scholarly journals The MITO8 phase 3 international multicenter randomized study testing the effect on survival of prolonging platinum-free interval (PFI) in patients with ovarian cancer (OC) recurring between 6 and 12 months after previous platinum based chemotherapy. A collaboration of MITO, Mango, AGO Study Group, BGOG, ENGOT, and GCIG

2016 ◽  
Vol 27 ◽  
pp. iv2
Author(s):  
M.C. Piccirillo ◽  
G. Scambia ◽  
A. Bologna ◽  
I. Vergote ◽  
K. Baumann ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Randomized Study ◽  
Study Group ◽  
Phase 3 ◽  
Free Interval ◽  
Platinum Based Chemotherapy ◽  
International Multicenter

Management of platinum-sensitive relapsed ovarian cancer, with particular reference to the International Collaboration in Ovarian Neoplasm-4/Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer-2.2 trial

2005 ◽  
Vol 15 (Suppl 1) ◽  
pp. 31-35
Author(s):  
S. B. Kaye
Keyword(s):  
Ovarian Cancer ◽  
International Collaboration ◽  
Progression Free Survival ◽  
Ovarian Neoplasm ◽  
Hematologic Toxicity ◽  
Gynäkologische Onkologie ◽  
Platinum Sensitive ◽  
Free Interval ◽  
Platinum Based Chemotherapy ◽  
Substantial Progress

Substantial progress has been made since the early 1990s regarding the treatment of patients with ovarian cancer. Those patients relapsing more than 6 months after platinum-based chemotherapy may benefit from repeat chemotherapy that includes carboplatin. When the treatment-free interval is >12 months, carboplatin combined with paclitaxel (or possibly another agent) is likely to provide a survival advantage compared with carboplatin monotherapy. Evidence to support this comes from the International Collaboration in Ovarian Neoplasm-4/Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer-2.2 trial, a prospective randomized trial of 802 patients designed to assess the potential benefit of combining carboplatin with paclitaxel. One arm of the trial contained patients randomized to conventional platinum-based therapy, while those randomized to the second arm received a paclitaxel–platinum combination. There was a 7% increase in survival for paclitaxel-based treatment (2-year increase from 50% to 57%; P = 0.02) and a 10% increase in progression-free survival (1-year increase from 40% to 50% in favor of paclitaxel-based treatment; P = 0.0004). The major observed differences between the treatment arms in terms of toxicity were significant alopecia (25% versus 86% in arms 1 and 2, respectively), neurotoxicity (1% versus 20%), and hematologic toxicity (46% versus 29%). When the treatment-free interval was between 6 and 12 months, the extent of the benefit was less clear and further trials are certainly warranted.

OPSALIN: A phase II placebo-controlled randomized study of ombrabulin in patients with platinum-sensitive recurrent ovarian cancer treated with carboplatin (Cb) and paclitaxel (P).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS5112-TPS5112
Author(s):  
Eric Pujade-Lauraine ◽  
Ignace B. Vergote ◽  
Aurore Allard ◽  
Augustin A. Rey ◽  
Cristiana Sessa ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Randomized Study ◽  
Recurrent Ovarian Cancer ◽  
Disease Recurrence ◽  
Prior History ◽  
Vascular Disrupting Agent ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy

TPS5112 Background: Most women with ovarian cancer have disease recurrence after responding to their first treatment with platinum-based chemotherapy and are considered to have platinum-sensitive disease if the relapse-free period is more than 6 months. Although CbP is standard first-line chemotherapy for ovarian cancer, patients with platinum-sensitive recurrent disease are often retreated with CbP. Ombrabulin (AVE8062) is a vascular disrupting agent and analogue of combretastatin A4 that damages established tumor vasculature causing tumor necrosis and has synergistic antitumor activity with platinum agents in tumor models in vivo (Cancer Sci. 2003;94:200). A phase I study showed that treatment with vivo ombrabulin plus CbP is feasible in patients with advanced solid tumors (NCI-AACR-EORTC 2010;Abs 386). We initiated OPSALIN, a phase II randomized trial, to evaluate whether the addition of ombrabulin to CbP improves outcomes in patients with platinum-sensitive recurrent ovarian cancer (NCT01332656; EFC10260). Methods: Eligibility criteria include age of at least 18 years, ECOG PS 0–2, measurable carcinoma of the ovarian epithelium, fallopian tube, or primary peritoneum that is platinum sensitive, and completion of only one previous line of platinum-based chemotherapy. Exclusion criteria include uncontrolled brain metastases, peripheral neuropathy >grade 1, and a prior history of cardiovascular disease. Patients are being randomized (1:1) to receive either ombrabulin 35mg/m2 or placebo plus CbP every 3 weeks. Assigned treatment will continue until disease progression or death, unacceptable toxicity, or consent withdrawal. The primary endpoint is progression-free survival stratified by the time of first disease recurrence (6–12 months or >12 months). Secondary endpoints include safety, response rate, overall survival, pharmacokinetics, and analysis of predictive/prognostic biomarkers. Planned randomization is a total of 150 patients at approximately 45 sites globally. Sixty-five patients have been randomized as of January 2012.

