scholarly journals Evolution of Clinical Trials in Ovarian Cancer Management over the Past 20 Years: Never Settle Down, Always Go Beyond

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Francesca De Felice ◽  
Laura Vertechy ◽  
Elena Giudice ◽  
Raffaella Ergasti ◽  
Serena Boccia ◽  
...  

Purpose. A practice synthesis of available evidence-based medicine data in ovarian cancer (OC), aiming to provide directions for future research. Materials and Methods. We performed a systematic review. PubMed was searched for relevant OC trials between January 2000 and December 2019. Results. Out of 865 references screened, 199 trials were found eligible for inclusion. Most trials were multicenter (83.9%). There was a trend reduction in the number of patients enrolled/per study over the years. Studies testing targeted/biological therapies dominated the second decade (60 trials in 2010–2019 versus 2 trials in 2000–2009). The proportion of trials with positive survival and clinical outcomes significantly increased from 23.8% in early 2000s to 54.1% in the last 5 years. Trials with histology/molecular biomarker criteria were more likely to meet progression-free survival endpoint than those without these selection criteria (69.2% versus 32.6%). Conclusion. This systematic review suggests a trend of increased positive studies, mainly linked to precision medicine.

2000 ◽  
Vol 18 (17) ◽  
pp. 3084-3092 ◽  
Author(s):  
Jan P. Neijt ◽  
Svend A. Engelholm ◽  
Malgorzata K. Tuxen ◽  
Peter G. Sørensen ◽  
Mogens Hansen ◽  
...  

PURPOSE: To determine the side effects and feasibility of cisplatin and carboplatin each in combination with paclitaxel as front-line therapy in advanced epithelial ovarian cancer. PATIENTS AND METHODS: Patients were randomly allocated to receive paclitaxel 175 mg/m2 intravenously as a 3-hour infusion followed by either cisplatin 75 mg/m2 or carboplatin (area under the plasma concentration-time curve of 5), both on day 1. The schedule was repeated every 3 weeks for at least six cycles. Women allocated to paclitaxel-cisplatin were admitted to the hospital, whereas the carboplatin regimen was administered to outpatients. RESULTS: A total of 208 eligible patients were randomized. Both regimens could be delivered in an optimal dose and without significant delay. Paclitaxel-carboplatin produced significantly less nausea and vomiting (P < .01) and less peripheral neurotoxicity (P = .04) but more granulocytopenia and thrombocytopenia (P < .01). The overall response rate in 132 patients with measurable disease was 64% (84 of 132 patients), and in patients with elevated CA 125 levels at start, it was 74% (132 of 178 patients). With a median follow-up time of 37 months, the median progression-free survival time of all patients was 16 months and the median overall survival time was 31 months. The small number of patients entered onto the study caused wide confidence intervals (CIs) around the hazards ratio for progression-free survival of paclitaxel-carboplatin compared with paclitaxel-cisplatin (hazards ratio, 1.07; 95% CI, 0.78 to 1.48) and did not allow conclusions about efficacy. CONCLUSION: Paclitaxel-carboplatin is a feasible regimen for outpatients with ovarian cancer and has a better toxicity profile than paclitaxel-cisplatin.


Cancers ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 573
Author(s):  
Stefania Rizzo ◽  
Lucia Manganaro ◽  
Miriam Dolciami ◽  
Maria Luisa Gasparri ◽  
Andrea Papadia ◽  
...  

The objective of this systematic review was to assess the results of radiomics for prediction of overall survival (OS) and progression free survival (PFS) in ovarian cancer (OC) patients. A secondary objective was to evaluate the findings of papers that based their analyses on inter-site heterogeneity. This systematic review was conducted according to the PRISMA statement. After the initial retrieval of 145 articles, the final systematic review comprised six articles. Association between radiomic features and OS was evaluated in 3/6 studies (50%); all articles showed a significant association between radiomic features and OS. Association with PFS was evaluated in 5/6 (83%) articles; the period of follow-up ranged between six and 36 months. All the articles showed significant association between radiomic models and PFS. Inter-site textural features were used for analysis in 2/6 (33%) articles. They demonstrated that high levels of inter-site textural heterogeneity were significantly associated with incomplete surgical resection in breast cancer gene-negative patients, and that lower heterogeneity was associated with complete resectability. There were some differences among papers in methodology; for example, only 3/6 (50%) articles included validation cohorts. In conclusion, radiomic models have demonstrated promising results as predictors of survival in OC patients, although larger studies are needed to allow clinical applicability.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15516-e15516
Author(s):  
Amit Rauthan ◽  
Poonam Patil ◽  
S. P. Somashekhar ◽  
Shabber Zaveri

