Introduction <p>There is limited evidence for the malignancy risk posed by new nodules appearing at annual screening rounds or at short-term interval nodule follow-up (NFU) CTs in lung cancer screening programmes. We investigated incidence rate and malignancy risk in new nodules appearing at NFU and at first annual CT in a screening cohort and investigated nodule and participant characteristics which predicted malignancy.</p> Methods <p>11,566 participants underwent baseline CT screening between April 2019 and April 2020. CTs were read in conjunction with computer-aided detection software with semi-automated volumetry. Nodule management was based on British Thoracic Society guidelines, with the addition of a lower threshold for new solid nodules appearing at incident rounds; those ≥ 30 and &lt; 200 mm<sup>3</sup> underwent a further 3-month interval scan, and new nodules ≥ 200 mm<sup>3</sup> were referred directly for definitive investigation.</p> Results <p>New nodules were identified in 8.4% of participants at NFU-CT and 11.1% at Y1. 0.63% (95% confidence interval (CI) 0.016–3.433) of new nodules at NFU-CT and 2.98% (95% CI 1.83–4.57) at annual CT proved malignant. Malignancy risk in new nodules at Y1 was 1.67% in nodules &lt; 30 mm<sup>3</sup>, 2.2% in nodules 30–200 mm<sup>3</sup> and 11.0% in nodules &gt; 200 mm<sup>3</sup>. No nodules with typical perifissural or subsolid morphology were malignant. There was no significant difference in age, smoking status, smoking history or predicted cancer risk between participants with new nodules which proved malignant and those which were benign.</p> Conclusion <p>Our findings validate the need for lower volume thresholds for further surveillance or definitive investigation in new solid nodules at annual scans. Malignancy risk in new nodules with subsolid or typical perifissural morphology and in new nodules appearing in a shorter time frame of NFU CTs is low.</p> Key Points <p><Emphasis Type="BoldItalic">Question</Emphasis> <i>What is the incidence&#xa0;and malignancy risk of new nodules appearing at annual and nodule follow-up interval CTs in lung cancer screening?</i></p> <p><Emphasis Type="BoldItalic">Findings</Emphasis> <i>New nodules were seen in 11.1% and 8.4% of participants at annual low-dose CT and 3-month interval CT, respectively. Malignancy risk at annual CT increased with nodule size.</i></p> <p><Emphasis Type="BoldItalic">Clinical relevance</Emphasis> <i>In a lung cancer screening programme, new nodules at annual and nodule follow-up CTs occur in around 1 in 10 participants. Lower size thresholds for further surveillance or definitive investigation should be considered compared to nodules at baseline CT.</i></p> Graphical Abstract <p></p>

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Incidence rate and malignancy risk in new nodules in a lung cancer screening programme