A phase 3, open-label, randomized study of nivolumab plus ipilimumab or standard of care (SOC) versus SOC alone in patients (pts) with previously untreated unresectable or metastatic urothelial carcinoma (mUC; CheckMate 901).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS539-TPS539 ◽  
Author(s):  
Matt D. Galsky ◽  
Thomas Powles ◽  
Shengting Li ◽  
Delphine Hennicken ◽  
Guru Sonpavde
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Clinical Activity ◽  
Open Label ◽  
Phase 3 ◽  
Tumor Biopsy ◽  
Primary Endpoints ◽  
Platinum Based Chemotherapy ◽  
Independent Review

TPS539 Background: Cisplatin-containing regimens have been SOC for mUC for nearly 40 years, but durable responses are rare with such treatments. Furthermore, a large proportion of pts with unresectable/mUC are ineligible for cisplatin therapy. Treatment approaches conferring longer-term disease control and extending to broader mUC pt populations are urgently needed. Recently, the programmed death-1 (PD-1) inhibitor, nivolumab, induced durable responses in pts with unresectable/mUC progressing despite platinum-based chemotherapy, and nivolumab combined with ipilimumab (a CTLA-4 inhibitor) demonstrated acceptable safety and clinical activity. This phase 3 study will evaluate nivolumab + ipilimumab and nivolumab + SOC vs SOC in previously untreated pts with unresectable/mUC (NCT03036098). Methods: Key inclusion criteria: cisplatin-eligible and -ineligible pts with measurable disease, no prior systemic chemotherapy for unresectable/mUC, and evaluable tumor biopsy. Key exclusion criteria: active brain metastases, autoimmune disease, and prior treatment with drugs specifically targeting T-cell co-stimulation or checkpoint pathways. Cisplatin-eligible and -ineligible pts will be randomized 1:1 to arm A (nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks up to 4 doses, followed by nivolumab 480 mg every 4 weeks until disease progression or unacceptable toxicity) or arm B (gemcitabine-cisplatin or gemcitabine-carboplatin for up to 6 cycles). Additional cisplatin-eligible pts will be randomized to arm C (nivolumab 360 mg + gemcitabine-cisplatin every 3 weeks for up to 6 cycles, followed by nivolumab 480 mg) or arm D (gemcitabine-cisplatin for up to 6 cycles). Stratification factors: PD-1 ligand 1 status, cisplatin eligibility, and liver metastasis. Co-primary endpoints: overall and progression-free survival (OS and PFS) by blinded independent review committee (BIRC) in cisplatin-ineligible pts receiving nivolumab + ipilimumab vs SOC, and PFS by BIRC in cisplatin-eligible pts receiving nivolumab + SOC vs SOC. Enrollment began March 2017 with a target of 897 pts. Clinical trial information: NCT03036098.

Gemcitabine and Vinorelbine Combination in Platinum-Sensitive Recurrent Ovarian Cancer

2009 ◽  
Vol 19 (9) ◽  
pp. 1529-1534 ◽  
Author(s):  
Annamaria Ferrero ◽  
Vilma Logrippo ◽  
Pier Giorgio Spanu ◽  
Luca Fuso ◽  
Stefania Perotto ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Response Rate ◽  
Response Duration ◽  
Recurrent Ovarian Cancer ◽  
Ca 125 ◽  
Cancer Antigen 125 ◽  
Median Response ◽  
Platinum Sensitive ◽  
Free Interval ◽  
Platinum Based Chemotherapy

Objectives:Most patients with ovarian cancer are candidates for second-line or salvage treatments often for prolonged periods. Patients with platinum-sensitive disease can benefit from a platinum retreatment with a likelihood of response dependents on the treatment-free interval. Alternative agents and combination chemotherapy are potential therapeutic approaches. At our institution, we carried out a phase II trial to evaluate feasibility, efficacy, and toxicity of gemcitabine and vinorelbine combination in recurrent ovarian carcinoma. The aim of the present study was to evaluate the role of this combination in patients with platinum-sensitive disease.Patients and Methods:Patients with platinum-sensitive disease recurring after 1 or more lines of platinum-based chemotherapy were included. Vinorelbine at 25 mg/m2followed by gemcitabine at 1000 mg/m2was administered intravenously on days 1 and 8 every 3 weeks. Response Evaluation Criteria in Solid Tumors and cancer antigen 125 test (CA-125 Kinetics [Rustin criteria]) were adopted to classify responses. Toxicity was assessed according to the National Cancer Institute Common Toxicity Criteria.Results:Thirty-nine patients were eligible. Platinum-free interval (PFI) was 6 to 12 months in 13 patients (33.3%; PFI 6-12) and more than 12 months in 26 patients (66.7%; PFI > 12). The overall response rate was 48.7%, with 6 complete responses. Median response duration was 38 weeks. The response rate was 23% in PFI 6-12 and 62% in PFI >12. The most frequently observed toxicity was hematological, with 23% of the patients having grade 3 or 4 neutropenia.Conclusions:Gemcitabine and vinorelbine combination is effective and well tolerated in recurrent platinum-sensitive ovarian cancer. It may represent an option in the management of these patients because the chronic nature of the disease.

Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: a retrospective MITO group study

2021 ◽  
pp. ijgc-2020-002343
Author(s):  
Sabrina Chiara Cecere ◽  
Lucia Musacchio ◽  
Michele Bartoletti ◽  
Vanda Salutari ◽  
Laura Arenare ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Cytoreductive Surgery ◽  
Response Rate ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Free Survival ◽  
Platinum Sensitive ◽  
Free Interval ◽  
Platinum Based Chemotherapy

IntroductionThe role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer.MethodsThis retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed.ResultsAmong 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P<0.001). Median overall survival was nearly double in patients undergoing surgery before chemotherapy (55 vs 28 months, P<0.001). Post-progression therapy was assessed in 127 patients: response rate to chemotherapy was 29.2%, 8.8%, and 9.0% in patients with platinum-free interval >12 months, between 6 and 12 months, and <6 months, respectively.ConclusionCytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.

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