Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1.

Purpose: Cabozantinib is an inhibitor of kinases, including MET and vascular endothelial growth factor receptors, and has shown activity in men with previously treated metastatic castration-resistant prostate cancer (mCRPC). This blinded phase III trial compared cabozantinib with prednisone in patients with mCRPC.

Patients And Methods: Men with progressive mCRPC after docetaxel and abiraterone and/or enzalutamide were randomly assigned at a two-to-one ratio to cabozantinib 60 mg once per day or prednisone 5 mg twice per day.

One stage curative resection of double intestinal neuroendocrine tumors with thirty-two bilobar liver metastases. A case report.

Neuroendocrine tumours (NETs) of the midgut are often multifocal and have a noticeable attitude to metastasize to locoregional lymph nodes and liver. Surgery is the only curative treatment for metastatic NETs of the midgut, even though only a minority of patients are candidates to radical surgical resection. The optimal timing for surgical resection in case of synchronous presentation of primary intestinal neoplasms and resectable LM is still controversial, especially when LM are multiple and/or involve multiple liver segments.

Chemotherapy-induced nausea and vomiting in Italian cancer centers: results of CINVDAY, a prospective, multicenter study.

Purpose: Guideline consistency in the prevention of chemotherapy-induced nausea and vomiting (CINV) remains low (29% in the Pan European Emesis Registry study) and very low (11%) in regimens with a high emetogenic risk. The aim of this study was to evaluate the guideline consistency of CINV prophylaxis for acute emesis in daily clinical practice in Italy.

Methods: This was a prospective, observational, multicenter study.

Phase II randomized study of vandetanib plus gemcitabine or gemcitabine plus placebo as first-line treatment of advanced non-small-cell lung cancer in elderly patients.

Introduction: The aim of the present study was to evaluate the efficacy and tolerability of vandetanib plus gemcitabine (V/G) compared with gemcitabine alone in elderly patients with untreated advanced non-small-cell lung cancer.

Methods: This was a phase II, randomized, double-blind study. A total of 124 elderly patients (mean age, 75 yr; age range, 70-84 yr; 73% men) received V/G (n = 61) or placebo plus gemcitabine (n = 63).

Impact of use of oral anticancer drugs on activity of Italian oncology practices: results of a survey conducted by the Italian Society of Medical Oncology (AIOM).

Aims And Background: In recent years, the number of oral anticancer drugs used in clinical practice has rapidly increased. The Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of the use of oral anticancer drugs on the daily activity of Italian oncology practices.

Methods And Study Design: A survey questionnaire was distributed to the coordinators of the regional sections of AIOM.

Phase II trial of non-pegylated liposomal doxorubicin and low-dose prednisone in second-line chemotherapy for hormone-refractory prostate cancer.

Aims And Background: Non-pegylated liposomal doxorubicin (NPLD) (Myocet) has shown marked in vitro activity in castration-resistant prostate cancer (CRPC) and also in docetaxel-resistant cells, higher than that shown by pegylated liposomal doxorubicin. Its activity would seem to be due to a high intracellular drug concentration and induction of Golgi-dependent apoptosis. On the basis of these results, a clinical study was designed to assess the activity of NPLD and low-dose prednisone in second-line therapy.

Gemcitabine and paclitaxel combination as second-line chemotherapy in patients with small-cell lung cancer: a phase II study.

Background: Although small-cell lung cancer is a chemosensitive malignancy, most patients rapidly relapse. Results of second-line treatment are generally poor. We conducted a phase II study to evaluate the activity and toxicity of a combination of gemcitabine and paclitaxel as second-line chemotherapy.

Use of metronomic chemotherapy in oncology: results from a national Italian survey.

Aims And Background: Metronomic chemotherapy refers to the administration of low doses of cytotoxic agents over a prolonged period of time with no or only short drug-free intervals. It is designed to overcome acquired tumor resistance to chemotherapy and reduce neo-angiogenesis despite a lower toxicity than with standard chemotherapy. The role of metronomic chemotherapy remains controversial, and its optimal therapeutic use has not yet been defined.

Disparity in the "time to patient access" to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian Society of Medical Oncology (AIOM).

Aims And Background: In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the "time to patient access" to new anti-cancer drugs in Italian regions.

Prednisone plus gefitinib versus prednisone plus placebo in the treatment of hormone-refractory prostate cancer: a randomized phase II trial.

Background: Abnormal epidermal growth factor receptor expression and pre-clinical data prompted us to investigate the activity of gefitinib, a selective epidermal growth factor receptor tyrosine kinase inhibitor, in hormone-refractory prostate cancer.

