Prevalence of malnutrition in patients at first medical oncology visit: the PreMiO study.

BACKGROUND: In cancer patients, malnutrition is associated with treatment toxicity, complications, reduced physical functioning, and decreased survival. The Prevalence of Malnutrition in Oncology (PreMiO) study identified malnutrition or its risk among cancer patients making their first medical oncology visit. Innovatively, oncologists, not nutritionists, evaluated the nutritional status of the patients in this study. METHODS: PreMiO was a prospective, observational study conducted at 22 medical oncology centers across Italy. For inclusion, adult patients (>18 years) had a solid tumor diagnosis, were treatment-naive, and had a life expectancy >3 months. Malnutrition was identified by the Mini Nutritional Assessment (MNA), appetite status with a visual analog scale (VAS), and appetite loss with a modified version of Anorexia-Cachexia Subscale (AC/S-12) of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT). FINDINGS: Of patients enrolled (N=1,952), 51% had nutritional impairment; 9% were overtly malnourished, and 43% were at risk for malnutrition. Severity of malnutrition was positively correlated with the stage of cancer. Over 40% of patients were experiencing anorexia, as reported in the VAS and FAACT questionnaire. During the prior six months, 64% of patients lost weight (1-10 kg). INTERPRETATION: Malnutrition, anorexia, and weight loss are common in cancer patients, even at their first visit to a medical oncology center.

[Regional Cancer Registries as observational points for clinical pathways in oncological networks.] / I Registri Tumori come punto di osservazione dei percorsi di cura nelle Reti Oncologiche. La valutazione degli indicatori di processo e di outcome dei PDTA.

Regional Cancer Registries collect population data on incidence and survival for all forms of cancer on a national scale, providing basic elements for National and Regional Health Planning. The availability of the reliable and homogeneous measurement elements about patient outcomes is the key to improving quality and assessing the efficiency of the national healthcare. These measurement elements can be aggregated into predefined indicators for the clinical pathways of the individual regions to calculate their value and assess the phenomenon of health migration.

[Value-based cancer care. From traditional evidence-based decision making to balanced decision making within frameworks of shared values]. / La decisione oncologica basata sui valori Dal tradizionale processo decisionale oncologico evidence-based a scelte basate su valori bilanciati e condivisi.

Clinical decision making in oncology is based so far on the evidence of efficacy from high-quality clinical research. Data collection and analysis from experimental studies provide valuable insight into response rates and progression-free or overall survival. Data processing generates valuable information for medical professionals involved in cancer patient care, enabling them to make objective and unbiased choices. The increased attention of many scientific associations toward a more rational resource consumption in clinical decision making is mirrored in the Choosing Wisely campaign against the overuse or misuse of exams and procedures of little or no benefit for the patient. This cultural movement has been actively promoting care solutions based on the concept of "value". As a result, the value-based decision-making process for cancer care should not be dissociated from economic sustainability and from ethics of the affordability, also given the growing average cost of the most recent cancer drugs. In support of this orientation, the National Comprehensive Cancer Network (NCCN) has developed innovative and "complex" guidelines based on values, defined as "evidence blocks", with the aim of assisting the medical community in making overall sustainable choices.

Topical Application of a Galenical Formulation for the Management of Everolimus-Induced Mucositis in Patients with Metastatic Cancer: a Retrospective Study.

INTRODUCTION: Stomatitis is a common and potentially dose-limiting adverse event of the mammalian target of rapamycin (mTOR) inhibitor therapy. To minimize dose reductions or treatment delays that may affect therapeutic outcomes, management includes patient education, pain management strategies, and drug treatment. The aim of this study was to evaluate the effectiveness of a topically-applied galenical preparation to minimize the impact of everolimus-associated oral mucositis in patients with advanced cancer. METHODS: Patients receiving everolimus plus exemestane for advanced breast cancer or everolimus alone for advanced renal cancer were eligible for inclusion. All patients were advised on procedures to maintain good oral hygiene and directed to use a dexamethasone-containing galenical preparation at the first signs of mucositis. Questionnaires were administered at baseline, and after cycles one, two, and three to evaluate the presence, duration, and intensity of oral mucositis. RESULTS: Of the 19 patients included in the study (mean age 66 years; 16% male), mucositis developed in 10.5%, 47.4%, and 52.6% of patients after the first, second, and third cycles of everolimus, respectively. The median time to development of mucositis was 18.0 days, and the median time to mucositis resolution was 30.0 days. After the first, second, and third cycles of therapy, 5.3%, 10.5%, and 10.5% of patients required interruption of everolimus therapy; however, no dosage reductions for mucositis were necessary. CONCLUSIONS: Patient education and the provision of an effective galenical preparation can minimize the effect of mTOR inhibitor-related mucositis.

