A phase II study of up-front red blood cell transfusion before chemotherapy followed by maintenance Erythropoetin-alpha subcutaneous support during chemotherapy of anaemic breast-, colorectal- and ovarian cancer patients

2012 ◽  
Author(s):  
A C Ogilvie
Keyword(s):  
Ovarian Cancer ◽  
Blood Cell ◽  
Cancer Patients ◽  
Phase Ii ◽  
Red Blood Cell ◽  
Phase Ii Study ◽  
Red Blood Cell Transfusion

A phase II study of early up-front red blood cell transfusion followed by maintenance epoetin-alpha subcutaneously support during chemotherapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20719-e20719
Author(s):  
J. W. Nortier ◽  
A. Ogilvie
Keyword(s):  
Adverse Events ◽  
Blood Cell ◽  
Phase Ii ◽  
Red Blood Cell ◽  
Phase Ii Study ◽  
Tumor Oxygenation ◽  
Red Blood Cell Transfusion ◽  
Target Range ◽  
Serious Adverse Events ◽  
Epoetin Alpha

e20719 Background: To determine in patients with cancer related anaemia (Hb<11,3 g/d) starting with their chemotherapy the efficacy and safety of up-front red blood cell transfusion and subsequently maintenance epoetin-alpha (Epo) administration. The study target was the range of low-normal Hb levels of 11,3 to 12,9 g/dL aiming at improving tumor oxygenation. Methods: A multicenter, open label, single-arm phase II study. All eligible patients with metastatic solid cancers received around their first or second chemotherapy cycle a transfusion of 1–3 units of erythrocytes depending on their Hb level. This was followed by Epo subcutaneously weekly at an initial dose of 40,000 IU during the chemotherapy period. Epo was only administered when the Hb level was below the lower margin of the target Hb range. All patients started with pre-emptive oral iron suppletion. Primary objectives were: correction of anemia to the Hb level target range and safety. Secondary objectives were: Quality of Life, Length of Treatment Duration and Time to Treatment Failure. Safety included: blood pressure, thrombo-embolic events, adverse events and serious adverse event. Results: 18 Patients enrolled in this study from March 30, 2006 to November 11, 2008. An intention-to-treatment analysis was performed for the primary objectives in 16 patients (8 with breast-, 4 with colorectal-, 1 with ovarian- and 1 with pancreatic cancer) and reported here. Patients were during a median of 12 weeks (range 1 to 32 weeks) on study. Median Hb increased from 10,2 g/dL to 11,2 g/dL after transfusion and stayed at that level during the first 19 weeks of Epo administration; Hb levels were between 10,0 and 11,5 g/dL. In the following period until the final 32nd studyweek, Hb levels increased slightly, ranging from 10,3 to 11,8 g/dL. Two patients remained during the study in the Hb level target range. The safety of Epo was good. Grade 3/4 adverse events and serious adverse events that occurred were found to be all chemotherapy or progressive disease related. Conclusions: Although this up-front treatment increased Hb to stable levels during chemotherapy, the target Hb levels were not reached in most patients. This was presumably related to the lesser than projected yield of the red blood cell transfusion. [Table: see text]

Phase II study of letrozole in estrogen receptor (ER) positive relapsed epithelial ovarian cancer (EOC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5025-5025 ◽  
Author(s):  
C. Gourley ◽  
J. F. Smyth ◽  
M. Mackean ◽  
A. Stevenson ◽  
A. Williams ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Cytotoxic Agents ◽  
First Line ◽  
Peritoneal Cancer ◽  
Biomarker Analysis ◽  
Er Positive ◽  
Radiological Response

5025 Background: Letrozole is a potent oral aromatase inhibitor which rapidly suppresses circulating estrogen levels by 99% in postmenopausal women. By comparison with cytotoxic agents it is very well tolerated. We previously demonstrated an ‘endocrine sensitive’ subgroup of ovarian cancer patients with ER histoscore cutoff of ≥150 (Bowman et al, Clin Can Res 2002). Methods: This was a phase II study with a planned sample size of 33 patients. Eligible patients had relapsed EOC or primary peritoneal cancer with an ER histoscore of ≥150 and a rising CA125 that had progressed according to Rustin’s criteria. Patients were treated with letrozole 2.5mg daily until clinical or marker evidence of disease progression. The primary endpoint was response according to CA125 and RECIST criteria. Biomarker analysis by tissue microarray is also being performed. Results: 46 patients were accrued, 45 of whom were eligible. The median age was 61 (range 39–81). 24, 10 and 10 patients had received 1,2 and >2 previous lines of chemotherapy respectively. Of 43 patients evaluable for CA125 response, 7 (16%) had a response (decrease of >50%) and 16 (37%) patients had not progressed (doubling of CA125) following 12 weeks on treatment. In the CA125 responders, the nadir CA125 ranged from 0.7–49% of baseline (actual % of baseline: 0.7, 2.6, 11.1, 17.6, 23.6, 42.6, 49). Of the 7 responding patients, 5 had received only one previous line of chemotherapy. The time taken to achieve the nadir CA125 value ranged from 10 to 36 weeks, with a median of 13 weeks. Of 33 patients evaluable for radiological response, 3 (9%) had a PR and 14 (42%) had stable disease at 12 weeks. Overall, 11 patients (26%) had a PFS of >6 months and 2 patients (5%) had a PFS of ≥2 years. Conclusions: To our knowledge this is the first study of a hormonal agent in a selected ER +ve population of ovarian cancer patients. Promising efficacy of the agent is demonstrated in this population of pre-treated patients, many with a considerable bulk of disease. Given the median time of 13 weeks to response, we suggest that this strategy should be tested in ER+ve ovarian cancer patients in the adjuvant setting following first line chemotherapy No significant financial relationships to disclose.