e15516 Background: The standard of care for patients with recurrent platinum resistant ovarian cancer is treatment with non cross-resistant drugs. Carboplatin retreatment is usually not an option in the platinum resistant population. Weekly paclitaxel has been tried in recurrent patients. But paclitaxel can cause hypersensitivity reactions due to its Cremophor based solvent. nab-paclitaxel being a nano-particle albumin bound paclitaxel is devoid of this toxictity. Also, it is thought that nab-paclitaxel may have a higher intratumoral uptake leading to enhanced anti-tumor action. We looked at a regimen using weekly carboplatin with weekly nab-paclitaxel in platinum resistantrelapsed carcinoma ovary who had failed multiple lines of treatment. Methods: We treated 10 patients with recurrent platinum resistant ovarian cancer with measurable disease with nab-paclitaxel 100mg/m2 on days 1,8,15 with carboplatin at AUC 1.5 on days 1,8,15 intravenously, repeated every 28 days for 4 cycles. All patients had received 3 or more lines of chemotherapy for recurrent disease. We looked for response rate, progression free survival and toxicities. Results: Three patients had complete response, 5 patients had partial response and 2 patients had disease progression. Median PFS was 6 months. There were no instances of paclitaxel induced hypersensitivity reactions. Two patients developed grade 3 neutropenia. One patient developed grade 3 thrombocytopenia. Three patients required blood transfusions. One patient developed grade 3 neuropathy. Conclusions: Weekly combination of nab-paclitaxel with weekly carboplatin is a safe and potentially active treatment in recurrent platinum resistant ovarian cancers who had failed multiple lines of treatment. Considering the efficacy and favorable toxicity profile, this weekly combination needs to be tested in a larger number of patients.


Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1404 ◽  
Author(s):  
Emanuele Rinninella ◽  
Anna Fagotti ◽  
Marco Cintoni ◽  
Pauline Raoul ◽  
Giuseppe Scaletta ◽  
...  

Among all gynaecological neoplasms, ovarian cancer has the highest rate of disease-related malnutrition, representing an important risk factor of postoperative mortality and morbidity. Hence, the importance of finding effective nutritional interventions is crucial to improve ovarian cancer patient’s well-being and survival. This systematic review of randomized controlled trials (RCTs) aims at assessing the effects of nutritional interventions on clinical outcomes such as overall survival, progression-free survival, length of hospital stay (LOS), complications following surgery and/or chemotherapy in ovarian cancer patients. Three electronic bibliographic databases (MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials) were used to conduct a systematic literature search based on fixed inclusion and exclusion criteria, until December 2018. A total of 14 studies were identified. Several early postoperative feeding interventions studies (n = 8) were retrieved mainly demonstrating a reduction in LOS and an ameliorated intestinal recovery after surgery. Moreover, innovative nutritional approaches such as chewing gum intervention (n = 1), coffee consumption (n = 1), ketogenic diet intervention (n = 2) or fruit and vegetable juice concentrate supplementation diet (n = 1) and short-term fasting (n = 1) have been shown as valid and well-tolerated nutritional strategies improving clinical outcomes. However, despite an acceptable number of prospective trials, there is still a lack of homogeneous and robust endpoints. In particular, there is an urgent need of RCTs evaluating overall survival and progression-free survival during ovarian oncology treatments. Further high-quality studies are warranted, especially prospective studies and large RCTs, with more homogeneous types of intervention and clinical outcomes, including a more specific sampling of ovarian cancer women, to identify appropriate and effective nutritional strategies for this cancer, which is at high risk of malnutrition.


