Topotecan, paclitaxel, and carboplatin in advanced ovarian cancer: A phase II trial of the Minnie Pearl Cancer Research Network

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15015-15015 ◽  
Author(s):  
J. D. Zubkus ◽  
J. D. Hainsworth ◽  
D. R. Spigel ◽  
J. F. Patton ◽  
D. L. Shipley ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Standard Dose ◽  
Advanced Ovarian Cancer ◽  
Response Rates ◽  
Research Network ◽  
Stage Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3

15015 Background: Topotecan (T) is standard therapy for patients (pts) with relapsed platinum refractory ovarian cancer (OC). The addition of T to paclitaxel/carboplatin (PC) may improve the first-line therapy for pts with stage III/IV OC. Methods: The primary endpoints were to assess the toxicity and response rate of TPC in previously untreated pts with advanced OC. Pts with previously untreated stage III/IV OC with performance (PS) 0 or 1, normal hematologic and organ function were eligible. Topotecan 1mg/m2 per day IV days 1, 2, and 3; paclitaxel 175mg/m2 IV on day 3 and carboplatin (AUC=5) IV on day 3 were administered at 21-day intervals for 6 cycles with standard dose modifications for toxicities. Responses were assessed clinically after 2 cycles and at completion of therapy. Second look laporatory (SLL) was required for pts without evaluable tumor. Results: 50 pts were enrolled: age range 27–79 (median 63); performance status 0=16, 1=34; suboptimal debulking surgery (tumor > 1 cm) 32; 70% high grade tumors. Intent to treat response rates: complete response (CR) 20 pts (40%); partial response (PR) 12 pts (24%); stable (S) 13 pts (26%); progression 2 pts (4%); not evaluable 3 pts (6%). 13 pts had SLL with 5 CR, 5 PR and 3 S. Toxicities included: grade 3/4 neutropenia/thrombocytopenia 84%/44%; grade 3/4 fatigue/infection 10%/10%; no treatment-related deaths. Median progression-free survival (PFS) for all pts was 13.6 months and 1-, 2-, 3-year PFS 60%, 42%, 36%. Median survival 33.9 months for all pts with 1-, 2-, 3-year survivals 90%, 65%, 49%. Conclusions: The combination of TPC is active and relatively well tolerated with PC given on day 3. The response rates, PFS, and survivals appear similar to standard regimens. Randomized prospective trials will be required to determine the value of T added to PC for first-line therapy of advanced OC. [Table: see text]

Concordance with National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (CPGs): A Quality of Care Tool for Newly Diagnosed Patients (pts) with Mantle Cell Lymphoma (MCL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3328-3328
Author(s):  
Maria Alma Rodriguez ◽  
Anna Ter Veer ◽  
Auayporn Nademanee ◽  
Joyce Niland ◽  
Eva Lepisto ◽  
...  
Keyword(s):  
Standard Dose ◽  
High Rate ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
First Line ◽  
Nccn Guidelines ◽  
First Line Therapy ◽  
Line Therapy

Abstract Introduction: In 1999, the NCCN published its first NHL CPG and in 2000, established the NCCN NHL Outcomes Database Project to monitor patterns of care, CPG concordance and outcomes in participating institutions. We report here on clinical characteristics and CPG concordance among newly diagnosed (dx) pts with MCL in the database. Methods: We prospectively collected demographic, staging, and treatment information on consecutive pts with MCL presenting at 5 geographically diverse NCCN institutions (Dana-Farber, Roswell Park, City of Hope, Fox Chase and MD Anderson). We assessed concordance with 2 CPG’s relevant to the concordance impacting the majority of pts: 1) bone marrow biopsy (BMBx) as part of the initial work-up and 2) use of an endorsed first line regimen among pts with stage III/IV disease. CPG concordance was assessed by comparing each pt’s care against the version on the NCCN guideline in effect at the time the pt was diagnosed. Results: Between 7/2000 and 10/2005, we enrolled 132 MC evaluable pts. Median age was 58; 43% had high-intermediate or high risk disease according to the IPI at presentation; 123 (93%) pts presented with stage III/IV disease. The median follow-up was 22.6 months. Overall, 91% of pts underwent a staging BMBx as recommended by the guidelines. Concordance varied by institution, low 78% to high 98%. Among 123 pts with stage III/IV disease, first-line therapy was concordant with CPG recommendations in only 59%. Use of rituximab accounted for 92% of all non-concordance. When the guidelines were modified in 2003 to include rituximab as an option for first-line therapy of MCL, concordance rose from 31% (2000) to 100% (2003–5). Of concordant pts receiving combination chemotherapy, 33% received CHOP-based standard dose therapy and 62% received dose-intense therapy. NCCN guidelines consider all therapy administered as part of a clinical trial to be concordant; trial-directed treatment accounted for 42% of concordant care. Conclusions: Our data suggest that the majority of MCL pts in these centers receive care that is concordant with current standards. In this subgroup of patients, participation in clinical trials occurred at an impressively high rate. However, not all pts undergo BMBx as a routine component of staging as recommended by NCCN guidelines suggesting that this is an area for potential quality improvement. This study also highlights that differences in management exist even within national comprehensive cancer centers. Because long-term follow-up is possible with this database, future studies will assess the initial treatment and guideline concordance on long-term outcomes in this unique group of pts.

