Evaluation of CA 125, BUN, and Creatinine Serum in Ovarian Cancer Patients Receiving Paclitaxel-Cisplatin Chemotherapy Treatment

Abstract This study was undertaken to determine if advanced epithelial ovarian cancer was associated with increased serum and ascitic levels of soluble interleukin-2 receptor alpha (sIL-2R alpha). Serum and ascitic fluid samples from 23 ovarian cancer patients were analyzed for sIL-2R alpha using an enzyme-linked immunosorbent assay and compared with the serum and peritoneal levels in 18 normal females. The samples were analyzed for CA-125 levels using a radioimmunoassay and the total protein was also measured. Normal individuals had low serum levels of sIL-2R alpha (367.5 +/- 44.6 U/mL), with similar levels of sIL-2R alpha in the normal peritoneal fluid (438.6 +/- 48.8 U/mL). In contrast, the serum and ascitic fluid levels in ovarian cancer patients were significantly higher (746.7 +/- 82.9 U/mL, P = .0006; 2,656.7 +/- 373.7 U/mL, P = .00002, respectively). The results for sIL-2R alpha were also significant when the levels were expressed per milligram of total protein. More importantly, in almost every ovarian cancer patient the ascitic sIL-2R alpha level far exceeded the serum level, a pattern also observed for CA-125. There was no correlation between the serum and ascitic sIL-2R alpha levels, or between the serum and ascitic CA-125 levels. Although the serum levels of sIL-2R alpha and CA-125 were elevated in the same patient, overall there was no correlation between the serum sIL-2R alpha and serum CA-125 levels, either when the levels were expressed in absolute units or per milligram of total protein. Similarly, there was no correlation between sIL-2R alpha and CA-125 levels in individual ascitic samples. While CA-125 levels may reflect an independent index of tumor burden, these results suggest that selective accumulation of sIL-2R alpha in the ascites may be one of the factors associated with the known nonresponsiveness of the infiltrating lymphocytes against ovarian carcinoma cells.

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Phase II study of vinorelbine in patients with pretreated advanced ovarian cancer: activity in platinum-resistant disease.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.9.2546 ◽

1996 ◽

Vol 14 (9) ◽

pp. 2546-2551 ◽

Cited By ~ 104

Author(s):

E Bajetta ◽

A Di Leo ◽

L Biganzoli ◽

L Mariani ◽

F Cappuzzo ◽

...

Keyword(s):

Ovarian Cancer ◽

Confidence Interval ◽

Cancer Patients ◽

Response Rate ◽

Advanced Ovarian Cancer ◽

Dose Intensity ◽

Ca 125 ◽

Resistant Disease ◽

Platinum Resistant ◽

Exact Confidence Interval

PURPOSE The aim of the study was to evaluate the activity of vinorelbine (VNLB) in a population of advanced ovarian cancer patients, with particular attention to defining its role in platinum-resistant disease. PATIENTS AND METHODS Thirty-three patients were recruited and treated with VNLB 25 mg/m2 intravenously (IV) weekly. the median age was 53 years, performance status 0 to 2, and number of previous chemotherapy regimens two (range, one to five). Twenty-four patients were platinum-resistant; the remaining nine either were platinum-sensitive (four cases) or had undetermined sensitivity (five cases). RESULTS The mean delivered dose-intensity of VNLB was 67% of the planned level, because 60% of the cycles were delayed due to neutropenia or anemia. Four partial responses (PRs) and one complete response (CR) were observed, for an overall response rate of 15% (95% exact confidence interval, 5.1% to 31.9%). All the responses occurred in the subgroup of 24 platinum-resistant cases, in whom the response rate was 21% (95% exact confidence interval, 7.1% to 42.1%). Seven patients became stabilized on VNLB, and 27% of the cases showed a reduction in serum cancer antigen 125 (CA 125) levels. G3/G4 side effects consisted of neutropenia, anemia, and worsening of preexisting peripheral neuropathy. No treatment-related deaths occurred. CONCLUSION VNLB led to a 21% response rate in the population of heavily pretreated and platinum-resistant ovarian cancer patients. Further studies of VNLB alone or in combination with taxanes are warranted in patients with less pretreatment.

