Efficacy and long-term safety with bevacizumab included in neoadjuvant and adjuvant therapies in patients with advanced ovarian cancer: Results of the ANTHALYA trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5538-5538 ◽  
Author(s):  
Florence Joly ◽  
Paul H. Cottu ◽  
Sebastien Gouy ◽  
Eric Lambaudie ◽  
Frédéric Selle ◽  
...  
Keyword(s):  
Objective Response ◽  
Advanced Ovarian Cancer ◽  
Response Rates ◽  
Figo Stage ◽  
Circulating Tumor Cell ◽  
Complete Resection ◽  
Ca 125 ◽  
Stage Iiic ◽  
Cell Counts

5538 Background: ANTHALYA showed that neoadjuvant Bevacizumab (B) added to Carboplatin and Paclitaxel (CP) was well tolerated and achieved encouraging complete resection rates at IDS (58.6%) in unresectable FIGO stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma (EJC 2017;70:133–42). We report response rates, PFS and long-term safety. Methods: Patients (pts) in ANTHALYA were randomized 2:1 to 4 cycles (c) of neoadjuvant CP ±3 c of B (15 mg/kg), IDS for eligible patients, then 1 c of CP + 3 c CPB + 21 c of B. Response and progression were evaluated by RECIST 1.1 using CT scan and CA-125. Circulating tumor cell counts (CTC) were evaluated at baseline, c2 and IDS. Results: 95 pts were treated in CP (n=37) or BCP (n=58) groups (mean study duration were 16.1 months [mo] and 16.9 mo, respectively). 80 pts (CP: 81% / BCP: 88%) had a CA-125 response (50% reduction in CA-125 level) before IDS. Objective response rates were 65% (62% CP / 67% BCP) before IDS (28 days after c4), 46% at c8 (46% CP/ 47% BCP) and 19% at c26 (19% CP/ 19% BCP). 24 (64.9%) CP pts and 26 (44.8%) BCP pts progressed during follow up (median PFS 21.2 mo [95%CI: 14.5, 26.7] and 23.5 mo [18.5, 30.6], respectively). Median PFS was respectively: 25.8 mo (21.0, 30.0) and 17.1 mo (13.5, 22.2) for pts with/without complete resection at IDS; 21.0 mo (15.0, 25.4) and 25.8 mo (18.5, 27.2) for pts with/without baseline CTCs (n=29 / 59); 21.8 mo (17.5, 27.1) and 22.2 mo (15.3, 38.0) for pts with FIGO IIIC and IV tumors. 36 pts did not receive adjuvant therapy within the study (21 were unresectable for IDS), 59 pts (57% CP / 66% BCP) received it. Of those, 34 pts (52% CP / 61% BCP) had Grade ≥3 adverse events including neutropenia (29% CP / 34% BCP), HBP (10% CP / 8% BCP), proteinuria (10% CP / 0% BCP), deep venous thrombosis (5% CP / 3% BCP), pulmonary embolism (0% CP / 8% BCP). Conclusions: Neoadjuvant BCP followed by IDS and adjuvant BCP achieves high response rates and extended PFS with an acceptable toxicity in this specific population of pts with FIGO stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma not eligible for primary debulking surgery. IDS outcome and CTC counts should be further explored as long term prognostic factors. Clinical trial information: NCT01739218.

TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7)

2019 ◽  
Vol 29 (8) ◽  
pp. 1327-1331 ◽  
Author(s):  
Alexander Reuss ◽  
Andreas du Bois ◽  
Philipp Harter ◽  
Christina Fotopoulou ◽  
Jalid Sehouli ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Cytoreductive Surgery ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Complete Resection ◽  
Peritoneal Carcinoma ◽  
Exclusion Criteria ◽  
Platinum Based Chemotherapy

