Real world data of durvalumab consolidation after chemoradiotherapy in stage III non-small-cell lung cancer

Jung, Hyun Ae; Noh, Jae Myoung; Sun, Jong‐Mu; Lee, Se‐Hoon; Ahn, Jin Seok; Ahn, Myung‐Ju; Pyo, Hongryull; Ahn, Yong Chan; Park, Keunchil

doi:10.1016/j.lungcan.2020.05.035

Cited by 97 publications

(93 citation statements)

References 18 publications

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“…In the real-world of Korea study, researchers found that V20 ≥ 35% and MLD ≥ 20 Gy were associated with more grade 2 or higher-grade RP (61.9% vs. 15.0%; 70.6% vs. 15.9%). 25 In our study, the higher V20 was associated with more grade 2 RP (V20 ≥ 20% vs. V20 < 20%; 77.8% vs. 18.2%, P = 0.027). We therefore propose that the total lung V20 to highest thresholds such as 28% or less is reasonable.…”

Section: Discussionsupporting

confidence: 48%

“…Finally, the PACIFIC study specified a lung V20 of ≤35% or a mean lung dose of ≤20 Gy. In the real‐world of Korea study, researchers found that V20 ≥ 35% and MLD ≥ 20 Gy were associated with more grade 2 or higher‐grade RP (61.9% vs. 15.0%; 70.6% vs. 15.9%) 25 . In our study, the higher V20 was associated with more grade 2 RP (V20 ≥ 20% vs. V20 < 20%; 77.8% vs. 18.2%, P = 0.027).…”

Section: Discussionmentioning

confidence: 98%

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Efficacy and safety of immune checkpoint inhibitor consolidation after chemoradiation in patients of Asian ethnicity with unresectable stage III non‐small cell lung cancer: Chinese multicenter report and literature review

Zhang

et al. 2020

Thoracic Cancer

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Background: The PACIFIC study has defined a new standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC) in the form of immune checkpoint inhibitor (ICI) consolidation therapy. However, there is little specific data pertaining to the safety and efficacy of this approach in Chinese NSCLC patients. Methods: This was a prospective multicenter cohort study. Between September 2018 and January 2020, patients with unresectable stage III NSCLC that had undergone chemoradiation therapy (CRT) and ICI consolidation treatment were enrolled in this study. The short-term safety, tolerability, and efficacy of ICI combination with CRT were evaluated in these patients. Results: Of the 20 Chinese patients eligible for inclusion, 17 (85.0%) underwent concurrent CRT treatment. In these patients, a median period of 40.5 days (range: 1-85 days) passed between the end of CRT and initiation of consolidation therapy. Pneumonitis occurred in 80.0% of patients, with seven (35.0%) being diagnosed with grade 1 pneumonitis and nine (45.0%) with grade 2 pneumonitis. No patients experienced grade 3 or higher pneumonitis or other ICI-related toxicities. Lung V20 ≥ 20% was associated with higher grade 2 pneumonitis (77.8%; ≥20% vs. 18.2%; <20%, P = 0.027). The overall response rate (ORR) in these patients was 95.0%. Over a median follow-up period of 11.3 months (range: 6.2-21.8 months), 12-month PFS of these patients were 89.5% (95% CI: 76.7-100.0%), and 12 months OS was 100.0%. Conclusions: These data indicate that ICI consolidation therapy can achieve favorable short-term efficacy, while exhibiting good safety and acceptable toxicity profiles in Chinese patients with unresectable stage III NSCLC.

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Section: Discussionsupporting

confidence: 48%

Section: Discussionmentioning

confidence: 98%

Efficacy and safety of immune checkpoint inhibitor consolidation after chemoradiation in patients of Asian ethnicity with unresectable stage III non‐small cell lung cancer: Chinese multicenter report and literature review

Zhang

et al. 2020

Thoracic Cancer

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“…The PACIFIC trial tested the effect of adjuvant Durvalumab after Chemoradiotherapy in Stage III NSCLC [121,122]. PFS and OS were longer among patients who received durvalumab than among those who received placebo in patients with tumor cells with PD-L1 expression of more than 1% [121,[123][124][125]. Hypofractionated thoracic radiotherapy plus Durvalumab in elderly and/or frail NSCLC stage III patients unfit for chemotherapy is currently studied in the TRADE-hypo trial [126] and the SPIRAL-RT study [127].…”

