BackgroundPeritoneal metastasis (PM) is a common occurrence in gynaecological and gastrointestinal cancers and is associated with poor survival. Patients typically present with ascites, abdominal pain, malnutrition, nausea, emesis, and bowel obstruction which significantly compromise the quality of life (QoL). The treatment remains a particular challenge, with palliative systemic chemotherapy being the standard of care. However, the efficacy of systemic chemotherapy is poor but with high potential for side effects and complications. QoL plays an important role in patients with PM and is deteriorating continuously until death. Thus, there is an obvious medical need for better therapeutic options in PM for prolonging survival and preserving QoL by reducing both disease-related symptoms and therapy side effects. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel technique for delivering pressurized normothermic chemotherapy into the abdominal cavity as an aerosol. This concept seems to enhance the effectiveness of intraperitoneal chemotherapy by taking advantage of the physical properties of gas and pressure by generating an artificial pressure gradient and enhancing tissue uptake and distributing drugs homogeneously within the closed and expanded peritoneal cavity.MethodsThe primary objective of this study is to assess QoL and symptoms in a consecutive cohort of patients with PM treated with PIPAC procedure in comparison with conventional systemic intravenous chemotherapy. QoL is assessed prospectively using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30(Version 3.0) questionnaire. QLQ-C30 is a 30-question self-administered questionnaire inquiring about global health status, 9 individual symptoms, and 5 functional scales. Baseline QoL is measured using the global physical health functional score, and symptom scores derived from EORTC QLQ30 questionnaire before starting therapy, followed by at 60, 120, and 180 days after the first intervention. Calculated sample size is 119 and rounded to 120. For each treatment group, sample size of 60 will be enrolled; Intervention model: IV chemotherapy group (control group) and PIPAC group (experimental group); Study type: prospective randomized control intervention trialDiscussionAll consecutive patients diagnosed with advanced end-stage PM are randomized to be treated with PIPAC or IV chemotherapy. The primary objective of this study is to determine the QoL after three cycles of PIPAC in comparison with six cycles of systemic chemotherapy. The secondary outcome measures include morbidity and mortality. Analysis is by intention to treat.ResultsThe effect of systemic chemotherapy remains limited on the peritoneum due to poor vascularization and low penetration. Side effects after systemic chemotherapy for PM are relatively frequent. QoL plays an important role in these patients and is deteriorating continuously due to the disease or therapy related. Thus, there is need for better therapeutic options for prolonging survival and preserving QoL by reducing both disease-related symptoms and therapy side effects. PIPAC is a novel minimally invasive repeatable treatment modality which demonstrated potentially encouraging tumour response and only minimal toxicity in patients with PM of various origins. It can optimize local drug delivery and improve clinical outcome due to superior pharmacological properties as compared to systemic chemotherapy.Trial registrationREF/2018/08/021225 Registered on Clinical Trials Registry-India (CTRI); www.ctri.nic.in
BackgroundDespite optimal surgery and appropriate first-line chemotherapy, ∼70–80 % of patients with epithelial ovarian cancer will develop disease relapse. The prognosis is poor especially for women with Platinum resistant ovarian cancer. The standard treatment for these groups of patients is non-platinum-containing chemotherapy like taxanes, anthracyclines, gemcitabine, topotecan, and trabectedin. These drugs in various combinations and sequences provide modest survival or symptomatic benefit but with significant side effects. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) is a minimally-invasive drug-delivery technique specifically addressing limited tissue penetration and poor drug distribution with promising results. PIPAC is a novel method of delivering normothermic chemotherapy into the abdominal cavity as an aerosol under pressure. This concept seems to enhance the effectiveness of intra peritoneal chemotherapy by taking advantage of the physical properties of gas and pressure by generating an artificial pressure gradient and enhancing tissue uptake and distributing drugs homogeneously within the closed and expanded peritoneal cavity. Thus, due to the high local bioavailability during PIPAC, the chemotherapy dosage can be