Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer.

Fossella, Frank V.; Lee, J S; Shin, D M; Calayag, Mark; Huber, Martin; Pérez-Soler, R.; Murphy, William K.; Lippman, Scott M.; Benner, Steven E.; Glisson, Bonnie S.

doi:10.1200/jco.1995.13.3.645

Cited by 232 publications

(68 citation statements)

References 16 publications

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“…The response rate in our study (37%; 95% CI, 24-49) seems very promising and is higher than the reported 16-22% in phase II studies for single-agent docetaxel as second-line treatment [13][14][15]. Fossella et al found in a randomised phase III trial response rates of 11 and 7% for single-agent docetaxel 100 and 75 mg/m 2 every 3 weeks, respectively [17].…”

Section: Discussionsupporting

confidence: 40%

“…The activity of new cytotoxic drugs such as gemcitabine, vinorelbine and paclitaxel in second-line setting is not well defined [5][6][7][8][9][10][11][12]. Most promising experience in second-line chemotherapeutic treatment of NSCLC is with docetaxel, which in phase II studies showed favourable tumour responses ranged from 16 to 22% [13][14][15]. However, a randomised study with docetaxel at a dose of 75 mg/m 2 compared to best-supportive care showed a lower response rate (7%), but still a significant improvement in survival and quality of life, without an excess of toxicity [16].…”

Section: Introductionmentioning

confidence: 99%

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Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC

Wachters¹,

Putten

Boezen

et al. 2004

Lung Cancer

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Section: Discussionsupporting

confidence: 40%

Section: Introductionmentioning

confidence: 99%

Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC

Wachters¹,

Putten

Boezen

et al. 2004

Lung Cancer

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“…The most promising data were shown for chemotherapy with docetaxel and Pemetrexed (Hanna et al, 2004). Those drugs showed consistently good survival data in pretreated patients and represent the treatment of choice in second-line setting (Fossella et al, 1995(Fossella et al, , 2000b. Over the last years, also newly developed drugs such as EGFR or VEGFR blocking agents were introduced for second-line treatment.…”

Section: Discussionmentioning

confidence: 99%

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

et al. 2007

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Single-agent therapy with Docetaxel or Pemetrexed is the current therapy of choice for second-line treatment in advanced nonsmall-cell lung cancer (NSCLC). The role of older agents was underattended over the last years. This study presents the combination of Mitomycin C and Vinorelbine in pretreated patients. Forty-two patients (stage IIIB and IV, pretreated with platinum-based chemotherapy) received 8 mg m À2 Mitomycin C on day 1 and 25 mg m À2 Vinorelbine on days 1 and 8 of a 28-day cycle. End points were objective tumour response, survival, and toxicity. Additionally, quality of life (QoL) was assessed. Five patients (11.9 %) achieved partial responses and 13 patients (31.9%) stable disease. Progression-free survival was 16 weeks. The median overall survival was 8.5 month. Eleven patients (26.2 %) suffered from grade 3 or 4 neutropenia and four patients (9.52%) from grade 3 or 4 anaemia. Evaluation of QoL showed that some items ameliorated during therapy. The therapeutic concept including Mitomycin C and Vinorelbine offers an efficacious and well-tolerated regimen, with relatively low toxicity. Objective response and survival data correlate with other second-line studies using different medication. As costs of Mitomycin C and Vinorelbine are lower compared with current drugs of choice, this regimen is likely to be cost-saving.

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“…As a result, new drugs with demonstrated activity against NSCLC, such as the taxanes (Gatzemeier et al, 1995;Fossella et al, 1995), topoisomerase inhibitors (Fukuoka et al, 1992), gemcitabine (Noble and Goa, 1997) and vinorelbine (Lilenbaum and Grece, 1993;Goss et al, 1997) have aroused considerable interest. In particular, vinorelbine has been shown to increase survival in patients aged more than 70 years in comparison with the best supportive care alone (ELCVISG, 1999), and the favourable toxicological profile of gemcitabine allows its use in both unfit and elderly patients.…”

mentioning

confidence: 99%

Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

et al. 2000

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Summary Cisplatin-based combinations are efficacious in increasing the overall survival of patients with non-small cell lung cancer (NSCLC), but their toxicity makes them unsuitable for elderly and unfit patients. The primary objective of this non-randomized phase II study was to evaluate the feasibility and activity of the gemcitabine plus vinorelbine combination in previously untreated elderly and/or unfit patients with measurable stage III or IV NSCLC. Forty-three patients aged ≥ 65 years or with contraindications against cisplatin treatment (36 males and seven females: median age 66 years; range 48-75: PS 0 = 11, PS 1 = 19, PS 2 = 13) received intravenous (i.v.) gemcitabine 1000 mg m -2 , followed by vinorelbine 25 mg m -2 i.v. on day 1 and 8 every 21 days. Fifteen patients (34.9%) achieved partial remission (confidence interval: 27.6-42.2%) for a median duration of 6 months; the median survival of these patients has not yet been reached. A further 15 had stable disease for a median of 4 months and a median survival of 7 months. The 10 patients (23.2%) who experienced disease progression had a median survival of 4 months. Three patients are not evaluable. The 1-year actuarial survival rate is 31.1%. The treatment was well tolerated: only 35% of the patients had grade 3 or 4 granulocytopenia on day 14, none experienced episodes of neutropenic fever, and there was no evidence of severe haematological toxicity upon recycling. Only 9% of the patients suffered from gastrointestinal toxicity (grade 3); increased but reversible transaminase levels were observed in 11.6%. In conclusion, the results of this phase II study show that the combination of gemcitabine and vinorelbine is active and well tolerated in NSCLC, and thus encourage its use in elderly or unfit patients.

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Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer.

Abstract: Docetaxel administered at 100 mg/m2 intravenously every 3 weeks has notable activity against platinum-refractory non-small-cell lung cancer, with a 21% major response rate. Primary side effects were neutropenia, hypersensitivity, and fluid retention.

Cited by 232 publications

References 16 publications

Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC

Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

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