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| |  ICACT: Oxaliplatin Plus Gemcitabine Show Activity and Safety in Patients With Advanced Non-Small-Cell Lung Cancer By Chris Berrie PARIS, FRANCE -- February 1, 2005 -- The combination of gemcitabine and oxaliplatin may be a valid alternative to front-line cisplatin-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC), researchers report. These findings, from a multicentre, randomised, three-arm, phase 2 trial that was presented here February 1st at the 16th International Conference on Anti-Cancer Treatment. Diego Cortinovis, MD, Medical Oncologist, National Cancer Institute of Milan, Milan, Italy, presented the study on behalf of the Italian Trials in Medical Oncology. "As an alternative to cisplatin, carboplatin appears to be less efficacious but with a better toxicity profile, and so several platinum analogues are now being developed around carboplatin with the aim of improving the efficacy and tolerability of cisplatin regimens," Dr. Cortinovis said. Their own preliminary data of the sequential combination of gemcitabine with the new third-generation platinum compound oxaliplatin indicated that the encouraging antineoplastic activity and safe toxicity profile of oxaliplatin might make it a suitable alternative to cisplatin, he explained. In the study, patients who were not previously treated with chemotherapy were entered into Arms A and B of this study, which consisted of their standard carboplatin plus gemcitabine treatment. This regimen consisted of carboplatin at an area under the curve (AUC) of 5 on day 1 and gemcitabine at 1000 mg/m2 on days 1 and 8, repeated every 3 weeks for 3 or 6 cycles). A total of 48 patients with advanced NSCLC at stage IIIB or IV moved on to arm C of the trial. This group was 75% male and had a median age of 64 years (range, 36 to 75 years). They had Eastern Cooperative Oncology Group performance levels of 0 (n = 29), 1 (n = 18) and 2 (n = 1). A large majority of patients had adenocarcinoma (n = 29). In arm C of the study, patients received up to 6 cycles at 3-week intervals of the combination of 130 mg/m2 oxaliplatin IV infusion over 3 hours on day 1 of each cycle and 1250 mg/m2 gemcitabine IV on days 1 and 8 of each cycle. After the third cycle and at the end of the programme, patients who were responsive or had stable disease were assessed according to the World Health Organisation criteria for NSCLC, and toxicity was assessed according to National Cancer Institute Common Toxicity Criteria. In the 36 patients assessed so far, 36% of patients had partial responses, 39% had disease stabilisation, and 22% had disease progression. One patient developed heart failure after the second cycle and was not evaluated. The median durations of the RR and patient stabilisation were 5 (range, 2-10+ months) and 4 (range, 1-8 months) months. Of the nonhaematological toxicities in the 180 cycles, transient nausea/vomiting was most frequent (18%), although 11% developed typical oxaliplatin neurotoxicity. While grade 3/4 neutropenia developed in 2% of cycles, grade 3/4 thrombocytopenia or leukopaenia were not common, as they were each associated with only a single cycle. There were no treatment-related deaths. Dr. Cortinovis noted that it was difficult to compare the results of this study directly with the limited patient data from previous studies that included oxaliplatin because they included different treatment schedules and small patient numbers. He concluded that the combination of oxaliplatin with gemcitabine evaluated in this study must be tested in phase 3 trials to determine if, indeed, it can be used as a substitute for the standard cisplatin plus gemcitabine treatment in patients with NSCLC, thereby avoiding the non-manageable toxicity profile associated with cisplatin use.
[Study Title: Oxaliplatin + Gemcitabine (L-OHP + GEM): a New Platinum-Analogue Doublet in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC): Subset Analysis of a Randomised, Three-Arms Phase 2 ITMO Study.]
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