Phase II study on the combination carboplatin-celecoxib in heavily pre-treated recurrent ovarian carcinoma patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15009-15009
Author(s):  
F. Legge ◽  
V. Salutari ◽  
A. Paglia ◽  
A. Testa ◽  
D. Lorusso ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Recurrent Ovarian Cancer ◽  
Platinum Resistant ◽  
Response To Chemotherapy ◽  
Short Period ◽  
Heavily Pretreated ◽  
Cox 2

15009 Background: Cyclooxygenase-2 (COX-2) has been shown to be involved in several steps of ovarian onset and progression and its overepression is associated with a poor chance of response to chemotherapy and poor prognosis in ovarian cancer. Celecoxib, an orally active selective COX-2 inhibitor, has been tested for its ability to potentiate the activity of carboplatin in treatment of heavily pretreated recurrent ovarian cancer patients. Methods: A phase II study was planned, considering the regimen active if at least 12 responses were observed among the 43 enrolled patients. Celecoxib (400 mg/die), and carboplatin (5 AUC) q28 were administered, until progression or unacceptable toxicity. Response was assessed by RECIST and also by Rustin criteria. Results: 34 pts (median age: 60 yrs, range 28–74) and an ECOG performance status (0/1/2) of (21/12/1), were enrolled. 58.8% of patients were platinum resistant (progressing during or < 6 months from primary treatment). Median number of previous chemotherapy regimens was 3 (range 2–6). Currently 27 patients are evaluable for response. The overall response rate (CR and PR) was 25.9% (2 CR, 5 PR) with stabilization of disease in 8 patients (29.6%). Four responses occurred in platinum sensitive and 3 in platinum resistant group Median time to response was 11 weeks (range 9–19) and median duration of response was 23 weeks (range 12–39). According to Rustin criteria 10 patients out of 25 (40%) were considered responsive to treatment (return of CA125 levels to normal level or >50% reduction). Overall, 143 cycles were administered with a median value of 3 cycles (range = 1–10). Moderate/severe toxicities were as follows: G3 anemia occurred in 2.3% cycles, G3 neutropenia in 4.6% cycles, G3 thrombocytopenia in 1.5% cycles, G3/4 gastrointestinal toxicity occurred in 4.6% cycles. Cutaneous diffuse erithema was observed in 2 patients, in both cases recovered with a short period of antihistaminic treatment; 2 cases of hypertension were documented, G2 hypersensitivity reactions during carboplatin infusion were observed in 4 cases. Conclusions: Celecoxib combined with carboplatin is well tolerated and has promising activity as salvage treatment in heavily pretreated recurrent ovarian cancer patients. No significant financial relationships to disclose.

scholarly journals The Impact of Perioperative Packed Red Blood Cell Transfusion on Survival in Epithelial Ovarian Cancer

2013 ◽  
Vol 23 (9) ◽  
pp. 1612-1619 ◽  
Author(s):  
Lindsay L. Morgenstern Warner ◽  
Sean C. Dowdy ◽  
Janice R. Martin ◽  
Maureen A. Lemens ◽  
Michaela E. McGree ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Propensity Score ◽  
Blood Cell ◽  
Epithelial Ovarian Cancer ◽  
Propensity Score Matching ◽  
Red Blood Cell ◽  
Red Blood Cell Transfusion ◽  
Improvement Program ◽  
Estimated Blood Loss ◽  
The Impact

ObjectivePerioperative packed red blood cell transfusion (PRBCT) has been implicated as a negative prognostic marker in surgical oncology. There is a paucity of evidence on the impact of PRBCT on outcomes in epithelial ovarian cancer (EOC). We assessed whether PRBCT is an independent risk factor of recurrence and death from EOC.MethodsPerioperative patient characteristics and process-of-care variables (defined by the National Surgical Quality Improvement Program) were retrospectively abstracted from 587 women who underwent primary EOC staging between January 2, 2003, and December 29, 2008. Associations with receipt of PRBCT were evaluated using univariate logistic regression models. The associations between receipt of PRBCT and disease-free survival and overall survival were evaluated using multivariable Cox proportional hazards models and using propensity score matching and stratification, respectively.ResultsThe rate of PRBCT was 77.0%. The mean ± SD units transfused was 4.1 ± 3.1 U. In the univariate analysis, receipt of PRBCT was significantly associated with older age, advanced stage (≥IIIA), undergoing splenectomy, higher surgical complexity, serous histologic diagnosis, greater estimated blood loss, longer operating time, the presence of residual disease, and lower preoperative albumin and hemoglobin. Perioperative packed red blood cell transfusion was not associated with an increased risk for recurrence or death, in an analysis adjusting for other risk factors in a multivariable model or in an analysis using propensity score matching or stratification to control for differences between the patients with and without PRBCT.ConclusionsPerioperative packed red blood cell transfusion does not seem to be directly associated with recurrence and death in EOC. However, lower preoperative hemoglobin was associated with a higher risk for recurrence. The need for PRBCT seems to be a stronger prognostic indicator than the receipt of PRBCT.

Sign in / Sign up

Export Citation Format

Share Document