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出境医 / 临床实验 / Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study

Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study

Study Description
Brief Summary:
This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

Condition or disease
Survival Outcomes of Patients With Pulmonary LCNEC

Detailed Description:

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.

The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.

The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Overall Survival and Progression Free Survival of Patients With Large Cell Neuroendocrine Lung Cancer and Combined Large Cell Neuroendocrine Lung Cancer Treated in Clinical Stage I-IV
Actual Study Start Date : January 1, 2002
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. PFS - Progression Free Survival [ Time Frame: 16 years ]
    the time from the start of treatment date to the date of first observation of documented local recurrence, metastases or disease progression. Patients without progression at the time of analysis will be censored.

  2. OS - Overall Survival [ Time Frame: 16 years ]
    is defined as the time from the histopathological confirmation to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.


Secondary Outcome Measures :
  1. Log-rank test [ Time Frame: 16 years ]
    assessment of differences in survival of patients between subgroups

  2. Cox proportional-hazards model [ Time Frame: 16 years ]
    multivariate analyses used for investigating the association between the survival time of patients and prognostic factors


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.
Criteria

Inclusion Criteria:

  • Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:

    1. LCNEC
    2. combined type LCNEC
  • Patients with LCNEC, combined LCNEC without prior treatment independently from the clinical stage according to the 8th edition of TNM 2017
  • Patients with generalized, unresectable of LCNEC, combined LCNEC before, during and after palliative treatment
  • Patients with generalized, unresectable LCNEC, combined LCNEC treated only symptomatically
  • Patients with locally advanced, unresectable LCNEC,combined LCNEC before, during and after radical treatment
  • Patients with locally advanced, resectable LCNEC, combined LCNEC before, during and after treatment

Exclusion Criteria:

  • NA
Contacts and Locations

Sponsors and Collaborators
Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Investigators
Layout table for investigator information
Study Chair: Jarosław B Ćwikła, MD, PhD University of Warmia and Mazury
Tracking Information
First Submitted Date June 18, 2019
First Posted Date June 26, 2019
Last Update Posted Date July 1, 2019
Actual Study Start Date January 1, 2002
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2019)
  • PFS - Progression Free Survival [ Time Frame: 16 years ]
    the time from the start of treatment date to the date of first observation of documented local recurrence, metastases or disease progression. Patients without progression at the time of analysis will be censored.
  • OS - Overall Survival [ Time Frame: 16 years ]
    is defined as the time from the histopathological confirmation to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 23, 2019)
  • Log-rank test [ Time Frame: 16 years ]
    assessment of differences in survival of patients between subgroups
  • Cox proportional-hazards model [ Time Frame: 16 years ]
    multivariate analyses used for investigating the association between the survival time of patients and prognostic factors
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study
Official Title Overall Survival and Progression Free Survival of Patients With Large Cell Neuroendocrine Lung Cancer and Combined Large Cell Neuroendocrine Lung Cancer Treated in Clinical Stage I-IV
Brief Summary This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.
Detailed Description

This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population.

The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population.

