After the discovery of its essential role in anticancer immunity, IL-2 cancer immunotherapy has shown that comparable results may be obtained with different schedules, including intravenous high-dose IL-2 as a bolus or as a 24-hour intravenous infusion or prolonged subcutaneous injection of low-dose IL-2 with or without IFN-α. This study shows the long-term results obtained in 92 metastatic renal cell cancer (RCC) patients with low-dose subcutaneous IL-2, which was given at 3 million IU twice/day for 5 days/week for 6 consecutive weeks. In nonprogressing patients, a second cycle was planned after a 21-day rest period, followed by maintenance therapy consisting of 5 days of treatment every month until disease progression. Complete response (CR) was achieved in only 2/92 (2%) patients, and partial response (PR) was observed in 19 patients (21%). Therefore, the response rate (CR + PR) was 21/92 (23%), with a median duration of response of 25 months. Stable disease (SD) occurred in 37 patients (40%), whereas the other 34 (37%) had a progressive disease (PD). The response rate was significantly higher in patients with a disease-free interval of >1 year than in those with a lower interval, in patients with a high performance status (PS) than in those with a low PS, and in patients with sites of disease other than the liver. A 5-year survival was obtained in 9/92 (9%) patients, and the percent of survival was significantly higher in patients with a response or SD than in those with PD. The treatment was well tolerated in all patients. This study confirms that low-dose subcutaneous IL-2 alone in an effective and well tolerated therapy of metastatic RCC, with results comparable to those described with more aggressive and toxic IL-2 schedules.
The aim of this study was to investigate the activity and safety of a regimen containing carboplatin and paclitaxel in patients affected by recurrent or metastatic head and neck cancer. Eligible patients were treated with a 3-week combination of paclitaxel 175 mg/m2 and carboplatin area under the concentration time curve 5 mg/ml/min for a maximum of four cycles. A total of 27 patients entered the study. One patient (3.7%) had a complete response, whereas six patients (22.2%) obtained a partial response. Stable disease was observed in seven patients (25.9%). The disease control rate was 51.8% (95% confidence interval: 32.0-71.3), whereas overall response rate was 25.9% (95% confidence interval: 11.1-46.3). The median overall survival was 8.0 months (range: 2-27), with a 1-year survival of 30.5%. The median progression-free survival was 1.0 month (range: 0-14). Treatment-related deaths or episodes of neutropenic fever were not registered. Grades 3-4 neutropenia was observed in two patients (7.4%), grades 3-4 anaemia and thrombocytopenia in four (14.8%) and one (3.7%) patients, respectively. Nine patients (33.3%) experienced grades 1-2 and one patient (3.7%) grade 3 peripheral neuropathy. The combination of carboplatin and paclitaxel is safe and moderately effective for the treatment of recurrent or metastatic head and neck cancer.
Skin toxicity is a frequent complication of anti-epidermal growth factor receptor therapy, which can be an obstacle in maintaining the dose intensity and may negatively impact on the clinical outcome of cancer patients. Skin lesions depend on the disruption of the keratinocyte development pathways and no treatment is clearly effective in resolving the cutaneous alterations frequently found during anti-epidermal growth factor receptor therapy. Among systemic treatments, oral tetracycline proved to be useful in preventing skin manifestations. We describe the case of a patient affected by metastatic colorectal cancer, for whom a combination of chemotherapy and cetuximab was used as second-line treatment. The patient developed a symptomatic papulopustular skin rash that disappeared completely after a twice-daily application of a hydrating and moisturizing cream, mainly consisting of a mixture of paraffin, silicone compounds, and macrogol. The marked cutaneous amelioration allowed the patient to continue cetuximab without any further symptoms and was associated with a partial radiological response.
Lymphocytosis is the main biomarker predicting the efficacy of subcutaneous IL-2 anticancer immunotherapy. In addition, it has been demonstrated the fundamental role of dendritic cells (DC) in the generation of an effective anticancer immunity. However, the relation between IL-2 and DC system needs to be further understood. This preliminary study was performed in an attempt to analyze changes in circulating DC during IL-2 cancer immunotherapy in relation to lymphocyte variations and clinical efficacy of treatment. The study included 20 metastatic renal cell cancer patients, who underwent subcutaneous low-dose IL-2 immunotherapy (6.000.000 IU/day for 6 days/week for 4 weeks). To evaluate DC, venous blood samples were collected before and after 2 weeks of IL-2 injections, corresponding to the period of maximum lymphocytosis. Immature (CD123(+) ) and mature (CD11c(+) ) DC were measured by FACS and monoclonal antibodies. IL-2 induced a significant increase in the mean number of circulating mature DC, whereas no substantial change occurred in immature DC mean number. The increase in mature DC was associated with a control of disease, whereas no rise was observed in patients who had progressed on IL-2 immunotherapy. Moreover, the increase in mature DC mean number was significantly higher in patients showing evident lymphocytosis, with lymphocyte enhancement greater than 1000 cells/mmc, than in patients with less pronounced lymphocytosis, even though no significant correlation was seen in between mature DC and lymphocyte increase. This preliminary study would suggest that IL-2 may stimulate DC system and that the clinical anticancer efficacy of IL-2 is associated with the increase in circulating mature DC, which could be considered as a new favourable biomarker during IL-2 immunotherapy.
e20600 Background: Early death for some patients can be explained by direct effect of tumor or can be secondary to cancer treatment.As for many patients it is not fully predictable, the factors influencing and determining early death in older individuals receiving chemotherapy for advanced NSCLC were analyzed. Methods: Advanced NSCLC patients, > 70 years, ECOG performance status 0-1, treatment naïve, stage IIIB and IV, EGFR and ALK negative, were eligible. Geriatric assessment was performed at baseline and included: Performance status, ADLs, IADLs, CIRSG score and index, Mini Nutritional Assessment (MNA), Mini Mental State Evaluation (MMSE), educational and social status assessment, Geriatric Depression Scale (GDS).All patients, according to their classification in frail, vulnerable or fit, received best supportive care, monotherapy or doublet chemotherapy.For all patients data on number of cycles, response, discontinuation of treatment, dose reductions, grade 3/4 hematological and non-hematological toxicity were recorded. Patients who died within 90 days of diagnosis were considered.A descriptive statistic was calculated and a logistic regression analysis with the assessment of factors and covariates influencing early death events was performed. Results: From June 2010 to March 2016, 204 patients were assigned to platinum-based doublet (n = 73) or single-agent chemotherapy (n = 131).Median age was 75, 72% were males, 52% had non-squamous histology. Median number of cycles was 4, and was 3 for comorbidities. IADLs were impaired in 42%, ADLs in 6%,MNA in 15% and MMSE 10% of patients.Sixty-eight percent of patients were dead at the time of the analysis; 24% (49/204) had partial response, 25% (51/204) had stable disease and 51% (104/204) had progressive disease.At multivariate logistic model IADLs (p 0.001, OR 1.4 95%CI 0.4-1.6),MNA (p 0.001, OR 1.35 CI 0.1-1.35) and polypharmacy (p 0.008, OR 1.2 CI 1-1.4) were significantly associated with the occurrence of early death. Conclusions: The identification and management of patients with nutritional and functional impairments could help oncologists to reduce the risk of early death during chemotherapy for advanced NSCLC.
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