BackgroundIn relation to the regional project UFAONCOEMA, at the enterprise level, a set of goals were fixed. They concerned: efficacy, efficiency, quality and performance safety. Among the quality goals, monitoring of waiting time for antiblastic chemotherapies was chosen as an indicator.PurposeThe purpose was to assess, for two UFA (antiblastic drugs unit) which joined the UFAONCOEMA project, whether waiting times met the requirements of a maximum of 60 min, set at the enterprise level, according to the standard requirements adopted by other reference enterprises.Material and methodsTimes were monitored over a period of 3 months. Monitoring started from therapy’s online confirmation by the prescriber, to pharmacist validation, to preparation and delivery by nurses, and ended when the unit received that therapy. Therapies for 2018 patients in the oncology and haematology day hospital (DH) were evaluated. It has been considered that after verifying the appropriateness of the prescription, validation starts at about 8.15am, and preparation in a clean room starts at about 8.45am, due to set up of the laminar flow hood and sterile field.ResultsFrom when it is possible to make the preparation to the moment of delivery to the unit, under optimal conditions (3 nurses present, no extraordinary maintenance for the hood and/or UFA machinery), for therapies confirmed the same morning when the administration is expected, waiting times are 60 min for oncology and 57 min for haematology. Considering that therapies for the afternoon shift in the oncology DH and therapies confirmed on time for the following day are made and sent before 1.30pm, waiting time for those patients (10% of therapies) is zero, so the average waiting time reduces to 56 min.ConclusionThis assessment shows that the average waiting times are included in a range of fixed requirements. 32% of morning therapies reach the applicant units within 50 mins. Transportation time (10 min) to the oncology DH, even it does not negatively affect the achievement of the goal, can be reduced with future transfer of the UFA centre in that unit. An increase in confirmed steady therapies for the day after can further reduce waiting time.No conflict of interest.
Background The addition of targeted treatment to chemotherapy and first and second line treatment significantly improves patient outcomes, raising the response rate with an increase of resectability in patients with metastasis and improving the long-term survival, as demonstrated by several randomised clinical trials. Purpose To evaluate the cost and effectiveness of treatment with bevacizumab or cetuximab in patients with metastatic colorectal cancer, in particular in maintenance treatment. Materials and Methods A retrospective analysis was conducted in two Sicilian cancer centres, in patients treated between 01/01/2008 and 30/06/2012, to assess the median time to progression (TTP) and the corresponding cost of maintenance treatment with bevacizumab and cetuximab. Results were compared using the log-rank test. Results Of 167 patients treated with bevacizumab plus chemotherapy, 41 (24.5%) responded and continued with maintenance treatment: 36 patients on first-line treatment (TTP 412.5 days) and 5 patients on second-line treatment (TTP 314.7 days). Of 71 patients treated with cetuximab plus chemotherapy, 15 (21.1%) responded and continued with maintenance treatment: 9 patients on first-line treatment (TTP 271.2 days), 6 patients on second-line treatment (TTP 366.5 days). Maintenance treatment showed an increase in TTP of 258.2 and 159.3 days on first-line treatment, 188.1 and 243 days on second-line treatment for bevacizumab and cetuximab, respectively. The additional cost of maintenance treatment with bevacizumab and cetuximab, for a standard 70 kg, 1.7 m² patient is €84/day and €118/day for each day of progression-free survival, respectively. Conclusions In patients responding to maintenance treatment, bevacizumab is more advantageous as TTP in first-line treatment gains about 100 days vs. cetuximab, while cetuximab is more advantageous as second-line treatment, with a gain of about 55 days in TTP vs. bevacizumab. From the economic analysis the most advantageous is bevacizumab, costing €34/day less than cetuximab. A study is in progress to consider the use of targeted treatment with different chemotherapy regimens. No conflict of interest.
Background Ovarian cancer is the next most lethal gynaecological malignancy after cervical cancer, with about 125,000 deaths each year worldwide. Treatment options are still limited and even though 80% of women respond to first-line treatment many undergo recurrence and death. In Italy trabectedin in combination with pegylated liposomal doxorubicin has been approved for the treatment of patients with relapsed platinum-sensitive ovarian cancer since March 2011, but NHS refunds are limited to only partially platinum-sensitive patients, who have relapsed between 6 and 12 months after treatment with platinum-based treatment. This ruling stems from the results obtained from the open-label randomised phase III OVA-301 clinical trial for this group of patients, which included only patients treated in second line. Purpose To analyse the responses in terms of progression-free survival (PFS) of 2 groups of patients who relapsed after treatment with platinum-based treatment: partially platinum-sensitive patients, who relapse between 6 and 12 months and platinum-sensitive patients, who relapse after 12 months. Materials and methods Clinical cards and protocol sequences with trabectedin were analysed contained in the database of the compounding centre of 2 cancer centres in Sicily. Patients were enrolled from 2010 to 2012, including multi-treated patients. Progression-free survival after the first platinum-based treatment and PFI (platinum free interval) were calculated and the relative PFS was calculated. Records of platinum-resistant patients who relapsed between 0 and 6 months after treatment were also analysed with permission of the Italian law no. 648/96. Results The patients who received trabectedin have mostly been heavily pre-treated (III and IV line), only 10% are receiving second-line treatment. The median PFS with PFI≥ 6 months is 6.96, and the platinum-resistant group (27%) shows a median PFS of 2.5 months. The partially platinum-sensitive group had a PFS of 6.96 months, and the platinum- sensitive group 5.6 months. Conclusions To confirm the relationship found in the trials, the PFI greatly influences the response even in multi-treated patients: the response in terms of PFS is greater in the partially platinum-sensitive. The limitation of the treatment only to the setting of partially platinum-sensitive patients imposed by the Italian regulatory agency allows for greater access to care for patients who can benefit most at the expense of those for which, however, there is no therapeutic alternative with comparable effectiveness. At the moment there are no studies on the use of trabectedin in association with III or IV line of treatment for a comparison of the responses in clinical practice. No conflict of interest.