The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.
Condition Survival Outcomes of Patients With Pulmonary LCNEC
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Rekhtman N. Neuroendocrine tumors of the lung: an update. Arch Pathol Lab Med. 2010 Nov;134(11):1628-38. doi: 10.1043/2009-0583-RAR.1. Review.
  • Travis WD. Advances in neuroendocrine lung tumors. Ann Oncol. 2010 Oct;21 Suppl 7:vii65-71. doi: 10.1093/annonc/mdq380. Review.
  • Gustafsson BI, Kidd M, Chan A, Malfertheiner MV, Modlin IM. Bronchopulmonary neuroendocrine tumors. Cancer. 2008 Jul 1;113(1):5-21. doi: 10.1002/cncr.23542. Review.
  • Detterbeck FC. Management of carcinoid tumors. Ann Thorac Surg. 2010 Mar;89(3):998-1005. doi: 10.1016/j.athoracsur.2009.07.097. Review.
  • Wolin EM. Challenges in the Diagnosis and Management of Well-Differentiated Neuroendocrine Tumors of the Lung (Typical and Atypical Carcinoid): Current Status and Future Considerations. Oncologist. 2015 Oct;20(10):1123-31. doi: 10.1634/theoncologist.2015-0198. Epub 2015 Aug 25. Review.
  • Chong CR, Wirth LJ, Nishino M, Chen AB, Sholl LM, Kulke MH, McNamee CJ, Jänne PA, Johnson BE. Chemotherapy for locally advanced and metastatic pulmonary carcinoid tumors. Lung Cancer. 2014 Nov;86(2):241-6. doi: 10.1016/j.lungcan.2014.08.012. Epub 2014 Aug 27.
  • Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2. Review.
  • Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59.
  • Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377. Review.
  • Vinik AI, Woltering EA, Warner RR, Caplin M, O'Dorisio TM, Wiseman GA, Coppola D, Go VL; North American Neuroendocrine Tumor Society (NANETS). NANETS consensus guidelines for the diagnosis of neuroendocrine tumor. Pancreas. 2010 Aug;39(6):713-34. doi: 10.1097/MPA.0b013e3181ebaffd.
  • Öberg K, Hellman P, Ferolla P, Papotti M; ESMO Guidelines Working Group. Neuroendocrine bronchial and thymic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii120-3.
  • Caplin ME, Baudin E, Ferolla P, Filosso P, Garcia-Yuste M, Lim E, Oberg K, Pelosi G, Perren A, Rossi RE, Travis WD; ENETS consensus conference participants. Pulmonary neuroendocrine (carcinoid) tumors: European Neuroendocrine Tumor Society expert consensus and recommendations for best practice for typical and atypical pulmonary carcinoids. Ann Oncol. 2015 Aug;26(8):1604-20. doi: 10.1093/annonc/mdv041. Epub 2015 Feb 2. Review.
  • Fisseler-Eckhoff A, Demes M. Neuroendocrine tumors of the lung. Cancers (Basel). 2012 Jul 31;4(3):777-98. doi: 10.3390/cancers4030777.
  • Detterbeck FC. Clinical presentation and evaluation of neuroendocrine tumors of the lung. Thorac Surg Clin. 2014 Aug;24(3):267-76. doi: 10.1016/j.thorsurg.2014.04.002. Review.
  • Pieterman CR, Conemans EB, Dreijerink KM, de Laat JM, Timmers HT, Vriens MR, Valk GD. Thoracic and duodenopancreatic neuroendocrine tumors in multiple endocrine neoplasia type 1: natural history and function of menin in tumorigenesis. Endocr Relat Cancer. 2014 May 6;21(3):R121-42. doi: 10.1530/ERC-13-0482. Print 2014 Jun. Review.
  • Aguayo SM, Miller YE, Waldron JA Jr, Bogin RM, Sunday ME, Staton GW Jr, Beam WR, King TE Jr. Brief report: idiopathic diffuse hyperplasia of pulmonary neuroendocrine cells and airways disease. N Engl J Med. 1992 Oct 29;327(18):1285-8.
  • Gosney JR. Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia as a precursor to pulmonary neuroendocrine tumors. Chest. 2004 May;125(5 Suppl):108S.
  • Koo CW, Baliff JP, Torigian DA, Litzky LA, Gefter WB, Akers SR. Spectrum of pulmonary neuroendocrine cell proliferation: diffuse idiopathic pulmonary neuroendocrine cell hyperplasia, tumorlet, and carcinoids. AJR Am J Roentgenol. 2010 Sep;195(3):661-8. doi: 10.2214/AJR.09.3811. Review.
  • Chong S, Lee KS, Chung MJ, Han J, Kwon OJ, Kim TS. Neuroendocrine tumors of the lung: clinical, pathologic, and imaging findings. Radiographics. 2006 Jan-Feb;26(1):41-57; discussion 57-8. Review.
  • Travis WD, Rush W, Flieder DB, Falk R, Fleming MV, Gal AA, Koss MN. Survival analysis of 200 pulmonary neuroendocrine tumors with clarification of criteria for atypical carcinoid and its separation from typical carcinoid. Am J Surg Pathol. 1998 Aug;22(8):934-44.
