Cediranib and Olaparib Combination Compared With Cediranib or Olaparib Alone, or Chemotherapy in Platinum-Resistant or Primary Platinum-Refractory Ovarian Cancer: NRG-GY005.

Purpose: We assessed the efficacy of cediranib, olaparib, and cediranib/olaparib compared with standard-of-care chemotherapy (SOC) in platinum-resistant or platinum-refractory epithelial ovarian cancer (PROC).

Patients And Methods: NRG-GY005 is an open-label, four-arm, phase II/III superiority trial enrolling patients with high-grade serous/endometrioid PROC and one to three previous therapies. Key exclusion criteria included previous receipt of poly(ADP-ribose) polymerase inhibitor or receipt of antiangiogenic therapy in the recurrent setting.

Attitudes of physicians and patients toward immediate and intraoperative chemotherapy treatment in colon cancer.

Introduction: We have shown in a Phase I trial that immediate adjuvant chemotherapy (IAC) during surgical resection and immediately postoperative is safe and feasible in patients with colon cancer (CC). IAC avoids delays in adjuvant treatment and has the potential to improve survival and quality of life. We aim to determine patients and providers attitudes toward this novel multidisciplinary treatment approach.

Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259).

Purpose: GOG-259 was a 3-arm randomized controlled trial of two web-based symptom management interventions for patients with recurrent ovarian cancer. Primary aims were to compare the efficacy of the nurse-guided (Nurse-WRITE) and self-directed (SD-WRITE) interventions to Enhanced Usual Care (EUC) in improving symptoms (burden and controllability) and quality of life (QOL).

Methods: Patients with recurrent or persistent ovarian, fallopian, or primary peritoneal cancer with 3+ symptoms were eligible for the study.

Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study.

Introduction: Chemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein.

Methods: QOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment.

GOG 244 - The Lymphedema and Gynecologic cancer (LeG) study: The impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function.

Objective: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244.

Methods: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery.

Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study.

Introduction: To 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.

Methods: Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.

Results: Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity).

Prospective follow-up of quality of life for participants undergoing risk-reducing salpingo-oophorectomy or ovarian cancer screening in GOG-0199: An NRG Oncology/GOG study.

Background: Risk-reducing salpingo-oophorectomy (RRSO) and ovarian cancer screening (OCS) are management options for women at increased risk of ovarian cancer. Long-term effects of these interventions on quality of life (QOL) are not well understood.

Methods: GOG-0199 is a prospective cohort study of women at increased ovarian cancer risk who chose either RRSO or OCS as their risk management intervention.

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

Purpose: 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.

Methods: 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 84 weeks after initiation of chemotherapy for women with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer.

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.

Neurotoxicity in ovarian cancer patients on Gynecologic Oncology Group (GOG) protocol 218: characteristics associated with toxicity and the effect of substitution with docetaxel: an NRG Oncology/Gynecologic Oncology Group study.

Objectives: 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.

Methods: 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.

Longitudinal change in telomere length and the chronic stress response in a randomized pilot biobehavioral clinical study: implications for cancer prevention.

Shortened telomere length is associated with increased cancer incidence and mortality. Populations experiencing chronic stress have accelerated telomere shortening. In this exploratory study, we examined associations between longitudinal changes in patient reported outcomes (PRO) of psychologic distress and peripheral blood mononuclear cell (PBMC) telomere length to test the hypothesis that modulation of the chronic stress response would also modulate telomere dynamics.

Quality-of-life results used to endorse changes in standard of care for recurrent platinum-sensitive ovarian cancer.

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 association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study.

Purpose: To explore the association between baseline quality of life (QOL) scores and overall survival (OS) in ovarian cancer patients receiving adjuvant chemotherapy.

Methods: Patients with stage III ovarian cancer on Gynecologic Oncology Group protocol #172 completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were then randomly assigned to either intravenous (IV) or intraperitoneal (IP) chemotherapy. The FACT scale includes physical, functional, social, and emotional well-being domains (PWB, FWB, SWB, EWB).

