A multicenter, randomized, phase 3 trial comparing fixed dose versus toxicity-adjusted dose of cisplatin + etoposide in extensive small-cell lung cancer (SCLC) patients: The Small-cell-lung cancer Toxicity Adjusted Dosing (STAD-1) trial.

Autor: Morabito A; Thoracic Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Daniele G; Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Costanzo R; Thoracic Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Favaretto AG; Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy., Filipazzi V; Medical Oncology, Sacco Hospital, Milano, Italy., Rossi A; Medical Oncology, S.G. Moscati Hospital, Avellino, Italy., Gebbia V; Medical Oncology, Casa di Cura La Maddalena, Palermo, Italy., Castiglione F; Medical Oncology, Ospedale San Lazzaro, Alba, Cuneo, Italy., Cavanna L; Medical Oncology, Guglielmo da Saliceto Hospital, Piacenza, Italy., Maiello E; Medical Oncology, Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy., Sandomenico C; Thoracic Medical Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Bonanno L; Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy., Piazza E; Medical Oncology, Sacco Hospital, Milano, Italy., Maione P; Medical Oncology, S.G. Moscati Hospital, Avellino, Italy., Piccirillo MC; Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Di Maio M; Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy; Department of Oncology, University of Turin, Division of Medical Oncology, Ordine Mauriziano Hospital, Turin., Rocco G; Division of Thoracic Surgery, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Gallo C; Medical Statistics, Department of Mental Health and Preventive Medicine, Second University, Napoli, Italy., Perrone F; Clinical Trials Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale', IRCCS, Italy., Gridelli C; Medical Oncology, S.G. Moscati Hospital, Avellino, Italy. Electronic address: cgridelli@libero.it.
Jazyk: angličtina
Zdroj: Lung cancer (Amsterdam, Netherlands) [Lung Cancer] 2017 Jun; Vol. 108, pp. 15-21. Date of Electronic Publication: 2017 Feb 27.
DOI: 10.1016/j.lungcan.2017.02.016
Abstrakt: Objectives: Data supporting the prognostic role of chemotherapy induced haematological toxicity suggest that toxicity-adjusted-dosing (TAD) of chemotherapy might improve treatment efficacy. We tested whether TAD of the cisplatin-etoposide combination might improve the response rate, in previously untreated extensive stage disease (ED)-SCLC patients, as compared with standard fixed-dosing (FD).
Methods: Patients with ED-SCLC were randomized to receive either TAD or FD of cisplatin-etoposide as first-line treatment. Primary endpoint was the objective response rate (ORR) according to the RECIST 1.0 criteria, secondary endpoints included progression free survival (PFS), overall survival (OS) and toxicity.
Results: Hundred-fifty-eight patients were randomized. Most patients were male, with ECOG-PS 1, without brain metastases and had not received radiotherapy before study entry. Response rate was 54.4 (95%CI: 43.5-64.9%) and 58.2 (95%CI: 47.2-68.5%) in the control and experimental arms, respectively (P=0.75). No significant differences were found in terms of PFS (HR 1.04; 95%CI: 0.74-1.44, P=0.84) and OS (HR1.01; 95%CI 0.71-1.42, p=0.97). Seven patients died on treatment, one in the standard arm and 6 in the experimental arm. The most frequent cause of death was neutropenia with infection and, apart in one, death was not related to dose modification. Severe toxicity was more frequent in the experimental arm (91% vs 60%).
Conclusions: In our population of chemonaïve ED SCLC patients, TAD failed to improve the ORR, PFS and OS over the FD of cisplatin-etoposide as first line chemotherapy and was associated with increased toxicity.
(Copyright © 2017 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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