Subject(s)
Abdominal Pain/etiology , Aerosols/adverse effects , Nebulizers and Vaporizers , Oxaliplatin/administration & dosage , Oxaliplatin/adverse effects , Peritoneal Neoplasms/drug therapy , Adenocarcinoma/drug therapy , Adenocarcinoma/pathology , Adenocarcinoma/secondary , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Clinical Trials, Phase II as Topic , Colonic Neoplasms/drug therapy , Colonic Neoplasms/pathology , Humans , Peritoneal Neoplasms/secondaryABSTRACT
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) represents a novel approach to deliver intraperitoneal chemotherapy. We report our experience with PIPAC in patients with peritoneal metastasis (PM) from gastric cancer (GC). Data from GC patients (n = 20) included in the prospective PIPAC-OPC1 and PIPAC-OPC2 studies are reported. All patients had received prior systemic chemotherapy. The mean peritoneal cancer index (PCI) was 10.5 (range 0-39) and nine patients had diffuse GC. PIPAC with cisplatin 7.5 mg/m2 and doxorubicin 1.5 mg/m2 were administered at 4-6-week intervals. Outcome criteria were objective tumour response, survival and adverse events. Twenty patients had 52 PIPAC procedures with a median follow-up of 10.4 months (3.3-26.5). Median survival from the time of PM diagnosis and after the first PIPAC procedure was 11.5 months and 4.7 months, respectively. Fourteen patients had repeated PIPAC (> 2), and the objective tumour response according to the histological peritoneal regression grading score (PRGS) was observed in 36%, whereas 36% had stable disease. Ten patients completed the three prescheduled sessions (per protocol group) and 40% of those displayed an objective tumour response, while 20% had stable disease. Only minor postoperative complications were noted, and none were considered causally related to the PIPAC treatment. PIPAC with low-dose cisplatin and doxorubicin can induce a quantifiable objective tumour response in selected patients with PM from GC. Survival data are encouraging and warrant further clinical studies.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Peritoneal Neoplasms/drug therapy , Peritoneum/pathology , Stomach Neoplasms/drug therapy , Administration, Topical , Adult , Aerosols , Aged , Cisplatin/administration & dosage , Doxorubicin/administration & dosage , Female , Humans , Male , Middle Aged , Peritoneal Neoplasms/mortality , Peritoneal Neoplasms/secondary , Peritoneum/drug effects , Pressure , Prospective Studies , Retrospective Studies , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology , Treatment OutcomeABSTRACT
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new laparoscopic administration of chemotherapy for peritoneal metastasis (PM). PIPAC is repeated every 5th week, and seems to stabilize or improve quality of life, and might improve survival. So far, PIPAC has been well tolerated. With this paper, we aim to highlight a potential severe adverse reaction, as we describe the first cases of severe peritoneal sclerosis (SPS) caused by PIPAC. Patients with isolated PM were included in a prospective PIPAC protocol. Following insufflation of normothermic CO2, laparoscopy was performed at an intraabdominal pressure of 12 mmHg. After peritoneal lavage and quadrant biopsies of the PM, the patients were treated with oxaliplatin 92 mg/m2 (flowrate 0.5 ml/s, maximum pressure of 200 per square inch). Treatment related toxicity was evaluated after 2 weeks. Response was evaluated histologically by the Peritoneal Regression Grading Score (PRGS) and cytologically by analysis of the lavage fluid. In a series of 24 PIPAC patients treated with oxaliplatin, two patients developed SPS. Patient one had a mucinous adenocarcinoma of the appendix with PM, the mean PRGS was reduced from 2.75 to 1.75 during the course of therapy. Patient two had an appendiceal goblet cell carcinoid with a dominating mucinous adenocarcinoma component with PM, the mean PRGS was reduced from 2.00 to 1.67. Repeated applications of PIPAC with oxaliplatin can lead to SPS.
Subject(s)
Adenocarcinoma, Mucinous/drug therapy , Adenocarcinoma, Mucinous/secondary , Antineoplastic Agents/adverse effects , Appendiceal Neoplasms/pathology , Carcinoid Tumor/drug therapy , Carcinoid Tumor/secondary , Oxaliplatin/adverse effects , Peritoneal Fibrosis/chemically induced , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/secondary , Adult , Aerosols , Aged , Antineoplastic Agents/administration & dosage , Appendiceal Neoplasms/drug therapy , Humans , Infusions, Parenteral , Male , Oxaliplatin/administration & dosage , Peritoneal Fibrosis/pathology , Prospective Studies , Severity of Illness IndexABSTRACT
BACKGROUND: Acute post-operative pain is a predictor in the development of chronic pain after laparoscopic cholecystectomy. Music has been shown to reduce surgical stress. In a randomized, clinical trial, we wanted to test the hypothesis that perioperative and post-operative soft music reduces pain, nausea, fatigue and surgical stress in patients undergoing laparoscopic cholecystectomy as day surgery. METHOD: The study was performed in otherwise healthy Danish patients eligible for day surgery. Ninety-three patients were included and randomized to either soft music or no music perioperatively and post-operatively. Using visual analog score pain, nausea and fatigue at baseline, 1 h, 3 h, 1 day and 7 days after surgery were recorded. C-reactive protein and cortisol were sampled before and after surgery. RESULTS: Music did not lower pain 3 h after surgery, which was the main outcome. The music group had less pain day 7 (P = 0.014). Nausea was low in both groups and was not affected by music. The music group experienced less fatigue at day 1 (P = 0.042) and day 7 (P = 0.015). Cortisol levels decreased during surgery in the music group (428.5-348.0 nmol/l), while it increased in the non-music group (443.5-512.0 nmol/l); still, the difference between the two groups were only significant using general linear models as post-hoc analysis. Soft music did not affect C-reactive protein levels. CONCLUSION: Soft music did not reduce pain 3 h after laparoscopic cholecystectomy. Soft music may reduce later post-operative pain and fatigue by decreasing the surgical stress response.
