Docetaxel and cisplatin combination chemotherapy for advanced epithelial ovarian cancer with bulky residual disease

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15030-15030
Author(s):  
A. Shaharyar ◽  
K. Shabbir ◽  
M. Hafeez ◽  
Z. Alauddin ◽  
E. U. Rehman

15030 Background: The combination of docetaxel and cisplatin as an alternative to the gold standard carboplatin and paclitaxel chemotherapy has not been explored in our patients. Docetaxel is more potent of the taxanes, therefore, this combination might yield a better outcome. This phase II study was designed to evaluate the efficacy and toxicity of docetaxel and cisplatin combination in epithelial ovarian cancer with bulky residual disease. Methods: Thirty-two new patients were enrolled between November 2003 and August 2005. Eligible patients had histopatholgically confirmed epithelial ovarian cancer, were older than 18 years and had FIGO stage IIC-IV cancer with bulky residual disease after primary cytoreductive surgery. Patients had a KPS >70 with adequate marrow and hepatic function. Patients with creatinine clearance by Cockroft-Gault formula of >60 ml/min were included. Written informed consent was obtained. Patients with diabetes mellitus, peripheral neuropathy, or cardiac co morbidity were excluded. Docetaxel and cisplatin were given at a dose of 75 mg/m2 each on day-1 of a 21-day cycle. Dexamethasone 8 mg was given thrice before and thrice after and tropisetron 5mg was given one hour before and 12 hours after chemotherapy. Docetaxel was given in 250 ml of NaCl in one-hour followed by cisplatin 75 mg/m2 in 1L of NaCl in 3 hours with pre and post hydration. NCI toxicity criteria version 2.0 and RECIST was used for evaluation. Results: Thirty patients were evaluable for response and toxicity. Final evaluation revealed CR in 12 (40%) (95% CI, 22.7–59.4%), PR in 14 (46.6%) with an ORR of 86.6% (95% CI, 69.3–96.2%). Three (10%) had SD and 1 (3.33) had PD. Grade 2 toxicity included alopecia 18 (60%), vomiting 6 (20%), diarrhea 7 (23.3%) and stomatitis in 5 (16%). Grade 3 and 4 neutropenia were seen in 12 (40%) and 9 (30%) respectively. Sensory neuropathy of grade 1 and 2 was seen in 4 (13.3%) and 2 (6.7%) respectively. Conclusion: Docetaxel and cisplatin combination chemotherapy is an effective and safe regimen in epithelial ovarian cancer with bulky residual disease. It gives a high overall response rate and has a manageable toxicity profile. No significant financial relationships to disclose.

Chemotherapy ◽  
2016 ◽  
Vol 61 (6) ◽  
pp. 287-294
Author(s):  
Lindy M.J. Frielink ◽  
Brenda M. Pijlman ◽  
Nicole P.M. Ezendam ◽  
Johanna M.A. Pijnenborg

Background: Adjuvant platinum-based chemotherapy improves survival in women with early-stage epithelial ovarian cancer (EOC). Yet, there is a wide variety in clinical practice. Methods: All patients diagnosed with FIGO I and IIa EOC (2006-2010) in the south of the Netherlands were analyzed. The percentage of patients that received adjuvant chemotherapy was determined as well as the comprehensiveness of staging and outcome. Results: Forty percent (54/135) of the patients with early-stage EOC received adjuvant chemotherapy. Treatment with adjuvant chemotherapy was associated with FIGO stage, clear-cell histology and nonoptimal staging. Optimal staging was achieved in 50%, and nonoptimal staging was associated with advanced age, comorbidity and treatment in a non-referral hospital. Overall, there was no difference in outcome between patients with and without adjuvant chemotherapy. Yet, in grade 3 tumors, adjuvant chemotherapy seems beneficial. Conclusions: Selective treatment of patients with early-stage EOC might reduce adjuvant chemotherapy without compromising outcome.


2020 ◽  
Vol 30 (6) ◽  
pp. 888-892 ◽  
Author(s):  
Simone Koole ◽  
Ruby van Stein ◽  
Karolina Sikorska ◽  
Desmond Barton ◽  
Lewis Perrin ◽  
...  

BackgroundThe addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.Primary objectiveThe primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.Study hypothesisWe hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.Trial designThis international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.Major eligibility criteriaPatients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.Primary endpointThe primary endpoint is overall survival.Sample sizeTo detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.Estimated dates for completing accrual and presenting resultsThe OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.Trial registrationClinicalTrials.gov:NCT03772028


1988 ◽  
Vol 6 (9) ◽  
pp. 1433-1439 ◽  
Author(s):  
M F Schray ◽  
A Martinez ◽  
A E Howes ◽  
K C Podratz ◽  
S C Ballon ◽  
...  