"Green Oncology": the Italian medical oncologists' challenge to reduce the ecological impact of their clinical activity.

For decades Western medicine has followed a biomedical model based on linear thinking and an individualized, disease-oriented doctor-patient relationship. Today this framework must be replaced by a biopsychosocial model based on complexity theory and a person-oriented medical team-patient relationship, taking into account the psychological and social determinants of health and disease. However, the new model is already proving no longer adequate or appropriate, and current events are urging us to develop an ecological model in which the medical team takes into account both individual illness and population health as a whole, since we are all part of the biosphere. In recent years, the rising costs of cancer treatment have raised a serious issue of economic sustainability. As the population of our planet, we now need to rapidly address this issue, and everyone of us must try to reduce their ecological footprint, measured as CO2 production. Medical oncologists need to reduce the ecological footprint of their professional activity by lowering the consumption of economic resources and avoiding environmental damage as much as possible. This new paradigm is endorsed by the Italian College of Hospital Medical Oncology Directors (CIPOMO). A working group of this organization has drafted the "Green Oncology Position Paper": a proposal of Italian medical oncology (in accordance with international guidelines) that oncologists, while aiming for the same end results, make a commitment toward the more appropriate management of health care and the careful use of resources in order to protect the environment and the ecosphere during the daily exercise of their professional activities.

Impact of anemia management with EPO on psychologic distress in cancer patients: results of a multicenter patient survey.

AIM: We investigated the role of erythropoietin (EPO) in reducing anemia and preventing the development of psychological distress in patients treated with chemotherapy. PATIENTS & METHODS: This prospective observational study enrolled 591 adult patients receiving EPO at a dose of 30,000 IU administered once weekly for chemotherapy-induced anemia (mean baseline hemoglobin [Hb] level was 9.55 g/dl) over a 12-month period. RESULTS: The majority of patients (371 [71%] patients) achieved a Hb increase >2 g/dl after 4 weeks of treatment. Interestingly, the nonresponder group had a statistically significant deterioration of their psychological conditions as indicated by psychological distress score (p = 0.01). However, within the group of responders to EPO, the Psychological Distress Inventory score remained unchanged. In the present study, severe side effects associated with EPO were not recorded. CONCLUSION: Hb increase, induced by EPO, ameliorates the psychological conditions of cancer patients.

Targeted therapy in renal carcinoma: a case of long-term effect with complete control of toxicity.

Although advances in imaging techniques have allowed earlier diagnosis of renal cell carcinoma (RCC) in recent decades, one-third of patients who have undergone radical resection of organ-confined disease will eventually develop metastases. The treatment of metastatic RCC was revolutionized by the advent of targeted therapy with tyrosine kinase inhibitors. We have followed seven patients with metastatic RCC who were treated with first-line pazopanib at our center. The case of one of these patients is described here in detail. The patient was first diagnosed with RCC in 1999 and metastases were detected in 2006 and 2012. Treatment with pazopanib at the standard dose of 800 mg/day for 29 months led to a partial response that persisted over time. Side effects (hypertension and painful mucositis) were successfully managed with supportive care at our oral therapy clinic. Early management of adverse events using a multidisciplinary approach is paramount to the favorable outcome of treatment with pazopanib and other targeted agents.

Improvement of quality of life in third-line chemotherapy with lapatinib in a case of metastatic breast cancer.

We describe a case of a 72-year-old patient suffering from metastatic breast cancer. The disease had progressed slowly and was almost asymptomatic for a significant time. Toxicity, following third-line treatment with lapatinib, was not significant, and side effects were well controlled. The case is an excellent example of a chronic neoplastic disease in a patient who could be defined as "long-surviving".