Methods: Eighty-two patients were randomly assigned to receive prednisone plus gefitinib (pG; n = 44) or prednisone plus placebo (ppl; n = 38). On progression, patients initially assigned to placebo were offered the possibility to receive gefitinib.

Switching to an aromatase inhibitor provides mortality benefit in early breast carcinoma: pooled analysis of 2 consecutive trials.

Background: The superiority of new generation aromatase inhibitors over tamoxifen in the adjuvant treatment of early breast carcinoma has emerged from several randomized trials. However, until now not all previous studies have shown a mortality benefit.

Methods: A pooled analysis of 2 prospective multicentric trials, sharing the same study design and nearly identical inclusion criteria, was performed.

Pemetrexed in patients with locally advanced or metastatic breast cancer who had received previous anthracycline and taxane treatment: phase II study.

Purpose: The objective of this study was to assess the efficacy and safety of pemetrexed in pretreated patients with advanced-stage breast cancer.

Patients And Methods: Patients with advanced-stage or metastatic breast cancer, Eastern Cooperative Oncology Group performance status 0-2, and progressive or relapsed disease after treatment with regimens containing anthracyclines and taxanes were eligible. Pemetrexed 500 mg/m2 was administered as a 10-minute intravenous infusion on day 1 every 21 days.

The impact of chemotherapy-induced nausea and vomiting on health-related quality of life.

Goal Of Work: The objectives of this prospective observational study were to estimate the frequency of patients who reported an impact of chemotherapy-induced nausea and vomiting (CINV) on their daily life and to evaluate the determinants of such an impact.

Materials And Methods: Adult cancer patients at seven Italian oncology centers who were receiving cisplatin-containing regimens reported incidence and intensity of CINV for eight consecutive days in a diary and completed a Functional Living Index for Emesis (FLIE) questionnaire.

Main Results: Overall, 34% of patients reported vomiting and 62% reported nausea after chemotherapy.

The cost of chemotherapy-induced nausea and vomiting in Italy.

Goals Of Work: The aim of this paper is to analyze the costs of chemotherapy-induced nausea and vomiting (CINV) in Italy.

Materials And Methods: In this prospective observational study at seven public oncology centers, incidence and intensity of CINV daily for 8 days after chemotherapy in consecutive patients receiving cisplatin-containing chemotherapy were recorded. All costs related to CINV (direct medical, direct nonmedical, and indirect) were recorded (in 2003 euros).

Diagnostic criteria for psychosomatic research and psychosocial variables in breast cancer patients.

The aim of the study was to examine the relationship of the Diagnostic Criteria for Psychosomatic Research (DCPR) with psychosocial variables and quality of life among cancer patients. Of 105 women with breast cancer who participated in the study, 40 (38.1%) had symptoms meeting the criteria for at least one DCPR syndrome, and 30 (28.

Incidence of chemotherapy-induced nausea and emesis after modern antiemetics.

Background: The authors determined the incidence of acute and delayed chemotherapy-induced nausea and emesis (vomiting) (CINV) among patients receiving highly (HEC) or moderately (MEC) emetogenic chemotherapy. They also assessed whether physicians and nurses accurately recognized the incidence of acute and delayed CINV in their own practices.

Methods: A prospective, observational study of adult patients receiving HEC or MEC for the first time was performed.

Bolus fluorouracil and leucovorin with oxaliplatin as first-line treatment in metastatic colorectal cancer.

Purpose: A phase II trial investigated the activity and toxicity of a bolus administration schedule of oxaliplatin, fluorouracil (5-FU), and leucovorin (LV) therapy in patients with untreated advanced colorectal cancer.

Patients And Methods: Forty-five patients in this multicenter, open, nonrandomized study received oxaliplatin 130 mg/m(2) on the first day of each course and 5-FU and LV 350 mg/m(2) and 20 mg/m(2), respectively, as a daily bolus for 5 days, every 21 days, for a maximum of six courses.

Results: Partial responses occurred in 18 patients, giving an intent-to-treat response rate of 40.

Radiosensitization by oxaliplatin in a mouse adenocarcinoma: influence of treatment schedule.

Purpose: The aim of our study was to investigate if oxaliplatin (1-OHP) could be used as a radiosensitizer in vivo.

Materials And Methods: Experiments were performed in mice (C3D2F1) bearing a transplanted mammary carcinoma in a foot. Drugs, 1-OHP and cis-diammine-dichloro-platinum (CDDP), were administered i.