Between 1979 and 1984, 53 patients received whole abdominal irradiation in a curative salvage effort for residual (32 patients) or recurrent (21 patients) epithelial ovarian cancer after combination chemotherapy (cisplatin-based in 48 patients). Residual cancer less than or equal to 2 cm in diameter was confirmed at operation in all patients before irradiation consisting of 2,550 to 3,000 rad to the whole abdomen with partial liver/kidney shielding and boosting of the dose to the diaphragmatic/paraaortic nodal regions and pelvis to approximately 4,000 and 5,000 rad, respectively. Twelve patients (23%) did not complete therapy as a result of hematologic intolerance. Actuarial overall and disease-free survival at 3 years are 35% and 30%, respectively, with follow-up for disease-free patients ranging from 30 to 79 months (median, 43 months). Twenty-seven of 36 relapses (75%) occurred within the irradiated abdomen alone. At 3 years, 70% of patients with well- or moderately-differentiated tumors were disease-free v 10% of those with poorly differentiated tumors (P less than .001). Among prognostic factors evaluated, including grade, initial residual disease before chemotherapy, residual disease at time of irradiation, age, chemotherapy response v progression, and completion of irradiation, only grade and initial residual disease before chemotherapy were statistically significant in multivariate analysis (both P less than .01). Patients with the combination of high-grade tumor, initial residual disease greater than 2 cm before chemotherapy, and macroscopic disease after "second-look" laparotomy do not benefit from irradiation. Eleven patients (21%) developed an apparent treatment-related bowel obstruction after completion of irradiation. Selected subsets of patients do well; however, the role of irradiation in this setting can be confirmed only with randomized clinical study.


2004 ◽  
Vol 14 (1) ◽  
pp. 42-50 ◽  
Author(s):  
E. C. Brockbank ◽  
T. E. J. Ind ◽  
D. P. J. Barton ◽  
J. H. Shepherd ◽  
M. E. Gore ◽  
...  

IntroductionWomen with epithelial ovarian cancer (EOC) are conventionally treated with primary cytoreductive surgery. For those with a low probability of optimal primary surgical debulking, an alternative management option is primary chemotherapy with delayed primary surgery. Selection criteria are required to identify women who may benefit from this approach.Patients and methodsPatient age, presence of ascites, preoperative serum CA-125 level, surgical procedures performed, postoperative residual disease, FIGO stage, and histology data were collected on 97 women with preoperative clinical evidence of advanced EOC. Univariate and multivariate analysis was performed to identify which preoperative factors predict disease that will be suboptimally debulked. Receiver–operator curves were constructed for CA-125 level as a predictor for residual disease.ResultsThe best predictor of disease suboptimally cytoreduced was serum CA-125 level (OR = 22.76, 95% CI = 7.13–72.69). Other predictive factors included age over 60 years (OR = 3.16, 95% CI = 1.04–9.56) and clinical evidence of ascites (OR = 3.30, 95% CI = 1.03–10.62). The optimal cut-off for serum CA-125 as a predictor of suboptimal debulking was 586 IU (sensitivity 80.0%, specificity 88.5%, PPV 85.7%).ConclusionSerum CA-125 level is a reliable component of the preoperative assessment of women with EOC.


2009 ◽  
Vol 17 (3-4) ◽  
pp. 51-55
Author(s):  
Lilia Gocheva ◽  
Bojidar Slavchev

