Prognostic impact of the time interval between surgery and chemotherapy in advanced ovarian cancer: Analysis of prospective randomised phase III trials

2013 ◽  
Vol 49 (1) ◽  
pp. 142-149 ◽  
Author(s):  
S. Mahner ◽  
C. Eulenburg ◽  
A. Staehle ◽  
K. Wegscheider ◽  
A. Reuss ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Time Interval ◽  
Prognostic Impact ◽  
Phase Iii Trials

Prognostic impact of the time interval between primary surgery and start of first-line chemotherapy in patients with advanced ovarian cancer: Analysis of prospective randomized phase III trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5514-5514
Author(s):  
S. Mahner ◽  
A. Staehle ◽  
C. zu Eulenburg ◽  
K. Wegscheider ◽  
A. Reuss ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Advanced Ovarian Cancer ◽  
Residual Tumor ◽  
Phase Iii ◽  
Time Interval ◽  
Prognostic Impact ◽  
First Line ◽  
Primary Surgery ◽  
Line Chemotherapy

5514 Background: Primary surgery followed by platinum-taxane chemotherapy is the standard therapy of advanced ovarian cancer. It is not clear, whether the time interval between surgery and start of first line chemotherapy (time to chemo - TTC) has an impact on the clinical outcome. Methods: Individual patient data meta-analysis of three prospective randomized AGO-OVAR/GINECO trials (AGO OVAR 3, 5, and 7) conducted between 1995 and 2002 to investigate platinum-taxane based chemotherapy regimens in advanced ovarian cancer. Cox proportional hazard models were applied to evaluate the prognostic impact of different variables on survival; TTC was introduced as a continuous variable. Results: A total of 3,326 patients were analyzed. Chemotherapy was started within 8 weeks after surgery. Median progression-free survival (PFS) was 17.91 months (95% CI: 17.15–18.73 months) and median overall survival (OS) 37.83 months (95% CI: 36.57–38.90 months). The median TTC was 19 days (95% CI: 18–19 days, range 1–56 days). By multivariate analysis of the total cohort, there was no significant association between TTC and PFS (p = 0.131) or OS (p = 0.372). In the subgroup of patients with no residual tumor after debulking surgery (n = 1.101), a significant and independent correlation between early start of chemotherapy and improved overall survival was observed (p = 0.022). Conclusions: Our analysis represents the largest study investigating treatment delivery and outcome in ovarian cancer. The time interval between primary surgery and start of first line chemotherapy seems to have no general impact in all patients. However, it could be demonstrated for the first time that a delayed start of chemotherapy was independently associated with decreased overall survival in patients with complete surgical debulking. As previously shown for other biological factors in ovarian cancer, the presence of residual tumor after surgery seems to prevail over the prognostic impact of therapy initiation. No significant financial relationships to disclose.

Does alopecia predict response to chemotherapy and prognosis in patients with advanced ovarian cancer? A meta-analysis of prospective randomized phase III trials with 5,114 patients of the AGO meta data base.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5553-5553
Author(s):  
Jalid Sehouli ◽  
Edibe Erol ◽  
Rolf Richter ◽  
Alexander Reuss ◽  
Christina Fotopoulou ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Poor Response ◽  
Favourable Outcome ◽  
Phase Iii ◽  
Prognostic Impact ◽  
Poor Overall Survival ◽  
Response To Chemotherapy ◽  
Phase Iii Trials

5553 Background: Alopecia is a relevant side effect of chemotherapy. Our aim was to validate and unconfirmed broad patient´s opinion that a low rate of alopecia may predict poor response to chemotherapy and poor overall survival (OS). Methods: Individual patient data analysis of 5114 patients from four prospective randomised phase III trials conducted between 1995 and 2004 to investigate platinum-taxane based chemotherapy regimens in advanced ovarian cancer. Uni- and multivariate analyses were performed adjusted for age, number of cycles, individual trial, residual mass, tumor stage and histology. Results: 5,114 patients with ovarian cancer (OC) were analyzed. Most patients presented with advanced stage FIGO III/IV (87.8%). A median of 6 cycles were applied (range 0-11). Worst alopecia grade was 0 in 2.2%, 1 in 2.7% and 2 in 87.1%. In 8% patients no data about alopecia were documented. Patients with complete alopecia were more likely to achieve remission (OR 2.83, 95% CI 1.68-4.78 for grade 2 compared to grade 0/1) and had favourable progression-free survival of 19.0 months, (95%CI 18,2-19.7) compared to patients with grade 0/1 (13.8, 95%CI 12.2-15.3 and 14.3, 95%CI 10.8-17.8). Median OS was also significantly longer after grade 2 alopecia 48.8 months (95%CI 47.0-50.5), compared to 28.1 months (95%CI 22.3-33.9) and 33.9 months (95%CI24.3-43.6) for grade 0 and 1, respectively. This prognostic impact was not reteined in multivariate analysis. However, onset of alopecia was an independent prognostic factor for OS: patients with complete alopecia after cycle 3 had a favourable outcome compared to patient who experienced alopecia later during therapy (HR 1.22, 95%CI 1.02-1.46) or no alopecia (HR 1.29, 95%CI 0.98-1.70). Conclusions: We could show for the very first time that there is no evidence that the rate of alopecia is associated with the effect of chemotherapy is of any prognostic relevance. The observation that early onset of alopecia is associated with OS should be confirmed.

