (Brcam)

ABSTRACT Aim: Maintenance monotherapy with the PARP inhibitor olaparib significantly prolonged progression-free survival (PFS) versus placebo in patients with PSR SOC, and subsequent analysis has shown that patients with a BRCAm receive greater treatment benefit (Ledermann et al Lancet Oncol 2014). As preserved HRQoL may support chronic administration in the maintenance setting, the effect of olaparib on HRQoL was evaluated in this randomized, double-blind Phase II trial (NCT00753545). Methods: Patient-reported HRQoL and disease-related symptoms were evaluated using the Functional Assessment of Cancer Therapy Ovarian (FACT-O) questionnaire, FACT/NCCN Ovarian Symptom Index (FOSI) and Trial Outcome Index (TOI). Patients completed the FACT-O questionnaire at baseline and every 28 days until progression. Individual symptom severity over 7 days was measured using the five-item Likert scale; physical, social/family, emotional, functional wellbeing and specific concerns to ovarian cancer patients were assessed. The TOI of the FACT-O was the primary HRQoL endpoint. FOSI is the sum of a subset of eight symptom-related items. Results: Of patients randomized to olaparib (n = 136) or placebo (n = 129), BRCA mutation status data were available for 254/265 (96%), of whom 136/254 (53.5%) had a known deleterious/suspected deleterious germline or somatic BRCA mutation. Most patients reported a best response of ‘improved’ or ‘no change’ on TOI (Table); this trend was also seen in other HRQoL measures. There were no statistically significant differences in improvement rates or time to worsening of TOI, FOSI and Total FACT-O. Overall BRCAm BRCAwt Olaparib Placebo Olaparib Placebo Olaparib Placebo TOI N = 115 N = 111 N = 64 N = 53 N = 49 N = 54 Improved * 23 (20.0) 20 (18.0) 16 (25.0) 10 (18.9) 7 (14.3) 10 (18.5) No change† 72 (62.6) 67 (60.4) 38 (59.4) 30 (56.6) 32 (65.3) 36 (66.7) Worsened†† 16 (13.9) 20 (18.0) 7 (10.9) 10 (18.9) 9 (18.4) 8 (14.8) Non-evaluable 4 (3.5) 4 (3.6) 3 (4.7) 3 (5.7) 1 (2.0) 0 BRCAwt, BRCA wild type, includes patients with no known BRCAm or a variant of unknown significance. * Best response of improved defined as two visit responses of 'improved' a minimum of 21 days apart without an intervening visit response of 'worsened'. †Defined as two visit responses of 'no change' or a response of 'no change' and a response of 'improved' a minimum of 21 days apart without an intervening visit response of 'worsened'. No change is defined as a change from baseline of greater than -7 but less than +7.††Defined as a visit of 'worsened' without a response of 'improved' or 'no change' within 21 days. Worsened is defined as a change from baseline of less than or equal to -7. Conclusions: HRQoL was not negatively impacted during maintenance therapy with olaparib. Phase III trials are enrolling. Disclosure: J.A. Ledermann: Travel grants from AstraZeneca; P. Harter: Received a grant from AstraZeneca; C. Gourley: Served on advisory boards for, and received travel grants from, AstraZeneca; G.J.S. Rustin: Served on advisory boards for AstraZeneca, Oxigene, Roche, Amgen, Boehringer Ingelheim and Clovis; C. Scott: Received travel grants from AstraZeneca; A. Fielding, S. Spencer, B. Bennett and D. Parry: Employee of AstraZeneca and stock ownership. All other authors have declared no conflicts of interest.

Development of the measure of ovarian symptoms and treatment concerns: aiming for optimal measurement of patient-reported symptom benefit with chemotherapy for symptomatic ovarian cancer.

