Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC)

Biliary tract cancer is a rare malignant tumor. Accordingly, to perform prospective and randomized trials is difficult and the knowledge of its natural history and optimal management remains limited. Chemotherapy is commonly used to improve the outcome and to delay tumor progression in advanced disease. Only recently, cisplatin-gemcitabine combination was identified as the new standard first-line therapy. Despite the outcome improvement, disease progression is a constant and approximately half of patients failing upfront treatment maintain a good performance status and are willing to undergo further treatment. No standard salvage chemotherapy regimen has been identified yet. Experiences of salvage therapy in advanced biliary tract cancer are sparse and yielded disappointing results. Well designed multi-institutional randomized trials are warranted to clarify the role and the activity of a second-line therapy.

Second-line therapy in advanced biliary tract cancer: what should be the standard?

Gemcitabine plus oxaliplatin combination (GEMOX regimen) in pretreated patients with advanced non-small cell lung cancer (NSCLC): a multicenter phase II study.

Purpose: It was the aim of this study to evaluate the activity and tolerance of gemcitabine and oxaliplatin in pretreated metastatic breast cancer patients. Methods: Thirty-one patients who had disease relapse or progression after completion of an anthracycline- and/or taxane-based front-line regimen were treated with gemcitabine 1,500 mg/m2 on days 1 and 8 as a 30-min intravenous infusion and oxaliplatin 130 mg/m2 on day 8 as a 4-hour intravenous infusion, in cycles of 21 days. Results: Complete response occurred in 1 patient (3%) and partial response in 4 patients (13%) (overall response rate 16%; 95% confidence interval 3.2–29.1). Nine patients (29%) had stable disease and 17 (55%) progressive disease. Three partial responses (13%) were achieved among 23 patients receiving the regimen as third-line treatment. The median duration of response was 6 months (range 3–44.8), the median time to tumor progression 4.6 months (range 0.8–43.8), and the median survival 14.4 months (range 2.1–44.8). Grade 3 and 4 neutropenia occurred in 14 patients (45%), grade 3 and 4 thrombocytopenia in 6 patients (20%), and grade 2 and 3 asthenia in 4 patients (13%). There was no episode of febrile neutropenia. Conclusion: The gemcitabine-oxaliplatin combination is a relatively active and well-tolerated salvage regimen in patients with heavily pretreated metastatic breast cancer.

Salvage chemotherapy with gemcitabine and oxaliplatin in heavily pretreated patients with metastatic breast cancer: a multicenter phase II study.

A platinum-based doublet with a third-generation agent (paclitaxel, vinorelbine, gemcitabine, docetaxel) represents the standard first-line treatment for advanced non-small cell lung cancer patients with good performance status (PS). Traditional chemotherapy provides response rates of 20%-40% and a median survival of 8-10 months. In an attempt to improve its outcome, alternative schedules have been proposed, namely sequential, alternating, and maintenance/consolidation therapy. Sequential chemotherapy with a platinum-based doublet followed by a single agent is feasible in patients with good PS; preliminary results from randomized phase III trials with combination chemotherapy as a comparator are promising, suggesting similar efficacy and a better toxicity profile for the sequential arm. The use of sequential single agents is an option for elderly and frail patients unsuitable for a platinum-based combination. Based on trials published so far, it is unlikely that an alternating chemotherapy strategy will be proven superior to standard chemotherapy in patients with good PS. However, sufficient evidence exists that it could be appropriate in the elderly or in unfit individuals. Consolidation/maintenance chemotherapy may provide additional benefit for patients achieving disease control after standard first-line chemotherapy. Better results are seen when maintenance consists of an agent that has proven active in the induction phase. Further evaluation of this strategy, as well as of consolidation/maintenance therapy with targeted agents, is warranted. In conclusion, these approaches may improve the outcome in selected patients with advanced non-small cell lung cancer, but further results from randomized trials are needed. In the meantime, sequential, alternating, and maintenance/consolidation therapy should still be considered investigational.

Sequential, alternating, and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer : A review of the literature

7118 Background: Platinum analogues have shown good activity and better toxicity profile than cisplatin/GEM regimens in advanced NSCLC, while sequential administration of two platinum/non-platinum ...

Preliminary results of a randomized phase II three-arm, multicentric study of carboplatin + gemcitabine (CBDCA + GEM), or oxaliplatin (L-OHP) + GEM, or sequential CBDCA + GEM→ docetaxel (DCT) + GEM in chemo-naive patients (pts) with advanced/metastatic non small cell lung cancer (NSCLC)

6626 POSTER Efficacy and Safety of RAD001 as Second Line Therapy in Biliary Tract Cancer (BTC) Patients (pts) – a Phase II I.T.M.O. (Italian Trials in Medical Oncology) Group Study

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Preliminary results of a randomized phase II three-arm, multicentric study of carboplatin + gemcitabine (CBDCA + GEM), or oxaliplatin (L-OHP) + GEM, or sequential CBDCA + GEM→ docetaxel (DCT) + GEM in chemo-naive patients (pts) with advanced/metastatic non small cell lung cancer (NSCLC)

6626 POSTER Efficacy and Safety of RAD001 as Second Line Therapy in Biliary Tract Cancer (BTC) Patients (pts) – a Phase II I.T.M.O. (Italian Trials in Medical Oncology) Group Study