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Biomedical subjects

Domenico Galetta

Publications and source records attributed to Domenico Galetta.

At least 37 records · Page 2Linked to original sources

Topotecan plus ifosfamide in patients with platinum refractory advanced/metastatic non-small cell lung cancer: a phase II trial.

A number of second line treatments have been proposed in patients with advanced pretreated non-small cell lung cancer (NSCLC). However, either single agents or two or three drug combinations achieved very poor results with no superiority of any combination over monotherapy. We have treated 42 patients (30 males) affected by advanced/metastatic NSCLC progressing during front line cisplatin-based chemotherapy with a combination of topotecan (1.2 mg/m2) plus ifosfamide (1200 mg/m2) for 3 consecutive days every 3 weeks. The median age was 63 years (range 43-76); cell types were: squamous carcinoma (n=17), adenocarcinoma (n=16), large cell carcinoma (n=3), broncho-alveolar carcinoma (n=2) and undifferentiated carcinoma (n=4). All patients were treated with a platinum containing chemotherapy: 39 patients with cisplatin, 2 patients with carboplatin and 1 patient with oxaliplatin, respectively. The ECOG PS was 0 in 8 patients (19%), 1 in 11 patients (26%), and 2 in 23 patients (55%). The median number of courses administered was 3 (range 1-8). Grade 3-4 neutropenia was the dose limiting toxicity, observed in 36% of patients. Moreover, grade 3-4 anemia and thrombocytopenia were observed in 17% and in 12% of patients, respectively. One PS 2 patient died of grade 4 hematological toxicity after the first cycle. No complete response was observed. Six (14.2%) subjects obtained a partial response (PR). In addition, 1 (2.4%) minimal response (MR) plus 14 (34%) stable diseases (SD) and 21 (51%) progressive diseases (PD) were observed. Median time to disease progression and median survival were 9 weeks (range 1-13) and 26 weeks (range 1-91+), respectively. The 1-year survival rate was 14%. Combination of topotecan and ifosfamide demonstrated antitumor activity in patients with relapsing or refractory NCSLC with a modest side effect profile and an overall disease control (PR + MR + SD) of 50.7%. Nevertheless, the still low response rate and the shortness of median survival indicates the need for more effective second line treatments in this disease.

Adult↗

Thoracoscopic management of postpneumonectomy empyema.

BACKGROUND: Even when there is no associated bronchopleural fistula, empyema is a serious complication of pneumonectomy. Aggressive surgical treatments are usually applied. However, a minimally invasive approach might achieve satisfactory results in selected patients. METHODS: Out of 17 patients presenting with a postpneumonectomy empyema (PPE), 11 had a thoracoscopic approach. There were 9 males and 2 females, (age, 38-74; mean, 59 years). Ten patients had no proven bronchopleural fistula (BPF). One of them had a minor (< 3 mm) BPF. Empyema was confirmed by thoracentesis and bacteriological examination. All patients had immediate chest tube drainage and underwent emergency thoracoscopic debridement of the empyema. No irrigation was used postoperatively. RESULTS: There was no mortality and no morbidity related to the procedure. The average duration of thoracoscopic debridement was 62 minutes (range: 45-80 minutes). In 8 patients the chest tube was removed between the fifth and thirteenth postoperative day (average, 8.6 days). They were discharged between the 9th and 24th postoperative day. In 3 patients, clinical and/or biological signs of infection persisted and reoperation was decided at day 5, day 10, and day 11. All 3 patients underwent open-window thoracostomy. The average follow-up of the 8 patients who underwent only thoracoscopy was 10 months (range, 2-27 months). None had recurrent empyema. The patient who presented with a minor BPF remained asymptomatic and is doing well after a 27 month follow-up. CONCLUSIONS: Thoracoscopy might be a valuable approach for patients presenting with PPE with or without minor bronchopleural fistula.

Adult↗

Pulmonary inverted Schneiderian papilloma.

Pulmonary inverted Schneiderian papilloma (ISP) is a very rare entity. We herein describe a case that, for its clinical and pathologic features, proved to be challenging.

Humans↗

Non-small cell lung cancer: from cytotoxic systemic chemotherapy to molecularly targeted therapy.