The aim of this study was to determine the optimal patient-reported outcome measure (PROM) for assessing symptom benefit in trials of palliative chemotherapy for women with symptomatic ovarian cancer. Candidate PROMs were EORTC QLQ-C30 plus ovarian-specific QLQ-OV28, Functional Assessment of Cancer Therapy-Ovarian (FACT-O), FACT Ovarian Symptom Index (FOSI), and gynecologic cancer-specific Symptom Representation Questionnaire. Predefined optimality criteria were inclusion of all symptoms necessary for the specified purpose, recall period covering typical length of palliative chemotherapy, numerical item rating scales, and all necessary symptoms included in a single symptom index. Qualitative and quantitative methods were applied to data from stage 1 of the Gynecologic Cancer Intergroup Symptom Benefit Study to determine the set of necessary symptoms and to objectively assess candidate PROMs against the optimality criteria. Ten necessary symptoms were identified: pain, fatigue, abdominal bloating/discomfort, sleep disturbance, bowel disturbance, nausea and vomiting, shortness of breath, poor appetite, urinary symptoms, and weight changes. Although QLQ-C30 and QLQ-OV28 together cover all these symptoms, they split them into numerous scales, dissipating potential symptom-benefit signal. Conversely, FACT-O does not cover all necessary symptoms and contains many other HRQoL-related items and treatment side effects, diluting potential symptom-benefit signal when summed into scales. Item response scales and composite scoring of all candidate PROMs were suboptimal to our specific purpose. We therefore developed a new PROM, the Measure of Ovarian Symptoms and Treatment (MOST) concerns, to provide optimal measurement for the specified purpose. This article documents the development of the MOST, a new PROM designed to assess patient-reported benefits and burden as end points in clinical trials of palliative chemotherapy for women with symptomatic ovarian cancer. The validity, reliability, and statistical efficiency of the MOST, relative to the best candidate scales of existing PROMs, will be assessed in the stage 2 of Gynecologic Cancer Intergroup Symptom Benefit Study.

Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: Results from a randomized clinical trial

Objectives A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer. This manuscript reports prospectively collected health-related quality of life (HRQL). Methods Participants were randomized to either weekly docetaxel 30 mg/m 2/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m 2/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC). The primary HRQL endpoint was the trial outcome index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, and was assessed as an intent-to-treat analysis. The secondary HRQL endpoints included the FACT-O total score, the FACT-General, and several domain scores of the FACT-O instrument (physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and the ovarian cancer specific (OCS) module). The FACT-O was administered at randomization, prior to each of 6 cycles of treatment, and at study endpoint. Results One hundred forty-eight participants were randomized to each group. Sequential docetaxel followed by carboplatin (sDC) was associated with significant improvements in the FACT-O TOI (p = 0.013), FACT-O total score (p = 0.033), and OCS (p = 0.029) compared to the combination docetaxel and carboplatin group (cDC). Conclusions Sequential single agent docetaxel followed by carboplatin is associated with improved HRQL when compared to cDC. The improved progression-free survival observed with cDC should be weighed against lower quality of life during treatment.

The effect of sleep disturbance on quality of life in women with ovarian cancer

ObjectiveTo estimate the prevalence of sleep disturbances, and to determine if there is an association between sleep disturbances with quality of life (QOL), depression or clinical demographic variables. MethodsPatients diagnosed with ovarian, fallopian tube or primary peritoneal cancer during the last 5years completed questionnaires regarding sleep patterns and disturbances [Pittsburgh Sleep Quality Index (PSQI)], depression [Beck Depression inventory (BDI)], and QOL [The Functional Assessment of Cancer Therapy-Ovarian (FACT-O), fatigue module (−F)]. Data were analyzed by Student's t-test or Pearson correlation coefficient to determine if there were differences between PSQI score with QOL, depression or clinical demographic variables. Results86/275 (31% response) of patients returned the surveys. Mean age was 58.1 (SD=14.6) years and 70% had advanced disease at diagnosis. Thirty-six percent had current disease of which 81% were receiving chemotherapy. Sixty-seven percent of patients had a PSQI score≥5 corresponding to overall poor sleep quality and 46% of patients reported using sleep medication at least once during the prior month. PSQI score was significantly inversely correlated with all QOL domains (physical: r=−.599, p<.001, functional: r=−.692, p<.001, social: r=−.212, p<.001, emotional: r=−.379, p<.001, fatigue; r=−.655 p<.001) and with depression (r=.539, p<.001). PSQI was not correlated with age, time since diagnosis, number of previous chemotherapy regimens. PSQI score did not differ by current disease or chemotherapy status. ConclusionsSleep disturbances reduce QOL, a prognostic indicator for survival, in ovarian cancer patients. These patients should undergo routine screening and would benefit from interventions that aim to promote restful sleep.

