Spolverini Hospital

Ariccia, Italy

Spolverini Hospital

Ariccia, Italy

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Di Lauro L.,Regina Elena Cancer Institute | Pizzuti L.,Regina Elena Cancer Institute | Barba M.,Regina Elena Cancer Institute | Barba M.,Italian National Cancer Institute | And 9 more authors.
Journal of Experimental and Clinical Cancer Research | Year: 2015

Background: The role of chemotherapy in the treatment of metastatic male breast cancer patients remains unknown, and the only available evidence stem from small, retrospective series evaluating outdated drugs and/or regimens. Methods: In this retrospective study we evaluated the activity of polychemotherapy, consisting of three-drug (anthracycline-containing and anthracycline-free) regimens, as a first-line therapy for metastatic male breast cancer patients who had received at least one prior endocrine therapy. Results: Fifty patients treated between 1978 and 2013 were included in the present analysis. Regarding best response, we recorded 1 (2%) complete response and 27 (54%) partial responses, for an overall response rate of 56% (95% CI, 42.2-69.8). Considering stable disease, the disease control rate was 84%. Median progression-free survival was 7.2 months (95% CI, 5.9-8.5), and median overall survival was 14.2 months (95% CI, 12.2-16.2). Albeit we observed some differences for all the outcomes explored when comparing anthracycline-containing and anthracycline-free regimens, they were not statistically significant. Conclusions: Chemotherapy, consisting in both anthracycline-containing and anthracycline-free regimens, showed encouraging antitumor activity in metastatic male breast cancer patients previously treated with endocrine therapy. © 2015 Di Lauro et al.; licensee BioMed Central.


PubMed | Regina Elena Cancer Institute, Spolverini Hospital and Reggio Calabria General Hospital
Type: | Journal: Journal of experimental & clinical cancer research : CR | Year: 2015

The role of chemotherapy in the treatment of metastatic male breast cancer patients remains unknown, and the only available evidence stem from small, retrospective series evaluating outdated drugs and/or regimens.In this retrospective study we evaluated the activity of polychemotherapy, consisting of three-drug (anthracycline-containing and anthracycline-free) regimens, as a first-line therapy for metastatic male breast cancer patients who had received at least one prior endocrine therapy.Fifty patients treated between 1978 and 2013 were included in the present analysis. Regarding best response, we recorded 1 (2%) complete response and 27 (54%) partial responses, for an overall response rate of 56% (95% CI, 42.2-69.8). Considering stable disease, the disease control rate was 84%. Median progression-free survival was 7.2months (95% CI, 5.9-8.5), and median overall survival was 14.2months (95% CI, 12.2-16.2). Albeit we observed some differences for all the outcomes explored when comparing anthracycline-containing and anthracycline-free regimens, they were not statistically significant.Chemotherapy, consisting in both anthracycline-containing and anthracycline-free regimens, showed encouraging antitumor activity in metastatic male breast cancer patients previously treated with endocrine therapy.


Di Lauro L.,Regina Elena Cancer Institute | Vici P.,Regina Elena Cancer Institute | Belli F.,Spolverini Hospital | Tomao S.,University of Rome La Sapienza | And 8 more authors.
Gastric Cancer | Year: 2014

Background: The incorporation of docetaxel into the cisplatin and fluorouracil backbone has been demonstrated to be an active combination in metastatic gastric cancer. Nevertheless, this regimen is burdened by nonnegligible toxicity. We hypothesized that replacing cisplatin and fluorouracil with oxaliplatin and capecitabine should be an active and safe option for metastatic gastric cancer patients.Methods: In this phase II study, we tested the activity of docetaxel in combination with oxaliplatin and capecitabine (DOC) as a first-line treatment. DOC was administered as follows: docetaxel (60 mg/m2) and oxaliplatin (100 mg/m2) on day 1, and capecitabine (500 mg/m2) was administered orally twice daily given continuously, with cycles repeated every 3 weeks. The primary endpoint was the overall response rate.Results: Forty-eight patients entered the study. All patients had metastatic disease (stage IV). None of the patients had previously received chemotherapy for advanced disease. Performance status was 0, 1, and 2 in 25, 58, and 17 % of patients, respectively; 13 patients (27 %) had adenocarcinoma of the gastroesophageal junction, and 29 patients (60.5 %) had two or more metastatic sites. The overall response rate was 52.1 %. Progression-free survival and overall survival were 6.9 and 12.6 months, respectively. The treatment was well tolerated with no treatment-related deaths. The most common grade 3–4 toxicity was neutropenia (41 %).Conclusions: DOC is an effective and tolerated first-line treatment, and the lower dose of docetaxel and oxaliplatin used in this study compared with other similar regimens does not seem to hamper the antitumor activity. © 2013, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.


