Randomized Trial of Paclitaxel Plus Supportive Care Versus Supportive Care for Patients With Advanced Non-Small-Cell Lung Cancer

Abstract

The addition of paclitaxel to best supportive care significantly improved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL.

Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

“…As for the PTX arm, MST (6.4 months) and 1-year SR (24%) achieved in our study were comparable to those (6.8 months, and 35%, respectively) reported in a phase III trial comparing this drug with supportive care alone (Ranson et al, 2000). Moreover, in a large randomised study evaluating the addition of carboplatin to PTX in NSCLC patients, the single-agent PTX treatment yielded in the subset of elderly patients a MST of 5.0 months, with 1-year SR of 31% (Bunn and Lilenbaum, 2003).…”

“…The first one of these studies has been the ELVIS trial (Elderly Lung cancer Vinorelbine Italian Study Group, 1999), which showed an advantage in the median survival time (MST) (28 vs 21 weeks) for elderly patients receiving single agent vinorelbine as compared to those treated with supportive care alone. Single agent paclitaxel was also demonstrated to produce a 2-month longer MST (6.8 vs 4.8 months) in comparison with supportive care in a randomised trial with no upper limit of age for accrual (Ranson, 2000), and this drug appeared highly attractive for treating elderly patients, in view of the increasing evidence that a weekly schedule may improve its toxicity profile (Alberola et al, 2002). Furthermore, retrospective (Martin et al, 1997;Shepherd et al, 1997) and prospective studies (Altavilla et al, 2000;Anderson et al, 2000;Ricci et al, 2000) have also supported the use of gemcitabine in elderly NSCLC patients, given its good tolerability and activity regardless of age.…”

A randomised phase II trial of docetaxel vs docetaxel and irinotecan in patients with stage IIIb–IV non-small-cell lung cancer who failed first-line treatment

“…Addition of irinotecan to docetaxel does not improve response rate, and increases gastrointestinal toxicity. Treatment with platinum-based chemotherapy improves survival and quality of life in patients with advanced non-small-cell lung cancer (NSCLC) (Souquet et al, 1993; Non-small Cell Lung Cancer Collaborative Group, 1995; Cullen et al, 1999;Anderson et al, 2000;Ranson et al, 2000;Schiller et al, 2002). Since two trials demonstrated clinically beneficial effects of docetaxel in second-line setting (Fossella et al, 2000;Shepherd et al, 2000), docetaxel 75 mg m À2 is currently considered the standard regimen to which other experimental schedules should be compared.…”

A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

“…In the majority of phase III studies, stage IIIB contribute 10 -40% (Frasci et al, 2000;Ranson et al, 2000;Kelly et al, 2001;Scagliotti et al, 2002;Schiller et al, 2002) of patients and stage IV patients would vary considerably in disease bulk outside the thorax (Frasci et al, 2000;Ranson et al, 2000;Scagliotti et al, 2002). Systemic therapy is associated with a median survival ranging from 6 to 8 months.…”

“…However, local control is still relevant in patients treated with chemotherapy alone, with up to 10 -50% requiring local palliative radiation. Ranson et al, 2000).…”