Background: The examination of the use of whole abdomen irradiation open field technique in optimally debulked patients with no residual disease with epithelial ovarian cancer (OC). Methods: Between 1993 and 2007, 20 patients with optimally cytoreduced epithelial OC were treated with WAI. The stage distribution was stage I in 15 patients, stage II in 1, and stage III in 4. The grade distribution was grade 1 in 10 patients, grade 2 in 4, and grade 3 in 6. WAI consisted of 30 Gy, delivered in daily fractions, mainly of 1.5 Gy (95%), 5 days/weekly, in 14 patients. After abdominal irradiation, in 75% of the patients a pelvic boost, and in 7 a boost to other risk sites was given to reach 45 - 50 Gy. Nine patients received platinum based chemotherapy (CT). Median follow-up was 7.96 years. Results: The overall survival (OS) rate was 82% and 70% at 5 and 10 years. A tendency to better survival was found in patients with age ? 40 than in those with > 40 years (100%:100% vs. 68%:51%; p=0.03). Patients with grade 1-2 tumors had significantly better 5- and 10-year survival rate than those with grade 3 tumors (100%:100% vs. 40%:20%; p<0.00). The 5- and 10-year OS for the patients 'with' and 'without' a pelvic boost turned to be in favor of the patients 'with' the boost (91%:91% vs. 60%:40%; p=0.02). In 15 patients (75%) RT was transiently interrupted because of acute gastrointestinal and hematological toxicity. Neither grade 4 acute complications nor was mortality observed. Late gastrointestinal effect developed in 1 patient, presented with grade 4 complications. The development of second primary malignancy was not observed during the follow-up period. Conclusion: WAI achieves a quite favorable 5- and 10-year survival rate with an acceptable risk of acute and late side effects in properly selected patients with epithelial OC.


2002 ◽  
Vol 12 (6) ◽  
pp. 720-727 ◽  
Author(s):  
R. A. M. Sagarra ◽  
L. A. L. A. Andrade ◽  
E. Z. Martinez ◽  
G. A. Pinto ◽  
K. J. Syrjänen ◽  
...  

The study was designed to evaluate the prognostic importance of clinical and pathologic variables with p53 and Bcl-2 in epithelial ovarian cancer using multivariate analysis. Tumor tissues from 90 patients were analyzed immunohistochemically for p53 and Bcl-2 expression. Hazard ratios were calculated in univariate and multivariate survival analyses. Forty-two (47%) were considered positive for p53 expression and 18 (20%) were positive for Bcl-2. Positive expression for p53 was less frequent in patients in FIGO stage I (22%). Positive staining for Bcl-2 correlated significantly with the histologic type (P < 0.01). No direct correlations could be demonstrated between p53 and Bcl-2 expression and age or histologic grade. In univariate analysis, p53 and Bcl-2 expression were not significantly correlated with overall survival, disease-free survival, or progression time. FIGO stage III and IV and residual disease ≥2 cm3 after first surgery were significantly correlated with poor outcome in univariate analysis. FIGO stage retained their independent prognostic value in multivariate analysis. Neither p53 nor Bcl-2 had any significant influence on outcome in multivariate survival analysis. FIGO stage proved to be the only significant independent prognostic factor in epithelial ovarian cancer, although residual disease remains correlated with disease-free survival.


2009 ◽  
Vol 19 (8) ◽  
pp. 1446-1453 ◽  
Author(s):  
Gregor Seliger ◽  
Lutz P. Mueller ◽  
Thomas Kegel ◽  
Eva J. Kantelhardt ◽  
Axel Grothey ◽  
...  

2018 ◽  
Vol 28 (3) ◽  
pp. 453-458 ◽  
Author(s):  
Parvin Tajik ◽  
Roelien van de Vrie ◽  
Mohammad H. Zafarmand ◽  
Corneel Coens ◽  
Marrije R. Buist ◽  
...  

ObjectiveThe revised version of the International Federation of Gynaecology and Obstetrics (FIGO) staging system (2014) for epithelial ovarian cancer includes a number of changes. One of these is the division of stage IV into 2 subgroups. Data on the prognostic and predictive significance of this classification are scarce. The effect of neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) in relation to the subclassification of FIGO stage IV is also unknown.MethodsWe used data of the EORTC 55971 trial, in which 670 patients with previous stage IIIC or IV epithelial ovarian cancer were randomly assigned to PDS or NACT; 160 patients had previous stage IV. Information on previous FIGO staging and presence of pleural effusion with positive cytology were used to classify tumors as either stage IVA or IVB. We tested the association between stage IVA/IVB and survival to evaluate the prognostic value and interactions between stage, treatment, and survival to evaluate the predictive performance.ResultsAmong the 160 participants with previous stage IV disease, 103 (64%) were categorized as stage IVA and 57 (36%) as stage IVB tumors. Median overall survival was 24 months in FIGO stage IVA and 31 months in stage IVB patients (P = 0.044). Stage IVB patients treated with NACT had 9 months longer median overall survival compared with IVB patients undergoing PDS (P = 0.025), whereas in IVA patients, no significant difference was observed (24 vs 26 months, P = 0.48).ConclusionsThe reclassification of FIGO stage IV into stage IVA or IVB was not prognostic as expected. Compared with stage IVA patients, stage IVB patients have a better overall survival and may benefit more from NACT.


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