SECOND LINE CHEMOTHERAPY FOR SCLC

Clin Lung Cancer. 2015 Mar;16(2):100-5. doi: 10.1016/j.cllc.2014.10.002. Epub 2014 Oct 29.

Second-Line Oral Chemotherapy (Lomustine, Cyclophosphamide, Etoposide) Versus Intravenous Therapy (Cyclophosphamide, Doxorubicin, and Vincristine) in Patients With Relapsed Small Cell Lung Cancer: A Randomized Phase II Study of GFPC 0501.

Gervais R1, Le Caer H2, Monnet I3, Falchero L4, Baize N5, Olivero G6, Thomas P7, Berard H8, Auliac JB9, Chouaid C10; Groupe Français de Pneumo-Cancérologie 0501 Team.

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Abstract

BACKGROUND: 

No reference second-line treatment of small-cell lung cancer is available. The aim of the present phase II randomized trial (Groupe Français de Pneumo-Cancérologie 0501) was to compare, in patients with progressive small-cell lung cancer after first-line platinum-based chemotherapy, oral multidrug chemotherapy (lomustine, cyclophosphamide, etoposide) and intravenous therapy with cyclophosphamide, doxorubicin, and vincristine (CAV) in terms of efficacy and tolerance. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, response rate, and tolerance.

PATIENTS AND METHODS: 

The study randomized 131 patients (76.7% male; median age, 61 ± 8.1 years, 85.5% with a performance status of 0-1), 65 to oral therapy and 66 to the CAV arm. No statistically significant differences were found in the baseline patient characteristics.

RESULTS: 

The OS and PFS was 6.1 and 3 months for the oral arm and 5.8 and 3.1 months for the CAV arm, respectively. The control disease rate was 61.6% and 45.5% in oral and CAV arms, respectively. No unexpected adverse events occurred, and no statistically significant difference was found between the 2 arms in terms of toxicity (grade 4 hematologic adverse events in 32.3% and 31.8% of patients in the oral and CAV arms, respectively).

CONCLUSION: 

Compared with CAV, oral therapy in this setting appears as feasible as, but not superior to, the efficacy in the CAV arm.