Relationship between social support, quality of life, and Th2 cytokines in a biobehavioral cancer survivorship trial.

ObjectiveBenefits of social support (SS) during cancer survivorship are complex. This study examines change in SS over time in cervical cancer (CXCA) survivors who have completed definitive treatment and how changing SS impacts quality of life (QOL) and T-helper type 2 (Th2) cytokines.MethodsWe conducted a randomized trial in 204 CXCA survivors to test if psychosocial telephone counseling (PTC) could improve QOL compared to usual care (UC). Although PTC did not target SS, data were collected at baseline, 4 and 9 months post-enrollment using the Medical Outcomes Survey Social Support scale. Biospecimens were collected to investigate associations with patient-reported outcomes. Data were analyzed using multivariate linear models and stepwise regression.ResultsParticipants' mean age was 43. PTC participants experienced increasing SS compared to UC at 4 months (PTC-UC = 5.1; p = 0.055) and 9 months (PTC-UC = 6.0; p = 0.046). Higher baseline SS and increasing SS were independently associated with improved QOL at 4 and 9 months after adjusting for patient characteristics (p < 0.05). Differences between study arms were not statistically significant. Improvements in QOL at 4 months were observed with increases in emotional/informational and tangible SS. Increasing SS predicted significant longitudinal decreases in IL-4 and IL-13 at 4 months that were larger in the PTC arm (interactions p = 0.041 and p = 0.057, respectively).ConclusionImproved SS was significantly associated with improved QOL independent of patient characteristics and study arm. Decreasing Th2 cytokines with increasing SS and QOL are consistent with a biobehavioral paradigm in which modulation of the chronic stress response is associated with shifts in immune stance

Validation of PROMIS emotional distress short form scales for cervical cancer.

ObjectivesCervical cancer patients are at high risk for emotional distress. In this study we evaluate the PROMIS emotional distress-Depression and -Anxiety Short Forms for assessing depression and anxiety in a cervical cancer population.MethodsA 15-item questionnaire was used in a cervical cancer biobehavioral randomized clinical trial, testing psychosocial telephone counseling (PTC) against usual care (UC). It was administered to 204 patients prior to randomization, four months post-enrollment, and nine months post-enrollment, together with legacy measures of depression. The short forms were evaluated in patients participating in this study over three time points for internal consistency, convergent validity, and responsiveness to change over time.ResultsOverall, 45% and 47% of patients scored in the moderate to severe range for anxiety and depression, respectively. Internal consistency coefficients were ≥ 0.95 at baseline, 4 months, and 9 months for depression and anxiety. The average inter-item correlation was 0.65 and 0.73 at baseline assessment for depression and anxiety, respectively. The depression short form T-score was correlated with legacy distress scales ranging from 0.44-0.76, and the anxiety short form ranging from 0.45-0.78. The depression short form demonstrated sensitivity to change as patients randomized to the counseling intervention reported greater improvement over time in depression (p = 0.014), and a nonsignificant improvement in anxiety, compared to the patients receiving usual care.ConclusionsThe PROMIS depression and anxiety short forms reliably and validly assess cervical cancer-specific emotional distress, capture salient features of distress in this population, and perform as well or better than legacy measures

Social Support for Chamorro Breast Cancer Survivors on Guam

Purpose: The purpose of this study was to assess the types of social support used by Chamorro (indigenous) breast cancer survivors on Guam. Methods: We assessed social support use among 25 self-reported Chamorro women with a diagnosis of breast cancer through interviews and construction of genograms and ecomaps -pictorial displays of the women's family relationships, medical history, and their social networks. Results: The mean age of the participants was 54.5 years. The average number of years since the diagnosis of breast cancer was 7.8 years. Respondents indicated that the nuclear family was the most important form of social support (34.2%). Indeed, nuclear family and other types of informal systems were the most common type of social support used by the women (60.2%). Formal support services, clubs, and organizations were reported by 17.9% of participants while spiritual and/or religious resources were reported by 21.9% of them. Conclusion: These Chamorro breast cancer survivors depended largely on family for social support. Support from family, although informal, should be recognized as a pivotal factor in recovery and survivorship. Future directions could incorporate formal and informal mechanisms to utilize this natural support resource

Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study

PURPOSE: To evaluate the impact of two different intraperitoneal (IP) chemotherapy regimens on progression-free survival (PFS) among women with newly diagnosed advanced ovarian carcinoma. METHODS: Eligible patients were randomly assigned to six cycles of IV paclitaxel 80 mg/m(2) once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m(2) once per week with IP carboplatin area under the curve 6 (IP carboplatin) versus once every 3 weeks IV paclitaxel 135 mg/m(2) over 3 hours day 1, IP cisplatin 75 mg/m(2) day 2, and IP paclitaxel 60 mg/m(2) day 8 (IP cisplatin). All participants received bevacizumab 15 mg/kg IV every 3 weeks in cycles 2 to 22. RESULTS: A total of 1,560 participants were enrolled and had 84.8 months of follow-up. The median PFS duration was 24.9 months in the IV carboplatin arm, 27.4 months in the IP carboplatin arm, and 26.2 months in the IP cisplatin arm. For the subgroup of 1,380 patients with stage II/III and residual disease of 1 cm or less, median PFS was 26.9 (IV-carboplatin), 28.7 (IP-carboplatin), and 27.8 months (IP cisplatin), respectively. Median PFS for patients with stage II/III and no residual disease was 35.9, 38.8, and 35.5 months, respectively. Median overall survival for all enrolled was 75.5, 78.9, and 72.9 months, respectively, and median overall survival for stage II/III with no gross residual disease was 98.8 months, 104.8 months, and not reached. Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores (Gynecologic Oncology Group) were similar for all arms, but the mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores during chemotherapy were statistically worse in the IP cisplatin arm. CONCLUSION: Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.National Cancer Institute (NCI) [U10 CA180822, U10 CA180868]; NCI [UG1 CA189867]; NSC [704865]; IND [7921]6 month embargo; published online 19 April 2019This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Recommended Patient-Reported Core Set of Symptoms and Quality-of-Life Domains to Measure in Ovarian Cancer Treatment Trials

There is no consensus as to what symptoms or quality-of-life (QOL) domains should be measured as patient-reported outcomes (PROs) in ovarian cancer clinical trials. A panel of experts convened by the National Cancer Institute reviewed studies published between January 2000 and August 2011. The results were included in and combined with an expert consensus-building process to identify the most salient PROs for ovarian cancer clinical trials. We identified a set of PROs specific to ovarian cancer: abdominal pain, bloating, cramping, fear of recurrence/disease progression, indigestion, sexual dysfunction, vomiting, weight gain, and weight loss. Additional PROs identified in parallel with a group charged with identifying the most important PROs across cancer types were anorexia, cognitive problems, constipation, diarrhea, dyspnea, fatigue, nausea, neuropathy, pain, and insomnia. Physical and emotional domains were considered to be the most salient domains of QOL. Findings of the review and consensus process provide good support for use of these ovarian cancer–specific PROs in ovarian cancer clinical trials

Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): a randomised, open-label phase 2/3 trial

BACKGROUND: Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma. METHODS: This international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m(2) by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40–50 mg/m(2) by body surface area once every 4 weeks; intravenous topotecan 4 mg/m(2) by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, and is active but not recruiting. FINDINGS: Between Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130). At the primary analysis, there were 217 progression-free survival events (101 [78%] in the trametinib group and 116 [89%] in the standard-of-care group). Median progression-free survival in the trametinib group was 13·0 months (95% CI 9·9–15·0) compared with 7·2 months (5·6–9·9) in the standard-of-care group (hazard ratio 0·48 [95% CI 0·36–0·64]; p<0·0001). The most frequent grade 3 or 4 adverse events in the trametinib group were skin rash (17 [13%] of 128), anaemia (16 [13%]), hypertension (15 [12%]), diarrhoea (13 [10%]), nausea (12 [9%]), and fatigue (ten [8%]). The most frequent grade 3 or 4 adverse events in the standard-of-care group were abdominal pain (22 [17%]), nausea (14 [11%]), anaemia (12 [10%]), and vomiting (ten [8%]). There were no treatment-related deaths. INTERPRETATION: Trametinib represents a new standard-of-care option for patients with recurrent low-grade serous carcinoma. FUNDING: NRG Oncology, Cancer Research UK, Target Ovarian Cancer, and Novartis

Survival disparities in non-Hispanic Black and White cervical cancer patients vary by histology and are largely explained by modifiable factors

PurposeWe investigated racial disparities in survival by histology in cervical cancer and examined the factors contributing to these disparities.MethodsNon-Hispanic Black and non-Hispanic White (hereafter known as Black and White) patients with stage I-IV cervical carcinoma diagnosed between 2004 and 2017 in the National Cancer Database were studied. Survival differences were compared using Cox modeling to estimate hazard ratio (HR) or adjusted HR (AHR) and 95% confidence interval (CI). The contribution of demographic, socioeconomic and clinical factors to the Black vs White differences in survival was estimated after applying propensity score weighting in patients with squamous cell carcinoma (SCC) or adenocarcinoma (AC).ResultsThis study included 10,111 Black and 43,252 White patients with cervical cancer. Black patients had worse survival than White cervical cancer patients (HR&nbsp;=&nbsp;1.40, 95% CI&nbsp;=&nbsp;1.35-1.45). Survival disparities between Black and White patients varied significantly by histology (HR&nbsp;=&nbsp;1.20, 95% CI&nbsp;=&nbsp;1.15-1.24 for SCC; HR&nbsp;=&nbsp;2.32, 95% CI&nbsp;=&nbsp;2.12-2.54 for AC, interaction p&nbsp;&lt;&nbsp;0.0001). After balancing the selected demographic, socioeconomic and clinical factors, survival in Black vs. White patients was no longer different in those with SCC (AHR&nbsp;=&nbsp;1.01, 95% CI 0.97-1.06) or AC (AHR&nbsp;=&nbsp;1.09, 95% CI&nbsp;=&nbsp;0.96-1.24). In SCC, the largest contributors to survival disparities were neighborhood income and insurance. In AC, age was the most significant contributor followed by neighborhood income, insurance, and stage. Diagnosis of AC (but not SCC) at ≥65&nbsp;years old was more common in Black vs. White patients (26% vs. 13%, respectively).ConclusionsHistology matters in survival disparities and diagnosis at ≥65&nbsp;years old between Black and White cervical cancer patients. These disparities were largely explained by modifiable factors

