Cisplatin, Gemcitabine, and Paclitaxel in Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: A Phase I-II Study

Frasci, G.; Panza, N.; Comella, Pasquale; Nicolella, Gianpaolo; Natale, Michele; Manzione, Luigi; Bilancia, Domenico; Cioffi, R; Maiorino, Luigi; Cataldis, Giuseppe De; Belli, M; Micillo, E; Mascia, Vittorio; Massidda, B.; Lorusso, Vito; Lena, M. De; Carpagnano, Francesco; Contu, A.; Pusceddu, G; Comella, G.

doi:10.1200/jco.1999.17.8.2316

Cited by 50 publications

(27 citation statements)

References 26 publications

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“…Combination of paclitaxel and cisplatin with either gemcitabine or vinorelbine in a 3-drug regimen has been shown to have high response rates at the expense of an acceptable toxic profile in advanced NSCLC [29, 30, 31, 32]. Furthermore, in a phase III trial performed by the Southern Italy Cooperative Oncology Group, the 3-drug regimens (cisplatin/gemcitabine with either vinorelbine or paclitaxel) were associated with improved outcome without an increase in major toxicity over cisplatin and gemcitabine [33].…”

Section: Discussionmentioning

confidence: 99%

Front-Line Paclitaxel/Cisplatin-Based Chemotherapy in Brain Metastases from Non-Small-Cell Lung Cancer

Cortés¹,

Rodríguez²,

Aramendía³

et al. 2002

Oncology

117

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Objective: Paclitaxel-cisplatin is considered to be a standard therapy for metastatic non-small-cell lung cancer (NSCLC). The aim of this study was to evaluate the activity and toxicity of this combination with vinorelbine or gemcitabine as front-line therapy in brain metastases from NSCLC. Methods: Twenty-six chemotherapy-naive patients with an ECOG performance status of 0–2 were treated with paclitaxel (135 mg/m²) on day 1, cisplatin (120 mg/m²) on day 1, and either vinorelbine (30 mg/m²) on days 1 and 15 or gemcitabine (800 mg/m²) on days 1 and 8. Whole-brain irradiation was offered early in case of progression and later as consolidation treatment. Results: All patients were evaluated for toxicity and 25 for response. An intracranial response rate was observed in 38% of the patients (95% CI: 22–59%). WHO grade 3–4 neutropenia and thrombocytopenia occurred in 31 and 4% of the patients, respectively. There was one treatment-related death. Non-hematological toxicities were mild. After a median follow-up of 46 months, the median overall survival for all patients was 21.4 weeks and the median time to progression was 12.8 weeks. Conclusions: Paclitaxel and cisplatin combined with vinorelbine or gemcitabine as front-line therapy in brain metastases seem to achieve responses similar to those for extracranial disease, suggesting a meaningful role in this setting.

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Section: Discussionmentioning

confidence: 99%

Front-Line Paclitaxel/Cisplatin-Based Chemotherapy in Brain Metastases from Non-Small-Cell Lung Cancer

Cortés¹,

Rodríguez²,

Aramendía³

et al. 2002

Oncology

117

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“…Paclitaxel, one of the two agents, is an established drug in a combined modality for NSCLC patients. Much data exist where paclitaxel has been administered with different agents (mainly cisplatin or carboplatin) (Akerley et al, 1997;Belani et al, 1999;Frasci et al, 1999;Bonomi et al, 2000;Johnson et al, 2004) as first-line treatment in advanced NSCLC. Irinotecan has been administered in NSCLC with agents other than paclitaxel either as second-line (Kakolyris (Cardenal et al, 2003;Negoro et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

