Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial

Enrica Capelletto, Maria Rita Migliorino, Alessandro Morabito, Rita Chiari, Francesco Grossi, Marcello Tiseo, Francesco Di Costanzo, Angelo Delmonte, Gianpiero Romano, Domenico Galetta, Vieri Scotti, Vanesa Gregorc, Salvatore Pisconti, Giovanni Luca Ceresoli, Alessandro Del Conte, Libero Ciuffreda, Ida Colantonio, Emilio Bria, Serena Ricciardi, Anna ManzoGiulio Metro, Anna Maria Morelli, Rossana Critelli, Maria Vittoria Pacchiana, Ilaria Stura, Giuseppe Migliaretti, Silvia Novello

Research output: Contribution to journalArticle

Abstract

Objectives: Despite the scant docetaxel's tolerability, second-line association with nintedanib still represents a standard-of-care for non-squamous non-small cell lung cancer (nsNSCLC), giving to rapidly-progressing patients the greatest survival advantage. The SENECA trial is a phase IIb, open-label, study evaluating whether nintedanib/docetaxel can be equally effective and safe regardless docetaxel schedule. Materials and Methods: Recurrent nsNSCLC patients were stratified into cohort 1 and 2, according to relapse-time (within or over 3 months) from end of first-line chemotherapy. They were treated with docetaxel (T1: 33 mg/mq on days 1 and 8 in a 21-days cycle; T2: 75 mg/mq q3wks) plus nintedanib, allowing maintenance in case of disease-control. Primary endpoint was progression-free survival (PFS) by investigator's assessment; secondary endpoints: overall survival (OS), safety and quality-of-life. Results: Between January 2016-April 2018, 212 patients were evaluated: 30 resulted screening-failures, 12 were excluded for lack of compliance. According to investigator's choice, 85 patients received T1 docetaxel and 85 T2; 138 (81.2%) were stratified in C1, 32 (18.8%) in C2, with a median relapse-time of 0.54 and 9.29 months, respectively. Baseline characteristics were balanced between groups. After 35.5 months follow-up, no survival differences appear between cohorts and treatments; toxicity seems to be slightly higher in T2, especially for chemotherapy-related events. Perception of quality-of-life remains stable and docetaxel schedule doesn't modify patients’ load. Conclusion: The SENECA trial confirms efficacy of second-line nintedanib/docetaxel for nsNSCLC, regardless time of recurrence and docetaxel schedule; higher toxicities for q3wks docetaxel, without alterations in quality-of-life, have been described, underling the possibility, adopting the weekly schedule, to maintain efficacy with better tolerability.

Original languageEnglish
Pages (from-to)210-217
Number of pages8
JournalLung Cancer
Volume134
DOIs
Publication statusPublished - Aug 1 2019

Fingerprint

docetaxel
Non-Small Cell Lung Carcinoma
Appointments and Schedules
Quality of Life
Recurrence
Survival
Research Personnel
nintedanib
Drug Therapy
Standard of Care

Keywords

  • Docetaxel
  • Nintedanib
  • Non-small cell lung cancer
  • Quality of life
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Capelletto, E., Migliorino, M. R., Morabito, A., Chiari, R., Grossi, F., Tiseo, M., ... Novello, S. (2019). Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial. Lung Cancer, 134, 210-217. https://doi.org/10.1016/j.lungcan.2019.06.028

Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial. / Capelletto, Enrica; Migliorino, Maria Rita; Morabito, Alessandro; Chiari, Rita; Grossi, Francesco; Tiseo, Marcello; Costanzo, Francesco Di; Delmonte, Angelo; Romano, Gianpiero; Galetta, Domenico; Scotti, Vieri; Gregorc, Vanesa; Pisconti, Salvatore; Ceresoli, Giovanni Luca; Conte, Alessandro Del; Ciuffreda, Libero; Colantonio, Ida; Bria, Emilio; Ricciardi, Serena; Manzo, Anna; Metro, Giulio; Morelli, Anna Maria; Critelli, Rossana; Pacchiana, Maria Vittoria; Stura, Ilaria; Migliaretti, Giuseppe; Novello, Silvia.

In: Lung Cancer, Vol. 134, 01.08.2019, p. 210-217.

