Pegylated liposmal doxorubicin prolongs survival compared to topotecan as second-line treatment in women with platinum-sensitive ovarian cancer

e17097 Background: Ovarian cancer (OC) is the first cause of gynecological cancer, and the fifth cause of women cancer-death in US. In Mexico, more than 4,500 new cases of ovarian cancer are diagnosed yearly and it represents the second cause of gynecological cancer mortality. Bevacizumab (BVZ) is an antiangiogenic antibody that has been approved for first-line and recurrence therapy in OC patients. The aim of the study was to evaluate the clinical benefit of BVZ in different lines of treatment in Mexican OC patients. Methods: A total of 94 OC patients treated with BVZ were recruited at the Ovarian Cancer Program of the Instituto Nacional de Cancerología, from February 2012 to September 2018. Clinicopathological characteristics and toxicity was correlated with line of treatment. PFS curves were estimated by the Kaplan–Meier method, while comparisons among groups were analyzed with log-rank or Breslow tests. Results: Most of the patients were stage IIIC (69.1%) with HGSP histology (73.4%). 24 patients (25.5%) received BVZ as first-line treatment before debulking surgery (50% for suboptimal and 45.8% for optimal cytoreduction). 48 patients (51.1%) received BVZ for second-line (72.9% after a platinum-resistant and 27.1% after a platinum-sensitive recurrence) and 22 patients (23.4%) for three or more lines of treatment. Venous thromboembolic events (VTE) were more frequent in multi-treated patients ( P= 0.030). The median PFS was 23.7, 11.7 and 5.8 months for first, second and third or more lines, respectively. Patients with optimal debulking surgery had a better PFS compared with suboptimal and BVZ in first-line patients (24.8 vs 20.9; P= 0.050). Patients with BVZ in second-line who are a platinum-sensitive recurrence had better PFS compared to those with a platinum-resistant disease (15.1 vs 7.6; P= 0.040). Conclusions: OC patients had clinical benefit from treatment with BVZ when used as first-line and first recurrence treatments. The use of BVZ for third or later line treatment has a questionable benefit and is associated with a higher rate of VTE. Also, we highlight that 77% of the patients had the greatest-benefit while 33% had limited-benefit.

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Which second-line treatment regimen should be used following relapse of platinum-sensitive ovarian cancer?

Nature Clinical Practice Oncology ◽

10.1038/ncponc0795 ◽

2007 ◽

Vol 4 (6) ◽

pp. 340-341

Author(s):

Sergio Pecorelli ◽

Franco Odicino

Keyword(s):

Ovarian Cancer ◽

Treatment Regimen ◽

Line Treatment ◽

Second Line ◽

Platinum Sensitive

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Docetaxel and oxaliplatin in the second-line treatment of platinum-sensitive recurrent ovarian cancer: a phase II study

Annals of Oncology ◽

10.1093/annonc/mdm136 ◽

2007 ◽

Vol 18 (8) ◽

pp. 1348-1353 ◽

Cited By ~ 18

Author(s):

G Ferrandina ◽

M Ludovisi ◽

R De Vincenzo ◽

V Salutari ◽

D Lorusso ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Recurrent Ovarian Cancer ◽

Line Treatment ◽

Second Line ◽

Platinum Sensitive

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Recurrence patterns after bevacizumab in platinum-sensitive, recurrent epithelial ovarian cancer

International Journal of Gynecological Cancer ◽

10.1136/ijgc-2020-001517 ◽

2020 ◽

Vol 30 (12) ◽

pp. 1943-1950

Author(s):

Se Ik Kim ◽

Eun Ji Lee ◽

Maria Lee ◽

Hyunhoon Chung ◽

Jae-Weon Kim ◽

...

Keyword(s):

Ovarian Cancer ◽

Epithelial Ovarian Cancer ◽

Control Group ◽

Study Group ◽

Line Treatment ◽

Second Line ◽

Debulking Surgery ◽

Platinum Sensitive ◽

Free Interval ◽

Recurrence Patterns

ObjectiveEvidence on recurrence patterns after bevacizumab in epithelial ovarian cancer is still insufficient. The aim of this study was to evaluate recurrence patterns after treatment with bevacizumab as second-line treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer.MethodsWe retrospectively identified epithelial ovarian cancer patients who relapsed ≥6 months after primary treatment consisting of surgery and platinum-based chemotherapy between January 2008 and June 2019. Only those who received platinum-based doublet chemotherapy with bevacizumab or without bevacizumab as second-line treatment were included (n=192). To adjust confounders, we conducted 1:2 propensity score matching for platinum-free interval and secondary debulking surgery. Imaging studies were performed to locate newly developed or enlarged pre-existing tumors. Recurrence patterns were compared between bevacizumab users (study group) and non-users (control group).ResultsAfter matching, the study group (n=52) and control group (n=104) showed similar baseline clinicopathologic characteristics including platinum-free interval (median (range) 15.3 (6.2–87.3) vs 14.0 (6.2–143.5) months; p=0.29) and patient age at the time of first recurrence (median (range) 55.5 (33.7–72.4) vs 55.0 (35.7–84.2) years; p=0.56). Initially, FIGO stage III disease was the most common in both two groups (55.8% vs 66.3%; p=0.20). Bevacizumab users were less likely to develop disease recurrence in the retroperitoneal lymph nodes (13.5% vs 34.6%; p=0.005), pelvis (17.3% vs 35.6%; p=0.018), and abdomen (40.4% vs 61.5%; p=0.012). However, no difference in distant metastasis was observed between the groups (23.1% vs 24.0%; p>0.99). Multivariate analyses adjusting for stage, histologic type, grade, platinum-free interval, and secondary debulking surgery revealed that the use of bevacizumab significantly reduced risks of nodal (adjusted HR (aHR) 0.24; 95% CI 0.10 to 0.56; p=0.001), pelvic (aHR 0.32; 95% CI 0.15 to 0.68; p=0.003), and abdominal recurrences (aHR 0.43; 95% CI 0.26 to 0.71; p=0.001). Nevertheless, use of bevacizumab did not influence risk of distant metastasis (aHR 0.70; 95% CI 0.35 to 1.40; p=0.32).ConclusionsIn patients with platinum-sensitive, recurrent epithelial ovarian cancer, second-line chemotherapy with bevacizumab is associated with reduced risks of nodal, pelvic, and abdominal recurrences, but similar risks of distant metastases.

