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• W4220760255 abstract "Central MessageRecent trials of perioperative systemic therapy continue to reveal exciting therapeutic prospects for patients with early-stage and locally advanced non–small cell lung cancer.See Article page 495. Recent trials of perioperative systemic therapy continue to reveal exciting therapeutic prospects for patients with early-stage and locally advanced non–small cell lung cancer. See Article page 495. In a flurry of recent clinical trials, immunotherapy and targeted therapies have been established as a promising new frontier for the treatment of early-stage non–small cell lung cancer (NSCLC). Indeed, the published literature is struggling to keep up with the tide of abstract presentations and press releases in this rapidly changing landscape. Several recent or soon-to-be published trials will significantly impact considerations for adjuvant and neoadjuvant systemic therapy. The ADAURA trial demonstrated a significant improvement in disease-free survival among patients with stage IB-IIIA NSCLC harboring activating mutations in the epidermal growth factor receptor (EGFR) receiving adjuvant osimertinib compared with placebo.1Wu Y.-L. Tsuboi M. He J. John T. Grohe C. Majem M. et al.Osimertinib in resected EGFR-mutated non–small-cell lung cancer.N Engl J Med. 2020; 383: 1711-1723Crossref PubMed Scopus (820) Google Scholar Meanwhile, recently disclosed results of CheckMate 816 comparing neoadjuvant nivolumab with chemotherapy versus chemotherapy alone for patients with stage IB-IIIA NSCLC (without EGFR/anaplastic large-cell lymphoma kinase mutations) show a significant improvement in pathologic complete response and event-free survival with the addition of nivolumab to chemotherapy.2Spicer J. Wang C. Tanaka F. Saylors G.B. Chen K.N. Liberman M. et al.Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable Non–Small Cell Lung Cancer (NSCLC).J Clin Oncol. 2021; 39: 8503Crossref Google Scholar These disclosures have led the Food and Drug Administration to approve combination cisplatin-based chemotherapy and nivolumab in the neoadjuvant setting. Finally, IMpower010, which compared adjuvant atezolizumab with best supportive care after adjuvant chemotherapy for patients with resected stage II-IIIA NSCLC, showed a statistically significant improvement in disease-free survival, particularly among patients with greater levels of PD-L1 expression.3Felip E. Altorki N. Zhou C. Csőszi T. Vynnychenko I. Goloborodko O. et al.Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non–small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial.Lancet. 2021; 398: 1344-1357Abstract Full Text Full Text PDF PubMed Scopus (440) Google Scholar,4Wakelee H.A. Altorki N.K. Zhou C. Csőszi T. Vynnychenko I.O. Goloborodko O. et al.IMpower010: primary results of a phase III global study of atezolizumab versus best supportive care after adjuvant chemotherapy in resected stage IB-IIIA Non–Small Cell Lung Cancer (NSCLC).J Clin Oncol. 2021; 39: 8500Crossref Google Scholar In this issue of the Journal, Altorki and colleagues5Altorki N. Villena-Vargas J. Wakelee H. Adjuvant therapy for early-stage non–small cell lung cancer: the breaking of a new dawn.J Thorac Cardiovasc Surg. 2023; 165: 495-499Abstract Full Text Full Text PDF Scopus (1) Google Scholar present an outstanding discussion of the current therapeutic landscape for early-stage NSCLC in light of these recent trials and pose several fundamental questions about the future of lung cancer therapeutics. One important point discussed in this Expert Review is the optimal timing of immunotherapy. There are theoretical advantages to neoadjuvant therapy due to the resultant immunologic effects both systemically and in the tumor microenvironment in addition to the opportunity to assess response to systemic therapy on surgical pathology. One potential drawback is the potential for patients to develop toxicities that preclude or delay definitive resection. Recent data, however, including those from CheckMate 816 suggest that the risk of “not making it to surgery” is low. There have now been several trials of neoadjuvant chemoimmunotherapy with nivolimumab2Spicer J. Wang C. Tanaka F. Saylors G.B. Chen K.N. Liberman M. et al.Surgical outcomes from the phase 3 CheckMate 816 trial: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable Non–Small Cell Lung Cancer (NSCLC).J Clin Oncol. 2021; 39: 8503Crossref Google Scholar and immunotherapy alone with nivolimumab,6Bott M.J. Yang S.C. Park B.J. Adusumilli P.S. Rusch V.W. Isbell J.M. et al.Initial results of pulmonary resection after neoadjuvant nivolumab in patients with resectable non–small cell lung cancer.J Thorac Cardiovasc Surg. 2019; 158: 269-276Abstract Full Text Full Text PDF PubMed Scopus (164) Google Scholar pembrolizumab,7Tong B.C. Gu L. Wang X. Wigle D.A. Phillips J.D. Harpole Jr., D.H. et al.Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non–small cell lung cancer.J Thorac Cardiovasc Surg. 2022; 163: 427-436Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar or a combination of nivolumab/ipilimumab,8Cascone T. William Jr., W.N. Weissferdt A. Leung C.H. Lin H.Y. Pataer A. et al.Neoadjuvant nivolumab or nivolumab plus ipilimumab in operable non–small cell lung cancer: the phase 2 randomized NEOSTAR trial.Nat Med. 2021; 27: 504-514Crossref PubMed Scopus (262) Google Scholar all of which have demonstrated significantly increased complete or major pathologic response among patients receiving the trial drug. Each study also revealed minimal delays in surgery, high rates of R0 resection, feasibility of minimally invasive approaches in carefully selected patients, and good perioperative outcomes. We eagerly await further trial data that will demonstrate whether surrogate pathologic end points ultimately predict meaningful improvements in disease-free and overall survival in this population. The results of IMpower010 demonstrate that, in the adjuvant setting, atezolizumab is also safe and effective, as thoroughly described by Altorki and colleagues. These results may lead one to ask whether “Is it ‘better’ to administer systemic therapy before or after resection?” As a multidisciplinary thoracic oncology community, when we evaluate patients and consider treatment strategies, we must beware the ever-tempting cross-trial comparison. As clinicians and scientists, it is important to bear in mind the differences in patient populations, inclusion/exclusion criteria, and outcome measurements across the myriad of trials in these exciting times. We should also temper our enthusiasm for and interpretation of exploratory end points and preliminary analyses. We don't know whether neoadjuvant or adjuvant is “better.” The question that we have to answer is “Based on what we know so far, what is the best therapeutic option for this individual patient?” It is also our responsibility to acknowledge what we don't yet know to patients and appropriately consider their concerns and priorities as they weigh therapeutic options. The great news is that in the era of ADAURA, IMpower010, and CheckMate 816, we now have more options than ever before. Perhaps the most exciting aspect of the changing therapeutic landscape in early-stage NSCLC is the possibility of truly personalized medicine. As Altorki and colleagues point out, all of this progress is reliant on equitable and widespread patient access to molecular testing and collaborative multidisciplinary teams. Ongoing trials include a variety of inclusion criteria based on mutational status and tumor markers (EGFR, anaplastic large-cell lymphoma kinase, programmed cell death protein 1/programmed cell death ligand 1), as well as a wide variety of therapeutic agents with or without chemotherapy given in either the neoadjuvant or adjuvant setting. Meta-analyses and comparative studies in meaningful clinical subgroups from these trials will be critical to ensure that individual patients receive the optimal therapeutic regimen at the optimal time—for the patient. The search continues for accurate, noninvasive biomarkers to predict response to therapy, which could allow for even further personalization of therapy including perhaps the omission of cytotoxic chemotherapy or local therapy altogether. An exciting new era of personalized lung cancer care is rapidly approaching for patients with resectable NSCLC, and the future is bright. Thoracic surgical oncologists should and will continue to play a critical role in bringing the future into focus. Adjuvant therapy for early-stage non–small cell lung cancer: The breaking of a new dawnThe Journal of Thoracic and Cardiovascular SurgeryVol. 165Issue 2PreviewFeature Editor's Introduction—The management of patients with advanced non-small cell lung cancer (NSCLC) is a quintessential example of precision medicine. Triaging modalities of first-line systemic therapy for patients with metastatic NSCLC require genome sequencing to identify tumor mutations that are precisely targetable with molecular therapy, and analysis of tumor cell PD-L1 expression prioritizes immunotherapy for many patients. In fact, we live in a world where targeted molecular therapies have been designed and approved to treat the unique resistance mutations that NSCLC tumors develop in response to receiving targeted therapy against their original mutations. Full-Text PDF" @default.
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• W4220760255 title "Commentary: Perioperative systemic therapy in early-stage non–small cell lung cancer: The future is bright" @default.
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