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OVX1 radioimmunoassay complements CA-125 for predicting the presence of residual ovarian carcinoma at second-look surgical surveillance procedures.

Journal of Clinical Oncology ◽

10.1200/jco.1993.11.8.1506 ◽

1993 ◽

Vol 11 (8) ◽

pp. 1506-1510 ◽

Cited By ~ 34

Author(s):

F J Xu ◽

Y H Yu ◽

L Daly ◽

K DeSombre ◽

L Anselmino ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Patients ◽

Elevated Serum ◽

Ca 125 ◽

Serum Samples ◽

Persistent Disease ◽

Second Look ◽

Normal Individuals ◽

Positive Results ◽

Apparently Healthy

PURPOSE At second-look surgical surveillance procedures, normal CA-125 levels can be associated with persistent disease in 50% to 60% of patients. A novel radioimmunoassay (RIA) has been evaluated for the ability to identify patients with persistent disease who have normal levels of CA-125. MATERIALS AND METHODS The OVX1 double-determinant assay used a murine monoclonal antibody to detect an epitope on a high-molecular weight mucin-like glycoprotein. RESULTS Apparently healthy individuals had serum OVX1 levels of 2.23 +/- 2.48 U/mL (mean +/- SD). Elevated serum OVX1 levels (> 7.2 U/mL) were found in 5% of 184 normal individuals and in 70% of 93 epithelial ovarian cancer patients with clinically evident disease. Among sera from these ovarian cancer patients, OVX1 was elevated in 68% of 76 samples with CA-125 levels more than 35 U/mL and in 76% of 17 samples with CA-125 levels less than 35 U/mL. In serum samples obtained at the time of positive second-look laparotomy, 59% of 41 patients with CA-125 levels less than 35 U/mL had elevated OVX1 antigen levels, whereas 41% of 22 patients with CA-125 levels more than 35 U/mL had elevated serum OVX1 levels. In patients with negative second-look laparotomies, false-positive results were eliminated by increasing the threshold of OVX1 to 10.5 U/mL. At this level, 32% of 41 patients with positive second-look operations had an elevated OVX1 level, despite a normal CA-125 level. When used in combination, CA-125 (> 35 U/mL) and OVX1 (> 10.5 U/mL) detected persistent disease in 56% of 63 patients with positive surveillance procedures, compared with 35% when CA-125 was used alone (P < .05). CONCLUSION An elevated OVX1 level can alert oncologists to the possibility that ovarian cancer has persisted, despite the return of CA-125 to a normal range.

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The real-life variability of CA 125 in ovarian cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2004.22.14_suppl.5014 ◽

2004 ◽

Vol 22 (14_suppl) ◽

pp. 5014-5014

Author(s):

M. Markman ◽

E. Tso ◽

F. Van Lente ◽

P. Elson ◽

D. Odar ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Patients ◽

Real Life ◽

Ca 125 ◽

The Real

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The utility of assessing physical activity in ovarian cancer patients following chemotherapy

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19666 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19666-19666 ◽

Cited By ~ 2

Author(s):

K. Zakashansky ◽

S. Higgins ◽

G. Montgomery ◽

P. Dottino ◽

D. Bovbjerg

Keyword(s):