The Challenge of Follow-Up in a Low-Income Colposcopy Clinic

OBJECTIVE: The study aimed to identify sociodemographic and disease-specific factors associated with follow-up in an inner-city multiethnic colposcopy clinic. MATERIALS AND METHODS: All charts of patients referred to colposcopy clinic for abnormal cervical cytology and/or high-risk human papillomavirus infections to the University of California, Irvine, Colposcopy Clinic in Santa Ana from November 2006 to December 2007 were reviewed. Compliance was defined as at least 1 follow-up evaluation within 3 to 14 months from initial colposcopy appointment. To determine compliance, the following factors were evaluated in a multivariate analysis: race, age, spoken language, insurance status, annual income, marital status, referral cytology, histology, and pregnancy status. RESULTS: Among the 1,046 scheduled appointments, 50% were attended. Of the patients, 458 with a minimum of 14 months of follow-up were included. The mean (SD) age of these patients was 31.0(10.7) years. 58% were white and 55% spoke Spanish. A total of 248 patients (54%) had appropriately timed repeat testing, whereas 210 (46%) failed to return within 14 months. In univariate analysis, women who were referred from outside the clinic, single, younger than 40 years, and with self-pay or government-funded insurance were more likely to be noncompliant although this was not statistically significant. In multivariate analysis, referral from outside the clinic, self-pay, or government-funded insurance, Spanish-speaking, and single marital status were all significantly associated with non-compliance. Although cervical intraepithelial neoplasia 2 or 3 was not associated with noncompliance, 45% of women with cervical intraepithelial neoplasia 2 or 3 still did not comply with recommendations. CONCLUSIONS: This inner-city clinic is perhaps successful at maintaining compliance for women at highest risk for cervical cancer when the triage originates from within the clinic and when the patient is married, English-speaking, and privately insured. However, reasons for those patients at highest risk for noncompliance in this clinic may need to be better characterized

Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology–Gynecologic Oncology Group protocol 240)

Background: GOG 240 was a practice-changing randomised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival, and the proportion of patients achieving an overall objective response, compared with chemotherapy alone. In this study, we aimed to analyse patient-reported outcomes in GOG 240. Methods: Eligible adult participants (aged ≥18 years) had primary stage IVB or recurrent or persistent carcinoma of the cervix with measurable disease and GOG performance status of 0-1. Participants were randomly assigned by web-based permuted block randomisation (block size 4) in a 1:1:1:1 ratio to the four treatment groups: cisplatin (50 mg/m2 intravenously on day 1 or 2 of the treatment cycle) and paclitaxel (135 mg/m2 intravenously over 24 h or 175 mg/m2 intravenously over 3 h on day 1), with or without bevacizumab (15 mg/kg intravenously on day 1 or 2), or paclitaxel (175 mg/m2 over 3 h on day 1) and topotecan (0·75 mg/m2 for 30 min on days 1-3) with or without bevacizumab (15 mg/kg intravenously on day 1). Treatment assignment was concealed at randomisation (everyone was masked to treatment assignment, achieved by the use of a computer encrypted numbering system at the National Cancer Institute) and became open-label when each patient was registered to the trial. Treatment cycles were repeated every 21 days until disease progression or unacceptable toxicity, whichever occurred first. The coprimary endpoints of the trial were overall survival and safety; the primary quality-of-life endpoint was the score on the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI). For our analysis of patient-reported outcomes, participants were assessed before treatment cycles 1, 2, and 5, and at 6 and 9 months after the start of cycle 1, with the FACT-Cx TOI, items from the FACT-GOG-Neurotoxicity subscale, and a worst pain item from the Brief Pain Inventory. All patients who completed baseline quality-of-life assessments and at least one further follow-up assessment were evaluable for quality-of-life outcomes. This study is registered with ClinicalTrials.gov, number NCT00803062. Findings: Between April 6, 2009, and Jan 3, 2012, a total of 452 patients were enrolled in the trial, of whom 390 completed baseline quality-of-life assessment and at least one further assessment and were therefore evaluable for quality-of-life outcomes. In these patients, patient-reported outcome completion declined from 426 (94%) of 452 (at baseline) to 193 (63%) of 307 (9 months post-cycle 1), but completion rates did not differ significantly between treatment regimens (p=0·78). The baseline FACT-Cx TOI scores did not differ significantly between patients who received bevacizumab versus those who did not (p=0·27). Compared with patients who received chemotherapy alone, patients who received chemotherapy plus bevacizumab reported FACT-Cx TOI scores that were an average of 1·2 points lower (98·75% CI -4·1 to 1·7; p=0·30). Interpretation: Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit. Funding: National Institutes of Health