Maugeri-Sacca M.,Regina Elena Cancer Institute | Pizzuti L.,Regina Elena Cancer Institute | Sergi D.,Regina Elena Cancer Institute | Barba M.,Regina Elena Cancer Institute | And 7 more authors.
Journal of Experimental and Clinical Cancer Research | Year: 2013

Background: The role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries. Nevertheless, these results cannot be broadly generalized as molecular studies suggested the existence of different sets of deregulated gene networks correlated with ethnicity. In the present study, we investigated the activity and safety of FOLFIRI given as a second-line therapy in metastatic gastric or gastro-esophageal junction cancer patients who experienced disease progression on or after first-line docetaxel-containing chemotherapy. Methods. Patients with histologically confirmed metastatic gastric cancer who failed docetaxel-containing first-line therapy and who received FOLFIRI in second line were eligible for the study. Seventy patients treated at three Italian cancer centers between 2005 and 2012 entered the study. Patients received every 2 weeks irinotecan 180 mg/m§ssup§2§esup§ as 1 h infusion on day 1, folinic acid 100 mg/m§ssup§2§esup§ intravenously days 1-2, and fluorouracil as a 400 mg/m§ssup§2§esup§ bolus and then 600 mg/m§ssup§2§esup§ continuous infusion over 22 hours days 1-2. Results: We observed 1(1.4%) complete response, 15 (21.4%) partial response, for an overall response rate of 22.8% (95% confidence interval (CI): 13.4-32.3). Stable disease was recorded in 21 (30%) patients. Median progression-free survival and overall survival were 3.8 months (95% CI: 3.3-4.4) and 6.2 months (95% CI: 5.3-7.1), respectively. The treatment was well tolerated, as the most common G3-4 toxicities were neutropenia (28.5%) and diarrhea (14.5%). Conclusions: FOLFIRI appears an effective and safe treatment option for pretreated metastatic gastric cancer patients, and deserves further investigation in randomized clinical trials. © 2013 Maugeri-Saccà et al.; licensee BioMed Central Ltd.


Di Lauro L.,Regina Elena Cancer Institute | Pizzuti L.,Regina Elena Cancer Institute | Barba M.,Regina Elena Cancer Institute | Sergi D.,Regina Elena Cancer Institute | And 9 more authors.
Journal of Hematology and Oncology | Year: 2015

Background: Male breast cancer is a rare malignancy. Despite the lack of prospectively generated data from trials in either the adjuvant or metastatic setting, patients are commonly treated with hormone therapies. Much controversy exists over the use of gonadotropin-releasing hormone analogues in metastatic male breast cancer patients. We conducted this study to provide more concrete ground on the use of gonadotropin-releasing hormone analogues in this setting. Methods: We herein present results from a pooled analysis including 60 metastatic male breast cancer patients treated with either an aromatase inhibitor or cyproterone acetate as a monotherapy (23 patients) or combined with a gonadotropin-releasing hormone analogue (37 patients). Results: Overall response rate was 43.5 % in patients treated with monotherapy and 51.3 % with combination therapy (p∈=∈0.6). Survival outcomes favored combination therapy in terms of median progression-free survival (11.6 months versus 6 months; p∈=∈0.05), 1-year progression-free survival rate (43.2 % versus 21.7 %; p∈=∈0.05), median overall survival (29.7 months versus 22 months; p∈=∈0.05), and 2-year survival rate (64.9 % versus 43.5 %; p∈=∈0.05). Conclusions: In metastatic male breast cancer patients, the combined use of gonadotropin-releasing hormone analogues and aromatase inhibitors or antiandrogens seems to be associated with greater efficacy, particularly in terms of survival outcomes, compared with monotherapy. Collectively, these results encourage considering these agents in the metastatic setting. © 2015 Di Lauro et al.; licensee BioMed Central.

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