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Abstract
Background. sequential chemotherapy can maintain dose intensity and preclude cumulative toxicity by increasing drug diversity. Purpose. to investigate the toxicity and efficacy of the sequential regimen of gemcitabine followed by paclitaxel in first line advanced stage non-small cell lung cancer (NSCLC) patients with good performance status (PS). Patients and methods. gemcitabine 1250 mg/m2 was administered on day 1 and 8 of course 1 and 2; Paclitaxel 150 mg/m2 on day 1 and 8 of course 3 and 4. Primary endpoint was response rate (RR), secondary endpoints toxicity and time to progression (TTP). Results. Of the 21 patients (median age 56, range 38–80 years; 62% males, 38% females) 10% (2/21) had stage IIIB, 90% (19/21) stage IV, 15% PS 0, 85% PS 1. 20% of patients had a partial response, 30% stable disease, 50% progressive disease. Median TTP was 12 weeks (range 6–52 weeks), median overall survival (OS) 8 months (range 1–27 months), 1-year survival was 33%. One patient had grade 3 hematological toxicity, 2 patients a grade 3 peripheral neuropathy. Conclusions. sequential administration of gemcitabine followed by paclitaxel in first line treatment of advanced NSCLC had a favourable toxicity profile, a median TTP and OS comparable with other sequential trials and might, therefore, be a treatment option for NSCLC patients with high ERCC1 expression.
Highlights
Even with the use of novel chemotherapeutic agents, the prognosis of patients with advanced non-small cell lung cancer (NSCLC) remains poor
In this non-randomised phase II study, the sequential administration of single agent gemcitabine followed by paclitaxel in the first line treatment of advanced NSCLC had a favourable toxicity profile, a median time to progression (TTP), and overall survival (OS) comparable with other sequential trials reported in the literature (Table 1) [9,10,11,12,13,14,15,16,17,18,19,20]
When we designed our study (2002-2003) Vansteenkiste et al reported that treatment of patients with symptomatic advanced NSCLC with single agent gemcitabine resulted in a superior clinical-benefit response rate compared to cisplatinbased combination chemotherapy
Summary
Even with the use of novel chemotherapeutic agents, the prognosis of patients with advanced NSCLC remains poor. Platinum-based chemotherapy combined with either gemcitabine, vinorelbine, paclitaxel, or docetaxel is currently the mainstay in the treatment of advanced NSCLC[1,2,3,4,5]. Chemotherapy may lead to the selection of chemoresistant tumor clones. Frequent exposure to different cytotoxic agents with brief intervals may inhibit tumor regrowth and limit the emergence of drug resistant cell lines [6, 7]. Sequential chemotherapy administration offers the possibility to increase drug diversity while maintaining dose intensity, potentially leading to less dose reductions, an optimal dose intensity, and prolonged treatment duration and disease control [6, 7]
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