2020 ◽  
Vol 30 (5) ◽  
pp. 654-663 ◽  
Author(s):  
Emanuele Rinninella ◽  
Anna Fagotti ◽  
Marco Cintoni ◽  
Pauline Raoul ◽  
Giuseppe Scaletta ◽  
...  

BackgroundMuscle mass plays a key role in predicting clinical outcomes in cancer. This systematic review and meta-analysis aimed to evaluate whether computed tomography (CT) scan indexes of muscle mass quantity and quality could be used as prognostic factors in ovarian cancer.MethodsThree electronic bibliographic databases (MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials) were used to conduct a systematic literature search from inception to January 2020. The primary outcome was overall survival. Pooled analyses of hazard ratios (HRs) and 95% confidence intervals (CIs) were performed with Review Manager 5.3. Heterogeneity was assessed by measuring inconsistency (I2 based on the χ2 test). Secondary outcomes included progression free survival, disease free survival, postoperative complications, and chemotoxicity. Study quality and quality of evidence were assessed.ResultsA total of 15 studies were included in the systematic review, of which six studies (1226 patients) were included in the meta-analysis. Summary unadjusted HRs (HR 1.11, 95% CI 0.84 to 1.46, p=0.47) and adjusted HRs (HR 1.10, 95% CI 0.84 to 1.43, p=0.49) did not show a significant association between low skeletal muscle index and overall survival (p>0.05) in ovarian cancer. Instead, although the quality of evidence was low, pooled data of three studies, comprising 679 patients, showed a significant association between low skeletal muscle radiodensity and poor overall survival (HR 1.63, 95% CI 1.28 to 2.07, p<0.0001). Moreover, the heterogeneity between studies precluded the possibility of performing a meta-analysis and reaching conclusions for progression free survival, disease free survival, surgical complications, and chemotoxicity.ConclusionsThis work suggested that the measurement of skeletal muscle radiodensity by routine CT scan at diagnosis, with standardization of diagnostic criteria, could be a reliable tool to select at risk patients and to individualize effective nutritional strategies. However, prospective homogeneous studies with a larger number of patients are required to confirm these results.


Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 640
Author(s):  
Shinichi Tate ◽  
Kyoko Nishikimi ◽  
Ayumu Matsuoka ◽  
Satoyo Otsuka ◽  
Makio Shozu

Background: This study aimed to evaluate the safety and efficacy of weekly paclitaxel and cisplatin chemotherapy (wTP) in patients with ovarian cancer who developed carboplatin hypersensitivity reaction (HSR). Methods: We retrospectively investigated 86 patients with ovarian, fallopian tube, and peritoneal carcinoma who developed carboplatin HSR during previous chemotherapy (carboplatin and paclitaxel) at our institution between 2011 and 2019. After premedication was administered, paclitaxel was administered over 1 h, followed by cisplatin over 1 h (paclitaxel 80 mg/m2; cisplatin 25 mg/m2; 1, 8, 15 day/4 weeks). We investigated the incidence of patients who successfully received wTP for at least one cycle, treatments compliance, progression-free survival (PFS), and overall survival (OS). Results: The median number of wTP administration cycles was 4 (Interquartile Range IQR, 3–7), 71 patients (83%) successfully received wTP, and 15 patients (17%) developed cisplatin HSR. The efficacy of treatment was as follows: 55 (64%) patients completed the scheduled wTP, 9 (10%) patients discontinued due to HSR to cisplatin within 6 cycles, 1 (1%) patient discontinued due to renal toxicity (grade 2) at the 6th cycle, and 21 (24%) patients discontinued due to progressive disease within 6 cycles. The median PFS and OS after administration of wTP were 10.9 months (95% CI: 7.7–17.7) and 25.9 months (95% CI: 19.0–50.2), respectively. Conclusions: wTP was safe and well-tolerated in patients who developed carboplatin HSR.


Sign in / Sign up

Export Citation Format

Share Document