Section: Durvalumab After Chemoradiotherapy In Stage III Nsclcmentioning

confidence: 99%

First line Immunotherapy for Non-Small Cell Lung Cancer

2020

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Immunotherapy for non-small cell lung cancer (NSCLC) is incorporated increasingly in first line treatments protocols. Multiple phase 3 studies have tested different medications targeting programmed death receptor 1 (PD-1), programmed death-ligand 1 (PD-L1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), with or without chemotherapy. The inclusion criteria differ between the various clinical trials, including the cut-off levels of PD-L1 expression on tumor cells, and the tumor histology (squamous or non-squamous). Patients with tumor expression levels of PD-L1 ≥ 50% are candidates for treatment with single agent Pembrolizumab or Atezolizumab. Patients with PD-L1 < 50% are candidates for immunotherapy with pembrolizumab as a single agent if PL-1 > 1%; immunotherapy doublet, Nivolumab and Ipilimumab, or single agent immunotherapy combined with chemotherapy. Here we review phase 3 clinical trials utilizing immunotherapy in the first line for treatment of NSCLC, including Pembrolizumab in KEYNOTE-024, KEYNOTE-042, KEYNOTE-189 and KEYNOTE-407; Nivolumab and Ipilimumab in CHECKMATE-227 and CHECKMATE 9LA; and Atezolizumab in IMpower110, IMpower130 and IMpower150.

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“…Moreover, the benefit of durvalumab was achieved without a detrimental effect on patient-reported outcomes [67]. Although risk of pneumonitis in the PACIFIC trial was low and not associated with baseline respiratory disorders, prior RT dose, or prior cisplatin or carboplatin use [68], careful patient selection and active surveillance is required, as real-world studies indicate a grade 3 pneumonitis rate of 14.3% [69].…”

Section: Unresectable Stage III Nsclcmentioning

confidence: 99%

“…The phase 3 Checkmate 73L (NCT04026412) trial is evaluating all of these treatment approaches. Another important question is the optimal treatment duration for consolidation therapy, especially as only 43% of patients enrolled in PACIFIC trial were able to complete the planned one-year of therapy [68]. Finally the role of predictive biomarkers, such as PD-L1 expression, and prospective validation of minimal residual disease assessed by dynamic circulating tumour DNA (ctDNA) may help to personalise consolidation ICI strategy after CRT [77].…”

Section: Unresectable Stage III Nsclcmentioning

confidence: 99%

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers

Mielgo-Rubio

Calvo

Luna³

et al. 2020

Cancers

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Despite numerous advances in targeted therapy and immunotherapy in the last decade, lung cancer continues to present the highest mortality rate of all cancers. Targeted therapy based on specific genomic alterations, together with PD-1 and CTLA-4 axis blocking-based immunotherapy, have significantly improved survival in advanced non-small cell lung cancer (NSCLC) and both therapies are now well-established in this clinical setting. However, it is time for immunotherapy to be applied in patients with early-stage disease, which would be an important qualitative leap in the treatment of lung cancer patients with curative intent. Preliminary data from a multitude of studies are highly promising, but therapeutic decision-making should be guided by an understanding of the molecular features of the tumour and host. In the present review, we discuss the most recently published studies and ongoing clinical trials, controversies, future challenges and the role of biomarkers in the selection of best therapeutic options.

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Real world data of durvalumab consolidation after chemoradiotherapy in stage III non-small-cell lung cancer

Cited by 97 publications

References 18 publications

Efficacy and safety of immune checkpoint inhibitor consolidation after chemoradiation in patients of Asian ethnicity with unresectable stage III non‐small cell lung cancer: Chinese multicenter report and literature review

Efficacy and safety of immune checkpoint inhibitor consolidation after chemoradiation in patients of Asian ethnicity with unresectable stage III non‐small cell lung cancer: Chinese multicenter report and literature review

First line Immunotherapy for Non-Small Cell Lung Cancer

Immunotherapy Moves to the Early-Stage Setting in Non-Small Cell Lung Cancer: Emerging Evidence and the Role of Biomarkers

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