Scandinavian phase III trial of neoadjuvant chemotherapy in NSCLC stages IB-IIIA/T3

Sørensen, Jakob Balslev; Riska, Henrik; Ravn, Jesper; Hansen, Ole Henrik; Palshof, Torben; Rytter, Carsten; Mattson, K.; Ladegaard, Lars; Pilegaard, Hans; Aaseboe, U.

doi:10.1200/jco.2005.23.16_suppl.7146

Cited by 26 publications

(26 citation statements)

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“…We could estimate an HR 39 for survival for one trial of 90 patients, 36 but not the remaining three trials. Two of these 34,35 (106 patients) did not report the appropriate information, and one (two patients) was unpublished 37 .…”

Section: Discussionmentioning

confidence: 99%

Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data

2014

The Lancet

649

254

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SummaryBackgroundIndividual participant data meta-analyses of postoperative chemotherapy have shown improved survival for patients with non-small-cell lung cancer (NSCLC). We aimed to do a systematic review and individual participant data meta-analysis to establish the effect of preoperative chemotherapy for patients with resectable NSCLC.MethodsWe systematically searched for trials that started after January, 1965. Updated individual participant data were centrally collected, checked, and analysed. Results from individual randomised controlled trials (both published and unpublished) were combined using a two-stage fixed-effect model. Our primary outcome, overall survival, was defined as the time from randomisation until death (any cause), with living patients censored on the date of last follow-up. Secondary outcomes were recurrence-free survival, time to locoregional and distant recurrence, cause-specific survival, complete and overall resection rates, and postoperative mortality. Prespecified analyses explored any variation in effect by trial and patient characteristics. All analyses were by intention to treat.FindingsAnalyses of 15 randomised controlled trials (2385 patients) showed a significant benefit of preoperative chemotherapy on survival (hazard ratio [HR] 0·87, 95% CI 0·78–0·96, p=0·007), a 13% reduction in the relative risk of death (no evidence of a difference between trials; p=0·18, I2=25%). This finding represents an absolute survival improvement of 5% at 5 years, from 40% to 45%. There was no clear evidence of a difference in the effect on survival by chemotherapy regimen or scheduling, number of drugs, platinum agent used, or whether postoperative radiotherapy was given. There was no clear evidence that particular types of patient defined by age, sex, performance status, histology, or clinical stage benefited more or less from preoperative chemotherapy. Recurrence-free survival (HR 0·85, 95% CI 0·76–0·94, p=0·002) and time to distant recurrence (0·69, 0·58–0·82, p<0·0001) results were both significantly in favour of preoperative chemotherapy although most patients included were stage IB–IIIA. Results for time to locoregional recurrence (0·88, 0·73–1·07, p=0·20), although in favour of preoperative chemotherapy, were not statistically significant.InterpretationFindings, which are based on 92% of all patients who were randomised, and mainly stage IB–IIIA, show preoperative chemotherapy significantly improves overall survival, time to distant recurrence, and recurrence-free survival in resectable NSCLC. The findings suggest this is a valid treatment option for most of these patients. Toxic effects could not be assessed.FundingMedical Research Council UK.

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Section: Discussionmentioning

confidence: 99%

Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data

2014

The Lancet

649

254

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“…A Scandinavian randomized trial 17 of preoperative chemotherapy in early-stage NSCLC closed prematurely after slow accrual (90 patients in 6 years). The median and 5-year OS rates were 34 months and 36% for preoperative chemotherapy versus 23 months and 24% for surgery alone (differences not significant).…”

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confidence: 99%

Surgery With or Without Preoperative Paclitaxel and Carboplatin in Early-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Trial S9900, an Intergroup, Randomized, Phase III Trial

Pisters

Vallières

Crowley

et al. 2010

JCO

200

153

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A B S T R A C T PurposePatients with early-stage non-small-cell lung cancer (NSCLC) have a poor prognosis even after complete resection. Earlier studies of preoperative (induction) chemotherapy in resectable NSCLC demonstrated feasibility and encouraging survival data. This randomized phase III trial compared overall survival (OS) for preoperative paclitaxel and carboplatin followed by surgery with surgery alone in patients with early-stage NSCLC. Patients and MethodsPatients with clinical stage IB-IIIA NSCLC (excluding superior sulcus tumors and N2 disease) were eligible. Patients were randomly assigned to surgery alone or to three cycles of paclitaxel (225 mg/m 2 ) and carboplatin (area under curve, 6) followed by surgical resection. The primary end point was OS; secondary end points were progression-free survival (PFS), chemotherapy response, and toxicity. ResultsThe trial closed early with 354 patients after reports of a survival benefit for postoperative chemotherapy in other studies. The median OS was 41 months in the surgery-only arm and 62 months in the preoperative chemotherapy arm (hazard ratio, 0.79; 95% CI, 0.60 to 1.06; P ϭ .11.) The median PFS was 20 months for surgery alone and 33 months for preoperative chemotherapy (hazard ratio, 0.80; 95% CI, 0.61 to 1.04; P ϭ .10.) Major response to chemotherapy was seen in 41% of patients; no unexpected toxicity was observed. ConclusionThis trial closed prematurely after compelling evidence supporting postoperative chemotherapy emerged. Although OS and PFS were higher with preoperative chemotherapy, the differences did not reach statistical significance. At present, stronger evidence exists for postoperative chemotherapy in early-stage NSCLC.

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“…Moreover, the results of Albain et al reported a significant improvement in disease-free survival in patients who were randomised to surgical trimodality treatment. While we were not able to include a subanalysis of the disease-free survival by Sorensen et al ,19 we would be very surprised if conventional levels of statistical significance could not be achieved.…”

Section: Discussionmentioning

confidence: 93%

Outcome of surgery versus radiotherapy after induction treatment in patients with N2 disease: systematic review and meta-analysis of randomised trials

McElnay

Choong

Jordan

et al. 2015

Thorax

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Scandinavian phase III trial of neoadjuvant chemotherapy in NSCLC stages IB-IIIA/T3

Cited by 26 publications

References 0 publications

Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data

Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data

Surgery With or Without Preoperative Paclitaxel and Carboplatin in Early-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Trial S9900, an Intergroup, Randomized, Phase III Trial

Outcome of surgery versus radiotherapy after induction treatment in patients with N2 disease: systematic review and meta-analysis of randomised trials

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