Advanced epithelial ovarian cancer (EOC): Is there a place for maintenance therapy in patients with sub-optimal debulking?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
R. Hariprasad ◽  
L. Kumar ◽  
S. Kumar ◽  
N. Bhatla ◽  
S. Thulkar ◽  
...  

e14580 Background: Survival of patients with advanced epithelial ovarian cancer (EOC) with initial suboptimal debulking surgery (residual disease (>1 cm) and those with recurrent EOC is poor. We used EGFR inhibitor gefitinib for maintenance and analyzed data on safety and toxicity. Methods: Between Nov. 2004 and Dec. 2008, Patients who achieved complete response (CR) following six cycles of paclitaxel and carboplatin received gefitinib as (Group I). Similarly, patients with recurrent EOC who achieved CR following six cycles of salvage CT received gefitinib (Group II). Both groups received gefitinib 250 mg once daily till evidence of relapse. Patients were examined every month and toxicity (CTC version II) was recorded. Serum CA-125 was done once in 2 months and CAT scan of abdomen & pelvis every 6 month. The study was approved by Institute Ethics Committee and informed written consent was obtained from each patient. Results: A total of 48 patients (median age 47 years, range 23 to 63) have been recruited. Group I: 17 subjects and Group II 31 patients (1st relapse- 13, 2nd- 9, 3rd -6 & 4th relapse in 3 patients). The mean duration of gefitinib treatment is 8.77 months (Gp-I: 14.4 months, Gp-II: 5.68 months). Toxicity was mainly in the form of skin rash & diarrhea. Skin rash: 16 patients (33.3%); Group I - 8 (grade I-2, II-4, III-3,) & Group II - 8 patients (grade I-3,II-4,III-1). Diarrhea: 12 patients (25%); Group I-3, group II- 9) all grade I. Two patients had both skin rashes and diarrhea. No pulmonary or hematological toxicity was observed. Currently, 13 patients are on gefitinib (mean duration of treatment 12.6 months); in 34 patients gefitinib has been discontinued due to relapse and in 1 patient due to grade III skin rashes over face. Among 18 patients with skin toxicity, 8 continue to be disease-free compared to 6 of 30 without skin toxicity (p=0.07). Conclusions: Gefitinib was tolerated well with mild toxicities limited to skin and GIT. Correlations between EGFR expressions vs. response may help to identify patients likely to benefit from gefitinib therapy. No significant financial relationships to disclose.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15046-15046 ◽  
Author(s):  
R. Hariprasad ◽  
L. Kumar ◽  
R. Patnaik ◽  
A. Gupta ◽  
S. Kumar

15046 Background: We aimed to evaluate the role of EGFR inhibitor, gefitinib among patients with advanced & recurrent EOC to prolong progression-free survival (PFS). Methods: Between Nov. 2004 and Dec. 2005, 32 patients (median age 45 years, range 33 to 63) have been recruited. The study subjects were - (i) eleven patients with EOC stage IIIC-IV who had gross residual disease (≥1 cm) after primary debulking surgery and had achieved complete response (CR) following six cycles of paclitaxel and carboplatin (Group-I) (ii) Group II - includes 21 patients who achieved CR following salvage chemotherapy for relapsed EOC (1st relapse- 8, 2nd- 8, 3rd -3 & 4th relapse in 2 patients). All Patients received gefitinib 250 mg once daily till evidence of relapse. Patients were examined every month and toxicity (CTC version II) was recorded. Serum CA-125 was done once in 2 months and CAT scan of abdomen & pelvis at 6 monthly interval. The study was approved by Institute Ethics Committee and informed written consent was obtained from each patient before starting Gefitinib. Results: The mean duration of treatment is -5.6 months (Gp-I: 7.7 months, Gp-II: 4.5 months). Toxicity was mild, mainly in the form of skin rash & diarrhoea. Skin rash occurred in 10 patients (31.3%); Group I - 8 patients (grade IV-2, III-2, I-4) & in 2 patients in group II (grade III-1, II-1). Diarrhoea occurred in 7 patients (22%); Group I-1, group II-6) all grade I. No pulmonary or hematological toxicity was observed. Currently, 18/32 patients are on Gefitinib (mean duration of treatment 6.1 months); in 12 patients gefitinib has been discontinued due to relapse (group I- 4, Group II-10). Among 10 patients with skin toxicity (Gp I-8, Gp II-2), 6 continue to be disease-free (Group I- 5, Group II-1) compared to 12 of 22 without skin toxicity. Conclusions: Toxicity to gefitinib was mild, and limited to skin and GIT. Correlation between EGFR expression vs. response can help in identifying patients who possibly might benefit with gefitinib therapy. No significant financial relationships to disclose.


Blood ◽  
1993 ◽  
Vol 81 (2) ◽  
pp. 424-429 ◽  
Author(s):  
DP Barton ◽  
DK Blanchard ◽  
B Michelini-Norris ◽  
SV Nicosia ◽  
D Cavanagh ◽  
...  

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.


2011 ◽  
Vol 22 (4) ◽  
pp. 269 ◽  
Author(s):  
Sokbom Kang ◽  
Tae-Joong Kim ◽  
Sang-Soo Seo ◽  
Byoung-Gie Kim ◽  
Duk-Soo Bae ◽  
...  

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5570-5570
Author(s):  
Alok Pant ◽  
Julian C. Schink

5570 Background: To define the incidence and prognostic significance of venous thromboembolism (VTE) in patients with advanced, epithelial ovarian cancer undergoing front-line adjuvant chemotherapy after extended period (28 day) post-operative prophylaxis. Methods: A retrospective analysis of patients with advanced, epithelial ovarian cancer who underwent surgery and chemotherapy at a single institution from January 2008 through December 2011 was performed. Exclusion criteria were prior history of VTE, VTE during the post-operative period, clear cell histology, use of anti-coagulation for a different indication, and lack of compliance with 28 days of post-operative prophylaxis with a low molecular weight heparin. Results: 128 patients met criteria for inclusion. Sixteen patients had a reported VTE during the time they were on front line chemotherapy (12.5%). Nine patients (7%) had a pulmonary embolus (PE) and 8 (6.3%) had a deep vein thrombus (DVT). The average BMI in the group that developed VTE was 28 and in the group without VTE was 26.5 (p = 0.23). Three out of 16 (23%) patients who developed VTE had undergone a suboptimal cytoreduction compared to 12/112 (11%) in the group with no VTE (p = 0.4). Six of the 16 (37%) patients who developed VTE during chemotherapy underwent a bowel resection and/or splenectomy during their cytoreductive surgery compared to 18 of 112 (16%) patients who did not develop VTE (p=0.079). Eight of the patients in the VTE group had indwelling venous catheters during chemotherapy (50%) compared to 39 (35%) in the group with no VTE (p = 0.27). In the group that developed VTE, there was a trend towards increased pre-operative CA-125, higher rates of bowel resection and/or splenectomy during surgery, decreased use of aspirin, and inferior survival. On multivariate analysis, patients who developed VTE had significantly longer post-operative hospital stays (7 vs 5 days [p = 0.009]) and lower rates of complete response (p = 0.01). Conclusions: A 12.5% risk of VTE merits consideration of prophylaxis during chemotherapy in this cohort. A randomized, controlled trial is needed to clarify whether the benefits of long term prophylaxis outweigh the risks and costs of such therapy.


2013 ◽  
Vol 139 (7) ◽  
pp. 1207-1210 ◽  
Author(s):  
Norman Häfner ◽  
Kristin Nicolaus ◽  
Stefanie Weiss ◽  
Manfred Frey ◽  
Herbert Diebolder ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document