A comparison of monthly symptom reports for older (≥ 70 years) versus younger (< 70 years) women with recurrent ovarian cancer over 1 year.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 85-85 ◽  
Author(s):  
Premal H. Thaker ◽  
Susan M. Sereika ◽  
Janet Arida ◽  
Robert P. Edwards ◽  
Heidi Donovan
Keyword(s):  
Ovarian Cancer ◽  
Peripheral Neuropathy ◽  
Sleep Disturbances ◽  
Recurrent Ovarian Cancer ◽  
Age Group ◽  
Linear Quadratic ◽  
Eligibility Criteria ◽  
Change Over Time ◽  
Patient Reported ◽  
Over Time

85 Background: Approximately 30% of ovarian cancer patients are 70 or older at diagnosis. Evidence to guide treatment in this age group is limited in the recurrent setting due to clinician concerns about toxicities and quality of life. Evidence based on patient-reported outcomes is scarce. The objective of this exploratory analysis is to compare patient-reported symptoms for women with recurrent ovarian cancer > age 70 vs. < age 70. Methods: Ancillary analysis of data from a 3-arm web-based symptom management RCT (NR010735; GOG-259). Eligibility criteria included recurrent or persistent ovarian, fallopian, or primary peritoneal cancer; experiencing 3 or more cancer or treatment-related symptoms. 497 women were accrued; of those, 60 (12%) were > age 70. Monthly severity data for 11 cancer- and treatment-symptoms rated “at their worst in the past week” on a 0 to 10 Likert-type scale are included in this analysis. Time (linear, quadratic, and cubic), age (young vs. old), and time by age group interactions were evaluated using random coefficient modeling for each of the symptoms over 12 months. Results: In general, the severity of these selected symptoms declined significantly (p < .05) either linearly (memory problems and anxiety) or nonlinearly (fatigue, pain, constipation, peripheral neuropathy, nausea, lack of appetite, depression, and sleep disturbances) over time, except for vomiting which did not demonstrate a significant change over time. Age effects or age by time interactions (significant, p < .05, or a trend, .05 < = p < .10) were found for pain, constipation, peripheral neuropathy, vomiting, and sleep disturbances, with generally higher initial values for younger ( < = 70 years) women for pain and sleep disturbances and higher overall means for younger women for vomiting. For constipation and peripheral neuropathy, the nonlinear change over time varied significantly by age group, with the decline over time being more precipitous for older women. Conclusions: A better understanding of the different propensity for symptoms based on age can help clinicians not only address them but also choose chemotherapies to minimize them.

Patient self-reporting of tolerability using PRO-CTCAE: A randomized double-blind placebo controlled phase II trial comparing gemcitabine in combination with adavosertib or placebo in women with platinum resistant epithelial ovarian cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5541-5541
Author(s):  
Ainhoa Madariaga ◽  
Sandra A. Mitchell ◽  
Tyler Pittman ◽  
Lisa Wang ◽  
Valerie Bowering ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Abdominal Pain ◽  
Objective Assessment ◽  
Area Under The Curve ◽  
Recurrent Ovarian Cancer ◽  
Median Number ◽  
Self Report ◽  
Double Blind ◽  
Patient Reported ◽  
Fatigue Severity

