Real life efficacy and safety data of bevacizumab-based front line treatment in advance or metastatic ovarian cancer patients: Focus on patients with malignant ascites—A phase IV study.

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.

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The role of bevacizumab plus front-line chemotherapy in patients with malignant ascites of ovarian cancer

Annals of Oncology ◽

10.1093/annonc/mdy285.184 ◽

2018 ◽

Vol 29 ◽

pp. viii348

Author(s):

M. Nikolaou ◽

N. Ziras ◽

I. Athanasiadis ◽

A. Ardavanis ◽

M. Vaslamatzis ◽

...

Keyword(s):

Ovarian Cancer ◽

Malignant Ascites ◽

Front Line ◽

Line Chemotherapy

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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

Clinical Ovarian Cancer ◽

10.1016/j.cloc.2011.04.010 ◽

2011 ◽

Vol 4 (1) ◽

pp. 4-6

Author(s):

Robert Mannel

Keyword(s):

Ovarian Cancer ◽

Standard Of Care ◽

Front Line ◽

Dose Dense ◽

Carboplatin Auc ◽

Line Management

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Safety and feasibility of consolidation pembrolizumab following concurrent chemoradiation for unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN14-179.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.8523 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 8523-8523 ◽

Cited By ~ 6

Author(s):

Greg Andrew Durm ◽

Cynthia Johnson ◽

Shadia Ibrahim Jalal ◽

Ahad Ali Sadiq ◽

Salma Jabbour ◽

...

Keyword(s):

Early Report ◽

Safety Data ◽

Standard Of Care ◽

Research Network ◽

Stage Iii ◽

Unresectable Stage ◽

Metastatic Setting ◽

Increased Risk ◽

Stage Iii Nsclc ◽

Grade 3

8523 Background: The standard of care for unresectable stage III NSCLC is concurrent chemorad. Following treatment, the risk of radiation pneumonitis is greatest at 1-3 mo. Pneumonitis risk increases with consolidation chemotherapy. A previous trial by our group (Hanna et al, JCO 2008) of consolidation docetaxel showed 80.8% completed 3 planned cycles of chemo with a grade 3-5 pneumonitis rate of 9.6% and 1 death. PD-1 inhibitors are also associated with an increased risk of pneumonitis in the metastatic setting. We conducted a phase II trial of consolidation pembro initiated 1-2 mo after concurrent chemorad, a period during which pts are at high risk of developing pneumonitis. Methods: Pts with stage III NSCLC who completed chemorad with either carbo/paclitaxel, cis/etop, or cis/pemetrexed plus 59-66.6 Gy of radiation and had no PD received pembro 200mg IV q3wk for up to 1 yr. Primary endpoint is time to metastatic disease. The objective of the study is to evaluate both safety and efficacy, and here we report preliminary safety and feasibility results. Evaluable pts for this analysis had ≥3 mo of f/u or went off study due to PD, toxicity, or death < 3 mos after initiation of pembro. Results: 93 pts enrolled. Median age 67 (range 46-84), 59 (63.4%) were male. 87 (93.5%) were former or current smokers. 68 (73.1%) received carbo/pac, 24 (25.8%) received cis/etop, and 1 received cis/pemetrexed. SqCC (n = 41), non-SqCC (n = 43), NSCLC NOS (n = 8), mixed (n = 1). IIIA (n = 56), IIIB (n = 37). At the time of analysis, 83 of 93 pts were evaluable. 66 of 83 (79.5%) received ≥ 3 mo of pembro. 17 (20.5%) pts developed any grade pneumonitis with 14 of 17 occurring in the first 12 wks (median 9 wks). Only 3 (3.6%) pts developed grade 3-5 pneumonitis related to pembro. There was 1 pneumonitis-related death and a second death from respiratory failure possibly related to pembro. Conclusions: This early report indicates that most patients can safely receive consolidation pembro within 1-2 mo of completing chemorad. The incidence of serious pneumonitis during the first 3 mo of treatment appears low. Updated safety data on all 93 pts will be presented at the ASCO meeting. Clinical trial information: NCT02343952.

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PAzopanib as first line in MEtastatic RCC patients: A “real-world” ITalian experience (PAMERIT study)—Preliminary results.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.7_suppl.611 ◽

2019 ◽

Vol 37 (7_suppl) ◽

pp. 611-611

Author(s):

Alessandra Mosca ◽

Ugo De Giorgi ◽

Giuseppe Procopio ◽

Umberto Basso ◽

Giacomo Carteni ◽

...

