Multicenter Randomized Open-Label Phase III Study Comparing Efficacy, Safety, and Tolerability of Conventional Carboplatin Plus Etoposide Versus Dose-Intensified Carboplatin Plus Etoposide Plus Lenograstim in Small-Cell Lung Cancer in “Extensive Disease” Stage

Abstract

Dose-intense CE with GM-CSF support can be administered safely but does not prolong overall or progression-free survival compared with standard therapy.

Carboplatin plus etoposide for extensive stage small-cell lung cancer: An experience with AUC 6 doses of carboplatin

“…Median survival in the conventional group and the dose-intensified group were 11.2 months and 11.7 months, respectively. [22] PFS was 6.7 months and 7.4 months, respectively. There was no statistically significant difference between these groups.…”

Hematopoietic growth factors in lung cancer

“…Most clinical trials involving SCLC employed dose-dense or dose-intense regimens, and in general schedules characterized by high risk of febrile neutropenia, such as cyclophosphamidedoxorubicin-etoposide, cyclophosphamide-epirubicin-etoposide or vincristine-ifosfamide-carboplatinetoposide. Although dose-dense or dose-intense regimens did not improve the outcomes, G-CSFs consistently improved neutrophil-related outcomes and reduced the incidence of chemotherapyrelated mucositis [31][32][33][34][35][36][37][38][39][40]. Notably, an Italian study assessed the feasibility of full-dose cisplatinetoposide (the current standard for SCLC) with lenograstim compared to attenuated doses of the same drugs for elderly patients affected by SCLC; the administration of full-dose with lenograstim, while characterized by increased incidence of myelotoxicity, was feasible and associated with better outcomes [41].…”

Treatment of metastatic small-cell lung cancer in 2012

“…L'ajout du paclitaxel au ciplatine-étoposide n'a pas montré d'amélioration de la survie globale dans deux essais de phase III dont l'un a été interrompu prématurément à cause d'un plus grand nombre de décès dans le bras traité par la trithérapie et dont l'autre était une étude de supériorité dont l'objectif principal était le temps à progression [23,26]. L'intensification des doses de chimiothé-rapie en associant des facteurs de croissance hématopoïétiques ou en injectant des cellules souches héma-topoiétiques autologues ne fournit aucune amélioration de la survie [2,12,20]. De même, raccourcir le traitement en diminuant l'intervalle entre deux cycles n'a pas non plus permis de prolonger la survie [33].…”