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• W2275325390 abstract "The optimal treatment of stage IIIA-N2 non–small cell lung cancer (NSCLC) continues to be debated. This is partly due to the heterogeneity of the disease's presentation, the important comorbidities of these patients, and the paucity of sufficiently powered randomized studies. After the seminal meta-analysis of Auperin et al., it was clear that concurrent chemotherapy and radiotherapy is better than the sequential combination in fit patients.1Aupérin A. Le Péchoux C. Rolland E. et al.Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer.J Clin Oncol. 2010; 28: 2181-2190Crossref PubMed Scopus (1324) Google Scholar The role of surgery was initially investigated in two phase III trials: European Organisation for Research and Treatment of Cancer 0841 and Intergroup (INT)-0139/Radiation Therapy Oncology Group (RTOG)-9309. In the European Organisation for Research and Treatment of Cancer trial, patients with stage IIIA-N2 disease, deemed unresectable at baseline evaluation, received cisplatin-based induction chemotherapy followed by either surgery or radiotherapy (60 Gy in 30 fractions) in responding patients.2van Meerbeeck J.P. Kramer G.W. Van Schil P.E. et al.Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer.J Natl Cancer Inst. 2007; 99: 442-450Crossref PubMed Scopus (596) Google Scholar In this trial, in which no fludeoxyglucose F 18 positron emission tomography (18F-FDG PET) staging was used, there was no significant difference in OS (overall survival), which was approximately 15% in both groups. In the Intergroup/RTOG study, patients with resectable stage IIIA-N2 at the time of staging received two cycles of cisplatin-etoposide concurrently with radiotherapy to a dose of 45 Gy in 25 fractions followed by either surgery or completion to so-called full-dose radiotherapy (61 Gy).3Albain K.S. Swann R.S. Rusch V.W. et al.Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial.Lancet. 2009; 374: 379-386Abstract Full Text Full Text PDF PubMed Scopus (1142) Google Scholar Again, in this trial without 18F FDG PET–computed tomography staging, no significant difference in OS was observed (a 5-year OS in the surgery arm of 27% versus 20% in the nonsurgery group, p = 0.10), but because of the better disease-free survival in the surgery arm, the exceptionally high mortality in patients who underwent right-sided pneumonectomy, and the higher OS in the unplanned “matched” lobectomy subgroup analysis, the debate on the role of surgery in the treatment of stage III disease continued. The two recent randomized studies investigated different questions: does sequential chemotherapy plus radiotherapy (44 Gy in 22 fractions in 3 weeks) before surgery improve the event-free survival compared with induction chemotherapy followed by surgery (the Swiss Group for Clinical Cancer Research study4Pless M. Stupp R. Ris H.B. et al.Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial.Lancet. 2015; 386: 1049-1056Abstract Full Text Full Text PDF PubMed Scopus (235) Google Scholar)? and does surgery improve OS when added to induction chemotherapy followed by concurrent chemoradiotherapy (45 Gy in 30 fractions in 3 weeks [1.5 Gy twice daily]) versus induction chemotherapy followed by full-dose concurrent chemoradiotherapy (45 Gy in 30 fractions in 3 weeks followed by 2 Gy once daily in an isotoxic, accelerated manner (total dose 65–71 Gy) (the ESPATUE trial5Eberhardt W.E. Pöttgen C. Gauler T.C. et al.Phase III study of surgery versus definitive concurrent chemoradiotherapy boost in patients with resectable stage IIIA(N2) and selected IIIB non-small-cell lung cancer after induction chemotherapy and concurrent chemoradiotherapy (ESPATUE).J Clin Oncol. 2015; 33: 4194-4201Crossref PubMed Scopus (226) Google Scholar)? In both studies, contemporary staging such as brain imaging and 18F FDG PET–computed tomography was used. Neither study showed a difference in the primary end point between both arms. At first glance, this would imply that for patients with operable and resectable stage IIIA-N2 NSCLC at diagnosis, either induction chemotherapy followed by surgery or definitive concurrent chemoradiotherapy are equal options. In nonresectable or inoperable disease, concurrent chemoradiotherapy remains the first choice.6Eberhardt W.E. De Ruysscher D. Weder W. et al.2nd ESMO Consensus Conference in Lung Cancer: locally advanced stage III non-small-cell lung cancer.Ann Oncol. 2015; 26: 1573-1588Crossref PubMed Scopus (284) Google Scholar However, a major drawback of both studies is their limited size. The Swiss trial included only 232 patients owing to poor accrual, and the ESPATUE study, which also included a few highly selected patients with stage IIIB disease, was closed after having enrolled 246 patients after an analysis for futility. Both studies could therefore detect a difference in their primary end point with a hazard ratio of approximately 0.67. This is not realistic because in stage III disease, all improvements in OS (with concurrent chemoradiotherapy, adjuvant chemotherapy after surgery, or accelerated radiotherapy) reached a hazard ratio ranging between 0.85 and 0.87.1Aupérin A. Le Péchoux C. Rolland E. et al.Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer.J Clin Oncol. 2010; 28: 2181-2190Crossref PubMed Scopus (1324) Google Scholar, 7Burdett S. Pignon J.P. Tierney J. et al.Adjuvant chemotherapy for resected early-stage non-small cell lung cancer.Cochrane Database Syst Rev. 2015; 3: CD011430PubMed Google Scholar, 8Mauguen A. Le Péchoux C. Saunders M.I. et al.Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis.J Clin Oncol. 2012; 30: 2788-2797Crossref PubMed Scopus (213) Google Scholar Significant and clinically relevant differences in OS could therefore remain undetected in the Swiss Group for Clinical Cancer Research study and the ESPATUE study. If pathological complete remission (pCR) would be used as a surrogate for treatment efficacy in eradicating the local tumor, the Swiss trial that did not use concurrent chemoradiotherapy but sequential chemotherapy and radiotherapy, achieved a pCR of 12% in the chemotherapy arm and 16% in the chemoradiotherapy arm, which is clearly lower than the 33% pCR rate in the ESPATUE trial. The pCR rates in both studies are similar to those reported in other studies with the same induction therapy. Importantly, although the ESPATUE trial included patients with more advanced local disease than the Swiss study did, the 5-year OS rates (34% for all patients and 40% and 44% in the surgery versus no-surgery arms, respectively, in patients who were randomized) are among the best ever achieved in a multicenter randomized study. For patients with resectable and operable bulky, necrotic tumors that are susceptible to excavation or already-excavated cancers, primary surgery followed by adjuvant systemic or local therapy or concurrent chemotherapy and radiotherapy followed by surgery avoids severe local complications and is therefore preferred.6Eberhardt W.E. De Ruysscher D. Weder W. et al.2nd ESMO Consensus Conference in Lung Cancer: locally advanced stage III non-small-cell lung cancer.Ann Oncol. 2015; 26: 1573-1588Crossref PubMed Scopus (284) Google Scholar Comorbidities, the surgical expertise, and the preferences of the patient should also be taken into account.9Phernambucq E.C. Hartemink K.J. Smit E.F. et al.Tumor cavitation in patients with stage III non-small-cell lung cancer undergoing concurrent chemoradiotherapy: incidence and outcomes.J Thorac Oncol. 2012; 7: 1271-1275Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar All these arguments should be considered at the multidisciplinary tumor board.10Vansteenkiste J. Van Damme V. Dooms C. Generalized or personalized treatment for stage IIIA-N2 non-small cell lung cancer?.Expert Opin Parmacother. 2010; 11: 1605-1609Crossref PubMed Scopus (4) Google Scholar As stage IIIA-N2 disease is a heterogeneous disease from the standpoints of anatomical, biological, and patient characteristics, the treatments for individual patients should differ as well. This may be one of the reasons why including sufficient numbers of patients in randomized trials proved to be very difficult. The question of what is the best systemic treatment to be given concurrently with radiotherapy remains unresolved, but cisplatin together with etoposide or vinorelbine, carboplatin and paclitaxel, and daily cisplatin are accepted options.6Eberhardt W.E. De Ruysscher D. Weder W. et al.2nd ESMO Consensus Conference in Lung Cancer: locally advanced stage III non-small-cell lung cancer.Ann Oncol. 2015; 26: 1573-1588Crossref PubMed Scopus (284) Google Scholar The optimal radiotherapy schedule remains a matter of debate as well. Although high-dose, accelerated radiotherapy alone leads to a better OS at 5 years than does conventional fractionated radiotherapy,8Mauguen A. Le Péchoux C. Saunders M.I. et al.Hyperfractionated or accelerated radiotherapy in lung cancer: an individual patient data meta-analysis.J Clin Oncol. 2012; 30: 2788-2797Crossref PubMed Scopus (213) Google Scholar whether this is also the case when radiotherapy is given concurrently with chemotherapy is unclear.11van Baardwijk A. Reymen B. Wanders S. et al.Mature results of a phase II trial on individualised accelerated radiotherapy based on normal tissue constraints in concurrent chemo-radiation for stage III non-small cell lung cancer.Eur J Cancer. 2012; 48: 2339-2346Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar The 2-year OS in the ESPATUE trial is similar to that of RTOG 0617 (60 Gy in the 30–once-daily fractions arm)12Bradley J.D. Paulus R. Komaki R. et al.Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study.Lancet Oncol. 2015; 16: 187-199Abstract Full Text Full Text PDF PubMed Scopus (1395) Google Scholar and to the long-term results of the PROCLAIM and the RADITUX studies,13Senan S. Brade A.M. Wang L. et al.Final overall survival (OS) results of the phase III PROCLAIM trial: pemetrexed (Pem), cisplatin (Cis) or etoposide (Eto), Cis plus thoracic radiation therapy (TRT) followed by consolidation cytotoxic chemotherapy (CTX) in locally advanced nonsquamous non-small cell lung cancer (nsNSCLC).J Clin Oncol. 2015; 33 ([abstract]): 7506Google Scholar, 14van den Heuvel M.M. Uyterlinde W. Vincent A.D. et al.Additional weekly cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating.Radiother Oncol. 2014; 110: 126-131Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar although the latter trials primarily included inoperable patients. In full-dose concurrent chemoradiotherapy, a dose of 60 to 66 Gy in 2-Gy once-daily fractions is therefore considered the standard of care. Because of the still-dismal prognosis in most patients with resectable stage IIIA-N2 disease, their inclusion in trials continues to be essential to address essential questions and to improve the outcome." @default.
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• W2275325390 title "The Optimal Local Treatment of Stage IIIA-N2 NSCLC: Is the Issue Finally Settled?" @default.
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