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.

Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial / 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.; Manzo, A.; Metro, G.; Morelli, A. M.; Critelli, R.; Pacchiana, M. V.; Stura, I.; Migliaretti, G.; Novello, S.. - In: LUNG CANCER. - ISSN 0169-5002. - 134:(2019), pp. 210-217. [10.1016/j.lungcan.2019.06.028]

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

Tiseo M.;
2019-01-01

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.
2019
Final results of the SENECA (SEcond line NintEdanib in non-small cell lung CAncer) trial / 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.; Manzo, A.; Metro, G.; Morelli, A. M.; Critelli, R.; Pacchiana, M. V.; Stura, I.; Migliaretti, G.; Novello, S.. - In: LUNG CANCER. - ISSN 0169-5002. - 134:(2019), pp. 210-217. [10.1016/j.lungcan.2019.06.028]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2862484
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