A Comparison of Quality-of-Life Domains and Clinical Factors in Ovarian Cancer Patients: A Gynecologic Oncology Group Study

Women diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions. The primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy. Patients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively). Ovarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4-2.5, P<0.001, effect size=0.37) lower in PWB, 0.9 points (95% CI 0.3-1.5, P=0.005, effect size=0.13) lower in FWB, 5.0 points (95% CI 4.6-5.3, P<0.001, effect size=0.74) higher in SWB, and 0.8 points (95% CI 0.3-1.2, P<0.001, effect size=0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r=0.53 (P<0.001). Age was positively correlated with EWB (r=0.193; 95% CI 0.09-0.29). Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.

Assessment of factors that contribute to decreased quality of life in Gynecologic Oncology Group ovarian cancer trials

The objective of this study was to assess which quality-of-life (QOL) line items on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) were associated with low QOL in women who were receiving chemotherapy for ovarian cancer. Patients with stage III or IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent primary surgery followed by intravenous paclitaxel and cisplatin completed the FACT-O. The FACT scale includes the 4 domains of physical, functional, social, and emotional well being (PWB, FWB, SWB, EWB, respectively). Women who had overall FACT-O scores in the lowest quartile (Q1) were compared with women in the upper 3 quartiles (Q2-Q4). The proportions of women in each group that selected the 2 worst categories for each item were compared. The level of significance was set at P<.005. Before Cycle 4, 361 patients (86.4%) provided valid QOL assessments. For PWB, a significantly greater proportion of women in Q1 versus Q2 through Q4 selected the 2 worst categories of several physical symptoms (nausea, pain, feeling ill, and being bothered by the side effects of treatment). For FWB, significant differences included being able to work, being content with the quality of their life, and sleeping well. For EWB, there were significant differences in feeling nervous and worrying about dying. There were virtually no differences between groups in SWB. Low interest in sex was reported by 56% to 88% of all patients (Q1-Q4). A large proportion of women with FACT-O scores in the lowest quartile reported problems that potentially were amenable to clinical interventions, such as symptom management and psychosocial support.

Validation of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Symptom Index (FOSI) in a phase II clinical trial of pertuzumab in patients with advanced ovarian cancer

16021 Background: The FOSI is a very brief(8-item) index derived from the FACT-O to measure symptom response to treatment for ovarian cancer(OC). We evaluated its performance in a single arm Phase II clinical trial. Methods: The FOSI was administered to patients with advanced OC participating in a single arm Ph II clinical trial of pertuzumab(Gordon et al, JCO (2006) v24:4324;2006)). Pertuzumab, a humanized HER2 antibody is the first in a new class of investigational agents known as HER dimerization inhibitors(HDIs). Patients completed the FOSI at D1 of each 3 week cycle, up to 17 cycles. Validation analyses focused on data from the first 4 cycles and included Cronbach's alpha coefficients plus cross-sectional and longitudinal comparisons of groups defined by ECOG performance status (PS). Results: 62 patients completed the FOSI at baseline (B), 54 at cycle 2, 44 at cycle 3 and 27 at cycle 4. The FOSI showed acceptable internal consistency reliability with alphas of 0.73 to 0.80. The FOSI differentiated patients with PS 0 from those with PS =1 at each cycle (Table). There was a difference in FOSI scores in patients with worsened PS from those whose PS improved or was unchanged at cycle 2 only (p&lt;0.001). The ES (mean change/ SD of change scores) for the group with worsened PS was -0.77. The minimally important difference was estimated to be 2–3 points. Conclusions: The FOSI is a valid symptom measure in this population of OC patients, demonstrating acceptable reliability, validity and responsiveness to clinical change. [Table: see text] No significant financial relationships to disclose.

Optimism, Distress, Health-Related Quality of Life, and Change in Cancer Antigen 125 Among Patients With Ovarian Cancer Undergoing Chemotherapy

This study investigated whether situational and dispositional optimism were protective against dimensions of distress and aspects of health-related quality of life (HQoL) in patients with ovarian cancer undergoing chemotherapy. This study also evaluated whether optimism predicted a decrease in cancer antigen (CA) 125 levels during treatment. Ninety women with epithelial ovarian cancer were assessed at the start and end of chemotherapy. Optimism, distress, and HQoL were measured by self-report; CA 125 levels were gathered from patients' medical charts. Both measures of optimism were inversely associated with baseline anxiety, perceived stress, and depression. In addition, situational optimism was positively associated with baseline social and physical well-being, and dispositional optimism was positively associated with baseline social and functional well-being. However, neither measure of optimism predicted domains of distress or HQoL at the follow-up assessment after controlling for baseline levels. Dispositional optimism predicted CA 125 at the end of treatment after controlling for baseline levels. However, neither situational nor dispositional optimism predicted CA 125 falling to normal levels (< or =35 U/mL). Consistent with prior research, optimism was inversely associated with distress and positively associated with HQoL in patients with ovarian cancer undergoing chemotherapy. Higher levels of dispositional optimism at the start of chemotherapy were associated with a greater decline in patients' CA 125 during treatment.