BackgroundPrimary cytoreductive surgery followed by chemotherapy has been considered standard management for patients with advanced ovarian cancer over decades. An alternative approach of interval debulking surgery following neoadjuvant chemotherapy was subsequently reported by two randomized phase III trials (EORTC‐GCG, CHORUS), which were criticized owing to important limitations, especially regarding the rate of complete resection.Primary ObjectiveTo clarify the optimal timing of surgical therapy in advanced ovarian cancer.Study HypothesisPrimary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer.Trial DesignTRUST is an international open, randomized, controlled multi-center trial investigating overall survival after primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery in patients with FIGO stage IIIB–IVB ovarian, tubal, and peritoneal carcinoma. To guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (eg, ≥50% complete resection rate in upfront surgery for FIGO IIIB–IVB patients, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST quality committee delegates. Patients in the primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas patients in the interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy after histologic confirmation of the disease, followed by interval cytoreductive surgery and subsequently, 3 cycles of platinum-based chemotherapy. The intention of surgery for both groups is complete tumor resection according to guideline recommendations.Major Inclusion/Exclusion CriteriaMajor inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB–IVB (IV only if resectable metastasis). Major exclusion criteria are non-epithelial ovarian malignancies and borderline tumors; prior chemotherapy for ovarian cancer; or abdominal/pelvic radiotherapy.Primary EndpointOverall survival.Sample Size772 patients.Estimated Dates for Completing Accrual and Presenting ResultsAccrual completion approximately mid-2019, results are expected after 5 years' follow-up in 2024.Trial RegistrationNCT02828618.

A phase II study of two induction schedules of high dose carboplatin (HDC) vs weekly paclitaxel/gemcitabine (WPG) followed by paclitaxel/carboplatin/gemcitabine (PCG) in advanced ovarian cancer (AOC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15062-15062
Author(s):  
G. Bolis ◽  
G. Polverino ◽  
C. Sciatta ◽  
G. Scarfone ◽  
G. Scambia
Keyword(s):  
Phase Ii ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Active Agent ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
High Dose ◽  
Stage Iiic ◽  
Standard Regimen ◽  
Grade 3

15062 Background: Patients (pts) with newly diagnosed AOC generally receive platinum plus taxane therapy. G represents a new active agent to improve the standard regimen. To investigate the safety of two schedules of induction treatments both followed by triplet PCG we have drafted a phase II study. Methods: 14 pts, suboptimally debulked (FIGO stage IIIc) entered the study. HDC ( AUC 7,5) was administered for 2 courses every 21 days ( arm A) and P ( 80 mg/sqm, d 1,8,15,22) + G ( 2500 mg/sqm, d 1,15) (arm B). Both regimens have been followed by standard triplet P ( 175 mg/sqm, d1) + C ( AUC 5, d1) + G ( 800 mg/sqm, d1,8) every 21 days for a total of 6 courses. Antiemetics, corticoids, antihistaminics and ranitidine have been added. Results: The median age was 57 y (39–68). Histology was serous in 64.3%, mixed 14.3% and other 21.4%. All pts had Grade 3 tumor but one. Seven pts received arm A schedule and 7 arm B both followed by PCG regimen. Worst haematological toxicities ( in term of nadir) observed in all courses for all pts were neutropenia G4 ( 42.8% arm A vs 71.4% arm B), anemia G2 (71.4% arm A vs 57.1% arm B), thrombocytopenia G2 ( 57.1% arm A vs 42.8% arm B). Most common non haematological toxicities were alopecia and mild nausea/vomiting. Mild paresthesias in both regimens were observed. No sepsis or neutropenic fever nor unespected toxicity or treatment-related deaths were observed. 71.4% of pts completed foreseen schedules of treatments. 78.5% of pts received erytropoietin and 28.5% G-CSF support. Conclusions: HDC and weekly PG followed by triplet PCG are feasible and safety regimens in AOC pts ( residual disease > 1 cm). Further phase II-III setting study using these schedules will be conducted. No significant financial relationships to disclose.

scholarly journals Retrospective analysis of surgical outcomes and survival in women with advanced ovarian cancer undergoing interval debulking surgery

2016 ◽  
Author(s):  
Neha Kumar ◽  
Amita Maheshwari ◽  
Sudeep Gupta ◽  
Jaya Ghosh ◽  
Jyoti Bajpai ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Ca 125 ◽  
Optimal Cytoreduction ◽  
Stage Iiic ◽  
Free Survival ◽  
Peritoneal Cancer ◽  
Interval Debulking Surgery