Background Trabectedin is a DNA minor groove binder of marine origin. It is indicated for the treatment of adult patients with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide, or for patients unsuited to receive these agents. In Italy it has been approved since 2009 and it has been included in the Register Monitoring Cancer Drugs. Purpose To asses the safety and efficacy of treatment for a 28-year-old male patient, with inoperable metastatic sarcoma, not responsive to ifosfamide or anthracyclines Materials and Methods The oncologist draws up a treatment protocol that is checked by the hospital pharmacist prior to preparation in the Clean Room. The patient was treated with 3 mg of trabectedin in elastomeric pump of 5 ml/h for 24 hours. This treatment was performed every 21 days. ResultsFrom August 2010 to February 2012 the patient was given trabectedin at the standard dose of 1.5 mg/m2. The first TAC in October 2010 showed stable disease. In March 2011, after 10 cycles, he was still progression-free. The disease started to progress only after 22 cycles. At the beginning of the treatment the patient had abdominal pain, at the end of it, he has neutropenia and increased levels of transaminases. The time to progression (TTP) was 20 months, while in a randomised study TTP was 13.9 months. Conclusions Trabectedin treatment in soft tissue sarcoma was well tolerated with a good safety profile, demonstrating also a low grade of side effects and a greater time to progression in comparison with the published studies. No conflict of interest.
Background Cetuximab is a chimeric monoclonal IgG specifically directed against epidermal growth factor receptors (EGFR). Among the drug-specific toxic effects of cetuximab are hypomagnesemia (10% of patients), and effects related to the infusion (10%), but the most common toxicity during treatment with cetuximab is a skin reaction, manifesting in 80% of patients treated, and is very severe in 10–20% of these. The epidermis consists of 90% keratocytes, rich in EGFR receptors, explaining the high incidence of skin toxicity. The presence and intensity of the skin reactions correlate favourably with the effectiveness of treatment and survival. Purpose To evaluate the toxicity of cetuximab in clinical practice and the possible correlation with the response to treatment in terms of PFS (progression free survival). Materials and methods A retrospective analysis was conducted on the clinical records of patients treated with cetuximab from January 2012 to June 2013, in two Sicilian cancer centres (study RG-SC). We evaluated the toxicity and PFS and compared them with the findings of the most authoritative RCTs (randomised controlled trials) conducted on cetuximab. Results Among the medical records examined 35 treatments were considered evaluable. Skin toxicity of any grade was observed in 63% of patients; in the first line in 60% with FOLFIRI-cetuximab and 71% with FOLFOX-cetuximab, in the second line in 80% of treated patients. Comparing our results to the regimens as reported in RCTs, grade 3–4 skin toxicity in the first line FOLFIRI-cetuximab was found to have occurred in 18.7% of our patients compared with 10%, and with FOLFOX-cetuximab in 14.1% of our patients vs. 14.3% of the RCT. In second line treatment none of our patients had skin toxicity vs. 8.2% in the RCT. From the correlation between the degree of skin toxicity and PFS between our study and the CRYSTAL study, it appears that dermal toxicity grade 0–1 went with a PFS of 7.2 or 5.4 months, the PFS for grade 2 was 11.7 vs. 9.4 and for grade 3 went with a PFS of 14.5 vs. 11.3 months, respectively. In our group of patients the length of treatment in patients with grade 4 dermal toxicity that caused interruption was 12.8 months. Conclusions Skin toxicity is the main specific toxicity of cetuximab and requires careful monitoring. In fact, with appropriate control measures it is usually manageable and rarely becomes a cause of discontinuation of treatment. The results showed that in clinical practice in the two cancer centres in Sicily skin toxicity was observed in a smaller percentage of patients than in RCTs. The positive correlation between onset, degree of toxicity and PFS observed in RCTs was confirmed in our study group with better than evidence in the literature. The onset of skin toxicity and its aggressiveness can be considered as factors predictive of response in patients treated with cetuximab. No conflict of interest.
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