Gemcitabine combined with either pemetrexed or paclitaxel in the treatment of advanced non-small cell lung cancer: a randomized phase II SICOG trial.

PURPOSE: To estimate the safety, activity, and impact on quality of life of a combination of gemcitabine and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in the context of a randomized two-stage phase II study. PATIENTS AND METHODS: Patients in stage IIIB or IV NSCLC were randomly allocated to receive either gemcitabine 1250 mg/m(2) on day 1, and pemetrexed (Alimta) 500 mg/m(2) followed by gemcitabine 1250 mg/m(2) on day 8 of a 3-weekly cycle (GA arm), or paclitaxel 120 mg/m(2) followed by gemcitabine 1000 mg/m(2), both given on days 1 and 8 of a 3-weekly cycle (PG arm). RESULTS: 105 (GA arm, 51; PG arm, 54) eligible patients (stage IV, 32 and 30, respectively) were enrolled into this study; thereafter, accrual was stopped due to first-stage analysis. The response rate was 20% (95% confidence interval [CI], 10-33%) in the GA arm, and 32% (95% CI, 20-46%) in the PG arm. Median progression-free survival was 5.1 (95% CI, 3.7-6.5) months in the GA arm, and 8.3 (95% CI, 5.9-10.7) months in the PG arm, while median overall survival was 10.5 (95% CI 7.1-13.9), and 13.3 (95% CI 11.7-14.9) months, respectively. Severe neutropenia (36% vs 22%), and febrile neutropenia (14% vs 7%) were more common with the GA regimen, while hair loss (52% vs 16%) and any grade peripheral neuropathy (31% vs 2%) occurred more frequently with PG regimen. Other severe side effects of GA regimen were diarrhoea (10%), liver enzyme derangement (10%), and fatigue (8%). CONCLUSION: The GA regimen was tolerated and moderately active in advanced or metastatic NSCLC. However, this combination did not yield any advantage in comparison with the PG regimen, and does not deserve further evaluation.

CT-guided radiofrequency ablation: a potential complementary therapy for patients with unresectable primary lung cancer--a preliminary report of 33 patients.

OBJECTIVE: We report our preliminary evaluation of the effectiveness, safety, technical feasibility, and complications of palliative CT-guided radiofrequency ablation of unresectable primary pulmonary malignancies. SUBJECTS AND METHODS: Thirty-three patients (26 men and seven women; age range, 44-75 years; mean age, 66 years) with unresectable malignant lung neoplasms underwent 35 CT-guided tumor ablation sessions. Follow-up CT was performed 6 months (29 cases) and 1 year (10 cases) after treatment. In 19 patients, these findings were correlated with cytohistopathologic assessment obtained with CT-guided fine-needle aspiration biopsy or core biopsy at 6-month follow-up. Size and CT appearance of the treated lesions were correlated with cytohistologic features and clinical scores. RESULTS: Thirty-five technically successful radiofrequency ablation treatments were performed. The only complications in the periprocedural period were three cases of minor pneumothorax, five cases of sputum cruentum, and three asymptomatic pleural effusions. Contrast-enhanced CT performed at 6-month follow-up showed four cases of complete and 13 cases of partial lesion ablation, 11 cases of stabilized lesion size, and one case of increased lesion size. Contrast-enhanced CT performed at 1-year follow-up showed unchanged lesion size in six cases and reduction in four cases. Six-month cytohistologic examinations showed total coagulation necrosis in seven lesions and partial necrosis in 12. Clinical improvement in pretreatment symptoms was observed in 12 of 29 patients seen at 6-month follow-up. Eight patients died within 1 year of treatment of non-procedure-related causes. CONCLUSION: Our experience suggests that radiofrequency ablation can be used successfully in unresectable lung cancer as an alternative or complementary treatment to radio- or chemotherapy. Larger studies are necessary to fully evaluate its potential combination with other treatment techniques.

Carboplatin plus vinorelbine plus G-CSF in elderly patients with extensive-stage small-cell lung cancer: a poorly tolerated regimen. Results of a multicentre phase II study.

PURPOSE AND METHODS: A multicentre phase II trial (single-stage design) was undertaken to test the activity and toxicity of carboplatin (AUC 5 according to Calvert, day 1) plus vinorelbine (25 mg/m(2) days 1 and 8) with lenograstim support, every 3 weeks in the first line treatment of elderly patients, aged 65 or more, affected by extensive small-cell lung cancer (SCLC). The primary end-point of the trial was the objective response rate. Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial. RESULTS: Twenty-eight patients were enrolled (median age 70 years). Treatment was remarkably toxic. Three patients died while on treatment. Eleven patients (39.3%, 95% exact confidence interval (CI): 21.5-59.4) had an objective response, that was complete in 2 cases. Median time to progression was 5.1 months (95% CI: 3.3-6.7). Median survival was 7.9 months (95% CI: 4.8-14.4). CONCLUSION: Carboplatin plus vinorelbine is poorly tolerated and not sufficiently active to warrant phase III comparison with standard chemotherapy regimens in elderly patients with extensive SCLC.