5541 Background: A 4 month improvement in OS was demonstrated when Wee1 inhibitor adavosertib (Ad) and gemcitabine (G; arm A) was compared to G and placebo (P; arm B) in a phase 2 trial in recurrent ovarian cancer (NCT02151292). The patient reported outcome version of the CTCAE (PRO-CTCAE) was used to capture self-report of the frequency, severity and/or interference (scored 0-4; higher scores indicating worse symptomatic adverse events [syAEs]). Methods: Ad/P was given orally on D1-2, D8-9, D15-16 with G D1, D8, D15 in a 28-day cycle. English speaking pts in 2 centres completed PRO-CTCAE items electronically in clinic at baseline, D1 and D15 of each cycle and off treatment. An exploratory objective was to characterize syAEs in the first 3 months of therapy. We calculated 12-week area under the curve (AUC12w) as a measure of syAE over time and incremental AUC12w (iAUC12w) for adjustment to baseline syAEs and compared arms A and B using an independent samples t-test. We assessed proportion of scores 3-4 at 6 time-points and compared them using Fisher’s Exact Test at each survey. Results: 51 pts were enrolled and completed ≥1 survey, 47 were evaluable for primary outcome (arm A: 28, B: 19). ECOG status was ≤1 in 44/47 pts. Median number of cycles of therapy were 5 (1-16) in arm A, and 2 (1-16) in B. Survey completion rates were high (arm A 93%, B 95%). Mean AUC12w fatigue severity (A 152 [standard error 9] vs B 112 [10]; p = 0.005) and interference (A 144 [11] vs 98 [15]; p = 0.018), diarrhea frequency (A 70 [12] vs B 33 [9]; p = 0.014), mucositis (A 23 [6] vs B 6 [3]; p = 0.012) and difficulty swallowing severity (A 10 [3] vs B 2 [2]; p = 0.023) were higher in arm A (any grade). There were no statistically significant between-arm differences in abdominal pain, bloating, nausea, vomiting and anxiety. The iAUC12w was significantly higher in arm A vs B for difficulty swallowing severity (A 10.1 [3] vs B -2.7 [4.7]; p = 0.02), mucositis severity (A 19.9 [6.6] vs B -3.1 [6.9]; p = 0.02) and fatigue severity (A 35.2 [8.2] vs B -3.1 [9.8]; p = 0.005). Proportions with high scores (3-4) were only significantly higher at C1D15 for fatigue severity in arm A (A 55% vs B 19%, p = 0.044). No significant differences were seen in other 3-4 scores per survey time. Conclusions: This is the first study evaluating pts self-reported toxicity with adavosertib in a randomized setting, allowing pts self-evaluation of toxicity in the context of improved PFS and OS. Greater fatigue, diarrhea, mucositis and difficulty swallowing were experienced by pts receiving adavosertib and gemcitabine, but score 3-4 reached significance on C1D15 fatigue only. No significant differences were detected in syAE profile for nausea, vomiting, abdominal pain, bloating and anxiety. This approach allows objective assessment of pts perception of toxicity with complex therapy. Clinical trial information: NCT02151292.

scholarly journals Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

2019 ◽  
Vol 37 (32) ◽  
pp. 2968-2973 ◽  
Author(s):  
Josep M. del Campo ◽  
Ursula A. Matulonis ◽  
Susanne Malander ◽  
Diane Provencher ◽  
Sven Mahner ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Partial Response ◽  
Maintenance Therapy ◽  
Clinical Benefit ◽  
Patient Reported Outcomes ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Platinum Based Chemotherapy ◽  
Patient Reported

PURPOSE In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS AND METHODS A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (g BRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCAmut (non–g BRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to g BRCAmut status and response to their last platinum-based therapy. Ovarian cancer–specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy–Ovarian Symptom Index. RESULTS Progression-free survival was improved in patients treated with niraparib compared with placebo in both the g BRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non–g BRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. CONCLUSION Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

Change over time in patient-reported symptoms and quality of life in Edmonton interdisciplinary menopause clinics

2019 ◽  
Vol 26 (9) ◽  
pp. 1031-1037
Author(s):  
Beate C. Sydora ◽  
Nese Yuksel ◽  
Vikas Chadha ◽  
Lori Battochio ◽  
Lori Reich-Smith ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Change Over Time ◽  
Patient Reported ◽  
Over Time

Determining priority symptoms of women with recurrent ovarian cancers: A Gynecologic Oncology Group study.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 101-101 ◽  
Author(s):  
Heidi AS Donovan ◽  
Lari B. Wenzel ◽  
Sandra Ward ◽  
Susan M. Sereika ◽  
Robert P. Edwards ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Sleep Disturbance ◽  
Symptom Severity ◽  
Gynecologic Oncology ◽  
Well Being ◽  
Recurrent Ovarian Cancer ◽  
Gynecologic Oncology Group ◽  
Peritoneal Cancer ◽  
Ovarian Cancers ◽  
Patient Reported

