Phase I/II study of weekly paclitaxel plus carboplatin and gemcitabine as first-line treatment of advanced-stage ovarian cancer: Pathologic complete response and longitudinal assessment of impact on cognitive functioning

2006 ◽  
Vol 102 (2) ◽  
pp. 270-277 ◽  
Author(s):  
Martee L. Hensley ◽  
Denise D. Correa ◽  
Howard Thaler ◽  
Andrew Wilton ◽  
Ennapadam Venkatraman ◽  
...  
2017 ◽  
Vol 53 (3) ◽  
pp. 139-146
Author(s):  
Urszula Rychlik ◽  
Ewa Wójcik ◽  
Jadwiga Tarapacz ◽  
Katarzyna Brandys ◽  
Zofia Stasik ◽  
...  

Introduction: The aim of the study was to assess the prognostic value of indicators calculated on the basis of initial hematology test results of neutrophil, lymphocyte, monocyte and platelet counts (NLR – neutrophil-to-lymphocyte ratio, LMR – lymphocyte-to-monocyte ratio, PLR – platelet-to-lymphocyte ratio) in patients with ovarian cancer and their compliance with the overall response to treatment. Materials and methods: Hematological tests were performed before first course of first-line chemotherapy in 145 patients with ovarian cancer. Response to treatment was assessed according to the RECIST1.1 criteria in all patients. Results: After the completion of first-line treatment, 70 (48.3%) patients had a complete response (CR) to the therapy. In this group, progression of disease occurred in 22 (31.4%) patients during 12 months of follow-up. In the CR group with progression, 17 (77.2%) presented high NLR and PLR levels. Among 48 (68.6%) patients with CR without progression after 12 months of follow-up, high levels of NLR and PLR were observed in 21 (43.8%) and 17 (35.4%) of them, respectively. Low LMRs were observed in 16 (72.7%) patients with progression and 16 (33.3%) without progression. Conclusion: High levels of NLR and PLR and low levels of LMR before treatment seems to predict 12-month disease progression in patients with complete response to first-line treatment.


2007 ◽  
Vol 62 (2) ◽  
pp. 137-147 ◽  
Author(s):  
Patrick Petignat ◽  
Andreas du Bois ◽  
Ilan Bruchim ◽  
Daniel Fink ◽  
Diane M. Provencher

2019 ◽  
Author(s):  
Szymon Piatek ◽  
Grzegorz Panek ◽  
Zbigniew Lewandowski ◽  
Mariusz Bidzinski ◽  
Dominika Piatek ◽  
...  

Abstract Background: In clinical practice alterations in CA125 concentration within normal range in patients with ovarian cancer after first-line treatment are common. Even minor increase in CA125 concentration is associated with patients’ anxiety and difficult interpretation and counselling for clinicians. The aim of this study was to evaluate the significance of CA125 fluctuations within reference level in patients who suffered from ovarian cancer with complete response after first-line treatment.Results: 168 patients with epithelial ovarian cancer, who achieved complete remission after first line treatment were enrolled in the study. CA125 concentration assessment was carried out during follow up visits. The recurrence of the disease was diagnosed on the first appearance of symptoms: clinical, radiological or histopathological/cytological. PFS and 5-year survival rate was calculated with Kaplan-Meier plots. Statistical analysis was performed with SAS / STAT® 9.4 / 14.4, SAS Institute Inc., Cary, NC, USA, 2017. Median concentration of CA125 after first-line therapy was 10 U/ml. Increasing CA125 concentration by > 5U/ml, 3 and 6 months after the treatment was associated with higher risk of relapse (HR=7.6, p<0.0001 and HR=5.29, p<0.0001 respectively). 5-year survival rate was significantly lower in patients with increased CA125 by 5 U/ml, 3 and 6 months after therapy (56.79% vs 0% and 50.62% vs 15.55%).Conclusions: Increased concentration of CA125 by > 5 U/ml within normal range, 3 and 6 months after treatment was unfavorable prognostic factor in ovarian cancer patients with complete response to primary therapy.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 420-420
Author(s):  
Hani M. Babiker ◽  
Peter J. Schlegel ◽  
Lee G. Hicks ◽  
Andrea J. Bullock ◽  
Nafisa Burhani ◽  
...  

420 Background: RX-3117 is an oral small molecule antimetabolite, cyclopentyl pyrimidyl nucleoside that is activated by cancer-enriched uridine cytidine kinase 2. Single agent RX-3117 has demonstrated efficacy in a phase III single agent clinical study of RX-3117 in met-PC and bladder cancer. RX-3117 in combination with nab-pac is being evaluated as first line treatment of met-PC cancer. Methods: This is a multicenter, open label phase I/II study (NCT03189914). Eligible subjects (aged ≥ 18 years) have histologically or radiologically proven met-PC with no prior therapies for metastatic disease, ECOG PS 0-1, and normal lab values. phase I identified the MTD dose that is being further evaluated in the phase II: RX-3117 (700 mg administered orally once-daily for 5 consecutive days with 2 days off per week) and nab-pac (125 mg/m2 administered once weekly) for 3 weeks with 1 week off per 4-week cycle. The Safety Committee reviewed data from phase I before moving to phase II. The primary endpoint of phase II (dose expansion) is an adequate number of responders based on PFS at 4 months and/or objective clinical response per RECIST v1.1. Results: As of September 21, 2018, 8 phase I subjects and 13 phase II subjects were enrolled and treated (9 males and 12 females, median age 67 years). The most common (≥ 15%) related adverse events were nausea, diarrhea, fatigue, alopecia, decreased appetite, rash, vomiting, and anemia. Fourteen subjects had at least one on-study scan (after 2 cycles). One subject experienced a complete response (CR) after 6 cycles of therapy with normalization of CA19.9 (-76%). Three subjects exhibited a partial response (PR): two after 2 cycles (39-47%) and one after 4 cycles of therapy (36%). Eight subjects had stable disease for at least 2 months, and 4 subjects had PFS of at least 4 months. The disease control rate (CR+PR+SD) was 86% in evaluable subjects while the overall response rate (CR+PR) was 29%. Conclusions: RX-3117 in combination with nab-pac appears to be safe and well tolerated in subjects with met-PC. Antitumor activity per RECIST was observed in 12 subjects. Phase II of the clinical study is currently ongoing. Clinical trial information: NCT03189914.


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