The prognostic effects of performance status and quality of life scores on progression-free survival and overall survival in advanced ovarian cancer

2008 ◽  
Vol 108 (1) ◽  
pp. 100-105 ◽  
Author(s):  
M.S. Carey ◽  
M. Bacon ◽  
D. Tu ◽  
L. Butler ◽  
A. Bezjak ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Overall Survival ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Free Survival

Nonplatinum Topotecan Combinations Versus Topotecan Alone for Recurrent Ovarian Cancer: Results of a Phase III Study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group

2008 ◽  
Vol 26 (19) ◽  
pp. 3176-3182 ◽  
Author(s):  
Jalid Sehouli ◽  
Dirk Stengel ◽  
Guelten Oskay-Oezcelik ◽  
Alain G. Zeimet ◽  
Harald Sommer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Overall Survival ◽  
Objective Response ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Platinum Sensitive ◽  
Platinum Refractory

PurposeThe management of recurrent ovarian cancer remains controversial. Single-agent topotecan is an established treatment option, and preliminary evidence suggests improved tumor control by combining topotecan with etoposide or gemcitabine.Patients and MethodsWomen with relapsed ovarian cancer after primary surgery and platinum-based chemotherapy were randomly assigned to topotecan monotherapy 1.25 mg/m2/d, topotecan 1.0 mg/m2plus oral etoposide 50 mg/d, or topotecan 0.5 mg/m2/d plus gemcitabine 800 mg/m2on day 1 and 600 mg/m2on day 8 every 3 weeks. Patients were stratified for platinum-refractory and platinum-sensitive disease according to a recurrence-free interval of less or more than 12 months, respectively. The primary end point was overall survival. Secondary end points included progression-free survival, objective response rates, toxicity, and quality of life (as measured by the European Organisation for Research and Treatment of Cancer [EORTC] 30-item Quality-of-Life Questionnaire).ResultsThe trial enrolled 502 patients with a mean age of 60.5 years (± 10.2 years), 208 of whom were platinum resistant. Median overall survival was 17.2 months (95% CI, 13.5 to 21.9 months) with topotecan, 17.8 months (95% CI, 13.7 to 20.0 months) with topotecan plus etoposide (log-rank P = .7647), and 15.2 months (95% CI, 11.3 to 20.9 months) with topotecan plus gemcitabine (log-rank P = .2344). Platinum-sensitive patients lived significantly longer than platinum-refractory patients (21.9 v 10.6 months). The median progression-free survival was 7.0, 7.8, and 6.3 months, respectively. Objective response rates were 27.8%, 36.1%, and 31.6%, respectively. Patients under combined treatment were at higher risk of severe thrombocytopenia.ConclusionNonplatinum topotecan combinations do not provide a survival advantage over topotecan alone in women with relapsed ovarian cancer.

A randomized trial comparing cisplatin plus cyclophosphamide versus cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

1986 ◽  
Vol 4 (6) ◽  
pp. 965-971 ◽  
Author(s):  
P F Conte ◽  
M Bruzzone ◽  
S Chiara ◽  
M R Sertoli ◽  
M G Daga ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Median Survival ◽  
Stable Disease ◽  
Residual Disease ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Second Look

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.

The prognostic effects of performance status (PS) and quality of life (QoL) scores on progression-free survival (PFS) and overall survival (OS) in advanced ovarian cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5066-5066
Author(s):  
M. S. Carey ◽  
M. Bacon ◽  
D. Tu ◽  
A. Bezjak ◽  
G. C. Stuart
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Cognitive Functioning ◽  
Physical Function ◽  
Cox Model ◽  
Performance Status ◽  
Advanced Ovarian Cancer ◽  
Global Quality Of Life ◽  
Multiple Variables

5066 Background: Performance status is an important prognostic factor in advanced ovarian cancer. We sought to evaluate the relationship between PS and EORTC QLQ-C30 QoL scores and the PFS and OS in advanced ovarian cancer. Methods: Canadian data was analyzed as part of an intergroup randomized trial in ovarian cancer (NCIC-OV10). Patients were randomized to receive either standard chemotherapy using cisplatin/cyclophosphamide or cisplatin/paclitaxel chemotherapy. The EORTC QoL questionnaire QLQ-C30 was administered just prior to starting chemotherapy, at each cycle, and every 3 months thereafter for two years or until disease progression. We determined PS and QoL scores in the following domains: physical, role, emotion, cognitive, social function and global QoL at baseline and 6 months after completing chemotherapy. Effects of multiple variables including treatment, PS, QoL scores, age, stage, grade, residual disease and histology were analyzed by Cox stepwise regression using PFS and OS as the outcome variables. Results: At baseline and at 6 months after chemotherapy, there were 151 and 80 patients respectively who completed QoL assessments. The Cox model revealed that baseline PS, global QoL and treatment were independent predictors for both PFS and OS, and grade and cognitive functioning were additional independent predictors for OS. Physical function at six months after completion of chemotherapy was the only significant independent predictor of both PFS and OS, with age and grade as two additional independent predictors for subsequent OS. Conclusions: Performance status and global quality of life scores at baseline are prognostic factors in advanced ovarian cancer for both PFS and OS. Higher baseline cognitive functioning scores were also associated with improved survival. Higher physical function scores at six months after completing chemotherapy predicted longer PFS and OS. (This research was supported by the NCIC through funds received by the Canadian Cancer Society). No significant financial relationships to disclose.