Active coping mediates the association between religion/spirituality and quality of life in ovarian cancer

Objectives.This study investigated the role of religion/spirituality (R/S) and coping in quality of life (QOL) in 129 women immediately prior to a course of adjuvant chemotherapy for ovarian cancer. Methods.Participants completed the COPE, the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), and the Systems of Belief Inventory-15R (SBI-15R). Women averaged 58.9 years of age (SD = 11.5) and were primarily Caucasian (86%), married (74%), and had received at least some college education (67%). Eighty-five percent of the participants had stage III or IV ovarian cancer at study entry. Results.Correlational analyses revealed that R/S was associated with active coping (r = 0.23, P = 0.022), overall QOL (r = 0.25, P = 0.012), emotional and functional well-being (r = 0.24, P = 0.014 and r = 0.28, P = 0.004), and fewer ovarian cancer-specific concerns (r = 0.27, P = 0.006). In addition, active coping was related to overall QOL (r = 0.22, P = 0.029) and social and functional well-being (r = 0.20, P = 0.042 and r = 0.33, P = 0.001). Tests of mediation between these variables suggested that the positive associations between R/S and functional well-being and R/S and overall QOL were mediated through the use of active coping. Conclusion.Future studies are needed to better understand the complex relationships between R/S, coping, and QOL throughout the ovarian cancer treatment experience.

Quality-of-Life Comparisons in a Randomized Trial of Interval Secondary Cytoreduction in Advanced Ovarian Carcinoma: A Gynecologic Oncology Group Study

To compare self-reported quality of life (QOL) in patients who did versus did not undergo interval secondary cytoreduction after initial surgery and combination chemotherapy for advanced ovarian cancer and to assess the association between baseline QOL scores and survival. Consenting patients participating in a Gynecologic Oncology Group (GOG) phase III treatment trial (GOG 152) completed the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire and treatment-specific supplemental questions at the third and sixth chemotherapy cycles and at 6 and 12 months after starting treatment. For all patients, QOL decreased approximately 1 unit from the first to second assessment. Significant improvement observed at 6 months (P < .001) was sustained at 12 months, with no appreciable between-group difference. The baseline FACT-O score was associated with overall survival (P = .048) but not progression-free survival. Less neurotoxicity was reported among patients who did (38.4%) versus did not (54.0%) undergo interval secondary cytoreduction at the third assessment (P = .005), and older patients experienced more long-term effects. This is the first multicenter randomized trial in ovarian cancer to longitudinally examine self-reported QOL and establish a predictive value of baseline QOL on survival, attributed primarily to the lowest-scoring quartile. Although interval secondary cytoreduction resulted in no notable long-term difference, a clinically significant improvement was seen in both arms at 6 and 12 months after starting therapy. Interestingly, there were fewer complaints of neurotoxicity at 6 months among patients who did versus did not undergo interval secondary cytoreduction.

Quality of Life Evaluations of Caregivers of Ovarian Cancer Patients During Chemotherapy Treatment

