Gemcitabine and Cisplatin as Induction Regimen for Patients With Biopsy-Proven Stage IIIA N2 Non–Small-Cell Lung Cancer: A Phase II Study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group (EORTC 08955)

Zandwijk, Nico van; Smit, Egbert F.; Kramer, G.; Schramel, Franz M.N.H.; Gans, Steven; Festen, J.; Termeer, A.; Schlösser, N. J. J.; Debruyne, Channa; Curran, Desmond; Giaccone, Giuseppe

doi:10.1200/jco.2000.18.14.2658

Cited by 138 publications

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“…The toxicities of induction treatment were acceptable. The major difference in toxicity between this and prior EORTC study (Van Zandwijk et al, 2000) was in rates and degrees of thrombocytopenia. There were only 11% of patients with grade 3 thrombocytopenia in this study.…”

Section: Discussionmentioning

confidence: 66%

“…On the contrary, when cisplatin was given on day 2, 60% patients had grade 3/4 thrombocytopenia in 46% treatment cycles and the haematological toxicity resulted in day 15 reduction (23%) and omissions (34%) in many cycles. The difference in toxicity was due to the different dose and schedule used in Van Zandwijk et al (2000) study ( therapy in inoperable stage III NSCLC patients. (Albain et al, 1995).…”

Section: Discussionmentioning

confidence: 99%

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Gemcitabine and cisplatin in a multimodality treatment for locally advanced non-small cell lung cancer

et al. 2002

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The role of new cytotoxic agents like gemcitabine has not yet been proven in the neoadjuvant settings. We designed a phase II study to test the feasibility of using gemcitabine and cisplatin before local treatment for stage III non-small cell lung cancer patients. Patients received three cycles of induction chemotherapy of gemcitabine (1000 mg m 72 , days 1, 8, 15) and cisplatin (90 mg m 72 , day 15) every 4 weeks before evaluation for operability. Operable patients underwent radical resection. Inoperable patients and patients who had incomplete resection received concurrent chemoradiotherapy with daily low dose cisplatin. All patients who did not progress after local treatment received three more cycles of adjuvant chemotherapy of gemcitabine and cisplatin. Fifty-two patients received induction treatment. Two patients had complete response and 31 patients had partial response (response rate 63.5%) after induction chemotherapy. Thirty-six patients (69%) were operable. Eighteen patients (35%) had their tumours completely resected. Two patients had pathological complete response. Median overall survival was 19.1 months, projected 1-year survival was 66% and 2-year survival was 34%. Three cycles of gemcitabine and cisplatin is effective and can be used as induction treatment before surgery for locally advanced non-small cell lung cancer patients.

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Section: Discussionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Gemcitabine and cisplatin in a multimodality treatment for locally advanced non-small cell lung cancer

et al. 2002

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“…It was not possible to include all of these factors in the multivariate model (this table presents the updated analysis of our previous report (Betticher et al, 2003)). and gemcitabine preoperatively, the median survival was 18.9 months (Van Zandwijk et al, 2000), while two other trials reported median survival times of 19 and 22 months for patients with stage IIIA pN2 NSCLC who received neoadjuvant chemotherapy (Martini et al, 1993;Rosell et al, 1999). We sought to identify characteristics of the neoadjuvant chemotherapy, as well as other prognostic factors, which would allow enhancement of therapy and help select patients for thoracotomy.…”

Section: Discussionmentioning

confidence: 99%

Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer: 5-year follow-up of a phase II study

et al. 2006

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The aim was to investigate the efficacy of neoadjuvant docetaxel -cisplatin and identify prognostic factors for outcome in locally advanced stage IIIA (pN2 by mediastinoscopy) non-small-cell lung cancer (NSCLC) patients. In all, 75 patients (from 90 enrolled) underwent tumour resection after three 3-week cycles of docetaxel 85 mg m À2 (day 1) plus cisplatin 40 or 50 mg m À2 (days 1 and 2). Therapy was well tolerated (overall grade 3 toxicity occurred in 48% patients; no grade 4 nonhaematological toxicity was reported), with no observed late toxicities. Median overall survival (OS) and event-free survival (EFS) times were 35 and 15 months, respectively, in the 75 patients who underwent surgery; corresponding figures for all 90 patients enrolled were 28 and 12 months. At 3 years after initiating trial therapy, 27 out of 75 patients (36%) were alive and tumour free. At 5-year follow-up, 60 and 65% of patients had local relapse and distant metastases, respectively. The most common sites of distant metastases were the lung (24%) and brain (17%). Factors associated with OS, EFS and risk of local relapse and distant metastases were complete tumour resection and chemotherapy activity (clinical response, pathologic response, mediastinal downstaging). Neoadjuvant docetaxel -cisplatin was effective and tolerable in stage IIIA pN2 NSCLC, with chemotherapy contributing significantly to outcomes.