Introduction: Both primary (PDS) and interval debulking surgery (IDS) have reported similar progression free survival (PFS) and overall survival (OS) rates in various studies. Complete resection of all macroscopic disease is the strongest independent variable in predicting survival in both groups. Objective: To evaluate the demographics, surgical outcomes and survival in women with advanced ovarian cancer undergoing IDS. Methods: All women with Stage IIIC or Stage IV epithelial ovarian or primary peritoneal cancer, registered at our institution from January 2010 to December 2010, who were treated with NACT followed by IDS, were included in the study. Demographic data, CA-125 levels (baseline and presurgery), chemotherapy and surgical details were collected. Progression free survival (PFS) and overall survival (OS) were calculated and Cox regression and Kaplan-Meier survival analysis were used to evaluate factors associated with survival. Results: One hundred fifty women with Stage IIIC or Stage IV epithelial ovarian or primary peritoneal cancer were included in the analysis. The mean age was 51.08 years (27 to 73 years) and 97.3% had serous histology. Eighty percent (n = 120) had Stage IIIC and 20% (n = 30) had Stage IV disease. Ninety five percent women received Carboplatin and Paclitaxel or single agent Carboplatin as NACT and the median number of NACT cycles was 3. The median baseline CA-125 was 1649.3 U/ml (Range 16.4–235,100 U/ml) and the median CA-125 post NACT was 42.75 U/ml (Range 4.4–5151 U/ml). Seventy four percent women (n = 111) underwent an optimal cytoreduction – 62.7% (n = 94) had R0 and 11.3% (n = 17) had R1 resection. Twenty six percent women (n = 39) had R2 resection. The median CA-125 post NACT was 27.3 U/ml, 36 U/ml and 99 U/ml in women with R0, R1 and R2 resection respectively and the difference was statistically significant (p < 0.0005). The CA125 response was respectively, 97.6%, 95.7% and 93.8% in R0, R1 and R2 resection (p < 0.0005). The median follow up was 42.48 months (Range 1.48–70.93 months). The median PFS was 12.06 months (95% CI 10.02-14.1) – 12.98 months (95% CI 9.7–16.2) in R0, 9.56 months (95% CI 1.7–17.4) in R1 and 6.64 months (95% CI 4.9–8.3) in women with R2 resection (p = 0.158). The median OS was 38.9 months (95% CI 31.7–46.1) – 43.3 months (95% CI 33–53.5) in R0, 46.1 months (95% CI 26.6–65.5) in R1 and 28 months (95% CI 25–30.9) in R2 resection (p = 0.121). The median PFS and OS in women undergoing optimal cytoreduction (R0 and R1) was 12.98 months (95% CI 9.86–16.1) and 43.7 months (95% CI 34.7–52.7) respectively as compared to 6.64 months (95% CI 4.95–8.32) and 28 months (95% CI 25–30.9) respectively in women with R2 resection (PFS p = 0.064, OS p = 0.04). Multivariate analysis discussing the factors affecting the probability of optimal cytoreduction and the survival will be discussed. Conclusion: In women with advanced ovarian cancer undergoing NACT followed by IDS, a high rate of optimal cytoreduction is achieved. Residual disease is a primary factor affecting the survival of these women.

scholarly journals The clinical and pathological characteristics and survival of patients with advanced ovarian cancer

2021 ◽  
Vol 52 (3) ◽  
pp. 205-210
Author(s):  
Miroslav Popović ◽  
Tanja Milić-Radić ◽  
Arnela Cerić-Banićević
Keyword(s):  
Ovarian Cancer ◽  
Residual Disease ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Ovarian Tumour ◽  
Ca 125 ◽  
Optimal Cytoreduction ◽  
Chi Square ◽  
Pathological Characteristics ◽  
Significant Difference

Introduction: Ovarian cancer has the highest mortality rate of all gynaecologic malignancies. The aim of this study was the evaluation of the clinical pathological characteristics and survival analysis of primarily operated patients with advanced stages of malignant epithelial ovarian tumour. Methods: The research was conducted as a cohort study with 59 patients with FIGO stage III and IV, which were primarily operated between 1 January 2008 and 31 December 2010 (three years). Age, comorbidities, BMI, presence of ascites, the level of the marker CA-125, histopathology and FIGO stage were analysed. The survival rate was estimated at the level of 1, 3 and 5 years. Results: The median age was 53 years (range 29-86). The most common histopathological type was serous (66.1 %) and the most common FIGO stage was 3a (49.2 %). Optimal cytoreduction was performed in 35.5 % of patients, 84.7 % of patients survived for one year, 44.1 % three years and 37.3 % for five years. The median survival was 26.25 months (range 0-91). Chi-square test showed significant difference between the number of months of survival and: the value of CA125 (t = 2.004, p = 0.050), cytoreduction (p < 0.001) and FIGO stage (p < 0.01). Conclusion: According to the results of this study, optimal cytoreduction and FIGO stage significantly influence survival (p < 0.001). Optimal cytoreduction (< 2 cm of residual disease) had the highest prognostic value for survival. A total five-year survival in this study was 37.3 %.