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Assessing Type and Impact of Biases Potentially Occurring when Analyzing Real World Evidence: The Case of Second Line Treatment for Ovarian Cancer

Value in Health ◽

10.1016/j.jval.2018.04.1446 ◽

2018 ◽

Vol 21 ◽

pp. S213

Author(s):

F Kuehne ◽

M Arvandi ◽

LM Hess ◽

DE Faries ◽

R Matteucci Gothe ◽

...

Keyword(s):

Ovarian Cancer ◽

Real World ◽

Line Treatment ◽

Second Line ◽

Real World Evidence

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Multicenter Phase 2 Study of Combined Gemcitabine and Epirubicin as Second-Line Treatment for Patients With Advanced Ovarian Cancer

International Journal of Gynecological Cancer ◽

10.1111/igc.0b013e3181e4a6c1 ◽

2010 ◽

Vol 20 (6) ◽

pp. 953-957 ◽

Cited By ~ 4

Author(s):

Viviana Murgia ◽

Roberto Sorio ◽

Claudia Griso ◽

Orazio Caffo ◽

Carmela Arcuri ◽

...

Keyword(s):

Ovarian Cancer ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Advanced Ovarian Cancer ◽

Hematological Toxicity ◽

Line Treatment ◽

Second Line ◽

Phase 2 ◽

Platinum Resistant ◽

Gynecology And Obstetrics

Objective:The aim of this phase 2 trial was to evaluate the tolerability and efficacy of combined gemcitabine (G) and epirubicin (E) as second-line treatment for patients with advanced ovarian cancer.Methods:Treatment with G 1000 mg/m2 (days 1 and 8) and E 60 mg/m2 (day 1) every 3 weeks for 3 or, in the absence of progression, 6 courses.Results:Fifty patients with advanced ovarian cancer (31 serous, 2 endometrioid, 10 unclassified adenocarcinoma, and 7 other) and a median age of 60 years (range, 38-74 years) were enrolled after giving their informed consent. Performance status according to the Eastern Cooperative Oncology Group was 0 in 29 patients (58%), 1 in 17 patients (34%), and 2 in 4 patients (8%), and the initial stages according to the International Federation of Gynecology and Obstetrics were I to II in 4 patients (8%), III in 31 patients (62%), and IV in 15 patients (30%). They had previously received a median of 1.5 lines of treatment (range, 1-4). The median platinum-free interval was 5 months (range, 0-12 months): 32 patients had relapse within 6 months and 18 patients had relapse after 6 months.The response rate was 42% (2% complete response and 40% partial response), with a median duration of 7.2 months: the corresponding figures were 37.5% and 5.2 months in the platinum-resistant patients and 50% and 8.8 months in the platinum-sensitive patients. The main grade 3 to 4 hematological toxicity was neutropenia (56% of cases). After a median follow-up of 13.5 months, median progression-free survival was 5 months, and median overall survival was 23.5 months.Conclusions:This E + G combination seems to be active and safe in platinum-resistant/refractory patients.

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Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.12.3056 ◽

1996 ◽

Vol 14 (12) ◽

pp. 3056-3061 ◽

Cited By ~ 273

Author(s):

G J Creemers ◽

G Bolis ◽

M Gore ◽

G Scarfone ◽

A J Lacave ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Topoisomerase I ◽

Phase Ii Study ◽

Dose Intensity ◽

Complete Response ◽

Subsequent Treatment ◽

Line Treatment ◽

Second Line ◽

Chemotherapeutic Regimen

PURPOSE Topotecan is a topoisomerase I inhibitor with preclinical activity against various tumor types. We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who had failed to respond to one prior cisplatin-based chemotherapeutic regimen. PATIENTS AND METHODS Topotecan 1.5 mg/m2/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks. As the cisplatin-free interval relates to response in subsequent treatment, patients were stratified in subgroups, ie, cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive. RESULTS One-hundred eleven patients entered the study. Nineteen patients were considered to be ineligible; 92 patients were assessable for response. A total of 552 courses were given (median, four per patient; range, one to 17). The major toxicities were leukocytopenia and neutropenia, which were grade 3 to 4 in 54.2% and 69.1% of courses, respectively, but with only 4.3% of these being grade 4 neutropenia plus fever or infectious complications. Prophylactic granulocyte colony-stimulating factor (G-CSF) was given in 20.5% of courses to maintain dose-intensity. Other relatively frequent side effects were alopecia (82%), nausea (36.4%), and vomiting (17.5%). The overall response rate was 16.3%, with one complete response (CR) and 14 partial responses (PRs). In the cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive strata, the response rates were 5.9%, 17.8%, and 26.7%, respectively. The median duration of time of documented response was 21.7 weeks (range, 4.6 to 41.9). CONCLUSION Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer. Further investigations of topotecan in ovarian cancer, including first-line use and combination with other active agents, are indicated.

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