Phase III Comparative Study of High-Dose Cisplatin Versus a Combination of Paclitaxel and Cisplatin in Patients With Advanced Non–Small-Cell Lung Cancer

Gatzemeier, U.; Pawel, Joachim von; Gottfried, Maya; Velde, G. P. M. Ten; Mattson, K.; DeMarinis, Filipo; Harper, Peter; Salvati, Franco; Robinet, G.; Lucenti, A.; Bogaerts, Jan; Gallant, Gilles

doi:10.1200/jco.2000.18.19.3390

Cited by 196 publications

(91 citation statements)

References 33 publications

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“…Interestingly, in a paper reviewing the challenges of novel agents for the design of phase II trials and suggesting early progression as a surrogate endpoint to accept or reject new drugs, a 30% maximum PD rate was identified, above which the agent would have been rejected from further evaluation [79]. In a randomized trial of high-dose cisplatin versus cisplatin plus paclitaxel, the addition of the taxane resulted in a 9% higher ORR, whereas the risk for progression was 13% lower, with no significant difference in OS [80]. In a similar study of gemcitabine-cisplatin compared with cisplatin alone, the ORRs were 30.4% and 11.1%, respectively; the risk for PD was 18% lower and the median survival duration was significantly longer in the gemcitabine arm [10].…”

Section: Discussionmentioning

confidence: 99%

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

Grossi¹,

Aita²,

Defferrari³

et al. 2009

The Oncologist

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Background. The therapeutic equivalence of different third-generation agents in the first-line treatment of advanced non-small cell lung cancer (NSCLC) has long been accepted, although recent studies seem to suggest some superiority of gemcitabine-or docetaxel-containing regimens over other third-generation doublets.Objective. To assess the relative impact of different third-generation drugs on the activity of first-line chemotherapy in advanced non-small cell lung cancer by considering both response and progressive disease (PD) rates as outcome measures.Methods. Published and unpublished data were collected from randomized trials comparing a gemcitabine-, docetaxel-, vinorelbine-or paclitaxel-containing regimen with one or more gemcitabine-, docetaxel-, vinorelbine-or paclitaxel-free combinations. For

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Section: Discussionmentioning

confidence: 99%

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

Grossi¹,

Aita²,

Defferrari³

et al. 2009

The Oncologist

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“…In spite of the fact that a phase III randomised trial showed better survival with paclitaxel plus cisplatin, when comparing etoposide with cisplatin (Bonomi et al, 2000), many studies have not demonstrated better survival with paclitaxel plus cisplatin or carboplatin, when compared with conventional chemotherapy (Giaccone et al, 1998;Gatzemeier et al, 2000;Raftopoulos et al, 2002). The dosage and schedule of the paclitaxel used varied widely among the different studies and, thus, probably had different therapeutic effects on the patients.…”

mentioning

confidence: 99%

A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Shih

et al. 2004

Br J Cancer

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Phase II studies have suggested that weekly paclitaxel has a higher response rate and better toxicity profile than the conventional schedule of once every 3 or 4 weeks. Our aim was to evaluate the efficacy of weekly paclitaxel plus cisplatin (PC) vs vinorelbine plus cisplatin (VC) in chemonaïve non-small-cell lung cancer (NSCLC) patients. From October 2000 to May 2002, 140 patients were enrolled. The treatment dose was P 66 mg m À2 intravenous infusion (i.v.) on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, or V 23 mg m À2 i.v. on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, every 4 weeks. In all, 281 cycles of PC and 307 cycles of VC were given to the patients in the PC and VC arms, respectively. There were 26 partial responses and one complete response (overall 38.6%) in the PC arm, and no complete responses, but 27 partial responses (overall 38.6%) in the VC arm. Myelosuppression was more common in the VC arm (Po0.001). Peripheral neuropathy and myalgia were significantly more common in the PC arm (Po0.001). The median time to disease progression was 6 months in the PC arm and 8.4 months in the VC arm (P ¼ 0.0344). The median survival time was 11.7 months in the PC arm and 15.4 months in the VC arm (P ¼ 0.297). We concluded that weekly PC is not suggested for NSCLC patients due to the relatively shorter progression-free survival and more common nonhaematological toxicities.

