Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of 6 randomized trials.

Autor: Gargiulo P; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Arenare L; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Gridelli C; Division of Medical Oncology, Ospedale 'S.G. Moscati', Contrada Amoretta, 83100, Avellino, Italy., Morabito A; Thoracic Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Ciardiello F; Department of Precision Medicine, Medical Oncology, Università degli Studi della Campania 'Luigi Vanvitelli', Via S. Pansini 5, 80131, Naples, Italy., Gebbia V; La Maddalena Clinic for Cancer, Department Promise, Medical Oncology, Università di Palermo, 90100, Palermo, Italy., Maione P; Division of Medical Oncology, Ospedale 'S.G. Moscati', Contrada Amoretta, 83100, Avellino, Italy., Spagnuolo A; Division of Medical Oncology, Ospedale 'S.G. Moscati', Contrada Amoretta, 83100, Avellino, Italy., Palumbo G; Thoracic Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Esposito G; Thoracic Medical Oncology, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Della Corte CM; Department of Precision Medicine, Medical Oncology, Università degli Studi della Campania 'Luigi Vanvitelli', Via S. Pansini 5, 80131, Naples, Italy., Morgillo F; Department of Precision Medicine, Medical Oncology, Università degli Studi della Campania 'Luigi Vanvitelli', Via S. Pansini 5, 80131, Naples, Italy., Mancuso G; La Maddalena Clinic for Cancer, Department Promise, Medical Oncology, Università di Palermo, 90100, Palermo, Italy., Di Liello R; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Gravina A; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Schettino C; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Di Maio M; Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Via Magellano 1, 10028, Turin, Italy., Gallo C; Medical Statistics, Università degli Studi della Campania 'Luigi Vanvitelli', Via L. Armanni, 80128, Napoli, Italy., Perrone F; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy., Piccirillo MC; Clinical Trials Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Via Mariano Semmola, 80131, Naples, Italy. m.piccirillo@istitutotumori.na.it.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2021 May 14; Vol. 21 (1), pp. 549. Date of Electronic Publication: 2021 May 14.
DOI: 10.1186/s12885-021-08323-4
Abstrakt: Background: Chemotherapy-induced neutropenia (CIN) has been demonstrated to be a prognostic factor in several cancer conditions. We previously found a significant prognostic value of CIN on overall survival (OS), in a pooled dataset of patients with advanced non-small-cell lung cancer (NSCLC) receiving first line chemotherapy from 1996 to 2001. However, the prognostic role of CIN in NSCLC is still debated.
Methods: We performed a post hoc analysis pooling data prospectively collected in six randomized phase 3 trials in NSCLC conducted from 2002 to 2016. Patients who never started chemotherapy and those for whom toxicity data were missing were excluded. Neutropenia was categorized on the basis of worst grade during chemotherapy: absent (grade 0), mild (grade 1-2), or severe (grade 3-4). The primary endpoint was OS. Multivariable Cox model was applied for statistical analyses. In the primary analysis, a minimum time (landmark) at 180 days from randomization was applied in order to minimize the time-dependent bias.
Results: Overall, 1529 patients, who received chemotherapy, were eligible; 572 of them (who received 6 cycles of treatment) represented the landmark population. Severe CIN was reported in 143 (25.0%) patients and mild CIN in 135 (23.6%). At multivariable OS analysis, CIN was significantly predictive of prognosis although its prognostic value was entirely driven by severe CIN (hazard ratio [HR] of death 0.71; 95%CI: 0.53-0.95) while it was not evident with mild CIN (HR 1.21; 95%CI: 0.92-1.58). Consistent results were observed in the out-of-landmark group (including 957 patients), where both severe and mild CIN were significantly associated with a reduced risk of death.
Conclusion: The pooled analysis of six large trials of NSCLC treatment shows that CIN occurrence is significantly associated with a longer overall survival, particularly in patients developing severe CIN, confirming our previous findings.
Databáze: MEDLINE
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