Green oncology: cultivating sustainability in medical oncology.

INTRODUCTION: Green oncology is a new conceptual and operational paradigm of oncology, which compared to the traditional biomedical model focused on the interest of a single patient and on its exclusive relationship with the doctor, represents a complex evolutionary step towards clinical activities that have to be eco-responsible of the potential current and future impact on the human, professional, structural, technological, and organizational environment, where they arise, as well as on the biosphere. DEFINITION: Green oncology works through ethical and managerial choices that incorporate, besides the traditional criteria of efficiency and effectiveness, the criterion of cultural, economic, environmental, and social sustainability as they are fair, livable, and possible to be realized.

Advanced adult esthesioneuroblastoma successfully treated with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine.

The esthesioneuroblastoma is a rare neuroendocrine tumor that derives from the olfactory cells. In the last 20 years, around 1,000 cases have been described, with an overall survival rate of 60-70% at 5 years. The most common symptoms are nasal bleeding, nasal clogging and, in locally advanced cases, signs/symptoms of intracranic hypertension such as papilla edema, cefalea, and vomiting. The standard treatments are surgery and radiotherapy. Chemotherapy can be used in an adjuvant/neoadjuvant setting and in the metastatic phase, even if its role is still not established with certainty. Here, the case is reported of a young man (38 years old) with a locally advanced esthesioneuroblastoma. Two months before coming to our clinic, he had been treated elsewhere with debulking surgery through bilateral frontal craniotomy. After surgery, MRI showed residual disease in the nasal cavities and in the medial wall of the orbits responsible for blindness and bilateral exophthalmos within a month: a very short time. Octreoscan and whole body CT scan confirmed a locally advanced disease, in the absence of metastases. Chemotherapy was begun with cisplatin and etoposide alternated with doxorubicin, ifosfamide and vincristine with granulocyte colony-stimulating factor (G-CSF) support after every cycle. Soon after the first cycle, an important reduction of pain and decrease of the exophthalmos and vertigos was observed. No improvement in blindness was seen. The patient is still stable after 24 months of follow up.

Preferences of patients with advanced colorectal cancer for treatment with oral or intravenous chemotherapy.

BACKGROUND: In recent years, patient-reported outcomes such as health-related quality of life have become important areas of clinician focus in general cancer management. Patients' preferences for, and/or satisfaction with, oral versus intravenous (IV) chemotherapy schedules may have a major impact on such outcomes. OBJECTIVE: To evaluate preferences for oral or IV chemotherapy in patients with advanced colorectal cancer. METHODS: A multicenter, randomized, crossover trial was conducted in 12 hospitals in Southern Italy, in which 22 patients with advanced colorectal cancer received one cycle of oral capecitabine ± irinotecan or oxaliplatin, followed by one cycle of an IV de Gramont or similar regimen (arm A), or the same regimens in reverse order (arm B). Patients were aged 50-70 years and 21% had a higher level of education (graduate or similar). Patients received oral capecitabine 3500 mg/m/day for 7 days (± irinotecan 180 mg/m or oxaliplatin 85 mg/m on day 1 only), followed by an IV de Gramont regimen ± irinotecan (FOLFIRI) or oxaliplatin (FOLFOX); or the two schedules administered in reverse order.The main outcome measure was patients' preferences for oral versus IV chemotherapy, as determined by a pre- and post-treatment therapy preference questionnaire (TPQ). RESULTS: Before treatment, 75% of patients preferred oral therapy. Characteristics that patients considered to be important were that treatment should not interfere with daily activities (100% of patients) and should not cause fatigue (95%), diarrhea (76%), or painful mouth ulcers (76%); other factors considered important were the risk of infection and nausea (90%), and that treatment could be administered at home (65%). After receiving both chemotherapy schedules, only 45% of patients preferred oral therapy, while 55% preferred IV therapy. Among the latter, the most important characteristics influencing treatment choice were less nausea (66%), fewer mood effects (65%), the safety of hospital IV treatment (62%), less interference with family relationships (55%), less vomiting (55%), less interference with daily activities (50%), and less diarrhea (50%). Although the order in which patients received therapy did not influence treatment preference, significantly fewer patients with a lower rather than higher educational level preferred oral therapy (47% vs 80%; chi-square test = 9.9; p = 0.002). CONCLUSION: These results suggest that there may be a correlation between educational level and the preference of patients with advanced colorectal cancer for oral or IV chemotherapy.

