Assessing response to immunotherapy in patients with non-small cell lung cancer using circulating tumor DNA

Goldberg, Sarah B.; Narayan, Azeet; Kole, Adam J.; Decker, Roy H.; Teysir, Jimmitti; Carriero, Nicholas; Lee, A.; Nemati, Roxanne; Nath, Sameer K.; Mane, Shrikant; Deng, Yanxiang; Sukumar, Nitin; Zelterman, Daniel; Boffa, Daniel J.; Politi, Katerina; Gettinger, Scott; Wilson, Lynn D.; Herbst, Roy S.; Patel, Abhijit A.

doi:10.1093/annonc/mdx380.043

Cited by 2 publications

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“…In addition, their fluctuation over time could be a useful parameter in treatment monitoring. 28,29 Their assessment at diagnosis, treatment start and at the first evaluation could overcome the difficulties in TGR analysis in 1 st line setting in the near future. Future analysis could also include PET scan derived parameters, such as metabolic tumor volume, that may have a role in evaluating response to ICI as well as they have in prediting response 30,31 thanks to its ability of taking into account the whole tumor burden instead of the RECIST based target lesions.…”

Section: Discussionmentioning

confidence: 99%

Monitoring tumor growth rate to predict immune checkpoint inhibitors’ treatment outcome in advanced NSCLC

et al. 2022

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Introduction: Radiological response assessment to immune checkpoint inhibitor is challenging due to atypical pattern of response and commonly used RECIST 1.1 criteria do not take into account the kinetics of tumor behavior. Our study aimed at evaluating the tumor growth rate (TGR) in addition to RECIST 1.1 criteria to assess the benefit of immune checkpoint inhibitors (ICIs). Methods: Tumor real volume was calculated with a dedicated computed tomography (CT) software that semi-automatically assess tumor volume. Target lesions were identified according to RECIST 1.1. For each patient, we had 3 measurement of tumor volume. CT-1 was performed 8–12 weeks before ICI start, the CT at baseline for ICI was CT0, while CT + 1 was the first assessment after ICI. We calculated the percentage increase in tumor volume before (TGR1) and after immunotherapy (TGR2). Finally, we compared TGR1 and TGR2. If no progressive disease (PD), the group was disease control (DC). If PD but TGR2 < TGR1, it was called LvPD and if TGR2 ⩾ TGR1, HvPD. Results: A total of 61 patients who received ICIs and 33 treated with chemotherapy (ChT) were included. In ICI group, 18 patients were HvPD, 22 LvPD, 21 DC. Median OS was 4.4 months (95% CI: 2.0–6.8, reference) for HvPD, 7.1 months (95% CI 5.4–8.8) for LvPD, p = 0.018, and 20.9 months (95% CI: 12.5–29.3) for DC, p < 0.001. In ChT group, 7 were categorized as HvPD, 17 as LvPD and 9 as DC. No difference in OS was observed in the ChT group (p = 0.786) Conclusion: In the presence of PD, a decrease in TGR may result in a clinical benefit in patients treated with ICI but not with chemotherapy. Monitoring TGR changes after ICIs administration can help physician in deciding to treat beyond PD.

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Section: Discussionmentioning

confidence: 99%

Monitoring tumor growth rate to predict immune checkpoint inhibitors’ treatment outcome in advanced NSCLC

et al. 2022

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“…Studies have shown that asymptomatic rather than symptomatic recurrences are more likely to be treated with curative intent and that these patients have improved overall survival after such interventions. [9][10][11] However, despite improved outcomes for asymptomatic patients, over 60% are still diagnosed with recurrence secondary to symptoms, a scenario associated with poor clinical outcomes. 12 Historically, the decision to administer adjuvant chemotherapy postsurgery and during surveillance has depended on the presence of clinical features that are considered high-risk according to the standard of care.…”

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confidence: 99%

BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer

et al. 2021

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IntroductionColorectal cancer (CRC) is a highly prevalent disease, wherein, ~30%–40% of patients with CRC relapse postresection. In some patients with CRC, adjuvant chemotherapy can help delay recurrence or be curative. However, current biomarkers show limited clinical utility in determining if/when chemotherapy should be administered, to provide benefit. Circulating tumour DNA (ctDNA) can measure molecular residual disease (MRD) and relapse with high specificity and sensitivity. This study protocol investigates the clinical utility of ctDNA for optimal use of adjuvant chemotherapy in patients with surgically resected CRC and to detect early disease progression in the surveillance setting.Methods and analysisThis is a multicentre prospective, observational cohort study. A total of 2000 stage I–IV patients will be enrolled in up to 200 US sites, and patients will be followed for up to 2 years with serial ctDNA analysis, timed with the standard-of-care visits. The primary endpoints are to observe the impact of bespoke ctDNA testing on adjuvant treatment decisions and to measure CRC recurrence rates while asymptomatic and without imaging correlate. The secondary endpoints are MRD clearance rate (MRD+ to MRD−) during or after adjuvant chemotherapy, percentage of patients that undergo surgery for oligometastatic recurrence, survival of MRD-negative patients treated with adjuvant chemotherapy versus no adjuvant chemotherapy (active surveillance), overall survival, examine the number of stage I CRC that have recurrent disease detected postsurgery, and patient-reported outcomes.Ethics and disseminationThis study has received ethical approval from the Advarra Institutional Review Board (IRB) protocol: Natera—20-041-NCP/3766.01, BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer (BESPOKE CRC) (Pro00041473) on 10 June 2021. Data protection and privacy regulations will be strictly observed in the capturing, forwarding, processing and storing of patients’ data. Publication of any study results will be approved by Natera in accordance with the site-specific contract.Trial registration numberNCT04264702.

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Assessing response to immunotherapy in patients with non-small cell lung cancer using circulating tumor DNA

Cited by 2 publications

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Monitoring tumor growth rate to predict immune checkpoint inhibitors’ treatment outcome in advanced NSCLC

Monitoring tumor growth rate to predict immune checkpoint inhibitors’ treatment outcome in advanced NSCLC

BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer

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