101 Background: The purpose of this study is to recommend a core set of priority symptoms to be assessed in research and clinical settings for women with recurrent ovarian cancers. Methods: We used baseline data of 497 women with recurrent ovarian, fallopian, or primary peritoneal cancer participating in a symptom management randomized clinical trial (GOG-0259) to identify a core index of patient-reported priority symptoms. We used the Symptom Representation Questionnaire to assess priority rankings of 28 symptoms based on four criteria: (1) symptom prevalence, (2) patient-reported symptom severity, (3) percentage of women identifying each symptom as one of top three symptoms “I would like to get better control over”, and (4) the association between symptom severity and functional wellbeing as measured by the Functional Assessment of Cancer Therapy - Ovarian. Final priority ranking included all symptoms that were ranked in the top 10 for any of the four criteria. Results: Of the original 28 symptoms, 19 were ranked in the top 10 for at least one criterion: fatigue, sleep disturbance, pain, anxiety, peripheral neuropathy, constipation, abdominal bloating, drowsiness, mood swings, memory problems, weight gain, nausea, sexual concerns, vomiting, hair loss, lymphedema, lack of appetite, shortness of breath, and depression. Fatigue, sleep disturbance, and pain were each ranked one of the top 10 symptoms for all four criteria. Anxiety, peripheral neuropathy, and constipation were each ranked in the top 10 for three of the 4 criteria. Conclusions: We propose a core index of 19 patient-reported symptoms to be systematically assessed among patients with recurrent ovarian cancer. These symptoms are common, severe, poorly managed, and/or interfere with survivors’ functioning and can be efficiently assessed in 1-2 minutes. Systematic assessment in clinical and research settings could advance understanding about the predictors and consequences of poorly managed symptoms and could lead to more proactive, personalized interventions to improve functional well-being in this at-risk patient population.

scholarly journals Trends and Contributing Factors of the Change of HIV Prevalence Over Time Among Reproductive Age Group Women in Ethiopia Evidenced by Ethiopian Demographic and Health Survey (EDHS) Data: a Cross-sectional Study: Multivariate Decomposition Analysis.

2021 ◽  
Author(s):  
Yilkal Negesse ◽  
Dereje Alemayehu ◽  
Melsew Setegn ◽  
Abebaw Addisu ◽  
Wondimagegn Wondimu ◽  
...  
Keyword(s):  
Behavioral Change ◽  
Decomposition Analysis ◽  
Hiv Prevalence ◽  
Reproductive Age ◽  
Age Group ◽  
Contributing Factors ◽  
Change Over Time ◽  
The World ◽  
Over Time ◽  
Reproductive Age Group

Abstract Background: Human immunodeficiency virus remains the leading cause of morbidity and mortality throughout the world. At the beginning of the epidemic, around 76.1 million people were infected and 32 million people died from AIDS-related illnesses in the world. Sub-Saharan Africa regions are the most affected regions and accounted for 67% of HIV infections worldwide, and 72% of the world’s AIDS-related deaths.Objective: To show trends and contributing factors for the change of HIV prevalence over time among reproductive age group women in Ethiopia.Methods: This study was conducted based on Ethiopian Demographic and Health Surveys data. A total of 10423 in 2005, 15153 in 2011, and 14159 in 2016 women were involved in the study. Multivariate decomposition analysis was performed using the mvdcmp Stata package to identify the contributing factors of change of HIV prevalence over time. The 95% confidence interval was used for the test of significance. Results: This study showed that 90.4 % of the change in HIV prevalence over time was attributable to behavioral change over time, particularly in women who were rural residents and not exposed to media. The behavioral change of women who live in rural areas was the major factor for the decline of HIV for the last ten years. The behavioral change of women who hadn’t exposure to media contributed 98.4% to the decline of HIV prevalence over the past ten years.Conclusion: The prevalence of HIV among reproductive age group women in Ethiopia was significantly declined over the last ten years and the decline was due to behavioral change over time. The major factor for the reduction of HIV prevalence overtime was the behavioral change of rural resident women. Therefore Ethiopian government should primarily focus on the strengthening and scaling up of behavioral change packages related to HIV prevention and control methods.

scholarly journals Homoeopathic management of chronic replapsing pancreatitis in a paediatric patient: A case report