What Surveillance Plan Should Be Advised for Patients in Remission After Completion of First-Line Therapy for Advanced Ovarian Cancer?

2010 ◽  
Vol 20 (Suppl 2) ◽  
pp. S27-S28 ◽  
Author(s):  
Gordon J. S. Rustin
Keyword(s):  
Ovarian Cancer ◽  
Medical Research Council ◽  
Advanced Ovarian Cancer ◽  
Clinical Indication ◽  
Ca 125 ◽  
First Line ◽  
The Third ◽  
First Line Therapy ◽  
Line Therapy

Based on the results of the Medical Research Council OVO5/European Organisation for Research and Treatment of Cancer 55955 trial, the follow-up plan I recommend for patients in remission after completion of first-line therapy for advanced ovarian cancer is appointments: every 3 months for 2 years, every 4 months on the third year, then every 6 months thereafter, and discharge if no relapse by 10 years. History and examination (not internal) should be performed at each appointment. CA-125 should only be measured if there is a suspicion of relapse or at patient's request. No scans should be performed unless clinical indication or rising CA-125.

Economic and policy implications of adopting paclitaxel as first-line therapy for advanced ovarian cancer: an Ontario perspective.

1997 ◽  
Vol 15 (2) ◽  
pp. 632-639 ◽  
Author(s):  
L M Elit ◽  
A Gafni ◽  
M N Levine
Keyword(s):  
Ovarian Cancer ◽  
Cost Effectiveness ◽  
Cancer Patients ◽  
Standard Therapy ◽  
Advanced Ovarian Cancer ◽  
Policy Implications ◽  
Sensitivity Analyses ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

PURPOSE To determine the potential economic and policy implications that result from incorporating paclitaxel into first-line therapy for stage 3 and 4 ovarian cancer patients in the province of Ontario, Canada. METHODS A cost-effectiveness analysis was conducted to compare cisplatin/cyclophosphamide (CC), a standard therapy, with cisplatin/paclitaxel (CT). Based on survival curves from a clinical trial, mean costs and survival were calculated. Sensitivity analyses were conducted based on altering the duration of paclitaxel infusion, discount rates, and efficacy of paclitaxel. RESULTS The mean survival duration is prolonged from 2.06 years with the standard therapy to 2.44 years with the paclitaxel combination. The paclitaxel therapy is more expensive, with a mean cost of $17,469 (Canadian) per patient treated with CT compared with $5,228 per patient with CC. The incremental cost-effectiveness ratio is $32,213 per year gained. Sensitivity analyses show that the conclusions remain unchanged. The use of CT as first-line treatment for advanced ovarian cancer patients in Ontario requires an additional $9 million per year over and above the present costs to treat this patient population. CONCLUSION Although paclitaxel-based therapy prolongs survival, it comes at an increased cost. It may not be possible to fund paclitaxel treatment using resources presently allocated to first-line chemotherapy for advanced ovarian cancer. The policy implications for absorbing the cost of paclitaxel in the context of a publicly funded health care system are discussed.

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