Informal caregiving burden in advanced non-small cell lung cancer: the HABIT study.

INTRODUCTION: This study's aim was to assess economic data regarding the home assistance burden for advanced non-small cell lung cancer (NSCLC) patients in Italy. PATIENTS AND METHODS: One hundred four NSCLC patients in second-line chemotherapy (2LC) or in supportive therapy (ST) were enrolled in 18 Italian oncology departments and were observed for 3 months. The main caregiver's workload was assessed monthly by a task scale; other caregivers' activities were also registered. Eastern Cooperative Oncology Group performance status was assessed by physicians, and patients completed the Lung Cancer Symptoms (LCS) subscale. Formal caregiving time was valued according to market prices; informal caregiving hours were valued using the wage rate for an equivalent service. Covariance analysis was performed to check for influential factors in assistance costs. RESULTS: The mean age of the total sample was 65.5 years, and prevalence of males was over 80%. In over 70% of cases, the principal caregiver was patient's spouse, living with the patient and not working. Principal caregiver support was the main cost item: 2.368 euros in 2LC and 2.805 euros in ST, representing 74% of total trimonthly assistance costs. Regression analysis showed a positive correlation between the severity of symptoms and the costs of assistance. The caregiving burden was higher in patients with bone and/or cerebral metastases; other metastasis sites seemed to have no impact on assistance costs. CONCLUSION: Considering quality of life as the ultimate health outcome, clinicians are challenged to contribute to a research and policy agenda that holds burden of care in due consideration.

Feasibility of sequential therapy with FOLFIRI followed by docetaxel/cisplatin in patients with radically resected gastric adenocarcinoma. A randomized phase III trial.

OBJECTIVE: Combination therapies of fluorouracil (FU) with irinotecan (CPT-11) and docetaxel plus cisplatin have been proven to be active in metastatic gastric cancer. In this paper, we present the results of a phase III trial in which these two combinations given sequentially were compared to mitomycin C (MMC) monochemotherapy in an adjuvant setting. METHODS: 169 patients with radically resected gastric cancer were randomized to receive CPT-11 (180 mg/m2 day 1), leucovorin (100 mg/m2 days 1-2), FU (400-600 mg/m2 days 1-2, q 14; for four cycles; FOLFIRI regimen), followed by docetaxel (85 mg/m2 day 1), cisplatin (75 mg/m2 day 1, q 21; for three cycles; arm A), or MMC (8 mg/m2 days 1-2 as 2-hour infusion, q 42; for four cycles; arm B). All patients had histologically confirmed gastric carcinoma with nodal positivity or pT3/4. A total of 166 patients (85 in arm A and 81 in arm B) were treated. Adjuvant treatment was completed in 76% of the patients in arm A and in 70% of the patients in arm B. The main grade 3/4 side effects recorded were neutropenia in 35%, with only 1 febrile patient, and diarrhea in 11% in arm A, and thrombocytopenia in 10% and neutropenia in 7% in arm B. The FOLFIRI regimen and docetaxel/cisplatin given in sequence was well tolerated and feasible in adjuvant setting. This sequence treatment currently represents the experimental arm of an ongoing multicenter trial.

Differences in transplant-related complications between hematologic malignancies and solid tumors receiving high-dose chemotherapy and autologous peripheral blood stem cell transplantation.

