Comparison of docetaxel/cisplatin to docetaxel/gemcitabine as first-line treatment of advanced non-small cell lung cancer: early results of a randomized trial

Georgoulias, Vassilis; Samonis, George; Papadakis, E.; Alexopoulos, Athanasios; Tsiafaki, Xanthi; Rapti, Aggeliki; Veslemes, M.; Grigoratou, T.; Palamidas, Ph.; Kouroussis, Ch.; Mavroudis, Dimitriοs; Kakolyris, Stylianos; Giannakakis, T.; Vlachonikolis, John

doi:10.1016/s0169-5002(01)00417-2

Cited by 33 publications

(14 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Another 10 articles were excluded after peer review for the reasons shown in Fig. 1a [11][12][13][14][15][16][17][18][19][20]. Thus, 9 trials were ultimately assessed and analyzed [5][6][7][21][22][23][24][25][26].…”

Section: Resultsmentioning

confidence: 99%

Non-platinum regimens of gemcitabine plus docetaxel versus platinum-based regimens in first-line treatment of advanced non-small cell lung cancer: a meta-analysis on 9 randomized controlled trials

et al. 2012

Cancer Chemother Pharmacol

View full text Add to dashboard Cite

show abstract

Section: Resultsmentioning

confidence: 99%

Non-platinum regimens of gemcitabine plus docetaxel versus platinum-based regimens in first-line treatment of advanced non-small cell lung cancer: a meta-analysis on 9 randomized controlled trials

et al. 2012

Cancer Chemother Pharmacol

View full text Add to dashboard Cite

show abstract

“…The current trial combined two active third-generation NSCLC drugs, gemcitabine and vinorelbine, and yielded active response rates, comparable survival rates, and fewer and less severe toxic effects than were seen in previous Phase II or III studies of carboplatin/ cisplatin-based chemotherapy. The arguments for a nonplatinum-based regimen are strengthened by a recent randomized trial by Georgoulias et al 36,37 wherein docetaxel in combination with cisplatin was compared with docetaxel and gemcitabine. In that trial, although response and survival rates were equivalent between the two arms, the docetaxel and gemcitabine combination had a statistically significantly lower incidence of Grades 3 and 4 toxic effects.…”

Section: Discussionmentioning

confidence: 99%

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Herbst

Khuri

et al. 2002

Cancer

View full text Add to dashboard Cite

BACKGROUNDGemcitabine and vinorelbine are two of the most active third‐generation agents for the treatment of advanced nonsmall cell lung carcinoma (NSCLC). The authors conducted a formal Phase II trial to evaluate the efficacy of this combination in both untreated and previously treated patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC.METHODSA total of 78 patients were treated on the current Phase II trial of front‐line or second/third‐line therapy with gemcitabine and vinorelbine in NSCLC. Eligible patients manifested either untreated disease (n = 42) or had received at least one but not more than two prior chemotherapy regimens (n = 36). The median age was 59 years (range, 33–79) with 57 men (73%) and 21 women (27%). The median performance status was one (range, one to two). The initial eight patients (four untreated and four previously treated) were treated at a previously established maximum tolerated dose of vinorelbine (30 mg/m2) and gemcitabine (1000 mg/m2) on Days 1, 8, and 15, with significant myelosuppression seen in five out of eight patients requiring dose omission in the first cycle. The next 70 patients received a reduced dose of vinorelbine (25 mg/m2) followed by gemcitabine (900 mg/m2) on Days 1, 8, and 15.RESULTSSeventy eight patients were treated. Fifteen (36%) of the 42 evaluable patients who received front‐line therapy had objective responses and 14 (33%) had stable disease. In the patients with prior treatment, 6 (17%) of 36 patients had partial response and 18 patients (50%) had stable disease. Median survival time for the previously untreated patient group was 10.1 months, with a one year survival of 43% and a two year survival rate of 32%. For the previously treated patients, the median survival time was 8.5 months, with a one year survival rate of 30%. Toxic effects were notable for significant myelosuppression, with ≥Grade 3 granulocytopenia seen in 55% of the patients on the untreated arm and 67% of the patients on the previously untreated arm. Additionally, 9.5% and 13.9% (untreated and previously treated), respectively, of these patients experienced Grades 3 and 4 thrombocytopenia at some point in their treatment. A full dose delivery analysis showed that this myelosuppression resulted in Course 1, Day 15 skipped doses (even at the reduced dose level) in 42% of previously untreated patients and 47% of pretreated patients. Other side effects seen at Grades 3 and 4 in previously untreated and treated patients included anemia (9.5% and 2.8%), asthenia (4.8% and 5.5%), infection (14.3% and 5.6%), pain (9.5% and 19.4%), and pulmonary complications (4.8% and 13.8%).CONCLUSIONSGemcitabine/vinorelbine is an active, well‐tolerated combination in both front‐line and second/third‐line therapy for Stage IIIB/IV NSCLC. The response rate, median survival rate, and one year survival rate compare favorably with platinum‐based regimens. The toxicity profile of the gemcitabine/vinorelbine combination was quite favorable, with minimal Grade 3 and 4 toxic effects aside from granulocytopenia, which resulted in numerous Day 15 skipped doses but no significant febrile neutropenia or infection. The combination of gemcitabine and vinorelbine could be a useful regimen in standard clinical practice and has the potential for efficient combination with biologic/targeted therapy. Multiple randomized trials of this combination versus platinum combinations are now ongoing. Cancer 2002;95:340–353. © 2002 American Cancer Society.DOI 10.1002/cncr.10629