Research output: Contribution to journalArticle

Capelletto, E, Migliorino, MR, Morabito, A, Chiari, R, Grossi, F, Tiseo, M, Costanzo, FD, Delmonte, A, Romano, G, Galetta, D, Scotti, V, Gregorc, V, Pisconti, S, Ceresoli, GL, Conte, AD, Ciuffreda, L, Colantonio, I, Bria, E, Ricciardi, S, Manzo, A, Metro, G, Morelli, AM, Critelli, R, Pacchiana, MV, Stura, I, Migliaretti, G & Novello, S 2019, 'Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial', Lung Cancer, vol. 134, pp. 210-217. https://doi.org/10.1016/j.lungcan.2019.06.028
Capelletto, Enrica ; Migliorino, Maria Rita ; Morabito, Alessandro ; Chiari, Rita ; Grossi, Francesco ; Tiseo, Marcello ; Costanzo, Francesco Di ; Delmonte, Angelo ; Romano, Gianpiero ; Galetta, Domenico ; Scotti, Vieri ; Gregorc, Vanesa ; Pisconti, Salvatore ; Ceresoli, Giovanni Luca ; Conte, Alessandro Del ; Ciuffreda, Libero ; Colantonio, Ida ; Bria, Emilio ; Ricciardi, Serena ; Manzo, Anna ; Metro, Giulio ; Morelli, Anna Maria ; Critelli, Rossana ; Pacchiana, Maria Vittoria ; Stura, Ilaria ; Migliaretti, Giuseppe ; Novello, Silvia. / Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial. In: Lung Cancer. 2019 ; Vol. 134. pp. 210-217.
@article{2f1c9e81792d4724bdc63dfaee24639c,
title = "Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial",
abstract = "Objectives: Despite the scant docetaxel's tolerability, second-line association with nintedanib still represents a standard-of-care for non-squamous non-small cell lung cancer (nsNSCLC), giving to rapidly-progressing patients the greatest survival advantage. The SENECA trial is a phase IIb, open-label, study evaluating whether nintedanib/docetaxel can be equally effective and safe regardless docetaxel schedule. Materials and Methods: Recurrent nsNSCLC patients were stratified into cohort 1 and 2, according to relapse-time (within or over 3 months) from end of first-line chemotherapy. They were treated with docetaxel (T1: 33 mg/mq on days 1 and 8 in a 21-days cycle; T2: 75 mg/mq q3wks) plus nintedanib, allowing maintenance in case of disease-control. Primary endpoint was progression-free survival (PFS) by investigator's assessment; secondary endpoints: overall survival (OS), safety and quality-of-life. Results: Between January 2016-April 2018, 212 patients were evaluated: 30 resulted screening-failures, 12 were excluded for lack of compliance. According to investigator's choice, 85 patients received T1 docetaxel and 85 T2; 138 (81.2{\%}) were stratified in C1, 32 (18.8{\%}) in C2, with a median relapse-time of 0.54 and 9.29 months, respectively. Baseline characteristics were balanced between groups. After 35.5 months follow-up, no survival differences appear between cohorts and treatments; toxicity seems to be slightly higher in T2, especially for chemotherapy-related events. Perception of quality-of-life remains stable and docetaxel schedule doesn't modify patients’ load. Conclusion: The SENECA trial confirms efficacy of second-line nintedanib/docetaxel for nsNSCLC, regardless time of recurrence and docetaxel schedule; higher toxicities for q3wks docetaxel, without alterations in quality-of-life, have been described, underling the possibility, adopting the weekly schedule, to maintain efficacy with better tolerability.",
keywords = "Docetaxel, Nintedanib, Non-small cell lung cancer, Quality of life, Toxicity",
author = "Enrica Capelletto and Migliorino, {Maria Rita} and Alessandro Morabito and Rita Chiari and Francesco Grossi and Marcello Tiseo and Costanzo, {Francesco Di} and Angelo Delmonte and Gianpiero Romano and Domenico Galetta and Vieri Scotti and Vanesa Gregorc and Salvatore Pisconti and Ceresoli, {Giovanni Luca} and Conte, {Alessandro Del} and Libero Ciuffreda and Ida Colantonio and Emilio Bria and Serena Ricciardi and Anna Manzo and Giulio Metro and Morelli, {Anna Maria} and Rossana Critelli and Pacchiana, {Maria Vittoria} and Ilaria Stura and Giuseppe Migliaretti and Silvia Novello",
year = "2019",
month = "8",
day = "1",
doi = "10.1016/j.lungcan.2019.06.028",
language = "English",
volume = "134",
pages = "210--217",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial

AU - Capelletto, Enrica

AU - Migliorino, Maria Rita

AU - Morabito, Alessandro

AU - Chiari, Rita

AU - Grossi, Francesco

AU - Tiseo, Marcello

AU - Costanzo, Francesco Di

AU - Delmonte, Angelo

AU - Romano, Gianpiero

AU - Galetta, Domenico

AU - Scotti, Vieri

AU - Gregorc, Vanesa

AU - Pisconti, Salvatore

AU - Ceresoli, Giovanni Luca

AU - Conte, Alessandro Del

AU - Ciuffreda, Libero

AU - Colantonio, Ida

AU - Bria, Emilio

AU - Ricciardi, Serena

AU - Manzo, Anna

AU - Metro, Giulio

AU - Morelli, Anna Maria

AU - Critelli, Rossana

AU - Pacchiana, Maria Vittoria

AU - Stura, Ilaria

AU - Migliaretti, Giuseppe

AU - Novello, Silvia

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objectives: Despite the scant docetaxel's tolerability, second-line association with nintedanib still represents a standard-of-care for non-squamous non-small cell lung cancer (nsNSCLC), giving to rapidly-progressing patients the greatest survival advantage. The SENECA trial is a phase IIb, open-label, study evaluating whether nintedanib/docetaxel can be equally effective and safe regardless docetaxel schedule. Materials and Methods: Recurrent nsNSCLC patients were stratified into cohort 1 and 2, according to relapse-time (within or over 3 months) from end of first-line chemotherapy. They were treated with docetaxel (T1: 33 mg/mq on days 1 and 8 in a 21-days cycle; T2: 75 mg/mq q3wks) plus nintedanib, allowing maintenance in case of disease-control. Primary endpoint was progression-free survival (PFS) by investigator's assessment; secondary endpoints: overall survival (OS), safety and quality-of-life. Results: Between January 2016-April 2018, 212 patients were evaluated: 30 resulted screening-failures, 12 were excluded for lack of compliance. According to investigator's choice, 85 patients received T1 docetaxel and 85 T2; 138 (81.2%) were stratified in C1, 32 (18.8%) in C2, with a median relapse-time of 0.54 and 9.29 months, respectively. Baseline characteristics were balanced between groups. After 35.5 months follow-up, no survival differences appear between cohorts and treatments; toxicity seems to be slightly higher in T2, especially for chemotherapy-related events. Perception of quality-of-life remains stable and docetaxel schedule doesn't modify patients’ load. Conclusion: The SENECA trial confirms efficacy of second-line nintedanib/docetaxel for nsNSCLC, regardless time of recurrence and docetaxel schedule; higher toxicities for q3wks docetaxel, without alterations in quality-of-life, have been described, underling the possibility, adopting the weekly schedule, to maintain efficacy with better tolerability.

AB - Objectives: Despite the scant docetaxel's tolerability, second-line association with nintedanib still represents a standard-of-care for non-squamous non-small cell lung cancer (nsNSCLC), giving to rapidly-progressing patients the greatest survival advantage. The SENECA trial is a phase IIb, open-label, study evaluating whether nintedanib/docetaxel can be equally effective and safe regardless docetaxel schedule. Materials and Methods: Recurrent nsNSCLC patients were stratified into cohort 1 and 2, according to relapse-time (within or over 3 months) from end of first-line chemotherapy. They were treated with docetaxel (T1: 33 mg/mq on days 1 and 8 in a 21-days cycle; T2: 75 mg/mq q3wks) plus nintedanib, allowing maintenance in case of disease-control. Primary endpoint was progression-free survival (PFS) by investigator's assessment; secondary endpoints: overall survival (OS), safety and quality-of-life. Results: Between January 2016-April 2018, 212 patients were evaluated: 30 resulted screening-failures, 12 were excluded for lack of compliance. According to investigator's choice, 85 patients received T1 docetaxel and 85 T2; 138 (81.2%) were stratified in C1, 32 (18.8%) in C2, with a median relapse-time of 0.54 and 9.29 months, respectively. Baseline characteristics were balanced between groups. After 35.5 months follow-up, no survival differences appear between cohorts and treatments; toxicity seems to be slightly higher in T2, especially for chemotherapy-related events. Perception of quality-of-life remains stable and docetaxel schedule doesn't modify patients’ load. Conclusion: The SENECA trial confirms efficacy of second-line nintedanib/docetaxel for nsNSCLC, regardless time of recurrence and docetaxel schedule; higher toxicities for q3wks docetaxel, without alterations in quality-of-life, have been described, underling the possibility, adopting the weekly schedule, to maintain efficacy with better tolerability.

KW - Docetaxel

KW - Nintedanib

KW - Non-small cell lung cancer

KW - Quality of life

KW - Toxicity

UR - http://www.scopus.com/inward/record.url?scp=85068129572&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85068129572&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2019.06.028

DO - 10.1016/j.lungcan.2019.06.028

M3 - Article

AN - SCOPUS:85068129572

VL - 134

SP - 210

EP - 217

JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

ER -