Keyword(s):

Real World ◽

Poor Prognosis ◽

Cell Cancer ◽

Safety Data ◽

Real Life ◽

Rank Correlation ◽

Progression Free Survival ◽

Standard Of Care ◽

Good Prognosis ◽

Real World Data

611 Background: Pazopanib (Pazo) became a standard of care in metastatic renal cell cancer (mRCC) patients (pts) based on 2 prospective trials, but “real life” data are slight. Methods: We retrospectively analyzed clinical outcomes in a large series of mRCC pts routinely treated with 1st line Pazo, among 39 Italian Centers. Descriptive statistics has been performed using Chi-Square and Pearson rank correlation test. Progression-free survival (PFS), overall survival (OS) and safety data are still under investigation. Results: 474 mRCC pts have been collected and divided in 4 age categories: 1) ≤50 yrs old (9.4%); 2) 51-64 yrs old (32.6%); 3) 65-74 yrs old (33.0%); 4) ≥75 yrs old (25.0%). According to Heng score, 25.6%, 48.4% and 10.4% pts had good, intermediate and poor prognosis, respectively, without correlations with age (p = 0.128). Clear cell was the most represented histology (87.3%), independently from age (p = 0.556). 84.6% pts underwent nephrectomy, mainly younger pts (p = 0.000). Pazo initial daily dose was 800 mg in 76.5% pts, 600 mg in 10.8% pts and 400 mg in 12.7% pts, with a significant dose reduction in elderly pts: Pazo 800 was administered in 86.7% of ≤50 yrs old pts and in 54.2% of ≥75 yrs old pts (p = 0.000). Complete (CR)/partial response (PR), stable and progressive disease have been recorded in 37%, 39.5% and 23.5% pts, respectively. Radiological response directly correlated either with age (CR/PR in 55.6% of ≤50 yrs old pts vs 28.8% of ≥75 yrs old pts; p = 0.009) and with Heng score (CR/PR in 47.1% of good prognosis pts vs 24.5% of poor prognosis pts; p = 0.002). Conclusions: “Real world” data showed that younger (≤50 yrs old) mRCC pts more frequently underwent nephrectomy, received Pazo 800 mg daily and obtained CR/PR, with respect to elderly pts (≥75 yrs old). CR/PR to Pazo is associated with good prognosis. PFS and OS will be provided.

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REAL-LIFE RESPONSE TO STANDARD OF CARE IN ADVANCED OVARIAN CANCER – AN OBSERVATIONAL MULTI-NATIONAL COHORT STUDY (RESPONSE)

10.26226/morressier.5fa3ee5d55b1fd4cc4dd93fb ◽

2020 ◽

Author(s):

Klaus Kaae Andersen

Keyword(s):

Ovarian Cancer ◽

Cohort Study ◽

Real Life ◽

Advanced Ovarian Cancer ◽

Standard Of Care ◽

National Cohort

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Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients

Frontiers in Pharmacology ◽

10.3389/fphar.2021.711813 ◽

2021 ◽

Vol 12 ◽

Author(s):

Dominique Berton ◽

Anne Floquet ◽

Willy Lescaut ◽

Gabriel Baron ◽

Marie-Christine Kaminsky ◽

...

Keyword(s):

Ovarian Cancer ◽

Real World ◽

Treated Patient ◽

Blood Pressure Measurement ◽

Real Life ◽

Pegylated Liposomal Doxorubicin ◽

Progression Free Survival ◽

Treatment Schedule ◽

Front Line ◽

Free Survival

Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real-world setting.Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab-containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front-line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co-medications, follow-up and monitoring, progression-free survival, and treatment at recurrence. In this non-interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease.Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment-related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression-free survival was 17.4 (95% CI, 16.4–19.1) months. The 3-year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin.Discussion: Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule.Clinical Trial Registration:ClinicalTrials.gov, Identifier NCT01832415.

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Microtubule-Interfering Drugs: Current and Future Roles in Epithelial Ovarian Cancer Treatment

Cancers ◽

10.3390/cancers13246239 ◽

2021 ◽

Vol 13 (24) ◽

pp. 6239

Author(s):

Joan Tymon-Rosario ◽

Naomi N. Adjei ◽

Dana M. Roque ◽

Alessandro D. Santin

Keyword(s):

Ovarian Cancer ◽

Epithelial Ovarian Cancer ◽

Clinical Data ◽

Standard Of Care ◽

Therapeutic Agents ◽

Chemotherapeutic Agents ◽

Front Line ◽

Current Standard ◽

The Past ◽

Taxane Resistance

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.

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