OA13.06 Surgical Outcomes Following Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Non-Small Cell Lung Cancer - NEOSTAR Study

Sepesi, Boris; Cascone, Tina; William, W.N.; Lin, Heather; Leung, Cerena; Weissferdt, A.; Walsh, Garrett L.; Rice, David C.; Roth, Jack A.; Mehran, Reza J.; Hofstetter, Wayne L.; Antonoff, Mara B.; Fossella, Frank V.; Mott, Frank E.; Le, Xiuning; Skoulidis, Ferdinandos; Zhang, J.; Byers, Lauren A.; Lam, Vincent K.; Glisson, Bonnie S.; Kurie, Jonathan M.; Blumenschein, George; Tsao, Anne S.; Lu, Charles; Altan, Mehmet; Elamin, Yasir Y.; Gibbons, Don L.; Papadimitrakopoulou, Vassiliki A.; Lee, J.; Vaporciyan, Ara A.; Swisher, Stephen G.

doi:10.1016/j.jtho.2019.08.481

Cited by 26 publications

(28 citation statements)

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“…In the study 24 of nivolumab neoadjuvant immunotherapy in 20 patients with stage IA–IIIA NSCLC, the postoperative incidence of AEs was ~30% (6/20) for atrial arrhythmias, and 5% (1/20) each for myocardial infarction, pulmonary embolism, and empyema. In the NEOSTAR study described above, 15 patients treated preoperatively with two cycles of nivolumab exhibited postoperative complications of persistent lung leakage (22%), bronchopleural fistula (9%), empyema (4%), pulmonary infection (4%), and nonspecific pneumonia (4%). In the most recent report from the NADIM study of 41 NSCLC patients treated with nivolumab plus carboplatin and paclitaxel, 6 the postoperative complication rate was 17.1% and included arrhythmia, persistent lung leakage, respiratory tract infection, postoperative pain, recurrent laryngeal nerve paralysis, thrombocytopenia, postoperative pulmonary infection, lower limb cellulitis, and atrial fibrillation.…”

Section: Prevention Of Iraesmentioning

confidence: 99%

“…One report 13 noted that patients receiving immunotherapy had significantly lower rates of any grade AEs (65.8% vs. 85.2%, odds ratio [OR] 0.35), grade ≥3 AEs (16.5% vs. 41.1%, OR 0.26), rate of treatment interruption due to AEs (6.4% vs. 10.8%, OR 0.55, 95% confidence interval 0.39–0.78), and rate of death due to treatment‐related AEs (0.87% vs. 1.28%) compared with patients receiving chemotherapy. The most common irAEs of any grade were (in order of frequency) diarrhea followed by hypothyroidism, elevated aspartate aminotransferase (AST), vitiligo, and elevated alanine aminotransferase (ALT), while the most common irAEs of grade ≥3 were elevated AST and ALT, pneumonia, diarrhea, and colitis 15 . irAEs usually emerge weeks to months after initiation of ICI therapy and are generally of long duration, sometimes lasting until and beyond the end of treatment.…”

Section: Introductionmentioning

confidence: 99%

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Clinical recommendations for perioperative immunotherapy‐induced adverse events in patients with non‐small cell lung cancer

Hao

Zhang

et al. 2021

Thoracic Cancer

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Perioperative adjuvant treatment has become an increasingly important aspect of the management of patients with non‐small cell lung cancer (NSCLC). In particular, the success of immune checkpoint inhibitors, such as antibodies against PD‐1 and PD‐L1, in patients with lung cancer has increased our expectations for the success of these therapeutics as neoadjuvant immunotherapy. Neoadjuvant therapy is widely used in patients with resectable stage IIIA NSCLC and can reduce primary tumor and lymph node stage, improve the complete resection rate, and eliminate microsatellite foci; however, complete pathological response is rare. Moreover, because the clinical benefit of neoadjuvant therapy is not obvious and may complicate surgery, it has not yet entered the mainstream of clinical treatment. Small‐scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancellation of surgery, additional illness, and even death, and have therefore attracted much attention. In this article, we draw on several sources of information, including (i) guidelines on adverse reactions related to immune checkpoint inhibitors, (ii) published data from large‐scale clinical studies in thoracic surgery, and (iii) practical experience and published cases, to provide clinical recommendations on adverse events in NSCLC patients induced by perioperative immunotherapy.