Front-line paclitaxel and irinotecan combination chemotherapy in advanced non-small-cell lung cancer: a phase I–II trial

et al. 2005

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Our purpose was to determine the efficacy of irinotecan plus paclitaxel administered on day 1, repeated every 2 weeks, in untreated patients with advanced or metastatic non-small-cell lung cancer (NSCLC). In total, 56 patients with inoperable or metastatic stage III and IV NSCLC with a histologically or cytologically confirmed diagnosis were enrolled. None of the patients had undergone prior chemotherapy or radiation therapy. Treatment involved irinotecan 125 mg m À2 and paclitaxel 135 mg m À2 administered on day 1 and repeated every 2 weeks for a planned number of nine cycles. With a standard dose of paclitaxel at 135 mg m À2 , the dosage of irinotecan was escalated at four levels: 75, 100, 125 and 150 mg m À2 ; 125 mg m À2 was established as the maximum tolerated dose; this dosage was administered to 46 patients. A total of 52 patients (median age 65 years, range 38 -77 years) were assessable for toxicity and survival and 46 for response rate. Out of 46 evaluable patients, 19 achieved partial response (41.3%), 17 had stable disease (37%) and 10 (21.7%) experienced disease progression. The median duration of response was 6 months (range 2 -9 þ months). The main adverse reactions were myelotoxicity (grades 3 and 4) in 10 (19.2%) patients and diarrhoea (grade 3) in four (7.7%) patients. Irinotecan combined with paclitaxel, administered every 2 weeks, appears to be an effective treatment for advancedstage NSCLC.

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“…At various dosing schedules, the response rates have ranged from 44% to 57% with 1-year survival rates of 42% to 45% (Frasci et al, 1999;Hainsworth et al, 1999;Sørensen et al, 1999) Myelosuppression was the commonest toxicity. From these studies, it is apparent that despite improvements in response, there was no survival advantage and the significant myelotoxicity suggests that paclitaxel/gemcitabine/cisplatin or carboplatin combinations may be more appropriate for patients with good performance status, possibly in a neoadjuvant setting.…”

Section: Discussionmentioning

confidence: 99%

Combined paclitaxel and gemcitabine as first-line treatment in metastatic non-small cell lung cancer: a multicentre phase II study

et al. 2001

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The efficacy and toxicity of combined paclitaxel and gemcitabine was evaluated in 54 chemotherapy-naive patients with metastatic non-small cell lung cancer (NSCLC). Gemcitabine i.v. 1000 mg/m 2 was administered on days 1 and 8 and paclitaxel 200 mg/m 2 as a continuous 3-hour infusion on day 1. Treatment was repeated every 21 days. Patients had a median age of 53 years. ECOG performance status was 0 or 1 in 48 patients. 41 patients (75.9%) had initial stage IV disease; histology was mainly adenocarcinoma (46.3%). 2 patients (4.3%) achieved a complete response and 15 (31.9%) achieved a partial response giving an overall response rate of 36.2% (95% CI: 22.4–49.9%); 19 patients (40.4%) had stable disease and 10 (21.3%) had progressive disease. The median survival time was 51 weeks (95% CI: 46.5–59.3), with a 1-year survival probability of 0.48 (95% CI: 0.34–0.63). Grade 3/4 neutropenia and febrile neutropenia occurred in 15.2% and 2.2% of courses, respectively. Grade 3/4 thrombocytopenia was rare (1.8% of courses). Peripheral neurotoxicity developed in 25 patients (47.2%), mostly grade 1/2. Arthalgia/myalgia was observed in 30 patients (56.6%), generally grade 1 or 2. Grade 3 abnormal levels of serum glutamate pyruvate transaminase (SGPT) and serum glutamate oxaloacetate transaminase (SGOT) occurred in 5 patients (9.4%) and 1 patient (1.9%), respectively. Combined paclitaxel and gemcitabine is an active and well-tolerated regimen for the treatment of advanced NSCLC, and warrants further investigation in comparative, randomized trials. © 2001 Cancer Research Campaign http://www.bjcancer.com

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Cisplatin, Gemcitabine, and Paclitaxel in Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: A Phase I-II Study

Cited by 50 publications

References 26 publications

Front-Line Paclitaxel/Cisplatin-Based Chemotherapy in Brain Metastases from Non-Small-Cell Lung Cancer

Front-Line Paclitaxel/Cisplatin-Based Chemotherapy in Brain Metastases from Non-Small-Cell Lung Cancer

Front-line paclitaxel and irinotecan combination chemotherapy in advanced non-small-cell lung cancer: a phase I–II trial

Combined paclitaxel and gemcitabine as first-line treatment in metastatic non-small cell lung cancer: a multicentre phase II study

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