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

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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., Costanzo, F. D., Delmonte, A., Romano, G., Galetta, D., Scotti, V., Gregorc, V., Pisconti, S., Ceresoli, G. L., Conte, A. D., Ciuffreda, L., Colantonio, I., Bria, E., Ricciardi, S., ... 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