  • Andrew W. Creamer,
  • Carolyn Horst,
  • Priyam Verghese,
  • Ruth Prendecki,
  • Amyn Bhamani,
  • Helen Hall,
  • Jennifer L. Dickson,
  • Sophie Tisi,
  • Chuen Ryan Khaw,
  • John McCabe,
  • Kylie Gyertson,
  • Anne-Marie Hacker,
  • Laura Farrelly,
  • Allan Hackshaw,
  • Arjun Nair,
  • Anand Devaraj,
  • Sam M. Janes,
  • Sam M. Janes,
  • Jennifer L. Dickson,
  • Carolyn Horst,
  • Sophie Tisi,
  • Helen Hall,
  • Priyam Verghese,
  • Andrew Creamer,
  • Thomas Callender,
  • Ruth Prendecki,
  • Amyn Bhamani,
  • Mamta Ruparel,
  • Allan Hackshaw,
  • Laura Farrelly,
  • Jon Teague,
  • Anne-Marie Mullin,
  • Kitty Chan,
  • Rachael Sarpong,
  • Malavika Suresh,
  • Samantha L. Quaife,
  • Anand Devaraj,
  • Vicky Bowyer,
  • Ethaar El-Emir,
  • Judy Airebamen,
  • Alice Cotton,
  • Kaylene Phua,
  • Elodie Murali,
  • Simranjit Mehta,
  • Janine Zylstra,
  • Karen Parry-Billings,
  • Columbus Ife,
  • April Neville,
  • Paul Robinson,
  • Laura Green,
  • Zahra Hanif,
  • Helen Kiconco,
  • Ricardo McEwen,
  • Dominique Arancon,
  • Nicholas Beech,
  • Derya Ovayolu,
  • Christine Hosein,
  • Sylvia Patricia Enes,
  • Qin April Neville,
  • Jane Rowlands,
  • Aashna Samson,
  • Urja Patel,
  • Fahmida Hoque,
  • Hina Pervez,
  • Sofia Nnorom,
  • Moksud Miah,
  • Julian McKee,
  • Mark Clark,
  • Jeannie Eng,
  • Fanta Bojang,
  • Claire Levermore,
  • Anant Patel,
  • Sara Lock,
  • Rajesh Banka,
  • Angshu Bhowmik,
  • Ugo Ekeowa,
  • Zaheer Mangera,
  • William M. Ricketts,
  • Neal Navani,
  • Terry O’Shaughnessy,
  • Charlotte Cash,
  • Magali Taylor,
  • Samanjit Hare,
  • Tunku Aziz,
  • Stephen Ellis,
  • Anthony Edey,
  • Graham Robinson,
  • Alberto Villanueva,
  • Hasti Robbie,
  • Elena Stefan,
  • Charlie Sayer,
  • Nick Screaton,
  • Navinah Nundlall,
  • Lyndsey Gallagher,
  • Andrew Crossingham,
  • Thea Buchan,
  • Tanita Limani,
  • Kate Gowers,
  • Kate Davies,
  • John McCabe,
  • Joseph Jacob,
  • Karen Sennett,
  • Tania Anastasiadis,
  • Andrew Perugia,
  • James Rusius

摘要

Introduction

There is limited evidence for the malignancy risk posed by new nodules appearing at annual screening rounds or at short-term interval nodule follow-up (NFU) CTs in lung cancer screening programmes. We investigated incidence rate and malignancy risk in new nodules appearing at NFU and at first annual CT in a screening cohort and investigated nodule and participant characteristics which predicted malignancy.

Methods

11,566 participants underwent baseline CT screening between April 2019 and April 2020. CTs were read in conjunction with computer-aided detection software with semi-automated volumetry. Nodule management was based on British Thoracic Society guidelines, with the addition of a lower threshold for new solid nodules appearing at incident rounds; those ≥ 30 and < 200 mm3 underwent a further 3-month interval scan, and new nodules ≥ 200 mm3 were referred directly for definitive investigation.

Results

New nodules were identified in 8.4% of participants at NFU-CT and 11.1% at Y1. 0.63% (95% confidence interval (CI) 0.016–3.433) of new nodules at NFU-CT and 2.98% (95% CI 1.83–4.57) at annual CT proved malignant. Malignancy risk in new nodules at Y1 was 1.67% in nodules < 30 mm3, 2.2% in nodules 30–200 mm3 and 11.0% in nodules > 200 mm3. No nodules with typical perifissural or subsolid morphology were malignant. There was no significant difference in age, smoking status, smoking history or predicted cancer risk between participants with new nodules which proved malignant and those which were benign.

Conclusion

Our findings validate the need for lower volume thresholds for further surveillance or definitive investigation in new solid nodules at annual scans. Malignancy risk in new nodules with subsolid or typical perifissural morphology and in new nodules appearing in a shorter time frame of NFU CTs is low.

Key Points

Question What is the incidence and malignancy risk of new nodules appearing at annual and nodule follow-up interval CTs in lung cancer screening?

Findings New nodules were seen in 11.1% and 8.4% of participants at annual low-dose CT and 3-month interval CT, respectively. Malignancy risk at annual CT increased with nodule size.

Clinical relevance In a lung cancer screening programme, new nodules at annual and nodule follow-up CTs occur in around 1 in 10 participants. Lower size thresholds for further surveillance or definitive investigation should be considered compared to nodules at baseline CT.

Graphical Abstract