Methodology to screen and evaluate cost/survival of anticancer drugs in advanced/metastatic gastrointestinal cancers.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 196-196
Author(s):  
Helmy M. Guirgis
Keyword(s):  
Quality Of Life ◽  
Anticancer Drugs ◽  
Generic Drugs ◽  
Progression Free Survival ◽  
Gastrointestinal Cancers ◽  
Free Survival ◽  
Colon Cancers ◽  
Pancreatic Cancers ◽  
Gi Cancers

196 Background: There is a paucity of methods to screen cost/survival of anticancer drugs in 1st-line advanced/metastatic (adv/met) gastrointestinal (GI) cancers. Methods: Average whole prices (AWP) in United States dollars (US $) of evaluated drugs for the entire course were divided by previously reported median survival gain in days. Generic drugs were given flat total costs of up to $750. A 100% crude score was assigned to cost/survival/day < $25 and 0% to cost/survival/day $750. Results were expressed as % scores of cost/progression-free-survival (cost/PFS) or cost/overall survival (cost/OS). Guidelines were suggested for corrections; lack of OS - 10%, adverse effects (AEs) - 0 -15%, Quality of life (QoL) - 0-10% and administration and preparation (A and P) - 0-10%. Results: Generic drugs scored 80%-90% in pancreatic and biliary followed by Trastuzumam 60% in gastric and Bevacizumab 0-40% in colon cancers (Table 1). Conclusions: Methodology based on limits on cost/survival/day was developed to screen anticancer drugs in GI cancers. Generic drugs in bilary and pancreatic cancers scored the highest. [Table: see text]

scholarly journals RBTT-04. DOES EXERCISE IMPROVE PROGRESSION FREE SURVIVAL AND QUALITY OF LIFE IN PATIENTS WITH GLIOBLASTOMA? A TRIAL IN PROGRESS

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi234-vi235
Author(s):  
Kim Edelstein ◽  
Kristin Campbell ◽  
Lori Bernstein ◽  
Ilyse Lax ◽  
Felicity Backhouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Progression Free Survival ◽  
Free Survival

scholarly journals The necessity of Ⅱb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Lei Wang ◽  
Liang Wang ◽  
Xuefei Song ◽  
Chang Cui ◽  
Chunyue Ma ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Squamous Cell Carcinoma ◽  
Oral Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Neck Dissection ◽  
Early Stage ◽  
Progression Free Survival ◽  
Oral Carcinoma ◽  
Free Survival

Abstract Background: There is growing discussion of the relationship between health¬–related quality of life (HRQoL) and patient survival, which has been going on for the last few decades. Clinicians´ greatest wish is to extend the latter while improving the former. After neck dissection of early–stage oral carcinoma, “shoulder syndrome” appears due to traction of the accessory nerve during removal of level Ⅱb, which greatly affects patient quality of life. Since occult metastasis in level Ⅱb of early–stage oral carcinoma is extremely low, some surgeons suggest that level Ⅱb can be exempt from dissection to improve HRQoL. However, other surgeons take the opposite view, and thus there is no consensus on the necessity of Ⅱb dissection in T1–2N0M0 oral squamous¬ cell carcinoma (OSCC). Methods: We designed a parallel–group, randomized, non–inferiority trial that is supported by Shanghai Ninth People´s Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China. We will enroll 522 patients of early oral carcinoma who match the inclusion criteria, and compare differences in 3–year overall survival, progression–free survival (PFS) and in HRQoL under different interventions (retention or dissection of level Ⅱb) between two groups. The primary end points will be tested by means of two-sided log-rank tests. Analysis of overall and progression–free survival will be performed in subgroups that were defined according to stratification factors with the use of univariate Cox analysis. In addition, we will use post hoc subgroup analyses on the basis of histological factors that were known to have effects on survival, such as death of invasion of the primary tumor. To evaluate HRQoL, we will choose the Constant–Murley scale to measure shoulder function. Discussion: Currently, there are no RCTs with large sample sizes on the necessity of IIb dissection in T1–T2N0M0 OSCC. We designed this reasonable non–inferiority RCT that combines survival rate and HRQoL to assess the feasibility of IIb neck dissection. The result of this trial may guide clinical practice and change the criteria of how early–stage oral cancer is managed. The balance between survival and HRQoL in this trial is based on early-stage breast cancer treatment and may provide new ideas for other malignancies.

