scholarly journals Counterpoint: Intraperitoneal Chemotherapy: An Investigational Treatment in Ovarian Cancer

2004 ◽  
Vol 2 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Robert F. Ozols
Keyword(s):  
Ovarian Cancer ◽  
Standard Therapy ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Systemic Circulation ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Phase Ii Trials

Intraperitoneal (IP) chemotherapy in ovarian cancer has been studied since 1978. Numerous phase II trials have been performed, which have shown that higher levels can be obtained in the peritoneal cavity compared with systemic circulation after administration of cytoxic agents in a large volume via a semi-permanent catheter. Three randomized trials have been performed in patients with ovarian cancer comparing different IP regimens to standard therapy with intravenous agents. The last two trials from the Gynecologic Oncology Group (GOG) and the Southwest Oncology Group (SWOG) compared two different IP regimens versus standard therapy with intravenous cisplatin plus paclitaxel. Although an improvement in progression-free survival was reported for the IP regimens, they have been associated with unacceptable toxicity, and no IP regimen can be considered standard therapy. Maintenance therapy with IP cisplatin also failed to improve survival in patients who obtained complete remission after intravenous chemotherapy. The GOG is considering another phase III trial of IP therapy that will compare a carboplatin-based regimen versus standard therapy with intravenous paclitaxel plus carboplatin. Unless such a trial shows an improvement in clinical outcome, intravenous carboplatin plus paclitaxel remains the standard of care and IP chemotherapy should not be used outside of a clinical trial.

scholarly journals Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer

2020 ◽  
Vol 16 (7) ◽  
pp. 225-246 ◽  
Author(s):  
Carolyn E Haunschild ◽  
Krishnansu S Tewari
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Double Blind ◽  
Free Survival ◽  
Platinum Sensitive ◽  
The Us ◽  
Us Fda

On 13 June 2018, Genentech, Inc. issued a press release announcing that the US FDA had approved the antiangiogenesis drug, bevacizumab, in combination with chemotherapy for frontline and maintenance therapy for women with newly diagnosed ovarian cancer. Regulatory approval was based on the National Cancer Institute-sponsored Gynecologic Oncology Group (GOG) protocol 0218, the Phase III, randomized, placebo-controlled, double-blind, multi-center and multi-national clinical trial that met its primary end point, progression-free survival. Bevacizumab is now approved in the frontline, platinum-sensitive recurrent and platinum-resistant recurrent settings for epithelial ovarian cancer. This review will address the broad range of clinical trials addressing the efficacy of bevacizumab use in ovarian cancer.

scholarly journals ASCO Value Framework Highlights the Relative Value of Treatment Options in Ovarian Cancer

2017 ◽  
Vol 13 (12) ◽  
pp. e1030-e1039 ◽  
Author(s):  
Jonathan Foote ◽  
Angeles Alvarez Secord ◽  
Margaret Liang ◽  
David E. Cohn ◽  
Elizabeth Jewell ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Benefit ◽  
Treatment Options ◽  
Gynecologic Oncology ◽  
Additional Cost ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Relative Value ◽  
Dose Dense

Purpose: The ASCO value framework allows physicians and patients to compare the relative value of novel treatments. Our aim was to assess the value of three frontline ovarian cancer therapies by using this framework. Methods: From phase III, randomized controlled clinical trial (RCT) data, the net health benefits (NHBs) for three frontline ovarian cancer treatment options—dose-dense paclitaxel (Japanese Gynecologic Oncology Group study JGOG 3016), intraperitoneal (IP)/intravenous (IV) chemotherapy (Gynecologic Oncology Group [GOG] study GOG 172), and concurrent plus maintenance bevacizumab (GOG 218 and the Seventh International Collaborative Ovarian Neoplasm study [ICON7])—were calculated. The ASCO value framework calculates the NHB by using six criteria: clinical benefit, toxicity, tail of the curve, symptom palliation, treatment-free interval, and quality of life. Clinical benefit calculation uses ASCO-assigned importance weights for overall survival and progression-free survival. The maximum possible NHB points is 180. NHBs were presented alongside the drug-acquisition cost (DAC) of each therapy. A benefit-cost ratio of NHB points per additional cost was calculated. Results: The NHB of dose-dense paclitaxel was 38, at an additional cost of $16 per cycle. IP cisplatin/IV + IP paclitaxel received 29 NHB points, at an additional cost of $1,629 per cycle. Concurrent plus maintenance bevacizumab received 24 NHB points, at an additional cost of $7,581 per cycle (GOG 218) or six NHB points ($3,790 per cycle; ICON7). The ratios of NHB points–to-dollar were as follows: dose-dense paclitaxel, 2.4 (highest); IP chemotherapy, 0.018; and bevacizumab, 0.003 (lowest). Conclusion: Using the ASCO value framework, we constructed value snapshots of three major frontline therapeutic options in ovarian cancer. Dose-dense paclitaxel provided the highest additional value when analysis accounted for NHB and cost. However, additional research is needed to include individual patient preferences and provide personalized value assessments.

