CON: Dose-dense Paclitaxel at 80 mg/m2 Weekly in Combination with Carboplatin AUC-6 Every Three Weeks Should Not be Considered Standard of Care in the Front Line Management of Ovarian Cancer

2011 ◽  
Vol 4 (1) ◽  
pp. 4-6
Author(s):  
Robert Mannel
2020 ◽  
Vol 122 (6) ◽  
pp. 766-770 ◽  
Author(s):  
Kosei Hasegawa ◽  
Muneaki Shimada ◽  
Satoshi Takeuchi ◽  
Hiroyuki Fujiwara ◽  
Yuichi Imai ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5562-5562
Author(s):  
Michail Nikolaou ◽  
Nikolaos Ziras ◽  
Ilias Athanasiadis ◽  
Alexandros Ardavanis ◽  
Michael Vaslamatzis ◽  
...  

5562 Background: The standard of care for Epithelial Ovarian cancer (EOC) is the combination of a taxane plus a platinum compound (TC) whereas the addition of bevacizumab (bev) to this regimen (TC-bev) has been shown to improve the PFS. Patients (pts) with ascites have more aggressive disease and less overall survival. The aim of the study was to evaluate the safety of the TC/bev regimen in the real life clinical practice. Methods: A multi-center observational study, approved by the ethics committees of the participating centers, including 314 pts with stage III/IV EOC, was conducted (11.2011-06.2014) in Greece. Two independent cohorts, with similar clinico-pathologic characteristics, were treated with front-line TC (n = 109) or TC/bev (n = 205) according to the physician’s choice. 83 (40.5%) and 40 (36.7%) in the TC/bev and TC groups presented with ascites. Results: Disease control was achieved in 90.7% and in 78.9% of patients treated with TC/bev and TC, respectively (p = 0.003). Pts with ascites treated with TC/bev experienced a better overall response rate (ORR) (68.7% Vs 55%) and less progression disease (PD) compared to patients receiving TC (13.2% Vs 30.8%). The median PFS in all pts was 21.5mo and 12.4mo (p < 0.001) and median PFS in ascites pts was 18.1mo and 10.3mo in the TC/bev and TC cohort , respectively (p < 0.001). The median OS was not reached in the TC/bev group and it was 36.9mo in the TC group, ( p = 0.059) while in the ascites pts also has not reached and it is 22.5m, respectively ( p = 0.023). The 3 year survival rate in all pts was 59.4% and 50.4% and in ascites pts was 55.3% and 30% in the TC/bev and TC respectively. Neutropenia was the most common grade 3/4 adverse event in 16.6% and 9.1% in TC/bev- and TC- treated patients ( p = 0.072) with no other adverse events > 5%. Conclusions: These real life data demonstrate that the combination of TC/bev represents an active and well tolerated regimen offering survival benefit in patients with stage III/IV EOC and especially in patients with ascites. Additional larger prospective studies are required to confirm these observations. Clinical trial information: NCT01982500.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18066-e18066
Author(s):  
Alexey Rumyantsev ◽  
Alexandra Tyulyandina ◽  
Ilya Pokataev ◽  
Konstantin Morkhov ◽  
Valentina Mikhailovna Nechuskina ◽  
...  

