Results of a clinical multicentric randomized phase-ii study of nonsmall cell lung-cancer treated with vinorelbine Cisplatin versus vinorelbine alone.

From July 1992 to December 1993, 62 patients with non-small cell lung cancer (NSCLC) were admitted to a multicentric randomized study. The patients were treated with vinorelbine (V) alone at a dose of 25 mg/m(2)/i.v. weekly or with V at a dose of 25 mg/m(2)/i.v. on day 1 and 8 plus cisplatin at a dose of 80 mg/m(2)/i.v. on day 1 every 3-4 weeks (VP). An objective response was observed in 42% of patients treated with VP versus 12.5% of those treated with vinorelbine alone (p=0.038). There was no significant difference in the median survival duration between the two groups (38 versus 30 weeks for VP and V, respectively). Toxicity was tolerable but more severe in the VP regimen. These data suggest that V is an active agent in NSCLC and that the VP regimen may yield results comparable to other cisplatin combinations for treatment of these tumors.

Non-pegylated liposome-encapsulated doxorubicin citrate plus cyclophosphamide or vinorelbine in metastatic breast cancer not previously treated with chemotherapy:a multicenter phase III study.

We conducted a phase III multicenter randomized trial to compare the efficacy of the combination of liposome encapsulated doxorubicin (Myocet(©)) plus either cyclophosphamide (MC) or vinorelbine (MV). Since July 2006, 233 patients affected with metastatic breast cancer were randomized to receive the combination of Myocet (M) 60 mg/m(2) i.v. plus cyclophosphamide (C) 600 mg/m2 on Day 1 of a 21­day cycle (Arm A) or Myocet (M) at 50 mg/m2 plus vinorelbine (V) 25 mg/m2 i.v. on Day 1 and V 60 mg/m2 orally on Day 8 on a 21­day cycle (Arm B). The primary endpoints of the study was time to progression (TTP); secondary endpoints were RR, toxicity and OS. Response was observed in 53/116 (45.7%) evaluable patients of Arm A vs. 51/112 (45.5%) of Arm B, respectively (P=NS). Median TTP was 41 weeks (95% CI, 32­51) and 34 weeks (95% CI, 26­39), for M/C and M/V, respectively (P=0.0234). The difference in median OS was not statistically significant (131 vs. 122 weeks; P=0.107). With regard to toxicity, patients treated with MV showed a slight increase of neutropenia and constipation, as compared to those treated with MC. No clinical signs of cardiotoxicity were observed. The MC combination remains as an unbeaten 'standard' in first line treatment of MBC.

Reconstruction of the inner canthus region with a forehead muscle flap: a report on three cases.

We report our experience of using a forehead flap to repair the defect left by the excision of skin tumours in the medial canthal region involving both eyelids in three patients. Both eyelids and the inner canthus were reconstructed using a myofascial flap taken from the forehead, combined with septal chondro-mucosal grafts, oral mucosa and skin grafts. After a careful anatomical study of the vascularisation of the frontal region, we used only the frontal myofascial portion, a part of the forehead muscle vascularised by the deep branch of the supraorbital artery and by the supratroclear artery; the skin left behind is adequately nourished by the fine mesh of anastomoses in the area between the two supratroclear arteries, the supraorbital artery and the terminal vessels of the superficial temporal artery. The particularly thin, elastic and resistant features of this flap enabled us to repair a loss of substance in a difficult area with a successful outcome in terms of morphology, function and cosmetic appearance.