Multicentre phase II trial of paclitaxel and carboplatin with concurrent radiotherapy in locally advanced non-small cell lung cancer.

AIM: To evaluate weekly induction chemotherapy followed by weekly concomitant chemoradiotherapy in a multicentre phase II study of patients with unresectable stage III non-small cell lung cancer (NSCLC; stage wet IIIB excluded). PATIENTS AND METHODS: Eligible patients received three weekly cycles of paclitaxel 100 mg/m2 and carboplatin AUC2 followed by six weekly cycles of paclitaxel 60 mg/m2 and carboplatin AUC2 in combination with thoracic radiotherapy (2 Gy per fraction and day to a total dose of 60 Gy). RESULTS: Sixty-four patients (40 males and 24 females) with a median age of 63 years (range, 43-79 years) entered the study. T and N stage were distributed as follows: T1 2 patients (3.2%), T2 10 patients (15.6%), T3 15 patients (23.4%), T4 37 patients (57.8%); N0 10 patients (15.6%), N1 1 patient (1.6%), N2 26 patients (40.6%), N3 26 patients (40.6%), and N missing 1 patient (1.6%). Seven patients (10.9%) suffered from grade 3/4 oesophagitis. Grade 1/2 oesophagitis occurred in 36 patients (56.3%) and pneumonitis grade 1/2 occurred in 10 patients (15.6%). Sixty-three patients were evaluated on an intent-to-treat basis. The overall response rate was 74.6%. The median time to progression was 247 days and median overall survival was 461 days. According to subgroup analyses, no statistically significant differences were noted according to gender, age (<65 vs. > or =65 years), performance status, histology, or study centre. CONCLUSION: Induction chemotherapy followed by concurrent chemoradiotherapy with weekly cycles of paclitaxel and carboplatin is feasible and generates moderate toxicity. Efficacy is comparable to other recently published regimens. However, prognosis remains, in general, poor for this group of patients and further work to develop better therapy is required.

Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial.

BACKGROUND: Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will ultimately develop in approximately 50% of patients, with the liver being the most common site for metastases. The median survival for patients with liver metastases is between 6 and 12 months, and no treatment has in randomized trials ever been shown to prolong survival. A previous phase II trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period (26 versus 12 months). METHODS/DESIGN: This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care (BAC). Inclusion criteria include liver metastases (verified by biopsy) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography (PET-CT). The primary endpoint is overall survival at 24 months, with secondary endpoints including response rate, progression-free survival, and quality of life. The planned sample size is 78 patients throughout five years. DISCUSSION: Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists. This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint. TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT01785316 (registered 1 February 2013). EudraCT registration number: 2013-000564-29.