scholarly journals Analysis of the Chemotherapy-Free Interval following Image-Guided Ablation in Sarcoma Patients

Sarcoma ◽  
2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Charles Sutton ◽  
Yachao Zhang ◽  
DaeHee Kim ◽  
Hooman Yarmohammadi ◽  
Etay Ziv ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Systemic Chemotherapy ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Histologic Subtype ◽  
Free Survival ◽  
Image Guided ◽  
Free Interval

One way to enhance quality of life for patients with metastatic sarcoma is to maximize time off chemotherapy—a chemotherapy-free interval. While image-guided ablation of sarcoma metastases may reduce the need for chemotherapy, it remains unknown how long ablation could extend the chemotherapy-free interval. The purpose of our study was to determine the chemotherapy-free interval in comparison to overall survival and progression-free survival in sarcoma patients who undergo ablation procedures. An IRB-approved, single institution, HIPAA compliant database was queried for sarcoma patients who underwent image-guided ablation procedures between 2007 and 2018. Patient demographics, histologic subtype, and other clinical characteristics were recorded. Kaplan-Meier analysis was performed to compute median overall survival, median progression-free survival (local and distant), and the median chemotherapy-free interval (systemic and cytotoxic) after ablation. Univariate and multivariate analyses were performed using the log-rank test and Cox proportional-hazards model, respectively. A total of 100 sarcoma patients were included in the analysis. The most common histologic subtype was leiomyosarcoma (38%). Median overall survival after ablation of sarcoma metastases was 52.4 months (95% CI: 46.9–64.0 months). The median systemic chemotherapy-free interval following ablation of sarcoma metastases was 14.7 months (95% CI: 8.6–34.3 months). The median cytotoxic chemotherapy-free interval following ablation of sarcoma metastases was 81.3 months (95% CI: 34.3-median not reached). In conclusion, ablation of sarcoma metastases can provide an extended systemic chemotherapy-free interval of greater than 1 year. Ablation of sarcoma metastases may improve patient quality of life by extending the chemotherapy-free interval.

scholarly journals PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of E Health-Based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated with Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant

2021 ◽  
Author(s):  
Tom Degenhardt ◽  
Peter A. Fasching ◽  
Diana Lüftner ◽  
Volkmar Müller ◽  
Christoph Thomssen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Overall Survival ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Patient Reported Outcome ◽  
Free Survival ◽  
Hormone Receptor Positive ◽  
Patient Reported

Abstract Background: Efficacy and quality of life (QoL) are key when selecting a therapy for metastatic breast cancer (MBC) patients. In hormone receptor positive (HR+) human epidermal growth factor receptor 2 minus (HER2-) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g. palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. Prerequiste for obtaining such benefit is adherence to therapy over the whole treatment duration. Adherence, maintaining patients’ satisfaction, early detection and management of side effects have thus become important challenges, in particular with these new oral drugs and new ways of continuous support for oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.Methods: PreCycle is a multicenter, randomized, phase IV trial in HR+ HER2+ MBC. All patients (n=960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g. adherence), genetic background, and drug efficacy, the trial includes both patient reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).Discussion: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform). EudraCT Number: 2016-004191-22

Gemcitabine Plus Carboplatin Compared With Carboplatin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer: An Intergroup Trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG

2006 ◽  
Vol 24 (29) ◽  
pp. 4699-4707 ◽  
Author(s):  
Jacobus Pfisterer ◽  
Marie Plante ◽  
Ignace Vergote ◽  
Andreas du Bois ◽  
Hal Hirte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Response Rate ◽  
Single Agent ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Primary Objective ◽  
Platinum Sensitive

