Prognostic value of circulating tumour cells in limited-stage small-cell lung cancer: analysis of the concurrent once-daily versus twice-daily radiotherapy (CONVERT) randomised controlled trial

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Abstract

Background

The clinical significance of circulating tumour cells (CTCs) in limited-stage small-cell lung cancer (LS-SCLC) is not well defined. We report a planned exploratory analysis of the prevalence and prognostic value of CTCs in LS-SCLC patients enrolled within the phase III randomised CONVERT (concurrent once-daily versus twice-daily chemoradiotherapy) trial.

Patients and methods

Baseline blood samples were enumerated for CTCs using CellSearch in 75 patients with LS-SCLC who were enrolled in the CONVERT trial and randomised between twice- and once-daily concurrent chemoradiation. Standard statistical methods were used for correlations of CTCs with clinical factors. Log-rank test and Cox regression analyses were applied to establish the associations of 2, 15 and 50 CTC thresholds with progression-free survival (PFS) and overall survival (OS). An optimal CTC count threshold for LS-SCLC was established.

Results

CTCs were detected in 60% (45/75) of patients (range 0–3750). CTC count thresholds of 2, 15 and 50 CTCs all significantly correlate with PFS and OS. An optimal CTC count threshold in LS-SCLC was established at 15 CTCs, defining ‘favourable’ and ‘unfavourable’ prognostic risk groups. The median OS in <15 versus ≥15 CTCs was 26.7 versus 5.9 m ( P = 0.001). The presence of ≥15 CTCs at baseline independently predicted ≤1 year survival in 70% and ≤2 years survival in 100% of patients.

Conclusion

We report the prognostic value of baseline CTC count in an exclusive LS-SCLC population at thresholds of 2, 15 and 50 CTCs. Specific to LS-SCLC, ≥15 CTCs was associated with worse PFS and OS independent of all other factors and predicted ≤2 years survival. These results may improve disease stratification in future clinical trial designs and aid clinical decision making.

Trial registration

ClinicalTrials.gov identifier: NCT00433563.

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Most cited references 17

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Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer.

Johann de Bono, Howard Scher, R. Montgomery … (2008)

A method for enumerating circulating tumor cells (CTC) has received regulatory clearance. The primary objective of this prospective study was to establish the relationship between posttreatment CTC count and overall survival (OS) in castration-resistant prostate cancer (CRPC). Secondary objectives included determining the prognostic utility of CTC measurement before initiating therapy, and the relationship of CTC to prostate-specific antigen (PSA) changes and OS at these and other time points. Blood was drawn from CRPC patients with progressive disease starting a new line of chemotherapy before treatment and monthly thereafter. Patients were stratified into predetermined Favorable or Unfavorable groups ( or =5 CTC/7.5mL). Two hundred thirty-one of 276 enrolled patients (84%) were evaluable. Patients with Unfavorable pretreatment CTC (57%) had shorter OS (median OS, 11.5 versus 21.7 months; Cox hazard ratio, 3.3; P 26 to 9.3 months). CTC are the most accurate and independent predictor of OS in CRPC. These data led to Food and Drug Administration clearance of this assay for the evaluation of CRPC.

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REporting recommendations for tumour MARKer prognostic studies (REMARK)

L M McShane, D Altman, W Sauerbrei … (2005)

Despite years of research and hundreds of reports on tumour markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumour marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalisability of the study results. The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. Similar to the successful CONSORT initiative for randomised trials and the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

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Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival.

Daniel Hayes, Massimo Cristofanilli, G Budd … (2006)

We reported previously that >or=5 circulating tumor cells (CTC) in 7.5 mL blood at baseline and at first follow-up in 177 patients with metastatic breast cancer (MBC) were associated with poor clinical outcome. In this study, additional follow-up data and CTC levels at subsequent follow-up visits were evaluated. CTCs were enumerated in 177 MBC patients before the initiation of a new course of therapy (baseline) and 3 to 5, 6 to 8, 9 to 14, and 15 to 20 weeks after the initiation of therapy. Progression-free survival (PFS) and overall survival (OS) times were calculated from the dates of each follow-up blood draw. Kaplan-Meier plots and survival analyses were done using a threshold of >or=5 CTCs/7.5 mL at each blood draw. Median PFS times for patients with or=5 CTC, median PFS from these same time points was significantly shorter: 2.7, 1.3, 1.4, 3.0, and 3.6 months, respectively. Median OS for patients with 18.5 months. For patients with >or=5 CTC, median OS from these same time points was significantly shorter: 10.9, 6.3, 6.3, 6.6, and 6.7 months, respectively. Median PFS and OS times at baseline and up to 9 to 14 weeks after the initiation of therapy were statistically significantly different. Detection of elevated CTCs at any time during therapy is an accurate indication of subsequent rapid disease progression and mortality for MBC patients.

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Author and article information

Journal

Journal ID (nlm-ta): Ann Oncol

Journal ID (iso-abbrev): Ann. Oncol

Journal ID (publisher-id): annonc

Title: Annals of Oncology

Publisher: Oxford University Press

ISSN (Print): 0923-7534

ISSN (Electronic): 1569-8041

Publication date (Print): July 2019

Publication date (Electronic): 24 April 2019

Publication date PMC-release: 24 April 2019

Volume: 30

Issue: 7 , Targeting the PI3-kinase pathway in triple-negative breast cancer

Pages: 1114-1120

Affiliations

[1 ]Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester

[2 ]Clinical and Experimental Pharmacology Group, CRUK Manchester Institute

[3 ]Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health

[4 ]Cancer Research UK Manchester Institute

[5 ]Manchester Centre for Cancer Biomarker Sciences, University of Manchester, Manchester

[6 ]Manchester Academic Health Science Centre Trials Co-ordination Unit

[7 ]Department of Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, UK

Author notes

Correspondence to: Prof. Fiona Blackhall, Division of Molecular and Clinical Cancer Sciences, University of Manchester; Department of Medical Oncology, The Christie NHS Foundation Trust, 550 Wilmslow Road, Manchester M20 4BX, UK. Tel: +44-161-4463745; E-mail: fiona.blackhall@ 123456christie.nhs.uk

Article

Publisher ID: mdz122

DOI: 10.1093/annonc/mdz122

PMC ID: 6637373

PubMed ID: 31020334

SO-VID: 7a28f2c4-f599-4c44-bcb6-3fdfbb5d12bc

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Page count

Pages: 7

Funding

Funded by: Cancer Research UK Clinical Trials Awards and Advisory Committee

Award ID: C17052/A8154

Funded by: French Ministry of Health

Funded by: Programme Hospitalier de Recherché Clinique

Award ID: NAT 2007-28-01

Funded by: Canadian Cancer Society Research Institute 10.13039/501100000015

Award ID: 021039

Funded by: European Organisation for the Research and Treatment of Cancer

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Prognostic value of circulating tumour cells in limited-stage small-cell lung cancer: analysis of the concurrent once-daily versus twice-daily radiotherapy (CONVERT) randomised controlled trial

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Abstract

Background

Patients and methods

Results

Conclusion

Trial registration

Related collections

Karger: Oncology

Most cited references 17

Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer.

REporting recommendations for tumour MARKer prognostic studies (REMARK)

Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival.

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Cited by 36

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