scholarly journals Evaluation of the feasibility of using weekly paclitaxel as neoadjuvant therapy in patients with epithelial ovarian cancer; a pre-post clinical trial

2020 ◽  
Vol 7 (1) ◽  
pp. e09-e09
Author(s):  
Sakineh Ebrahimi ◽  
Seyed Saeed Hashemi Nazari ◽  
Arash Dooghaie Moghadam ◽  
Shirin Haghighi

Introduction: Although weekly paclitaxel and carboplatin regimen is as effective as the standard method for treatment of advanced ovarian cancer, it has less frequently been used as neoadjuvant therapy. Objectives: To reduce the side effects of typical every three-week chemotherapy and increase progression-free survival (PFS) rate, this study aimed to evaluate the feasibility of using weekly paclitaxel as neoadjuvant therapy in patients with epithelial ovarian cancer. Patients and Methods: This pre-post clinical trial was conducted on 14 patients with stage IIIC (8 patients) and IV (6 patients) advanced ovarian carcinoma. All the patients received the three courses of treatment and then underwent interval debulking surgery. After the surgery, patients received three or five courses based on their stages. Every neoadjuvant chemotherapy course consisted of weekly paclitaxel (80 mg/m2 ) and carboplatin (AUC=6) every 3 weeks. After every 21 days of treatment course, the patients were evaluated to investigate their response to treatment and side effects. Patients were followed up for at least 6 months. Results: The mean (SD) age of the patients was 64±8 years. After three courses of neoadjuvant chemotherapy, one patient (7%) had a complete response and 13 patients (93%) had a partial response. During the treatment period, two patients (14%) developed anemia, one patient (7%) developed neutropenia, two patients (14%) developed thrombocytopenia, and six patients (43%) developed neuropathy. The median (interquartile range) of PFS was 13 months (9.5-16.25). Conclusion: The findings showed that a weekly paclitaxel and carboplatin regimen as neoadjuvant therapy could be effective in the treatment of advanced ovarian cancer. However, it is necessary to conduct multicenter studies with larger sample sizes. Trial registration: Registration of trial protocol has been approved in Iranian Registry of Clinical Trial (identifier: IRCT2017050333789N1; http://en.irct.ir/trial/25978)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16021-16021 ◽  
Author(s):  
J. Beaumont ◽  
S. Yount ◽  
D. Lalla ◽  
D. Lubeck ◽  
M. Derynck ◽  
...  

16021 Background: The FOSI is a very brief(8-item) index derived from the FACT-O to measure symptom response to treatment for ovarian cancer(OC). We evaluated its performance in a single arm Phase II clinical trial. Methods: The FOSI was administered to patients with advanced OC participating in a single arm Ph II clinical trial of pertuzumab(Gordon et al, JCO (2006) v24:4324;2006)). Pertuzumab, a humanized HER2 antibody is the first in a new class of investigational agents known as HER dimerization inhibitors(HDIs). Patients completed the FOSI at D1 of each 3 week cycle, up to 17 cycles. Validation analyses focused on data from the first 4 cycles and included Cronbach's alpha coefficients plus cross-sectional and longitudinal comparisons of groups defined by ECOG performance status (PS). Results: 62 patients completed the FOSI at baseline (B), 54 at cycle 2, 44 at cycle 3 and 27 at cycle 4. The FOSI showed acceptable internal consistency reliability with alphas of 0.73 to 0.80. The FOSI differentiated patients with PS 0 from those with PS =1 at each cycle (Table). There was a difference in FOSI scores in patients with worsened PS from those whose PS improved or was unchanged at cycle 2 only (p<0.001). The ES (mean change/ SD of change scores) for the group with worsened PS was -0.77. The minimally important difference was estimated to be 2–3 points. Conclusions: The FOSI is a valid symptom measure in this population of OC patients, demonstrating acceptable reliability, validity and responsiveness to clinical change. [Table: see text] No significant financial relationships to disclose.


2021 ◽  
Author(s):  
Jorge A. Alegría-Baños ◽  
José C. Jiménez-López ◽  
Arely Vergara-Castañeda ◽  
David F. Cantú de León ◽  
Alejandro Mohar-Betancourt ◽  
...  

Abstract Background Ovarian cancer (OC) is considered the most lethal gynecological cancer, of which more than 65% cases are diagnosed in advanced stages, requiring platinum-based neoadjuvant chemotherapy (NACT). Methods A prospective-longitudinal study was conducted among women with advanced epithelial ovarian cancer (AEOC), III and IV stages, and treated with NACT, at the National Cancer Institute – Mexico, from July 2017 to July 2018. Serum samples were obtained for quantification of CA125 and HE4 using ELISA at the first and in each of the three NACT cycles. The therapeutic response was evaluated through standard tomography. We determined whether CA125 and HE4, alone or in combination, were associated with TR to NACT during follow up. Results 53 patients aged 38 to 79 years were included, 92.4% presented papillary serous subtype OC. Higher serum HE4 levels were observed in patients with non-tomographic response (6.89 vs 5.19 pmol/mL; p = 0.031), specially during the second (p = 0.039) and third cycle of NACT (p = 0.031). Multivariate-adjusted models showed an association between HE4 levels and TR, from the second treatment cycle (p = 0.042) to the third cycle (p = 0.033). Changes from baseline HE4 levels during the first cycle was negative associated with TR. No associations were found between CA125 and TR. Conclusions Serum HE4 levels were independently associated with TR among patients with AOEC treated with NACT, also a reduction between baseline HE4 and first chemotherapy levels was also independently associated with the TR. These findings might be relevant for predicting a lack of response to treatment.


Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 626
Author(s):  
Ami Patel ◽  
Puja Iyer ◽  
Shinya Matsuzaki ◽  
Koji Matsuo ◽  
Anil K. Sood ◽  
...  

Epithelial ovarian cancer remains a leading cause of death amongst all gynecologic cancers despite advances in surgical and medical therapy. Historically, patients with ovarian cancer underwent primary tumor reductive surgery followed by postoperative chemotherapy; however, neoadjuvant chemotherapy followed by interval tumor reductive surgery has gradually become an alternative approach for patients with advanced-stage ovarian cancer for whom primary tumor reductive surgery is not feasible. Decision-making about the use of these approaches has not been uniform. Hence, it is essential to identify patients who can benefit most from neoadjuvant chemotherapy followed by interval tumor reductive surgery. Several prospective and retrospective studies have proposed potential models to guide upfront decision-making for patients with advanced ovarian cancer. In this review, we summarize important decision-making models that can improve patient selection for personalized treatment. Models based on clinical factors (clinical parameters, radiology studies and laparoscopy scoring) and molecular markers (circulating and tumor-based) are useful, but laparoscopic staging is among the most informative diagnostic methods for upfront decision-making in patients medically fit for surgery. Further research is needed to explore more reliable models to determine personalized treatment for advanced epithelial ovarian cancer.


2019 ◽  
Vol 29 (6) ◽  
pp. 1064-1071
Author(s):  
Camilla Nero ◽  
Anna Fagotti ◽  
Gian Franco Zannoni ◽  
Eleonora Palluzzi ◽  
Giovanni Scambia ◽  
...  

BackgroundGrowing evidence supports the role of neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer. Currently, there is no shared histopathologic scoring system to assess pathologic response in the specimens obtained at interval surgery after neoadjuvant chemotherapy This review aims to summarize the literature on pathologic response, focusing on proposed scoring systems.MethodsThe systematic review was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, focusing on the definition of pathologic response, its prognostic value, possible predictors, and future implications. Eighteen manuscripts focusing on pathologic response in epithelial ovarian cancer were selected for analysis.ResultsOverall, eight histopathologic scoring systems to evaluate pathologic response have been proposed. There are currently no available markers (serum, radiological, genomic) to select which patients could achieve the highest benefit from neoadjuvant chemotherapy experiencing a complete pathologic response. A three-tier scoring system (CRS) based on omental assessment and which classifies the response to neoadjuvant chemotherapy has been validated in external cohorts of epithelial ovarian cancer. This scoring system demonstrated adequate interobserver reproducibility. Data is limited on the pathologic complete response rate changes according to chemotherapy regimen.ConclusionsA histopathologic scoring system endowed with prognostic value could be helpful in personalizing the treatment decision in patients with epithelial ovarian cancer.


2011 ◽  
Vol 21 (1) ◽  
pp. 66-71 ◽  
Author(s):  
Michael R. Milam ◽  
Xia Tao ◽  
Robert L. Coleman ◽  
Robyn Harrell ◽  
Roland Bassett ◽  
...  

Background:We evaluated the impact of neoadjuvant chemotherapy (NC) relative to primary surgery (PS) to determine if there was a difference in the total time and number of chemotherapy cycles given in patients with advanced epithelial ovarian cancer.Methods:We identified 263 consecutive women meeting eligibility from 1993 to 2005 for this institutional review board-approved study. Eligible patients in this analysis were those women with advanced disease (stage IIIC-IV) in whom a maximal cytoreductive effort was planned either at PS or after NC. Time to start chemotherapy was defined as follows: (1) NC group: confirmation of diagnosis through biopsy, cytological diagnosis from ascites, and pleural effusion; (2) PS group: confirmation of diagnosis from the date of surgery that confirmed the diagnosis of epithelial ovarian cancer. Total chemotherapy cycles: (1) NC group: NC chemotherapy cycles plus postoperative cycles; (2) PS group: chemotherapy after primary tumor debulking surgery. Clinical information evaluated included chemotherapy type, chemotherapy cycle number, total time to administer frontline chemotherapy, and survival.Results:Median chemotherapy cycles were greater in the NC group compared with the PS group (9 [range, 4-30] vs 6 [range, 3-19];P< 0.01). The PS group was also more likely to undergo chemotherapy regimens involving platinum and taxane treatment compared with the NC group (79% vs 65%;P= 0.017). Total time undergoing primary chemotherapy from initial diagnosis was greater in the NC group compared with PS (223 vs 151 days;P< 0.01). No significant difference was observed in overall survival and progression-free survival in the 2 groups.Conclusions:In patients with advanced ovarian cancer, NC followed by abdominal hysterectomy is associated with improved perioperative outcomes including optimal cytoreduction, decreased blood loss, and decreased inpatient hospitalization. In this cohort, NC was also associated with prolonged chemotherapy treatment intervals and increased chemotherapy cycles without improvement in survival.


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