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.

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.

scholarly journals The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lei Wang ◽  
Liang Wang ◽  
Xuefei Song ◽  
Chang Cui ◽  
Chunyue Ma ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Squamous Cell Carcinoma ◽  
Oral Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Early Stage ◽  
Progression Free Survival ◽  
Oral Carcinoma ◽  
Free Survival ◽  
Randomized Controlled

Abstract Background There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend the latter while improving the former. Following neck dissection of early-stage oral carcinoma, “shoulder syndrome” appears due to traction of the accessory nerve during removal of level IIb, which greatly affects patient quality of life. Since occult metastasis in level IIb of early-stage oral carcinoma is extremely low, some surgeons suggest that level IIb can be exempt from dissection to improve the HRQoL. However, other surgeons take the opposite view, and thus there is no consensus on the necessity of IIb dissection in T1–2N0M0 oral squamous cell carcinoma (OSCC). Methods We designed a parallel-group, randomized, non-inferiority trial that is supported by Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China. We will enroll 522 patients with early oral carcinoma who match the inclusion criteria, and compare differences in 3-year overall survival, progression–free survival (PFS) and HRQoL under different interventions (retention or dissection of level IIb). The primary endpoints will be tested by means of two-sided log-rank tests. Analysis of overall and progression-free survival will be performed in subgroups that were defined according to stratification factors with the use of univariate Cox analysis. In addition, we will use post-hoc subgroup analyses on the basis of histological factors that were known to have effects on survival, such as death of invasion of the primary tumor. To evaluate HRQoL, we will choose the Constant–Murley scale to measure shoulder function. Discussion Currently, there are no randomized controlled trials with large sample sizes on the necessity of IIB dissection in T1–T2N0M0 OSCC. We designed this noninferiority RCT that combines survival rate and HRQoL to assess the feasibility of IIb neck dissection. The result of this trial may guide clinical practice and change the criteria of how early-stage oral cancer is managed. The balance between survival and HRQoL in this trial is based on early-stage breast cancer treatment and may provide new ideas for other malignancies. Trial registration Chinese Clinical Trial Registry, ChiCTR1800019128. Registered on 26 October 2018.

International Atomic Energy Agency Randomized Phase III Study of Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme

2015 ◽  
Vol 33 (35) ◽  
pp. 4145-4150 ◽  
Author(s):  
Wilson Roa ◽  
Lucyna Kepka ◽  
Narendra Kumar ◽  
Valery Sinaika ◽  
Juliana Matiello ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Survival Time ◽  
Progression Free Survival ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Frail Patients ◽  
Short Course ◽  
Newly Diagnosed Glioblastoma ◽  
Short Course Radiotherapy

Purpose The optimal radiotherapy regimen for elderly and/or frail patients with newly diagnosed glioblastoma remains to be established. This study compared two radiotherapy regimens on the outcome of these patients. Patients and Methods Between 2010 and 2013, 98 patients (frail = age ≥ 50 years and Karnofsky performance status [KPS] of 50% to 70%; elderly and frail = age ≥ 65 years and KPS of 50% to 70%; elderly = age ≥ 65 years and KPS of 80% to 100%) were prospectively randomly assigned to two arms in a 1:1 ratio, stratified by age (< and ≥ 65 years old), KPS, and extent of surgical resection. Arm 1 received short-course radiotherapy (25 Gy in five daily fractions over 1 week), and arm 2 received commonly used radiotherapy (40 Gy in 15 daily fractions over 3 weeks). Results The short-course radiotherapy was noninferior to commonly used radiotherapy. The median overall survival time was 7.9 months (95% CI, 6.3 to 9.6 months) in arm 1 and 6.4 months (95% CI, 5.1 to 7.6 months) in arm 2 (P = .988). Median progression-free survival time was 4.2 months (95% CI, 2.5 to 5.9) in arm 1 and 4.2 months (95% CI, 2.6 to 5.7) in arm B (P = .716). With a median follow-up time of 6.3 months, the quality of life between both arms at 4 weeks after treatment and 8 weeks after treatment was not different. Conclusion There were no differences in overall survival time, progression-free survival time, and quality of life between patients receiving the two radiotherapy regimens. In view of the reduced treatment time, the short 1-week radiotherapy regimen may be recommended as a treatment option for elderly and/or frail patients with newly diagnosed glioblastoma.

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