scholarly journals Exploratory analysis of serum CA-125 response to surgery and the risk of relapse in patients with FIGO stage IIIC ovarian cancer

2009 ◽  
Vol 115 (2) ◽  
pp. 209-214 ◽  
Author(s):  
Oliver Zivanovic ◽  
Camelia S. Sima ◽  
Alexia Iasonos ◽  
Katherine M. Bell-McGuinn ◽  
Paul J. Sabbatini ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Figo Stage ◽  
Exploratory Analysis ◽  
Ca 125 ◽  
Stage Iiic ◽  
Risk Of Relapse

scholarly journals Neutrophil-to-Lymphocyte Ratio and Platelet Count Predict Long-Term Outcome of Stage IIIC Epithelial Ovarian Cancer

2018 ◽  
Vol 46 (1) ◽  
pp. 178-186 ◽  
Author(s):  
Mingyi Zhou ◽  
Liankun Li ◽  
Xiaobin Wang ◽  
Chunyan Wang ◽  
Danbo Wang
Keyword(s):  
Ovarian Cancer ◽  
Platelet Count ◽  
Epithelial Ovarian Cancer ◽  
Group Versus ◽  
Figo Stage ◽  
Stage Iiic ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Lymphocyte Ratio

Background/Aims: Prognostic value of neutrophil-to-lymphocyte ratio (NLR) and platelet count (PC) in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC epithelial ovarian cancer (EOC) is controversial. Methods: A total of 370 stage IIIC EOC patients who underwent primary debulking surgery (PDS) at the Department of Gynecology of Liaoning Cancer Hospital and Institute between January 2003 and August 2016 and had full information were involved. Patients were stratified into a high NLR (H-NLR) group versus a low NLR (L-NLR) group and a high PC (H-PC) group versus a low PC (L-PC) group according to cutoff values calculated through receiver operating characteristic (ROC) curves. Prognostic values of NLR and PC for progression-free survival (PFS) and overall survival (OS) were assessed. Results: We identified the optimal cut-off value of 3.08 for NLR and 289.5*109/L for PC. The median PFS and OS of the patients with H-NLR were shorter than L-NLR (PFS: 16.9 months vs. 19.5 months, hazard ratio [HR] 1.3, 95% confidence interval [CI] 1.03–1.63, P = 0.022; OS: 33.5 months vs. 46.8 months, HR 1.3, 95% CI 1.01–1.66, P = 0.001). The median PFS and OS of the patients with H-PC were shorter than L-PC (PFS: 15.3 months vs. 21.6 months, HR 1.3, 95% CI 1.04–1.63, P < 0.001; OS: 37.3 months vs. 46.1 months, HR 1.14, 95% CI 0.89–1.46, P = 0.306). Conclusions: H-NLR and H-PC could predict poor long-term outcome of patients with FIGO stage III EOC.

Pazopanib (Paz) monotherapy in Asian women who have not progressed after first-line chemotherapy for advanced ovarian, Fallopian tube, or primary peritoneal carcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5512-5512 ◽  
Author(s):  
Rongyu Zang ◽  
Lingying Wu ◽  
Jianqing Zhu ◽  
Beihua Kong ◽  
Byoung-Gie Kim ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Fallopian Tube ◽  
Residual Disease ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Small Sample ◽  
Stage Ii ◽  
Ca 125 ◽  
Asian Women ◽  
Debulking Surgery

5512 Background: Paz, an oral multikinase inhibitor of VEGF, PDGF and c-Kit has showed activity in advanced ovarian cancer. This study evaluated paz as maintenance therapy in Asian women with advanced ovarian cancer. Methods: Subjects with FIGO stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after debulking surgery and followed by chemotherapy were randomized 1:1 to paz 800 mg once daily or placebo for up to 24 months. Primary endpoint was PFS by RECIST v1.0 based on visit date. If a progression occurred between the 2 scheduled visits (6 mos apart), progression was considered to have occurred at the next scheduled scan date. This minimized potential bias due to any imbalance of visit frequency between the arms. Results: 145 Asian subjects were randomized; 144 were treated. Mean age was 52.9 years. At diagnosis 17% were FIGO stage II, 73% stage III and 10% stage IV. After debulking surgery, 30% (n = 44) had no residual disease and 41% (n = 59) had. 47% (28/59) had residual disease ≤1cm. Prior to randomization, all subjects received median 8 cycles of chemotherapy; all subjects received platinum and taxane. At randomization 81% had ECOG status 0, 97% were disease free and all had normal CA-125. At clinical data cut-off median PFS was 18.1 months in both arms. Because of the small sample size a HR was not calculated but the KM curves indicated a trend in favor of paz from 6 to 18 mos; the curves crossed after 18 mos. The adverse event (AE) profile for paz was similar to previous reports except rates of hypertension and neutropenia were higher. The most frequent AEs (≥ 20%) on the paz arm were hypertension (76%), neutropenia (64%), leucopenia (53%), diarrhea (47%), hair color changes (40%), palm-plantar erythrodysaethesia syndrome (29%), ALT increase (28%), thrombocytopenia (24%), AST increase (22%) and TSH increase (21%). Most of these AEs were Grade 1-2. Conclusions: The results of this study alone cannot confirm the efficacy of paz maintenance treatment in Asian women with ovarian cancer, but should be interpreted in conjunction of AGO-OVAR16 study. Clinical trial information: NCT01227928.