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“…Despite use/ realisation of a high dose intensity of both chemotherapeutic drugs, in addition to a lower rate of neutropenia, also certain nonhaematologic toxicities such as arthralgia/myalgia, asthenia and gastrointestinal symptoms were less commonly seen when compared to other phase II/III studies of this particular drug combination in other disease entities (McGuire et al, 1996;Rose et al, 1999;Gatzemeier et al, 2000). Similarly, in the advanced gastric cancer trials of Roth et al (2000) and Ridwelski et al …”

Section: Discussionmentioning

confidence: 98%

“…The rationale for their combined use were: (1) the documented activity of both drugs in gastric cancer when used as single agent (Wils, 1996); (2) the apparent synergistic efficacy and safety of this combination in patients with ovarian-, head and neck cancer, and NSCLC (Ilson et al, 1998;Gatzemeier et al, 2000;Khuri et al, 2000;Pfisterer, 2000); (3) as well as the encouraging results of two recently published reports of a combination of cisplatin and the semisynthetic taxoid docetaxel (Roth et al, 2000;Ridwelski et al, 2001).…”

Section: Discussionmentioning

confidence: 99%

“…Favourable results were obtained when both drugs were combined in patients with ovarian cancer, advanced non-small cell lung cancer (NSCLC), head and neck-and oesophageal carcinomas (Ilson et al, 1998;Khuri et al, 2000;Gatzemeier et al, 2000;Pfisterer, 2000). Furthermore, two recently published phase II studies, investigating the combination of cisplatin with docetaxel, a semisynthetic taxoid, suggested a high antitumour activity with an overall response rate of 37 and 56%, respectively (Roth et al, 2000;Ridwelski et al, 2001).…”

mentioning

confidence: 99%

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Effective combination chemotherapy with paclitaxel and cisplatin with or without human granulocyte colony-stimulating factor and/or erythropoietin in patients with advanced gastric cancer

Kornek¹,

Raderer²,

Schüll³

et al. 2002

Br J Cancer

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A phase II trial was performed to determine the antitumour efficacy and tolerance of combined paclitaxel and cisplatin with or without hematopoetic growth factor support in patients with advanced gastric cancer. Forty-five patients with histologically confirmed metastatic gastric cancer were entered in this trial. Treatment consisted of 2-weekly courses of paclitaxel 160 mg per m 2 and cisplatin 60 mg per m 2 both given on day 1. Depending on absolute neutrophil counts on the days of scheduled chemotherapeutic drug administration (1000 -2000 per ml), a 5-day course of human granulocyte colony-stimulating factor 5 mg kg 71 per day was given subcutaneously; in addition, if haemoglobin was 512.0 mg dl 71 , erythropoietin 10 000 IU was administered subcutaneously three times per week. The confirmed overall response rate (intent-to-treat) was 44%, including five complete (11%) and 15 partial remissions (33%). Twelve patients had stable disease (27%), 11 (24%) progressed while on chemotherapy, and two patients were not evaluable. The median time to response was 3 months, the median time to progression 7.0 months, and the median survival time was 11.2 months with 12 patients currently alive. Haematologic toxicity was common, though WHO grade 4 neutropenia occurred in only five patients (11%). Apart from total alopecia in 16 patients (36%), severe non-haematologic adverse reactions included grade 3 peripheral neuropathy in six (13%) and anaphylaxis in two patients. In addition, there was one patient each who experienced grade 3 emesis, diarrhea, and infection, respectively. Our data suggest that the combination of paclitaxel and cisplatin with or without G-CSF and/or erythropoietin has promising therapeutic activity in patients with advanced gastric cancer.

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Phase III Comparative Study of High-Dose Cisplatin Versus a Combination of Paclitaxel and Cisplatin in Patients With Advanced Non–Small-Cell Lung Cancer

Cited by 196 publications

References 33 publications

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

Impact of Third-Generation Drugs on the Activity of First-Line Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Meta-Analytical Approach

A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Effective combination chemotherapy with paclitaxel and cisplatin with or without human granulocyte colony-stimulating factor and/or erythropoietin in patients with advanced gastric cancer

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