Physical Activity ◽

Ovarian Cancer ◽

Cancer Patients ◽

Daily Activity ◽

Objective Assessment ◽

Gynecologic Cancer ◽

Control Sample ◽

Activity Levels ◽

Chemotherapy Treatment ◽

Comparison Results

19666 Objective: The purpose of this preliminary study was to explore the utility of objective assessments of physical activity for investigating the patterns and predictors of reduced physical activity levels in patients receiving standard chemotherapy for ovarian cancer. Methods: Ovarian cancer patients receiving standard regimens of Taxol/Carboplatin chemotherapy (n=9) were recruited prior to their treatment infusion. After signing informed consent, they completed the 20-item Center for Epidemiologic Studies Depression Scale (CESD); post treatment daily activity levels were assessed with a wrist watch-sized, water proof, omnidirectional, actigraphy monitor (Actiwatch-64, Mini Mitter, Bend, OR) worn on the nondominant wrist for the three weeks between treatment cycles. Identical actigraphy data were collected on a sample of healthy female staff (n=9) over a 1 week interval to provide a benchmark for comparison. Results: As expected, waking activity levels in the control sample showed no significant changes across days (p=0.41), so mean levels (343.45 counts) and 95% confidence intervals were calculated for comparison purposes. Chemotherapy patients had significantly lower levels of activity, as well as evidence of recovering physical activity over the 21 days following treatment (p=0.01). Interestingly, the subset (n=4) of patients with higher levels of pretreatment depression (Hi-CESD) did not show significant recovery in physical activity while the Lo-CESD subgroup showed substantial recovery (p=0.001). Conclusions: Objective assessment of physical activity in ovarian cancer patients following chemotherapy treatment reveals significant reduction in activity levels, and a failure to recover in patients with higher levels of pretreatment depression. Actigraphy of daily activity levels may provide a sensitive means of quantifying reductions in physical activity and recovery patterns following chemotherapy treatment for gynecologic cancer. No significant financial relationships to disclose.

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INNOVATE: A phase II study of TTFields (200 kHz) concomitant with weekly paclitaxel for recurrent ovarian cancer—Updated safety and efficacy results.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.5580 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 5580-5580 ◽

Cited By ~ 2

Author(s):

Ignace Vergote ◽

Roger von Moos ◽

Luis Manso ◽

Cristiana Sessa

Keyword(s):

Ovarian Cancer ◽

Adverse Events ◽

Cancer Patients ◽

Electric Fields ◽

Skin Irritation ◽

Intermediate Frequency ◽

Weekly Paclitaxel ◽

Ca 125 ◽

Serious Adverse Events ◽

Platinum Resistant

5580 Background: TTFields are a non-invasive, regional antimitotic treatment modality, which have been approved for the treatment of recurrent and newly diagnosed glioblastoma by the FDA. TTFields act by delivering intermediate frequency alternating electric fields to the tumor, predominantly by disrupting the formation of the mitotic spindle during metaphase. INNOVATE was the first trial testing TTFields (200kHz) in ovarian cancer patients. Methods: Thirty-one recurrent, platinum-resistant, unresectable ovarian cancer patients were enrolled in the INNOVATE trial and treated with TTFields in combination with weekly paclitaxel. The primary endpoint was treatment emergent adverse events. Secondary endpoints included progression free-survival, overall survival and radiological response rate. Results: The median age was 60 (range – 45-77), most patients (77%) had serous histology. 52% had an ECOG score of 0. The median number of prior chemotherapy regimens was 4.1 (range 1-11). All patients were platinum-resistant, and 97% of patients received prior taxane-containing regimens. Ten (32%) patients suffered from serious adverse events (SAEs) during the study, none were related to TTFields. Of all reported SAEs, 31% were related to gastrointestinal disorders (ileus, jaundice and ascites) and 31% were respiratory events (dyspnea, pleural effusion and pulmonary embolism). Only one SAE which, related to the tumor, led to permanent discontinuation of the device. Most patients were reported to have mild-moderate, TTFields-related skin irritation, out of whom only two patients (6.4%) had severe-grade events. The median PFS was 8.9 months (95% CI 4.7, NA). Of the evaluable tumors, 25% had partial response and another 46.4% stable disease – a clinical benefit of 71.4%. Six patients (19.4%) had a CA 125 response, translating into a decrease of 50% or more in serum levels. The median OS was not reached. Conclusions: TTFields concomitant to weekly paclitaxel are tolerable and safe in heavily pre-treated platinum-resistant ovarian cancer ovarian cancer patients. These data support further clinical testing of TTFields with chemotherapy in ovarian cancer. Clinical trial information: NCT02244502.

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