Purpose Most patients with advanced ovarian cancer develop recurrent disease. For those patients who recur at least 6 months after initial therapy, paclitaxel platinum has shown a modest survival advantage over platinum without paclitaxel; however, many patients develop clinically relevant neurotoxicity, frequently resulting in treatment discontinuation. Thus, an alternative regimen without significant neurotoxicity was evaluated by comparing gemcitabine plus carboplatin with single-agent carboplatin in platinum-sensitive recurrent ovarian cancer patients. Methods Patients with platinum-sensitive recurrent ovarian cancer were randomly assigned to receive either gemcitabine plus carboplatin or carboplatin alone, every 21 days. The primary objective was to compare progression-free survival (PFS). Results Three hundred fifty-six patients (178 gemcitabine plus carboplatin; 178 carboplatin) were randomly assigned. Patients received a median of six cycles in both arms. With a median follow-up of 17 months, median PFS was 8.6 months (95% CI, 7.9 to 9.7 months) for gemcitabine plus carboplatin and 5.8 months (95% CI, 5.2 to 7.1 months) for carboplatin. The hazard ration (HR) for PFS was 0.72 (95% CI, 0.58 to 0.90; P = .0031). Response rate was 47.2% (95% CI, 39.9% to 54.5%) for gemcitabine plus carboplatin and 30.9% (95% CI, 24.1% to 37.7%) for carboplatin (P = .0016). The HR for overall survival was 0.96 (95% CI, 0.75 to1.23; P = .7349). While myelosuppression was significantly more common in the combination, sequelae such as febrile neutropenia or infections were uncommon. No statistically significant differences in quality of life scores between arms were noted. Conclusion Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer.

Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?

Therapies ◽  
2016 ◽  
Vol 71 (6) ◽  
pp. 625-632
Author(s):  
Mira Pavlovic ◽  
Jérôme Garnier ◽  
Isabelle Durand-Zaleski ◽  
Pascal Bilbault ◽  
Anne-Françoise Gaudin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Progression Free Survival ◽  
Free Survival

scholarly journals Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Consuelo Nóhpal de la Rosa ◽  
Jonathan Krell ◽  
Emily Day ◽  
Aaron Clarke ◽  
Meena Reddi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Standard Treatment ◽  
Progression Free Survival ◽  
Statistical Analysis Plan ◽  
Weekly Paclitaxel ◽  
Free Survival ◽  
Secondary Outcomes ◽  
Eortc Qlq

Abstract Background Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer. Objective To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase. Results This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis. Discussion The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant’s progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment in September 2018. An interim analysis was performed in early 2021, the results of which advised continuation of the trial. The study recruitment is ongoing and is due to complete by the end of 2021. Trial registration ClinicalTrials.govNCT03648489. Registered on 27 August 2018

Randomized Study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group Comparing Quality of Life in Patients With Ovarian Cancer Treated With Cisplatin/Paclitaxel Versus Carboplatin/Paclitaxel

2006 ◽  
Vol 24 (4) ◽  
pp. 579-586 ◽  
Author(s):  
Elfriede R. Greimel ◽  
Vesna Bjelic-Radisic ◽  
Jacobus Pfisterer ◽  
Felix Hilpert ◽  
Fedor Daghofer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Cancer Patients ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Response To Treatment ◽  
Free Survival ◽  
The Impact

Purpose The objective of this study was to compare the quality of life (QoL) of ovarian cancer patients treated with paclitaxel/carboplatin (TC) versus paclitaxel/cisplatin (PT) and to determine the impact of treatment toxicity on the various QoL domains. Patients and Methods In this phase III trial, 798 patients with ovarian cancer stages IIB-IV were randomly assigned to receive TC or PT. The primary end point was progression-free survival; secondary end points included toxicity, QoL, and response to treatment. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 before treatment, within 3 days before the second and the fourth chemotherapy cycle, and 3 weeks after completion of chemotherapy. Results Previously reported data showed that patients undergoing TC or PT did not differ in progression-free survival and overall survival. However, the TC arm was superior, indicating a better overall QoL compared with the PT arm. Controlling for toxicity and age, a significant treatment by assessment time interaction was found for four QoL functioning scales and three symptoms scales. Patients in the TC arm showed better means scores after treatment on overall QoL (P = .012), physical functioning (P = .012), role functioning (P = .005), and cognitive functioning (P = .024), compared with the PT arm. Concerning symptom experience, patients undergoing TC showed less nausea and vomiting (P < .001), less appetite loss (P < .001), and less fatigue (P = .033) after completion of treatment compared with patients undergoing PT. Conclusion The TC regimen achieved better QoL outcomes compared with the PT regimen. Thus, clinicians may consider replacing cisplatin with carboplatin when treating ovarian cancer patients with chemotherapy.

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