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Section: Prevention Of Iraesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical recommendations for perioperative immunotherapy‐induced adverse events in patients with non‐small cell lung cancer

Hao

Zhang

et al. 2021

Thoracic Cancer

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“…This is even more interesting, considering that IT use does not seem to negatively impact on pulmonary functions, and on resection rates. However, significant expertise is needed in this setting, considering the higher rate of technically difficult resection, and also the so-called nodal flare (pseudoprogression) often observed in this setting (31,32).…”

Section: Open Questionsmentioning

confidence: 99%

Immunotherapy for locally advanced non-small cell lung cancer: current evidence and future perspectives

Indini¹,

Rijavec²,

Bareggi³

et al. 2021

Curr Chall Thorac Surg

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Non-small cell lung cancer (NSCLC) is the most common type of lung tumors, and one of the leading causes of cancer deaths worldwide. Disease stage at diagnosis significantly impacts on survival, with overall 5-year survival rates ranging from 60% for localized disease, 33% for loco-regional disease, and 5.5% for subjects with distant metastases. Locally advanced NSCLC is a disease characterized by high tumor burden, frequently not amenable of surgical intervention. Overall, only 30% of patients present with potentially resectable disease at diagnosis, and usually undergo neoadjuvant chemotherapy (CT) before surgery. The majority of patients with locally advanced NSCLC (~70%) have unresectable disease at diagnosis. In such cases, multimodal treatment approach with the association of platinum-based CT and radiotherapy (RT), has demonstrated to be superior to sequential therapy or RT alone. Maintenance with immunotherapy after combined CT/RT has further improved the progression-free survival and overall survival. Evidence have suggested that concomitant CT/RT with immunotherapy (IT) enhance disease response, mainly due to its synergized effect on the immune system. Immune checkpoint inhibitors (ICI) have gained an unprecedented success in the treatment of metastatic NSCLC, and represent a promising treatment strategy also in locally advanced disease. There is a strong biologic rationale supporting the use of ICI as a part of multimodal treatment combination of NSCLC. Several clinical trials are ongoing in locally advanced NSCLC, with the aim to explore the role of IT in earlier phases of treatment, combined with RT in place of CT, but also as a trimodal treatment. Considering non-resectable disease, ongoing efforts will help to clarify whether the association of RT with either CT and IT, alone or in combination, is feasible and effectively improve survival outcomes compared with maintenance IT alone. Results from ongoing trials will help to understand the way to improve the efficacy of IT, providing further changes in our standard of care for the treatment of locally advanced NSCLC.

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“…Results, which were presented by Cascone and coworkers 9 at the American Society of Clinical Oncology annual meeting in 2019, demonstrated MPR rate of 17% (4/23) after 3 cycles of nivolumab and 33% (7/21) after combined nivolumab and ipilimumab in the intention-to-treat analysis. A novel phenomenon of nodal immune flare (NIF) has been observed in the NEO-STAR study, 9 and detailed surgical outcomes from this trial 10 and features of nodal immune flare 11 were presented at the 2019 World Conference on Lung Cancer in Barcelona. Reports from NEOSTAR are forthcoming.…”

mentioning

confidence: 95%

Commentary: Neoadjuvant checkpoint inhibitors in resectable non–small cell lung cancer—Ready for prime time?

Sepesi

Cascone

2020

The Journal of Thoracic and Cardiovascular Surgery

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OA13.06 Surgical Outcomes Following Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Non-Small Cell Lung Cancer - NEOSTAR Study

Cited by 26 publications

References 0 publications

Clinical recommendations for perioperative immunotherapy‐induced adverse events in patients with non‐small cell lung cancer

Clinical recommendations for perioperative immunotherapy‐induced adverse events in patients with non‐small cell lung cancer

Immunotherapy for locally advanced non-small cell lung cancer: current evidence and future perspectives

Commentary: Neoadjuvant checkpoint inhibitors in resectable non–small cell lung cancer—Ready for prime time?

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