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“…The Toronto trial (65 patients) with mitomycin, vindesine and cisplatin for stage IIIa unresectable NSCLC reported an ORR of 67.7% (Burkes et al, 2005) and a trial (47 patients) of gemcitabine and cisplatin for biopsy-proven stage IIIa-N2 NSCLC reported an ORR of 70.2% (95% CI: 55.1 -82.7%) (Van Zandwijk et al, 2000). Finally, a trial (42 patients) of gemcitabine -cisplatin -paclitaxel for stage IIIa(N2)/IIIb inoperable NSCLC reported an ORR of 71% (95% CI: 57.2 -84.7%) (Cappuzzo et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

“…A response rate of 75% or more warranted further investigation of the chemotherapy regimens used, and a response rate of 55% or less warranted rejection. The upper limit of 75% was chosen because it is close to the observed response rate of the gemcitabine -cisplatin combination which is the most widely used induction regimen on the European continent (Van Zandwijk et al, 2000). In addition, since it is intensified chemotherapy that is applied with potentially more severe side effects we choose to set the upper limit on 75% for the power calculation of the study.…”

Section: Patient Criteria and Study Designmentioning

confidence: 99%

Multicenter phase II trial of accelerated cisplatin and high-dose epirubicin followed by surgery or radiotherapy in patients with stage IIIa non-small-cell lung cancer with mediastinal lymph node involvement (N2-disease)

et al. 2006

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To assess the therapeutic activity of accelerated cisplatin and high-dose epirubicin with erythropoietin and G-CSF support as induction therapy for patients with stage IIIa-N2 non-small-cell lung cancer (NSCLC). Patients with stage IIIa-N2 NSCLC were enrolled in a phase II trial. They received cisplatin 60 mg m −2 and epirubicin 135 mg m −2 every 2 weeks for three courses combined with erythropoietin and G-CSF. Depending on results of clinical response to induction therapy and restaging, patients were treated with surgery or radiotherapy. In total, 61 patients entered from March 2001 to April 2004. During 169 courses of induction chemotherapy, National Cancer Institute of Canada (NCI-C) grade III/IV leucocytopenia was reported in 35 courses (20.7%), NCI-C grade III/IV thrombocytopenia in 26 courses (15.4%) and NCI-C grade III/IV anaemia in six courses (3.6%). Main cause of cisplatin dose reduction was nephrotoxicity (12 courses). Most patients received three courses. There were no chemotherapy-related deaths. Three patients were not evaluable for clinical response. Twenty-eight patients had a partial response (48.3%, 95% CI: 36–61.1%), 24 stable disease and six progressive disease. After induction therapy, 30 patients underwent surgery; complete resection was achieved in 19 procedures (31.1%). Radical radiotherapy was delivered to 25 patients (41%). Six patients were considered unfit for further treatment. Median survival for all patients was 18 months. Response rate of accelerated cisplatin and high-dose epirubicin as induction chemotherapy for stage IIIa-N2 NSCLC patients is not different from more commonly used cisplatin-based regimen.

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Gemcitabine and Cisplatin as Induction Regimen for Patients With Biopsy-Proven Stage IIIA N2 Non–Small-Cell Lung Cancer: A Phase II Study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group (EORTC 08955)

Abstract: In patients with N2 stage IIIA NSCLC, GC is a highly active and well-tolerated induction regimen. GC should be explored in combination with surgery or radiotherapy in stage I and II patients.

Cited by 138 publications

References 14 publications

Gemcitabine and cisplatin in a multimodality treatment for locally advanced non-small cell lung cancer

Gemcitabine and cisplatin in a multimodality treatment for locally advanced non-small cell lung cancer

Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer: 5-year follow-up of a phase II study

Multicenter phase II trial of accelerated cisplatin and high-dose epirubicin followed by surgery or radiotherapy in patients with stage IIIa non-small-cell lung cancer with mediastinal lymph node involvement (N2-disease)

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