Comparing comparators: a look at control arms in kidney cancer studies over the years.

In the past decade, an increasing number of frequently positive randomised clinical trials have been completed, allowing new consideration of the present therapeutic armamentarium for advanced renal cell carcinoma. These studies were predominantly designed to compare the experimental drugs with 1 of 2 active control arms: interferon alpha-2a or sorafenib. Different from expectations, the final results of some of these studies were not in line with the predictions, and the reasons have not been fully investigated. Consequently, there is a great need for careful analysis of the studies carried out so far, chiefly the role and validity of the control arms. In this regard, the examination of patient baseline characteristics and other factors of potential interest seems fundamental for a correct analysis of the results of these trials and consequent optimal use of the available targeted agents.

Phase II study of high-dose paclitaxel and carboplatin in previously untreated, unresectable non-small cell lung cancer.

INTRODUCTION: This phase II study was designed to assess the activity and tolerability of the carboplatin-paclitaxel combination, given without routine growth factor support to previously untreated patients with stage IIIB and IV non-small cell lung cancer. PATIENTS AND METHODS: Sixty patients (15 stage IIIb and 45 stage IV) received paclitaxel 225 mg/ml on day 1, followed by carboplatin AUC 6 mg/ml per minute (Calvert formula) every 3 weeks. Paclitaxel was administered as a 3-h intravenous infusion followed by carboplatin over 30 min, on completion of paclitaxel administration. RESULTS: The combination showed a good safety profile with Grade 4 neutropenia occurring in 31% of patients without any serious infectious episodes requiring hospitalization. Moderate to severe anemia and thrombocytopenia seldom occurred. Sensorimotor peripheral neuropathy (Grade 2-3) and myalgia (Grade 3-4) were documented in 34 and 20% of the patients, respectively. Among 59 evaluable patients, there was one complete response and 26 partial responses for an overall response rate of 46% (95% C.I.: 34-59%). With a minimum follow-up duration of 16.5 months, the median overall survival time is 52 weeks and the 1-year survival rate is 50%. Median duration of response is 20 weeks (range: 4-52) and progression-free survival is 22 weeks (range: 5-77). CONCLUSION: In advanced NSCLC, the combination carboplatin-paclitaxel at doses of AUC 6 mg/ml per minute and 225 mg/ml every 3 weeks, is both active and relatively well-tolerated.

Gemcitabine and cisplatin combination in early-stage non-small-cell lung cancer.

A number of randomized clinical trials now support the conclusion that the combined-modality regimen that includes gemcitabine (Gemzar) and cisplatin (Platinol) may improve survival in disseminated non-small-cell lung cancer. Cisplatin is considered to be the "backbone" of this combination chemotherapy due to its proven activity. The regimen of gemcitabine and cisplatin has been tested and is now considered among the most active combinations in the treatment of disseminated non-small-cell lung cancer.

[Orbital embryonal rhabdomyosarcoma in adults. Report of 2 cases]. / Rabdomiosarcoma embrionale dell'orbita in età adulta. Descrizione di due casi.

Rhabdomyosarcoma (RMS) is the most frequent sarcoma of infancy. Embryonal RMS is generally correlated with a better response to chemotherapy. In the present paper two cases of embryonal RMS of the orbit affecting adult patients are reported. Both patients are male, aged 22 and 24 years respectively. In Case 1 the lesion arose primitively in the orbit, in Case 2 the orbit was affected by secondary involvement. Both patients presented a rapid response to chemotherapy, with reduction of the neoplastic mass and regression of symptoms.