Objectives: (1) To examine the quality of life (QOL) of caregivers of women undergoing chemotherapy for advanced ovarian cancers, and (2) to correlate the QOL measures of caregivers to those of the women undergoing chemotherapy.Methods: Over a 9-month period, all women undergoing chemotherapy for ovarian cancer at the Saskatoon Cancer Centre, and their caregivers, were offered participation. Two well-validated instruments were used to measure the "quality of life" concept. Women with ovarian cancer completed the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire in the clinic prior to each course of chemotherapy. Each caregiver completed a Caregiver Quality of Life Index - Cancer (CQOL-C) questionnaire at home at the start and Conclusion of each chemotherapy regimen (cycle I and after the last chemotherapy treatment). The demographics of the caregivers were described. A paired t test was used to detect changes to caregivers’ QOL scores before and after chemotherapy treatment. Correlation analysis was carried out to examine the relationship between the caregivers’ total QOL scores and the various subscale and total scores of the FACT-O questionnaires completed by the women with ovarian cancer. Multivariate regression models were constructed to examine the relative importance of each of the QOL domain measures of the woman with cancer in predicting the effect on her caregiver’s QOL.Results: Thirty different patient-caregiver pairs participated in the study. providing 50 separate assessments since not all pairs had completed the post-chemotherapy assessments. There was improvement (P < .05) in the caregiver’s QOL scores at the Conclusion of the chemotherapy treatment compared to the baseline assessments. The improvement was unrelated to the performance status or response to chemotherapy of the woman undergoing treatment. There was also a correlation (P < .05) between an increase in a caregiver’s distress and worsening scores in the "emotional;’ "functional;’ and "concerns" QOL domain assessments of the woman undergoing treatment. Stepwise regression analysis showed the "concerns" score, measuring specific ovarian cancer-related symptoms, to be the only predictor of a caregiver’s distress (P < .05).Conclusions: Standard chemotherapy for ovarian cancer does not worsen a caregiver’s QOL. There is a direct relationship between the QOL of women with cancer and that of their caregivers. Future research is required to identify how best to integrate the Results of QOL assessments in cancer treatment protocols and to examine the long-term effects of ovarian cancer and its treatment on both caregivers and the women for whom they care.

Quality of life evaluations in patients with ovarian cancer during chemotherapy treatment

Objectives. To examine the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. Patients and methods. Over 18 months period, all patients with ovarian cancer receiving chemotherapy at the Saskatoon Cancer Center were recruited. The Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. Platinum-based chemotherapy was used initially or in patients with a platinum-free interval of more than 6 months in a recurrence setting. After progression on the platinum-based regimens, liposomal doxorubicin, topotecan, and cisplatinum/etoposide were used as salvage chemotherapy pending on drug availability and convenience of administration to patients. Regression analysis was used to identify significant disease and treatment-related factors that can significantly affect patients' quality of life measures. Results. Seventy-two patients participated in the study providing 270 separate observations. The mean age was 57.81 years with a standard deviation of 13.40. The median duration of chemotherapy-free interval for patients with recurrent disease was 7 months. All patients had stage 3 or 4 disease. About half (52.2%) of the patients had optimal surgical resection with small (<1 cm) residual cancer masses before primary adjuvant chemotherapy. Seventy percent of the patients had either a first diagnosis or a first recurrence of cancer with the other 30% previously treated with two or more chemotherapy regimens. Sixty-two percent had an initial complete response to platinum-based chemotherapy. Multivariate regression analysis showed the use of topotecan or cisplatinum/etoposide, patients' poor responses to chemotherapy, experience with two or more previous line of chemotherapy treatment, and younger ages were significant predictors of poor quality of life during chemotherapy. Conclusion. There were significant differences in side effects of commonly used chemotherapy regimens on patients' quality of life. Quality of life assessments should be routinely incorporated in selecting specific chemotherapy to be used. Future research should be carried out to identify the best strategies to further integrate the results of quality of life assessments in cancer treatment protocols and to examine the long-term effects of cancer and its treatment on patients and their families.

Reliability and validity of the functional assessment of cancer therapy-ovarian.

To report the reliability and validity of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) in a consecutive series of outpatients with epithelial ovarian cancer. Two hundred thirty-two ovarian cancer patients attending an outpatient gynecologic oncology clinic completed questionnaires at baseline. The patients' FACT-O scores were compared with their performance status, disease stage, treatment status, and other factors hypothesized to be related to quality of life. Patients received a second questionnaire either one week after baseline to assess the instrument's test-retest reliability and/or two months after baseline to evaluate its sensitivity to change in performance status. Internal consistency and test-retest reliability of the FACT-O were adequate. Overall, the scales correlated with other measures as expected; all correlations were in the hypothesized direction. Patients with advanced disease, poor performance status, and who were receiving active treatment had lower scores on physical, functional, and ovarian cancer-specific scales. The total FACT-O and emotional well-being scores were lower for patients with poor performance status and patients in active treatment. The FACT-O total and all subscale scores except emotional well-being were sensitive to decreases in performance status. Overall, the FACT-O provides a reliable and valid assessment of the quality of life of women with ovarian cancer, and is appropriate as a brief quality of life assessment in clinical trials and descriptive studies.