2022 ◽  
Vol 4 ◽  
pp. 133-141
Author(s):  
Bipin Sohanraj Jain ◽  
Akshata Damodar Nayak
Keyword(s):  
Abdominal Pain ◽  
Case Report ◽  
Acute Exacerbation ◽  
Recurrent Fever ◽  
Age Group ◽  
Patient Reported ◽  
Paediatric Age ◽  
History Of ◽  
Chronic Relapsing Pancreatitis ◽  
Over Time

Chronic relapsing pancreatitis in the paediatric age group is a challenging case, especially when presenting in its acute exacerbation. This case report highlights the management of chronic relapsing pancreatitis in a 9-year-old female patient with homoeopathic treatment. The patient reported a year-long history of recurrent fever, abdominal pain, and raising titres of lipase and amylase; she had been admitted to a higher centre twice. The totality was constructed on day 1 and a homoeopathic remedy was prescribed. Detailed case taking, done after a week, confirmed the same remedy. Later, when the patient had an acute exacerbation, the same remedy-frequently repeated, helped settle the acute episode in a couple of days. The patient has been following up regularly for 3 years; the frequency and intensity of relapses reduced considerably over time and there have been no episodes for more than a year.

A phase II trial of combination irinotecan and oral etoposide chemotherapy in recurrent ovarian cancer: A Tohoku Gynecologic Cancer Unit (TGCU) study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5558-5558
Author(s):  
S. Kumagai ◽  
T. Shoji ◽  
Y. Yokoyama ◽  
T. Takano ◽  
H. Mizunuma ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Treatment Options ◽  
Gynecologic Cancer ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Median Number ◽  
Oral Etoposide ◽  
Eligibility Criteria ◽  
Platinum Resistant

5558 Background: Various problems still exist in the management of recurrent ovarian cancer and there are limited treatment options especially for the platinum resistant patients (pts). We conducted a phase II study to evaluate the efficacy and safety of the combination irinotecan/oral etoposide chemotherapy. Methods: Eligibility criteria included recurrent ovarian cancer with measurable disease or positive CA125, preserved organ function, and aged 20–75. Treatment was conducted with irinotecan (60 mg/m2 iv, day 1, 15) and oral etoposide (50 mg/body day 1–21), q 28 days until disease progression or unacceptable toxicity. Primary endpoint was response rate (RR) and secondary endpoints included toxicity, progression-free survival (PFS), and overall survival (OS). Results: 38pts were enrolled on this study from May 2003 to April 2007, and all pts were eligible. Median age was 57 yrs (range 37–74). PS 0 in 24 pts, 1 in 10 pts, and 2 in 4 pts. Median number of previous regimen was 2 (range 1–4). Median treatment cycles were 6 (range 2–27). RR (CR+PR) was 18/38 (47.4%), and CR+PR+SD rate was 31/38 (81.6%). Grade 3/4 adverse effect included leukopenia (50.0%), neutropenia (52.6%), anemia (18.4%) and thrombocytopenia (2.6%), nausea/vomiting (7.9%) and diarrhea (2.6%). Treatment-related death was not observed. Median PFS was 7 months (range 1–33) and OS was 19 months (range 4–60). Among 20 pts with platinum resistant cases, RR was 6/20 (30.0%), CR+PR+SD rate was 14/20 (70.0%), median PFS was 6 months (range 1–33), and OS was 24 months (range 5–60). Conclusions: Combination irinotecan/oral etoposide chemotherapy can achieve a superior management for the recurrent ovarian cancer without declining QOL, and also has the possibility to be one of the most effective regimens as second-line chemotherapy. No significant financial relationships to disclose.

Patient Preferences Regarding Side Effects of Chemotherapy for Ovarian Cancer: Do They Change over Time?

2002 ◽  
Vol 87 (1) ◽  
pp. 118-128 ◽  
Author(s):  
Charlotte C. Sun ◽  
Diane C. Bodurka ◽  
Michele L. Donato ◽  
Edward B. Rubenstein ◽  
Candice L. Borden ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Side Effects ◽  
Patient Preferences ◽  
Change Over Time ◽  
Over Time
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