show abstract

“…Die 1-Jahres-Überlebensrate war annähernd 50% [44]. Darüber hinaus wurde Taxotere/Gemcitabin auch in einer randomisierten Phase-II-Studie getestet und mit Taxotere/Cisplatin verglichen [45]. [49].…”

Section: Taxotere In Kombination Mit Nicht-platinhaltigen Zytostatikaunclassified

Docetaxel (Taxotere<sup>®</sup>) in der First-line-Therapie des fortgeschrittenen nicht-kleinzelligen Bronchialkarzinoms (NSCLC)

Manegold¹

2003

Oncol Res Treat

View full text Add to dashboard Cite

Docetaxel (Taxotere^®) as First-Line Therapy of Advanced Non-Small Cell Lung Cancer (NSCLC) Taxotere as a ‘stabilizing antitubuline’ and a second-generation Taxan has anti-tumor activity in a variety of solid neoplasms. In NSCLC Taxotere has shown encouraging response rates across a range of phase-II studies, and phase-III trials have confirmed its effectiveness in pretreated and chemotherapy-naive patients. Single agent Taxotere has shown that it can significantly improve both survival and quality of life when compared to either best supportive care or standard chemotherapy in previously treated patients. Therefore, it is considered standard for NSCLC second-line chemotherapy. Taxotere has also been evaluated in combination with platinum-compounds and non-platinum-based drugs for first-line treatment of NSCLC. The results recently published from a phase-III registration trial (TAX 326) have shown that the overall survival among patients randomized to receive Taxotere/Cisplatin was better than that among patients treated with Vinorelbin/Cisplatin and similar compared to Vinorelbin/Cisplatin for those patients who received Taxotere/Carboplatin. Given concomitantly or sequentially with non-platinum-based compounds (i.e. Gemcitabine, Vinorelbine) Taxotere has also shown promising activity in randomized studies and may offer advantages for patients not eligible to receive platinum-based compounds.

show abstract

Comparison of docetaxel/cisplatin to docetaxel/gemcitabine as first-line treatment of advanced non-small cell lung cancer: early results of a randomized trial

Cited by 33 publications

References 9 publications

Non-platinum regimens of gemcitabine plus docetaxel versus platinum-based regimens in first-line treatment of advanced non-small cell lung cancer: a meta-analysis on 9 randomized controlled trials

Non-platinum regimens of gemcitabine plus docetaxel versus platinum-based regimens in first-line treatment of advanced non-small cell lung cancer: a meta-analysis on 9 randomized controlled trials

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Docetaxel (Taxotere<sup>®</sup>) in der First-line-Therapie des fortgeschrittenen nicht-kleinzelligen Bronchialkarzinoms (NSCLC)

Contact Info

Product

Resources

About