Vinorelbine versus paclitaxel for patients with advanced non-small cell lung cancer (NSCLC) and a performance status of 2.

AIM: The purpose of this study was to compare two single agents paclitaxel (intravenous) versus vinorelbine (oral) in non-small cell lung cancer (NSCLC) patients with performance status (PS):2. PATIENTS AND METHODS: The patients were randomized to receive either oral vinorelbine 60 mg/m(2) on days 1, 8, 15 every 4 weeks for 4 cycles (group A) or paclitaxel 90 mg/m(2) intravenously for 1 h on days 1, 8, 15 every 4 weeks for a total of 4 cycles (group B). RESULTS: Among the 74 eligible patients (36 in arm A and 38 in arm B) in arm A, two (6%) had a partial response (95% CI, 0.7-18.7) and 5 (14%) had stable disease (95% CI, 4.7-29.5). In arm B, five (13%) had a partial response (95% CI, 4.4-28.1) and 7 (18%) had stable disease (95% CI, 7.7-34.3). No significant difference was found in terms of clinical benefit between the two groups after two cycles of treatment except for appetite in favour of paclitaxel (p=0.01). Median survival was 3.1 months (95% CI, 2.2-4.0) for arm A and 5.1 months (95% CI, 2.7-7.6) for arm B (p=0.95). Toxicity was mild and only alopecia was more profound in the patients of arm B (p=0.008). CONCLUSION: No significant difference was found in clinical benefit between PS:2 NSCLC patients treated with either vinorelbine or paclitaxel.

Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: a prospective randomized phase II study of the Hellenic Cooperative Oncology Group.

BACKGROUND: The purpose of this study was to evaluate gemcitabine-carboplatin (GCb) versus single-agent gemcitabine (G) in patients with advanced non-small cell lung cancer (NSCLC) and a performance status (PS) of 2. The primary endpoint was clinical benefit. PATIENTS AND METHODS: Patients were randomly assigned to either 1250 mg/m of G (arm A) or 1250 mg/m of G plus carboplatin area under the curve of 3 (arm B). Both treatments were given on days 1 and 14 and were repeated every 28 days for up to four cycles. RESULTS: Among the 90 eligible patients (47 in arm A and 43 in arm B), in arm A, two (4%) had partial responses (95% CI, 0.52%-14.5%) and 10 (21%) had stable disease (95% CI, 10.7%-35.7%). In arm B, six (14%) had partial responses (95% CI, 5.3%-27.9%) and nine (21%) had stable disease (95% CI, 10%-36%) (p = 0.14). No significant difference was found in terms of clinical benefit between the two treatment groups after two cycles of treatment or at the end of chemotherapy. Furthermore, no association was found between clinical benefit and response to treatment (p > 0.05). Median survival was 4.8 months (95% CI, 2.45-7.25) for arm A and 6.7 months (95% CI, 2.47-10.8) for arm B (p = 0.49). Neutropenia (p = 0.007) and thrombocytopenia (p < 0.001) were more common in group B. Nevertheless, no significant differences were found in terms of severe toxicities (p > 0.05 in all cases). CONCLUSION: No significant difference was found in terms of clinical benefit in patients with NSCLC and PS 2 who received single-agent G or GCb. Nevertheless, GCb caused more toxicity, particularly neutropenia and thrombocytopenia.

Advanced stage mucinous epithelial ovarian cancer: the Hellenic Cooperative Oncology Group experience.

OBJECTIVE: Mucinous epithelial ovarian cancer (mEOC) representing about 10% of all EOC are known to be possibly resistant to platinum-based chemotherapy and bear a poorer prognosis with respect to other subtypes of EOC. This study was undertaken to compare response and survival to platinum-based chemotherapy between patients with advanced stages III and IV mEOC and serous EOC (sEOC). METHODS: A retrospective analysis was performed in 47 patients with advanced stage of mEOC treated with first-line platinum-based chemotherapy in the context of several study protocols of the Hellenic Cooperative Oncology Group (HeCOG) between 6/7/1983 and 25/2/2003. The outcome was compared to that of 94 patients with sEOC treated with the same protocols during the same study period (ratio mucinous: serous 1:2). RESULTS: One hundred forty-one patients (47 stages III and IV mEOC, 94 stages III and IV sEOC) treated with platinum-based chemotherapy were analyzed. The overall response rate for mEOC was 38.5% (complete remission 18%) (95% CI 23.4-55.4%) and 70% (complete remission 47%) (95% CI 58.5-80.3%) for sEOC (P = 0.001). After a median follow-up of 77.8 months, median survival and time to tumor progression (TTP) were not significantly different between the two groups (33.2 months [95% CI 23.3-43.1 months] vs. 38.0 months [95% CI 26.8-49.2 months], P = 0.46, 11.8 months [95% CI 7.2-16.4 months] vs. 20.0 months [95% CI 15.7-24.2 months], P = 0.18, respectively). CONCLUSION: Patients with mEOC have significantly lower response to first-line platinum-based chemotherapy compared to patients with sEOC. This low response to platinum-based chemotherapy was not translated in inferior TTP or survival. Our data indicate that a new strategy for chemotherapy in mEOC should be adopted, one that focuses on new agents without cross-resistance to platinum agents.