e18066 Background: Patients with advanced ovarian cancer have unfavorable prognosis after primary debulking surgery if the size of residual tumor exceeds 1 cm. The optimal approaches to systemic treatment of these patients remain unknown. We evaluated the efficacy and safety of dose-dose chemotherapy in frontline treatment of ovarian cancer patients after upfront non-optimal debulking surgery. Methods: This was a non-randomized single-arm phase II trial. We enrolled patients with advanced (FIGO III-IV) epithelial ovarian who underwent non-optimal upfront debulking surgery with residual tumor size > 10 mm. All patients were treated with dose-dense chemotherapy (ie, paclitaxel 80 mg/m2 day 1, 8, 15 + carboplatin AUC6 day 1, cycled every 21 days – 6 cycles). Patients in historical control arm received standard chemotherapy with paclitaxel 175 mg/m2 day 1 + carboplatin AUC6 day 1, cycled every 21 days – 6 cycles. No patient in experimental or control arm received front-line bevacizumab or PARP inhibitors. The primary endpoint of the trial was progression-free survival (PFS). According to the historical data of our department, 1-year PFS in this category of patients equals to 51%. To increase 1-year PFS to 70%, 40 patients should be enrolled with α = 0.05 and β = 0.20 and estimated data loss for 10% of patients. Results: The study enrolled 40 patients to dose-dense chemotherapy arm, control arm included 86 patients. The trial arms were balanced in terms of age, performance status and other characteristics. Median follow-up was 28.8 months. The 1-year PFS was 76.9% compared to 51% in historical arm, median PFS was 19.8 months and 12 months respectively (HR 0.61; 95% CI 0.39-0.95; p = 0,03). The 1-year overall survival rate was 92.3% with median OS not reached with specified follow-up period. Severe neutropenia, anemia, thrombocytopenia was observed in 82.1%, 53.8%, 15.3% of patients, respectively. Conclusions: The results of the study showed high efficacy of dose-dose chemotherapy as front line of treatment for advanced ovarian cancer patients after non-optimal upfront debulking surgery but one should consider high toxicity of this regimen.


Cancers ◽  
2021 ◽  
Vol 13 (24) ◽  
pp. 6239
Author(s):  
Joan Tymon-Rosario ◽  
Naomi N. Adjei ◽  
Dana M. Roque ◽  
Alessandro D. Santin

Taxanes and epothilones are chemotherapeutic agents that ultimately lead to cell death through inhibition of normal microtubular function. This review summarizes the literature demonstrating their current use and potential promise as therapeutic agents in the treatment of epithelial ovarian cancer (EOC), as well as putative mechanisms of resistance. Historically, taxanes have become the standard of care in the front-line and recurrent treatment of epithelial ovarian cancer. In the past few years, epothilones (i.e., ixabepilone) have become of interest as they may retain activity in taxane-treated patients since they harbor several features that may overcome mechanisms of taxane resistance. Clinical data now support the use of ixabepilone in the treatment of platinum-resistant or refractory ovarian cancer. Clinical data strongly support the use of microtubule-interfering drugs alone or in combination in the treatment of epithelial ovarian cancer. Ongoing clinical trials will shed further light into the potential of making these drugs part of current standard practice.


Author(s):  
Ursula Hasler-Strub

Platinum-based chemotherapy regimens are the mainstay of advanced ovarian cancer treatment. However, up to 85% of the patients experience recurrence under these settings. To fill this gap, novel front-line treatment strategies have been established, leading to unprecedented clinical benefits. For example, first-line bevacizumab, an anti-angiogenic agent, plus chemotherapy followed by bevacizumab maintenance, has emerged as a new standard of care for newly diagnosed high risk ovarian cancer patients. This was based on the results of the phase III GOG 0218 and ICON-7 trials. More recently, poly(ADP)-ribose polymerase (PARP) inhibitors, including niraparib, olaparib and veliparib, have offered a new treatment option as part of the front-line treatment in ovarian cancer. Here we provide an overview of three recent studies that may lead to a paradigm shift in the first-line treatment for advanced ovarian cancer.


2003 ◽  
Vol 13 (Suppl 2) ◽  
pp. 231-240 ◽  
Author(s):  
J. J. Biagi ◽  
E. A. Eisenhauer

Over the past two decades, the development of treatment policies and practice standards has become formalized. In ovarian cancer, most attention has been focused on the development of policies for front-line systemic treatment, using survival as the major outcome that should drive change. This review summarizes the evidence that supported the emergence of paclitaxel–carboplatin as a widely used standard of care for front-line therapy and some of the contradictory data from randomized studies. Furthermore, recently completed or ongoing randomized studies of the addition of a third cytotoxic agent to paclitaxel–carboplatin are summarized. Finally, some novel noncytotoxic approaches are discussed. New standards of care and treatment policies in the next decade will be based on high-quality evidence of improved survival from controlled studies. Many such trials are now ongoing or planned.


ESMO Open ◽  
2017 ◽  
Vol 1 (6) ◽  
pp. esmoopen-2016-000117 ◽  
Author(s):  
Andrea Milani ◽  
Rebecca Kristeleit ◽  
Mary McCormack ◽  
Fharat Raja ◽  
Daniela Luvero ◽  
...  

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