reduced which in turn largely prevents systemic side effects and organ toxicity.MethodsThe study aims to investigate the therapeutic efficacy measured as objective tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, of PIPAC in comparison with conventional Intravenous chemotherapy for women with recurrent platinum resistant ovarian cancer with peritoneal metastasis (PM). Consecutive patients diagnosed with PM secondary to platinum-resistant ovarian cancer will be randomized to PIPAC group or IV chemotherapy group. The primary objective of this study is to determine the efficacy after three cycles of PIPAC with cisplatin and doxorubicin in comparison with six cycles of systemic chemotherapy. The secondary outcome measures include morbidity and mortality, overall survival and disease specific survival. Analysis is by intention to treat.AimAssess the objective tumour response of PIPAC in comparison with systemic intravenous chemotherapy for women with platinum-resistant ovarian cancer.Study typeProspective randomized control intervention trial.Intervention modelIV Chemotherapy group (Control group) PIPAC group (Experimental group)MaskingOpen label.Primary purposeTreatment.Sample sizeCalculated sample size is 97 and rounded to 100. For each treatment group sample size of 50 will be considered.Primary outcome criteriaObjective tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1.Secondary outcome criteriaMorbidity;Disease-specific survival (months between inclusion and death due to ovarian cancer);OS (months between inclusion and death due to any cause);CA 125 levels.DiscussionPIPAC in women with platinum resistant ovarian PM has good response owing to superior tissue penetration and better drug distribution. The procedure is safe and well tolerated owing it to its minimal invasiveness. Typical side-effects of systemic chemotherapy, such as alopecia, peripheral neurotoxicity, nausea and myelosuppression are absent. We expect reduction of ascites with symptomatic relief and CA 125 levels. PIPAC is a novel technique for selected patients with platinum resistant ovarian PM and further investigation in comparative clinical trials with conventional chemotherapy will establish its role as a good palliative treatment option.Ethics committee approvalObtained.StatusRecruiting.Trial registration numberREF/2018/08/021223 Registered on Clinical Trials Registry – India (CTRI); www.ctri.nic.in
BackgroundIn peritoneal surface malignancy (PSM), in spite of optimal cytoreductive surgery (CRS), majority of recurrences that occur are intraperitoneal. In patients with PSM, studies employing fluorescent imaging and microscopic examination have shown normal looking peritoneum may harbor active disease. This study was done to assess the recurrence pattern, oncological outcomes, and morbidity and mortality of the extent of peritonectomy in patients who underwent total parietal peritonectomy (TPP) or involved field peritonectomy (IFP) as a part of the procedure during CRS and hyperthermic intraperitoneal chemotherapy (HIPEC).MethodsThis was a retrospective analysis of prospectively collected data, from February 2013 to December 2017. A total of 163 patients with PSM underwent TPP or IFP with CRS plus HIPEC. Their oncological outcomes, recurrence pattern, postoperative morbidity and mortality were analyzed.ResultsOf the 163 cases, the primary organs of origin were ovary, colorectal, appendicular pseudomyxoma, stomach, mesothelioma and others (67.4%, 16.5%, 6.1%, 4.9%, 2% and 2%), respectively. TPP was performed in 70 patients and IFP in 93 patients. TPP group had higher mean PCI (16 vs. 14), longer duration of surgery (11 vs. 9 h), and more blood loss (1,243 vs. 675 mL). Overall G3–G4 morbidity was comparable in both groups (42.8% vs. 33.3%) as was mortality (5.7% vs. 4.4%). Kaplan–Meier analysis showed that with a median follow-up of 45 months, TPP group had a recurrence-free survival (RFS) of 26 months and overall survival (OS) was yet to be achieved, whereas the IFP group had a RFS and OS of 21 and 43 months, respectively.ConclusionsPerforming TPP reduces the chance of missing the microscopic disease, therefore can minimize local recurrence, and better oncological outcomes. TPP can be performed with acceptable morbidity and mortality, at the cost of increased duration of surgery and higher blood loss.
Idiopathic granulomatous mastitis is uncommon benign breast disease that can be confused with two of the very common breast conditions, breast carcinoma and breast abscess. The management of IGM needs a holistic approach with the surgeon, pathologist and radiologist working in unison to unravel the difficulties that lie in treating this disease and bringing back the smile on patients face.
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