Single-agent pegylated liposomal doxorubicin (Caelix) in chemotherapy pretreated non-small cell lung cancer patients: a pilot trial.

Polyethylene glycol-coated (pegylated) liposomal doxorubicin (PLD) is a new formulation of doxorubicin with peculiar pharmacokinetic and pharmacodinamic properties, a favorable toxic profile and a demonstrated activity in solid tumors. We tested PLD in locally advanced or metastatic NSCLC patients, progressed after a platinum-based first-line chemotherapy. PLD was administered at the dose of 35 mg/m(2) every 21 days. After the first six patients had been accrued, due to the low toxicity shown in the first six patients, the dose was escalated to 45 mg/m(2). Seventeen patients were enrolled in the study and were considered eligible for evaluation of toxicity and response. Stomatitis, palmar-plantar erythrodysaesthesia (PPE) and asthenia were the most common toxicities and affected approximately half of the treated patients. Stomatitis occurred in 8/17 patients and was grade 3-4 in three. PPE was seen in 9/17 and was grade 3 in one. In the group treated at the dose of 45 mg/m(2) PPE was more frequent and severe and required treatment delay in some cases. Other toxicities were equally distributed among the two groups. Hematological toxicity was not common and never reached grade 3-4. However, one patient with grade 2 leucopenia had pneumonia and died. Clinically evident heart failure was never recorded. Left ventricular ejection fraction was assessed in three patients after PLD treatment (in one case after the first course, due to the occurrence of atrial fibrillation, and in two cases after six courses) and was unchanged compared to pre-treatment assessment. One confirmed partial response was observed (5.8%); five patients (29.4%) had stable disease (including one minor response) and nine (52.9%) had disease progression. Median time to progression was 9.5 weeks, median survival 18.6 weeks. PLD at the doses employed in this study can be safely administered and has shown activity in platinum pretreated NSCLC patients.

Implementation of the Liverpool Care Pathway (LCP) for the dying patient in the inpatient hospice setting: development and preliminary assessment of the Italian LCP program.

BACKGROUND: The Liverpool Care Pathway (LCP) is extensively used in hospices, but the literature on the process of implementation is scarce. AIM: Developing, piloting, and preliminarily assessing the LCP program within the inpatient hospice setting. METHODS: This is a phase 0-1 study, according to the Medical Research Council (MRC) Framework, divided into three phases: literature review on LCP in hospice and development of the Italian version of the LCP program (LCP-I), development of a procedure for assessing the quality of the implementation process and assessing the feasibility of the implementation process, and piloting the procedure in 7 inpatient Italian hospices. RESULTS: The LCP was implemented in all the hospices involved. A high proportion of physicians (50%-100%) and nurses (94%-100%) attended the self-education program. The self-implementation of the LCP-I program was completed in all hospices. The proportion of patients who died on LCP-I ranged between 35.6% and 89.1%. Professionals from 2 hospices reported a positive impact of the LCP-I. Conversely, professionals from 2 hospices did not recognize a positive impact of the program and did not agree to maintain the LCP-I in hospice. Finally, professionals from the other 3 hospices reported intermediate evaluations (1 stopped to use the LCP-I). Some weaknesses emerged from the external audits, related to the self-education and the self-implementation approach. Professionals required an external support from a trained palliative care team with reference to both phases. CONCLUSIONS: The LCP-I implementation within hospices is feasible, and the process of implementation is evaluable. Issues that occurred within the implementation process suggest the introduction of an external support from a trained palliative care team in implementing the LCP program.