scholarly journals Phase III Randomized Trial of Weekly Cisplatin and Irradiation Versus Cisplatin and Tirapazamine and Irradiation in Stages IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis: A Gynecologic Oncology Group Study

2014 ◽  
Vol 32 (5) ◽  
pp. 458-464 ◽  
Author(s):  
Paul A. DiSilvestro ◽  
Shamshad Ali ◽  
Peter S. Craighead ◽  
Joseph A. Lucci ◽  
Yi-Chun Lee ◽  
...  
Keyword(s):  
Gynecologic Oncology ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Cervix Cancer ◽  
Phase Iii ◽  
Hypoxic Cell ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Starting Dose ◽  
Original Target

Purpose This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. Patients and Methods Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. Results PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. Conclusion TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.

Principles and practice of intraperitoneal chemotherapy for ovarian cancer

2007 ◽  
Vol 17 (1) ◽  
pp. 1-20 ◽  
Author(s):  
K. Fujiwara ◽  
D. Armstrong ◽  
M. Morgan ◽  
M. Markman
Keyword(s):  
Ovarian Cancer ◽  
Survival Benefit ◽  
Meta Analysis ◽  
Gynecologic Oncology ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Clinical Aspects ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Phase Iii Trials

Intraperitoneal (IP) chemotherapy has been studied for years to improve the survival of patients with ovarian cancer. Recently, the result of Gynecologic Oncology Group 172 trial comparing IP versus intravenous administration of cisplatin-based chemotherapy was published, demonstrating the improvement of survival benefit in favor of the IP arm. This trial is the third trial that showed a survival benefit on IP chemotherapy. The National Cancer Institute (NCI) and Gynecologic Oncology Group have done a meta-analysis on the results of these three US trials and other phase III trials of IP versus intravenous chemotherapy, and significant improvement of survival was shown with IP therapy. Based on this meta-analysis, NCI has released a clinical announcement encouraging the gynecological oncology community to consider IP chemotherapy as the standard treatment for optimally debulked advanced ovarian cancer patients. However, there still are controversial issues regarding the use of IP chemotherapy. It is important to understand how IP chemotherapy works to solve those issues in the future. In this review article, we discuss the principles and clinical aspects of IP chemotherapy and also discuss the current problems and future perspectives in IP chemotherapy

Change in patient weight during platinum/paclitaxel-based chemotherapy for ovarian cancer: A Gynecologic Oncology Group study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5073-5073
Author(s):  
L. M. Hess ◽  
C. Tian ◽  
R. Barakat ◽  
R. Ozols ◽  
D. Alberts
Keyword(s):  
Ovarian Cancer ◽  
Weight Loss ◽  
Body Weight ◽  
Weight Change ◽  
Gynecologic Oncology ◽  
Relative Weight ◽  
Phase Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Risk Of Death

5073 Background: Platinum/paclitaxel (P)-based chemotherapy is current treatment (tx) for advanced epithelial ovarian cancer (EOC). Previous studies suggest this regimen may induce weight change, which is a surrogate for body reaction to tx and may predict quality of life and clinical outcomes. We sought to explore the association between weight change during treatment and survival. Methods: A retrospective data review was conducted of 792 patients who participated in a Gynecologic Oncology Group (GOG) phase III randomized treatment trial (GOG 158) using cisplatin (Cis)/P vs carboplatin (Carbo)/P in optimal stage III EOC. Pretreatment body mass index (BMI) was calculated based on patient height and weight following surgery. Weight change during tx was defined as the ratio of body weight at completion of protocol therapy to pretreatment body weight. Progression-free survival (PFS) and overall survival (OS), classified by BMI or relative weight change, were estimated by Kaplan-Meier, and the associations between BMI, relative weight change and PFS and OS were assessed using Cox model controlled for known prognostic variables. Results: The median BMI was 24.9. There was no significant difference in PFS or OS related to BMI; however, there was a significant relationship between median OS and weight change as follows: >5% decrease = 48.0 months; 0–5% decrease = 49.3 months; 0–5% increase = 61.1 months; and >5% increase = 68.2 months (p = 0.006). The relative risk of death increased by 7% for each 5% decrease in body weight (HR = 0.93, 95% CI = 0.88–0.99; p = 0.013) adjusted for covariates. Results suggest more evident weight loss in the Cis/P arm than the Carbo/P arm during the first cycle of tx (−2.2 kg vs. −1.2 kg), and decreased weight was more likely to return to pretreatment level in the Carbo/P arm. Conclusions: Loss of body weight, but not BMI, during platinum/P-based chemotherapy is an indicator for poor OS in EOC patients. Cis/P may be associated with more weight loss compared to Carbo/P. This exploratory study supports the development of treatment strategies that minimize weight loss-producing toxicities to improve outcomes in this patient population. No significant financial relationships to disclose.

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