Comprehensive care for sickle cell disease immigrant patients: a reproducible model achieving high adherence to minimum standards of care.

BACKGROUND: Comprehensive care and advances in clinical investigations have reduced morbidity and mortality in sickle cell disease (SCD), but only a minority of children with SCD has access to comprehensive care. In Europe the majority of patients with SCD are immigrants who present barriers in accessing the health system; therefore, new evidence-based models of comprehensive care are needed to ensure that all SCD patients receive high-quality care, overcoming patient- and health system-related barriers. We wanted to verify if addressing the specific needs of immigrant patients contributes to improving adherence. PROCEDURES: Linguistic, cultural, social issues were considered in organizing comprehensive care in 2006. Hospital's records were used to determine access from 2006 to 2010 and to compare adherence before and after 2006. RESULTS: Ninety-four patients with SCD were enrolled in comprehensive care; 94% were first generation immigrants (81% African). Age at diagnosis was higher for children born abroad vs. children born in Italy (66.08 vs 25.36 months, P < 0.005). Since 2006, children were seen at least once a year, with 100% adherence to follow-up appointments. Coverage increased from 26% to 97% for flu vaccination, from 80% to 92% for pneumococcus immunization, from 27% to 100% for Transcranial Doppler (TCD) screening (P < 0.001). Emergency Department access/patient/year and inpatient admissions/patient/year decreased from 2.3 to 0.98 and from 0.30 to 0.25, respectively (P < 0.001). CONCLUSIONS: Comprehensive care can be delivered to vulnerable groups obtaining high adherence if linguistic, cultural, social issues are addressed. This model may merit assessment in other communities where immigrants represent the majority of patients.

Hyperthermic intraoperative intraperitoneal chemotherapy with cisplatin and doxorubicin in patients who undergo cytoreductive surgery for peritoneal carcinomatosis and sarcomatosis: phase I study.

BACKGROUND: Hyperthermic intraperitoneal intraoperative chemotherapy (HIIC) combined with cytoreductive surgery (CS) has been proposed as a new multimodal treatment mainly for carcinomatosis of gastrointestinal origin. To evaluate whether this regimen could be used for other tumor types, the authors conducted a Phase I study on HIIC with doxorubicin and cisplatin in patients with peritoneal carcinomatosis or sarcomatosis. PATIENTS AND METHODS: Thirty-one patients with peritoneal carcinomatosis or sarcomatosis (PCS) were enrolled for the study. After completion of CS, HIIC was administered with drug doses that were increased for each consecutive cohort following a three-patient cohort scheme. Thereafter, the accrual was stopped when Grade 4 locoregional or systemic toxicity was observed. The maximum tolerated dose (MTD) was considered the dose in the previous triplet. Drug pharmacokinetics and procedure costs also were analyzed. RESULTS: After CS, residual tumors were not present or measured less than or equal to 3 mm (in dimension) in all cases. Maximum tolerated dose was 15.25 and 43.00 mg L(-1) for doxorubicin and cisplatin, respectively. The perfusate/plasma area under the curve ratios were favorable for both drugs, at 162+/-113 and 20.6+/-6.0, respectively, for doxorubicin and cisplatin. Doxorubicin levels in the peritoneum were higher than in tumor or normal tissue samples. There were no postoperative deaths. Surgery-related complications were observed in 25% of cases. Findings at cost analysis showed that the length of stay in the operation room and intensive care unit were the major cost drivers. CONCLUSIONS: Cytoreductive surgery combined with HIIC is an expensive but feasible therapeutic approach for locally advanced abdominal tumors. Because our preliminary findings for local disease control are encouraging, a Phase II study is now advisable to verify the activity of this promising treatment.