A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC)

Roszkowski, K.; Płużańska, A; Krzakowski, Maciej; Smith, A P; Saigí, Eugeni; Aasebø, Ulf; Parisi, Annamaria; Tran, Ngoc Pham; Olivares, Robert; Bérille, J.

doi:10.1016/s0169-5002(00)00094-5

Cited by 278 publications

(140 citation statements)

References 13 publications

Supporting

Mentioning

129

Contrasting

Unclassified

Order By: Relevance

“…than cisplatin. For example, single-agent paclitaxel (Ranson et al, 2000), docetaxel (Roszkowski et al, 2000), or vinorelbine (The Elderly Lung Cancer Vinorelbine Italian Study Group, 1999) significantly improved survival compared with best supportive care in patients with advanced NSCLC. Studies of single-agent gemcitabine (Perng et al, 1997) or irinotecan (Negoro et al, 2003) demonstrated a survival benefit comparable to that of second-generation chemotherapy regimens (cisplatin plus vindesine, cisplatin plus etoposide).…”

Section: Discussionmentioning

confidence: 99%

Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group Study (WJTOG9803)

Yamamoto

Fukuoka

et al. 2004

Br J Cancer

View full text Add to dashboard Cite

Docetaxel plus cisplatin and docetaxel plus irinotecan are active and well-tolerated chemotherapy regimens for advanced non-smallcell lung cancer (NSCLC). A randomised phase II study compared their efficacy and toxicity in 108 patients with stage IIIb/IV NSCLC, who were randomised to receive docetaxel 60 mg m À2 and cisplatin 80 mg m À2 on day 1 (DC; n ¼ 51), or docetaxel 60 mg m À2 on day 8 and irinotecan 60 mg m À2 on day 1 and 8 (DI; n ¼ 57) every 3 weeks. Response rates were 37% for DC and 32% for DI patients. Median survival times and 1-and 2-year survival rates were 50 weeks (95% confidence interval: 34 -78 weeks), 47 and 25% for DC, and 46 weeks (95% confidence interval: 37 -54 weeks), 40 and 18% for DI, respectively. The progression-free survival time was 20 weeks (95% confidence interval: 14 -25 weeks) with DC and 18 (95% confidence interval: 12 -22 weeks) with DI. Significantly more DI than DC patients had grade 4 leucopenia and neutropenia (Po0.01); more DC patients had grade X2 thrombocytopenia (Po0.01). Nausea and vomiting was more pronounced with DC (Po0.01); diarrhoea was more common with DI (P ¼ 0.01). Three treatment-related deaths occurred in DC patients. In conclusion, although the DI and DC regimens had different toxicity profiles, there was no significant difference in survival. Unfortunately, non-small-cell lung cancer (NSCLC) is a member of the group of neoplastic diseases that is relatively chemoresistant. Recent meta-analyses show that cisplatin-based chemotherapy improves survival (Non-Small Cell Lung Cancer Collaborative Group, 1995), and it is considered a standard treatment for NSCLC, Most cisplatin-based regimens have substantial toxicities that require close monitoring and supportive care. Thus, there is a need to develop active and less toxic chemotherapy regimens that include new active compounds with novel mechanisms of action.In the 1990s, several new, active therapies with single-agent response rates of 15 -30% became available for NSCLC, including irinotecan, docetaxel, paclitaxel, vinorelbine, and gemcitabine. Because irinotecan and docetaxel were approved for NSCLC earlier than the other drugs in Japan, development of regimens containing irinotecan or docetaxel is more advanced. Docetaxel 60 mg m À2

show abstract

Section: Discussionmentioning

confidence: 99%

Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group Study (WJTOG9803)

Yamamoto

Fukuoka

et al. 2004

Br J Cancer

View full text Add to dashboard Cite

show abstract

“…Second generation agents (gemcitabine, paclitaxel, docetaxel, vinorelbine, irinotecan and topotecan) showed response rates of 20 -25% . Moreover, randomised studies comparing monochemotherapy with paclitaxel, gemcitabine or docetaxel versus best supportive care showed a survival benefit in the chemotherapy arm, Ranson et al, 2000;Roszkowski et al, 2000) emphasising the results of the meta-analysis of the NSCLCCOG (Non-Small Cell Lung Cancer Collaborative Group, 1995). Additional reports of large randomised trials (one a pooled analysis of two trials), each conducted in more than 700 patients, have confirmed the survival benefit of cisplatinbased combined two-or three-agent chemotherapy versus best supportive care (Cullen et al, 1999;Stephens et al, 2002).…”

Section: Chemotherapymentioning

confidence: 99%

Platinum drugs in the treatment of non-small-cell lung cancer

Cosaert

Quoix

2002

Br J Cancer

View full text Add to dashboard Cite

The use of chemotherapy is considered standard therapy in patients with locally advanced non-small-cell lung cancer that cannot be treated with radiotherapy and in those with metastatic non-small-cell lung cancer and good performance status. This approach is also accepted in patients with earlier stage disease, when combined with radiotherapy in those with nonresectable locally advanced disease, or in the preoperative setting. Randomised clinical studies and meta-analyses of the literature have confirmed the beneficial survival effect of platinum-based chemotherapy. Cisplatin and carboplatin have been successfully used with other drugs in a wide variety of well-established two-drug combinations while three-drug combinations are still under investigation. Cisplatin and carboplatin use is limited by toxicity and inherent resistance. These considerations have prompted research into new platinum agents, such as the trinuclear platinum agent BBR3464, the platinum complex ZD0473 and oxaliplatin. These compounds could be developed in combination with agents such as paclitaxel, gemcitabine or vinorelbine in patients with advanced and/or refractory solid tumours.

show abstract

“…The survival benefit has been confirmed on a number of subsequent randomised trials comparing the newer agents (vinorelbine, paclitaxel, docetaxel) against best supportive care alone (Elvis, 1999;Ranson et al, 2000;Roszkowski et al, 2000). Furthermore, a gemcitabine study demonstrated significant improvements in relief of disease-related symptoms and quality of life (QoL) assessed by an EORTC validated questionnaire, with a reduction in hospitalisation and need for radiotherapy .…”

mentioning

confidence: 92%

Domiciliary chemotherapy with gemcitabine is safe and acceptable to advanced non-small-cell lung cancer patients: results of a feasibility study

et al. 2003

View full text Add to dashboard Cite

A study was conducted to investigate the feasibility and acceptability of administering single-agent gemcitabine to patients with advanced non-small-cell lung cancer (NSCLC) in their own homes. Gemcitabine is an active agent in NSCLC with a good toxicity profile and lends itself to this type of investigation. A total of 24 patients were studied; as only one patient required gemcitabine to be changed from home administration to hospital administration, domiciliary gemcitabine is feasible. A total of 249 injections of gemcitabine were given, the mean number of courses being 3.5, range 1 -6. The gemcitabine was given at 1000 mg m À2 on days 1, 8 and 15, the courses being repeated every 28 days. All patients received their first course in hospital and in total 147 were given at home and only 14 in hospital on courses 2 -6. Furthermore, both the patients and carers reported positively on the use of domiciliary gemcitabine and preferred it over hospital administration. There was no evidence of increasing burden to community services during the domiciliary chemotherapy. Further studies investigating this approach are warranted.

show abstract

A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC)

Cited by 278 publications

References 13 publications

Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group Study (WJTOG9803)

Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group Study (WJTOG9803)

Platinum drugs in the treatment of non-small-cell lung cancer

Domiciliary chemotherapy with gemcitabine is safe and acceptable to advanced non-small-cell lung cancer patients: results of a feasibility study

Contact Info

Product

Resources

About