Stress, immunity, and cervical cancer: biobehavioral outcomes of a randomized clinical trial [corrected].

Purpose: Cancer diagnosis and treatment imparts chronic stressors affecting quality of life (QOL) and basic physiology. However, the capacity to increase survival by improving QOL is controversial. Patients with cervical cancer, in particular, have severely compromised QOL, providing a population well-suited for the evaluation of novel psychosocial interventions and the exploration of mechanisms by which modulation of the psychoneuroimmune axis might result in improved clinical outcomes.

Supportive care for women with gynecologic cancers.

Supportive care is a multidimensional field, that involves caring for a patient's symptoms either during and/or after treatment. Ideally, once these supportive care needs are met, patients can enjoy an improved quality of life. Supportive care needs include all body systems, and are, therefore, difficult to manage, secondary to the fact that they require collaboration among multiple medical specialties.

Health-related quality of life in a racially diverse population screened for hemochromatosis: results from the Hemochromatosis and Iron Overload Screening (HEIRS) study.

Purpose: The HEIRS Study screened 101,168 primary care participants for iron overload with serum transferrin saturation (TS), serum ferritin (SF), and C282Y and H63D mutations of the HFE gene. The objective of this study was to evaluate the impact of screening on participants' well-being.

Methods: All C282Y homozygotes, participants with an elevated TS and SF concentration, and a control group of phenotype-genotype negative persons, with neither C282Y nor H63D mutations in the HFE gene were recalled for a clinical evaluation.

Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop.

Objective: The unique characteristics of cancer, particularly issues involving the use of surrogate endpoints in clinical trials, present special challenges in the development of cancer drugs. In response, the U.S.

Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: a Gynecologic Oncology Group Study.

Purpose: A Gynecologic Oncology Group (GOG) randomized phase III trial (GOG 172) in optimal stage III epithelial ovarian cancer showed that intravenous (IV) paclitaxel plus intraperitoneal (IP) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin. The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy.

Patients And Methods: Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions.

Quality of life considerations in gynecologic cancer. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer.

Quality of life (QOL) is a fundamental consideration for patients with life threatening diseases. Major evolving paradigms are discussed: improved QOL with laparoscopic surgery, the impact on QOL of intraperitoneal chemotherapy for optimally cytoreduced ovarian cancer, combination therapy, sexuality, and survivorship. The goals of treatment for many patients with gynecologic tumors remain largely palliative, and patient reported QOL is the primary outcome determining the utility of treatment.

Quality of Life Considerations in Gynecologic Cancer.

Quality of life (QOL) is a fundamental consideration for patients with life threatening diseases. Major evolving paradigms are discussed: improved QOL with laparoscopic surgery, the impact on QOL of intraperitoneal chemotherapy for optimally cytoreduced ovarian cancer, combination therapy, sexuality, and survivorship. The goals of treatment for many patients with gynecologic tumors remain largely palliative, and patient reported QOL is the primary outcome determining the utility of treatment.

Cervical cancer.

Behavioral and psychosocial factors affect all aspects of cervical cancer control, from prevention to posttreatment rehabilitation. Behavioral scientists gathered at the Second International Conference on Cervical Cancer (Houston, TX, April 11-14, 2002) reviewed selected studies of behavioral factors related to cervical cancer, including women's receptivity to emerging cervical cancer screening and diagnostic technologies, factors that influence adherence to follow-up colposcopy recommendations, and cervical cancer survivors' quality of life. Researchers reported that reduced distress during examinations with new technology may improve adherence to cervical cancer screening recommendations.

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.

Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population.

Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study.

Ovarian cancer is a life-threatening diagnosis which poses multiple challenges. The purpose of this study is to describe the quality of life (QOL) concerns and survivorship sequelae of long-term (>5 yr) early-stage ovarian cancer survivors accrued through the clinical cooperative Gynecologic Oncology Group. Forty-nine ovarian cancer survivors with a mean age at diagnosis of 55.