  • Igawa S, Watanabe R, Ito I, Murakami H, Takahashi T, Nakamura Y, Tsuya A, Kaira K, Naito T, Endo M, Yamamoto N, Kameya T. Comparison of chemotherapy for unresectable pulmonary high-grade non-small cell neuroendocrine carcinoma and small-cell lung cancer. Lung Cancer. 2010 Jun;68(3):438-45. doi: 10.1016/j.lungcan.2009.07.003. Epub 2009 Aug 21.
  • Watanabe R, Ito I, Kenmotsu H, Endo M, Yamamoto N, Ohde Y, Kondo H, Nakajima T, Kameya T. Large cell neuroendocrine carcinoma of the lung: is it possible to diagnose from biopsy specimens? Jpn J Clin Oncol. 2013 Mar;43(3):294-304. doi: 10.1093/jjco/hys221. Epub 2013 Feb 3.
  • Kujtan L, Muthukumar V, Kennedy KF, Davis JR, Masood A, Subramanian J. The Role of Systemic Therapy in the Management of Stage I Large Cell Neuroendocrine Carcinoma of the Lung. J Thorac Oncol. 2018 May;13(5):707-714. doi: 10.1016/j.jtho.2018.01.019. Epub 2018 Jan 31.
  • Hiroshima K, Mino-Kenudson M. Update on large cell neuroendocrine carcinoma. Transl Lung Cancer Res. 2017 Oct;6(5):530-539. doi: 10.21037/tlcr.2017.06.12. Review.
  • Yang G, Pan Z, Ma N, Qu L, Yuan T, Pang X, Yang X, Dong L, Liu S. Leptomeningeal metastasis of pulmonary large-cell neuroendocrine carcinoma: A case report and review of the literature. Oncol Lett. 2017 Oct;14(4):4282-4286. doi: 10.3892/ol.2017.6676. Epub 2017 Jul 26.
  • Ramirez RA, Chauhan A, Gimenez J, Thomas KEH, Kokodis I, Voros BA. Management of pulmonary neuroendocrine tumors. Rev Endocr Metab Disord. 2017 Dec;18(4):433-442. doi: 10.1007/s11154-017-9429-9. Review.
  • Tang H, Wang H, Xi S, He C, Chang Y, Wang Q, Wu Y. Perioperative chemotherapy with pemetrexed and cisplatin for pulmonary large-cell neuroendocrine carcinoma: a case report and literature review. Onco Targets Ther. 2018 May 7;11:2557-2563. doi: 10.2147/OTT.S160565. eCollection 2018.
  • Derks JL, van Suylen RJ, Thunnissen E, den Bakker MA, Groen HJ, Smit EF, Damhuis RA, van den Broek EC, Speel EM, Dingemans AC; PALGA group. Chemotherapy for pulmonary large cell neuroendocrine carcinomas: does the regimen matter? Eur Respir J. 2017 Jun 1;49(6). pii: 1601838. doi: 10.1183/13993003.01838-2016. Print 2017 Jun.
  • Prelaj A, Rebuzzi SE, Del Bene G, Giròn Berrìos JR, Emiliani A, De Filippis L, Prete AA, Pecorari S, Manna G, Ferrara C, Rossini D, Longo F. Evaluation of the efficacy of cisplatin-etoposide and the role of thoracic radiotherapy and prophylactic cranial irradiation in LCNEC. ERJ Open Res. 2017 Mar 29;3(1). pii: 00128-2016. doi: 10.1183/23120541.00128-2016. eCollection 2017 Jan.
  • Kim KW, Kim HK, Kim J, Shim YM, Ahn MJ, Choi YL. Outcomes of Curative-Intent Surgery and Adjuvant Treatment for Pulmonary Large Cell Neuroendocrine Carcinoma. World J Surg. 2017 Jul;41(7):1820-1827. doi: 10.1007/s00268-017-3908-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2019) 		132
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:

    1. LCNEC
    2. combined type LCNEC
  • Patients with LCNEC, combined LCNEC without prior treatment independently from the clinical stage according to the 8th edition of TNM 2017
  • Patients with generalized, unresectable of LCNEC, combined LCNEC before, during and after palliative treatment
  • Patients with generalized, unresectable LCNEC, combined LCNEC treated only symptomatically
  • Patients with locally advanced, unresectable LCNEC,combined LCNEC before, during and after radical treatment
  • Patients with locally advanced, resectable LCNEC, combined LCNEC before, during and after treatment

Exclusion Criteria:

  • NA
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 86 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03998332
Other Study ID Numbers LCNEC_2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jaroslaw B. Cwikla, MD, PhD, Professor UWM, University of Warmia and Mazury
Study Sponsor Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Collaborators Not Provided
Investigators
Study Chair: Jarosław B Ćwikła, MD, PhD University of Warmia and Mazury
PRS Account University of Warmia and Mazury
Verification Date June 2019

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