Surgery is the only method of cure in lung cancer. Seldom its application with radical intent is possible. Despite the efforts aimed at integrating all the therapeutic strategies, the overall outcome of the management of this disease remains disappointing. For this reason, in the last three decades, thousands of preclinical and clinical attempts have been realised in order to investigate any possible way to cure this disease and significant steps forward have been made on the basis of the increasing "molecular knowledge" in the so called "post-genomic era". Particularly the impressive step forward in the biological characterization of cancer as a result of genetic/epigenetic multistep process has brought in a multitude of variables with staggering classification potentialities. "Benchside" and "bedside" scientists have assembled in functional teams to move the common efforts "translationally" to bridge basic and clinical research for a mutual synergistic enhancement. This paper represents the effort of a lung cancer focused translational research team made up of molecular biologists, medical oncologists and thoracic surgeons to achieve a comprehensive, but simple, review of the current status of the shift from cytotoxic to molecularly targeted therapy in lung cancer treatment potentially useful in the planning of translational research trials.

Angiogenesis Inhibitors↗

Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial.

BACKGROUND: Vinorelbine prolongs survival and improves quality of life in elderly patients with advanced non-small-cell lung cancer (NSCLC). Some studies have also suggested that gemcitabine is well tolerated and effective in such patients. We compared the effectiveness and toxicity of the combination of vinorelbine plus gemcitabine with those of each drug given alone in an open-label, randomized phase III trial in elderly patients with advanced NSCLC. METHODS: Patients aged 70 years and older, enrolled between December 1997 and November 2000, were randomly assigned to receive intravenous vinorelbine (30 mg/m(2) of body surface area), gemcitabine (1200 mg/m(2)), or vinorelbine (25 mg/m(2)) plus gemcitabine (1000 mg/m(2)). All treatments were delivered on days 1 and 8 every 3 weeks for a maximum of six cycles. The primary endpoint was survival. Survival curves were drawn using the Kaplan-Meier method and analyzed by the Mantel-Haenszel test. Secondary endpoints were quality of life and toxicity. RESULTS: Of 698 patients available for intention-to-treat analysis, 233 were assigned to receive vinorelbine, 233 to gemcitabine, and 232 to vinorelbine plus gemcitabine. Compared with each single drug, the combination treatment did not improve survival. The hazard ratio of death for patients receiving the combination treatment was 1.17 (95% confidence interval [CI] = 0.95 to 1.44) that of patients receiving vinorelbine and 1.06 (95% CI = 0.86 to 1.29) that of patients receiving gemcitabine. Although quality of life was similar across the three treatment arms, the combination treatment was more toxic than the two drugs given singly. CONCLUSION: The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC.

Aged↗

Long-term results of endoscopic thoracic sympathectomy for upper limb hyperhidrosis.

BACKGROUND: Immediate results of endoscopic thoracic sympathectomy (ETS) for hyperhidrosis are good. Adverse effects are well known but are supposed to decrease with time. We report the long-term results of ETS with regard to efficacy, side effects and patient satisfaction. METHODS: From 1993 to 1998, 382 patients suffering from hyperhidrosis of the upper limbs were operated on by means of bilateral ETS. One hundred twenty-five could be reached. There were 91 females and 34 males with a mean age of 28 years. The mean follow-up was 3.8 years (range: 24 to 84 months). Patients answered a detailed questionnaire from an independent observer addressing the following issues: stability of the initial result, outcome of side effects, degree of satisfaction. RESULTS: The global recurrence rate was 8.8%: 6.6% for palmar hyperhidrosis and 65% for axillary hyperhidrosis. Compensatory sweating was observed in 86.4% of the patients. It was considered as minor by 61% of them, as embarrassing by 31.5%, and as disabling by 7.5%. Other reported side effects were: Horner's syndrome in 3 patients (2.4%), healing in 2 of them; chronic rhinitis in 3 (2.4%); gustatory sweating in 9 (7.2%); and hand dryness in 42%. Sixty-five percent of the patients were fully satisfied, 28.7% were globally satisfied, and 6.3% regretted the operation. Ninety-two percent of the patients claimed they would ask for the operation if it were to be redone. CONCLUSIONS: This study confirms that results of ETS are good and stable for palmar hyperhidrosis but deteriorate for axillary hyperhidrosis. Compensatory sweating does not improve with time and is the main cause of dissatisfaction. Recommendations drawn from these results are the following: (1) patients suffering from isolated axillary hyperhidrosis should rather be treated by local therapy; (2) patients should be better informed of adverse effects.

Adult↗