ABSTRACT
Objective@#Bevacizumab maintenance following platinum-based chemotherapy is an effective treatment for epithelial ovarian cancer (EOC), both in primary and recurrent disease. Our aim was to identify criteria to select elderly patients who can safely benefit from bevacizumab addition. @*Methods@#This is a case-control study on patients with primary or recurrent EOC who received platinum-based chemotherapy plus bevacizumab, between January 2015 and December 2016. Patient characteristics, treatment details and adverse events were reviewed and analyzed in 2 settings: younger (1.1 g/dL, estimated glomerular filtration rate (eGFR) ≤60 mL/min, ≥3 comorbidities were independently associated with a higher severe toxicity. @*Conclusions@#Elderly patients with EOC can safely be treated with bevacizumab; factors other than age, as higher creatinine serum levels, eGFR and number of comorbidities should be considered to better estimate bevacizumab-related toxicity risk.
ABSTRACT
1.1 g/dL, estimated glomerular filtration rate (eGFR) ≤60 mL/min, ≥3 comorbidities were independently associated with a higher severe toxicity.CONCLUSIONS: Elderly patients with EOC can safely be treated with bevacizumab; factors other than age, as higher creatinine serum levels, eGFR and number of comorbidities should be considered to better estimate bevacizumab-related toxicity risk.
Subject(s)
Aged , Female , Humans , Bevacizumab , Case-Control Studies , Comorbidity , Creatinine , Diagnosis , Drug Therapy , Glomerular Filtration Rate , Logistic Models , Ovarian NeoplasmsABSTRACT
OBJECTIVE: Evidences from animal models seem to suggest that minimally invasive surgery may enhance cisplatin diffusion when the drug is administered in the context of post-operative hyperthermic intraperitoneal chemotherapy (HIPEC). The present study evaluates the cisplatin pharmacokinetic profile in a prospective series of women with platinum sensitive recurrent epithelial ovarian cancer treated with open secondary cytoreductive surgery (O-SCS) or minimally-invasive secondary cytoreductive surgery (MI-SCS). METHODS: Cisplatin levels were assessed at 0, 20, 40, 60, and 120 minutes in: 1) blood samples, 2) peritoneal perfusate, and 3) peritoneal biopsies at the end of HIPEC. Median Cmax has been used to identify women with high and low drug levels. Progression-free survival (PFS) was calculated as the time elapsed between SCS+HIPEC and secondary recurrence or last follow-up visit. RESULTS: Nine (45.0%) women received MI-SCS, and 11 (55.0%) O-SCS. At 60 minutes, median cisplatin Cmax in peritoneal tissue was higher in patients treated with MI-SCS compared to O-SCS (Cmax=8.262 µg/mL vs. Cmax=4.057 µg/mL). Furthermore, median cisplatin plasma Cmax was higher in patients treated with MI-SCS compared to O-SCS (Cmax=0.511 vs. Cmax=0.254 µg/mL; p-value=0.012) at 120 minutes. With a median follow-up time of 24 months, women with higher cisplatin peritoneal Cmax showed a longer PFS compared to women with low cisplatin peritoneal levels (2-years PFS=70% vs. 35%; p-value=0.054). CONCLUSIONS: We demonstrate for the first time that minimally invasive route enhances cisplatin peritoneal tissue uptake during HIPEC, further evaluations are needed to confirm the correlation between peritoneal cisplatin levels after HIPEC and survival. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01539785
Subject(s)
Female , Humans , Biopsy , Cisplatin , Cytoreduction Surgical Procedures , Diffusion , Disease-Free Survival , Drug Therapy , Endoscopy , Follow-Up Studies , Injections, Intraperitoneal , Minimally Invasive Surgical Procedures , Models, Animal , Ovarian Neoplasms , Pharmacokinetics , Plasma , Platinum , Prospective Studies , RecurrenceABSTRACT
The purpose of this study was to analyze the quality of life in terms of sexual and reproductive outcome in patients suffering from early stage cervical cancer, submitted to an excisional cone as fertility-sparing treatment. A multicenter retrospective analysis about specific dimensions of physical, psychological, reproductive and sexual functions after a cold-knife conization plus pelvic laparoscopic lymphadenectomy was conducted at Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome-Italy and at Division of Gynecology, European Institute of Oncology, Milan-Italy. The aim of this study was twofold. It aimed to analyze the quality of life in patients submitted to minimally invasive surgery and to compare these data with radical trachelectomy. Twenty-three patients with an average age of 30 years decided to participate in this study. After the treatment, all women [100%] had regular menstruation, 7 [30.4%] had increased not invalidating dysmenorrhea; 1 [4.4%] experienced a cervical stenosis; 6 among 10 patients that tried to conceive [60%] obtained one spontaneous pregnancy; 4 more [40%] underwent in vitro fertilization and embryo transfer and only 1 of them [25%] was successful. About sexual assessment, 1 patient [4.4%] had trouble in lubricating, 3 [13%] had anxiety about performance, 6 [26.1%] complained of dyspareunia which was resolved within 3 subsequent months. All patients [100%] obtained a complete psychological and physical recovery. This study demonstrated preliminary encouraging data about sexual and reproductive outcome after excisional conization. A comparison with trachelectomy surely needs longer follow-ups, more cases and prospective analyses