scholarly journals First-line PARP inhibitors in ovarian cancer: summary of an ESMO Open - Cancer Horizons round-table discussion

ESMO Open ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e001110
Author(s):  
Susana Banerjee ◽  
Antonio Gonzalez-Martin ◽  
Philipp Harter ◽  
Domenica Lorusso ◽  
Kathleen N Moore ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Parp Inhibitor ◽  
Advanced Ovarian Cancer ◽  
Round Table ◽  
Parp Inhibitors ◽  
Phase Iii ◽  
European Medicines Agency ◽  
First Line ◽  
Phase Iii Trials

Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is the latest breakthrough in the management of newly diagnosed advanced ovarian cancer. The results of the SOLO-1 trial in 2018 led to European Medicines Agency and Food and Drug Administration approval of olaparib as first-line maintenance therapy in patients with BRCA1/2 mutation, establishing a new standard of care. Subsequently, the results of three phase III trials (PRIMA, PAOLA-1, VELIA) evaluating the use of first-line PARP inhibitors beyond patients with BRCA1/2 mutations and as combination strategies were presented in 2019, leading to the recent approval of maintenance niraparib irrespective of biomarker status and olaparib in combination with bevacizumab in homologous recombination deficiency-positive-associated advanced ovarian cancer. An ESMO Open - Cancer Horizons round-table expert panel discussed the four phase III trials of first-line PARP inhibitor therapy and how they are changing the clinical management of advanced ovarian cancer.

Point: Intraperitoneal Chemotherapy in the Management of Ovarian Cancer

2004 ◽  
Vol 2 (6) ◽  
pp. 549-554 ◽  
Author(s):  
Maurie Markman
Keyword(s):  
Ovarian Cancer ◽  
Small Volume ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Rational Approach ◽  
Pharmacokinetic Studies ◽  
Phase Ii Trials ◽  
Intraperitoneal Therapy ◽  
Phase Iii Trials ◽  
Optimal Approach

Both preclinical considerations and results of phase I safety and pharmacokinetic studies provided support for the argument that intraperitoneal antineoplastic drug delivery should be a rational approach to the management of ovarian cancer. Subsequently conducted phase II trials exploring regional treatment revealed surgically documented objective responses when the approach was employed as a second-line therapy. Recently, the results of three randomized phase III trials have shown that the use of primary cisplatin-based intraperitoneal therapy leads to superior survival compared with intravenous cisplatin-based treatment in patients with small-volume residual advanced ovarian cancer after initial surgical cytoreduction. Further exploration of this unique management strategy is indicated to develop an optimal approach that maintains the demonstrated enhanced efficacy while reducing the toxicity (principally because of cisplatin) of treatment.

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

scholarly journals Pegylated Liposomal Doxorubicin in the Management of Ovarian Cancer

2010 ◽  
Vol 2 ◽  
pp. CMT.S4456
Author(s):  
Gabriella Ferrandina ◽  
Marco Petrillo ◽  
Angelo Licameli ◽  
Gilda Fuoco ◽  
Giovanni Scambia ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Liposomal Doxorubicin ◽  
Advanced Ovarian Cancer ◽  
Pegylated Liposomal Doxorubicin ◽  
Phase Iii ◽  
Line Treatment ◽  
Front Line ◽  
Clinical Role ◽  
High Responsiveness ◽  
Phase Iii Trials

Despite the cytoreductive efforts, and the high responsiveness to standard carboplatin/pacllitaxel front-line treatment, ovarian cancer (OvCa) remains the most lethal gynaecological malignancy with a 5-yr overall survival of only 25%–30% in advanced stage disease. Among the pharmaceutical options available for treatment of OvCa, much attention has been dedicated to pegylated liposomal doxorubicin (PLD) (Doxil® in the US; Caelyx® in Canada and Europe); this drug has a unique formulation which has entrapped conventional doxorubicin in a bilayer lipidic sphere surrounded by a polyethylene glycol layer, which prolongs the persistence of the drug in the circulation and potentiates its intratumor accumulation. These properties represent the winning resource for this drug in that sustain its very favourable toxicity profile and the safe combination with other drugs. PLD has already been approved for treatment of advanced ovarian cancer patients failing first line platinum-based treatment. Moreover, Phase III trials have been completed, which will hopefully will bring PLD to front-line treatment, and in salvage setting in combination with platinum agents. This concise review will focus on the clinical role of PLD in the management of patients with epithelial OvCa.

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