Quantitative pathologic features as predictors of long-term survival in patients with advanced ovarian cancer treated with cisplatin

1994 ◽  
Vol 4 (3) ◽  
pp. 174-179 ◽  
Author(s):  
P. J. Van Diest ◽  
J. P.A. Baak ◽  
J. Brugghe ◽  
M. E.L. Van De Burg ◽  
A. T. Van Oosterom ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Survival Analysis ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Nuclear Area ◽  
Term Survival ◽  
Flow Cytometric ◽  
Pathologic Features ◽  
Tumor Load

The prognostic value of morphometric and DNA flow cytometric features were studied and compared with FIGO stage, preoperative tumor load, residual disease status, Karnofsky index and classic pathologic features such as Broders' grade and histologic type in 58 FIGO stage III and IV adequately debulked ovarian patients with long-term follow-up. The mitotic activity index, volume percentage of epithelium, and mean and SD of nuclear area were assessed by interactive morphometry, and tumor material was routinely processed for DNA flow cytometric assessment of DNA ploidy and S-phase fraction. Survival analysis (Kaplan-Meier curves, Mantel-Cox test), revealed FIGO stage (P= 0.013) and the mean and SD of nuclear area to be significant prognosticators (P= 0.027 andP= 0.012, respectively). In multivariate survival analysis (Cox model), a multivariate combination of FIGO stage, preoperative tumor load and mean nuclear area was the best prognostic combination of features (P= 0.0034). These results confirm the findings of previous studies. We conclude that, in accord with previous studies, morphometric features are good predictors of survival after cisplatin treatment in advanced ovarian cancer, especially in combination with FIGO stage and preoperative tumor load.

scholarly journals CA 125 regression after two completed cycles of chemotherapy: lack of prediction for long-term survival in patients with advanced ovarian cancer

1999 ◽  
Vol 81 (4) ◽  
pp. 662-666 ◽  
Author(s):  
C Peters-Engl ◽  
A Obermair ◽  
H Heinzl ◽  
P Buxbaum ◽  
P Sevelda ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Ca 125 ◽  
Term Survival ◽  
Long Term Survival

Improved survival for ovarian cancer patients stage IIIC treated at the Norwegian Radium Hospital between 1984 - 2001

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16044-16044
Author(s):  
C. Trope ◽  
H. Oksefjell ◽  
B. Sandstad
Keyword(s):  
Ovarian Cancer ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Figo Stage ◽  
Primary Treatment ◽  
Lymph Node Staging ◽  
Residual Tumour ◽  
Stage Iiic ◽  
Primary Surgery ◽  
Norwegian Radium Hospital

16044 Background: The aim of this study was to evaluate the treatment of FIGO stage IIIC patients who were primarily treated completely or partially at the Norwegian Radium Hospital (NRH) during a 15-year period in order to discover possibilities for improvement of prognosis of advanced ovarian cancer. Methods: A retrospective study based on record information from all patients with epithelial ovarian cancer stage IIIC treated at NRH 1985 - 2000, in total 776 patients. Results: We found age, amount of residual tumour after surgery for primary treatment and type of chemotherapy to be the most significant prognostic factors for overall survival. During the last 5-year period primary surgery was increasingly centralised, surgery was improved with lymph node staging and paclitaxel was used. Survival was significantly best during the last 5-year period and after macroscopically radical surgery. Also progression-free survival was best with no macroscopic tumour left. Conclusions: Improved survival during the last 5-year period is partly attributed to improved surgery, partly to the addition of paclitaxel. We believe that a further centralisation of primary surgery for advanced ovarian cancer can contribute towards a better prognosis. No significant financial relationships to disclose.

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