A Randomized Trial Comparing Preoperative Chemotherapy Plus Surgery with Surgery Alone in Patients with Non-Small-Cell Lung Cancer

Rosell, Rafael; Gómez-Codina, José; Camps, Carlos; Maestre, José; Padille, J; Cantó, A.; Mate, José Luís; Li, S; Roig, Jordi; Olazabal, Ainhoa Alonso

doi:10.1056/nejm199401203300301

Cited by 1,170 publications

(484 citation statements)

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“…On the other hand, several phase III studies have shown that cisplatincontaining induction chemotherapy may increase survival rate in stage IIIA or IIIB locally advanced non-small cell lung cancer (LAD-NSCLC) patients. Two randomized studies demonstrated increased survival in stage IIIA NSCLC patients if two to three cycles of chemotherapy were given before surgery (Rosell et al, 1994;Roth et al, 1994). In inoperable patients, induction with cisplatin plus vinblastine followed by radiotherapy demonstrated long-term survival advantage over radiotherapy alone in a randomized study (Dillman et al, 1996) and was confirmed subsequently by an intergroup study (Sause et al, 1995).…”

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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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confidence: 93%

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

et al. 2002

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“…[4][5][6][7][8] Two of these studies involved small cohorts (n ¼ 60) that included mainly stage IIIA, N2 disease, and showed a significant survival advantage associated with induction chemotherapy compared with surgery alone. 5,6 None of the other trials reported any beneficial outcome for bimodality therapy compared with surgery alone.…”

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A phase 3 study of induction treatment with concurrent chemoradiotherapy versus chemotherapy before surgery in patients with pathologically confirmed N2 stage IIIA nonsmall cell lung cancer (WJTOG9903)

Katakami

Tada

Mitsudomi

et al. 2012

Cancer

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BACKGROUND: This study sought to ascertain whether induction-concurrent radiotherapy added to chemotherapy could improve the survival of patients undergoing surgery for stage IIIA N2 nonsmall cell lung cancer (NSCLC). METHODS: Patients with pathologically proven N2 disease were randomized to receive either induction chemotherapy (docetaxel 60 mg/m 2 and carboplatin AUC [area under the receiver operating characteristic curve] ¼ 5 for 2 cycles) plus concurrent radiation therapy (40 Gy) followed by surgery (CRS arm) or induction chemotherapy followed by surgery (CS arm). They subsequently underwent pulmonary resection when possible. RESULTS: Sixty patients were randomly assigned between December 2000 and August 2005. The study was prematurely terminated in January 2006 because of slow accrual. The most common toxicity was grade 3 or 4 leukopenia in 92.9% of patients in the CRS arm and 46.4% in the CS arm. Induction therapy was generally well tolerated, and there were no treatment-related deaths in either arm. Downstaging in the CS arm and CRS arm was 21% and 40%, respectively. The progression-free survival (PFS) and overall survival (OS) in the CS arm were 9.7 months and 29.9 months (PFS, hazard ratio [HR] ¼ 0.68, P ¼ .187), and those in the CRS arm were 12.4 months and 39.6 months (OS, HR ¼ 0.77, P ¼ .397), respectively. The PFS with and without downstaging was 55.0 and 9.4 months, respectively (HR ¼ 3.39, P ¼ .001). The OS with and without downstaging was 63.3 and 29.5 months, respectively (HR ¼ 2.62, P ¼ .021). CONCLUSIONS: The addition of radiotherapy to induction chemotherapy conferred better local control without significant adverse events. Tumor downstaging is important for prolonging the OS in patients with stage IIIA (N2) NSCLC. Cancer 2012;118:6126-35.

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“…Several small randomised studies (Pass et al, 1992;Rosell et al, 1994;Roth et al, 1994) have demonstrated a benefit from neoadjuvant treatment in locally advanced disease (stage IIIA). In a large trial involving 355 patients with stage IB -IIIA NSCLC, a trend towards survival benefit was seen from neoadjuvant chemotherapy (median survival 37 months vs 26 months for surgery alone; P ¼ 0.15) (Depierre et al, 2002).…”

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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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A Randomized Trial Comparing Preoperative Chemotherapy Plus Surgery with Surgery Alone in Patients with Non-Small-Cell Lung Cancer

Abstract: Preoperative chemotherapy increases the median survival in patients with non-small-cell lung cancer.

Cited by 1,170 publications

References 27 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

A phase 3 study of induction treatment with concurrent chemoradiotherapy versus chemotherapy before surgery in patients with pathologically confirmed N2 stage IIIA nonsmall cell lung cancer (WJTOG9903)

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

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