Multiple factors contribute to transplant-related complications after high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation, including conditioning regimens, number of infused stem cells and clinical characteristics of patient at transplant. We compared the transplant-related complications of 141 patients affected with hematological malignancies with those of 109 patients with solid tumors. The total number of peripheral blood stem cell transplantations performed was 339. High-dose chemotherapy mainly consisted of melphalan-, busulphan- or thiotepa-based regimens. Despite the equal number of infused CD34+ cells, patients with a hematological malignancy showed a slower absolute neutrophil count (days to neutrophils > 0.5 x 10(9)/L, 10.6 +/- 3.6 for hematological malignancies versus 9.1 +/- 1.2 for solid tumors, P < 0.0001) and platelet recovery (days to platelets > 20 x 10(9)/L, 16.4 +/- 9.8 for hematological malignancies versus 12.3 +/- 4.1 for solid tumors, P < 0.0001) than patients with a solid tumor. A significantly higher requirement of red blood cell (3.3 +/- 4.1 versus 2.0 +/- 1.9, P < 0.0029) and platelet units (7.5 +/- 10.4 versus 4.2 +/- 3.4, P < 0.0001) was observed for hematological malignancies than for solid tumors. Five graft failures were documented exclusively in patients with a hematological malignancy. Moreover, such patients displayed a longer duration of mucositis (P < 0.0028) and hospital stay (P < 0.0001), but no difference was observed in terms of febrile episodes. Transplant-related mortality was similar between the two groups. In conclusion, patients with a hematological malignancy overall have more complications than those with a solid tumor.

High-dose chemotherapy with mitoxantrone + melphalan and autologous stem cell rescue in metastatic breast cancer patients: a study of feasibility and tolerability.

Hematological and extra-hematological toxicity of mitoxantrone-containing regimens with autologous stem cell rescue was evaluated in 32 metastatic breast cancer patients. The schedule was the final part of two high-dose chemotherapy programs, including an induction phase with three courses of conventional chemotherapy with epirubicin (120 mg/m2) and cyclophosphamide (600 mg/m2) plus three courses of docetaxel (100 mg/m2) and a first high-dose chemotherapy consisting of cyclophosphamide (6000 mg/m2), thiotepa (500 mg/m2) and carboplatin (800 mg/m2) or melphalan (160 mg/m2) plus thiotepa (600 mg/m2). The final second autograft phase included mitoxantrone (60 mg/m2) associated with melphalan (160 mg/m2) and autologous stem cell rescue infusion. The median duration of severe neutropenia and thrombocytopenia was 9 (range, 7-13) and 11.5 (range, 9-29) days. The median number of units of erythrocytes and platelets transfused was 1 (0-11) and 4 (1-9), respectively. Fever for a median of 2 (0-8) days developed in 71.8% of the patients. Mucositis was observed in 81.2% (WHO grade 3-4 in 25%). No acute or late cardiac toxicity was observed. One patient died because of a transplant-unrelated cause. The response according to the program phase showed an increased rate of complete response, from 12.5% at the end of conventional chemotherapy to 21.9% after the first high-dose chemotherapy course, to increase to 43.9% after the treatment with mitoxantrone-melphalan. We conclude that a conditioning regimen with high dose mitoxantrone-melphalan fits well within the high-dose chemotherapy program.

de Gramont schedule is a very low toxic and effective regimen in low performance status patients affected by metastatic gastric cancer: preliminary report.

UNLABELLED: Treatment of patients affected by metastatic gastric cancer with low performance status (PS) is a very hard choice. It is mandatory to define a very well-tolerated schedule to be employed in these subgroup of patients. PATIENTS AND METHODS: From June 1999 to December 2001, 21 patients (pts) affected by metastatic gastric cancer with low performance status (> or = 2 ECOG) were treated with bimonthly "de Gramont" schedule. Treatment was planned to perform 6 courses of chemotherapy for each patient plus other 2-4 if a response had been documented. RESULTS: A total of 161 courses of de Gramont schedule was administered to the 21 pts enrolled. We observed 8 PD (38%), 8 SD (38%), 5 objective responses (24%--2 MR, 3 PR). Duration of objective responses (OR) was 5 months, 3 months for 3 PRs and 2 and 1 months for two MRs respectively. At time of observation (June 2002) median overall survival (OS) was 14 months, median survival from the starting de Gramont schedule was 8 months. Toxicity was very mild: grade 3 leukopenia in 1 pt, grade 1-2 anemia and piastrinopenia in 3 pts, grade 1-2 nausea vomiting in 5 pts, grade 1 diarrhea in 4 pts, grade 3 mucositis in 2 pts. No other side effect was renowned. PS ameliorated in 12 (57%) pts, even if a major response was not noted. CONCLUSIONS: de Gramont schedule can be safely and effectively employed in metastatic gastric cancer pts with very low performance status.