BACKGROUND: This multicentric randomized phase II study investigated the feasibility and toxicity of temozolomide (TMZ) added to whole brain radiotherapy (WBRT) followed by adjuvant TMZ in patients with multiple brain metastases of non-small-cell lung cancer (NSCLC). METHODS:Patients with multiple brain metastases from NSCLC aged ≥ 18 years, classified according to recursive partitioning analysis class I or II and with adequate organ functions were eligible. Treatment consisted of WBRT + TMZ 75 mg/m² for 2 weeks followed at day 28 by TMZ 100 mg/m²/day 2 weeks on/2 weeks off for up to 6 months (radiochemotherapy, RCT) or WBRT alone (radiotherapy, RT). RESULTS: The study enrolled only 35 patients (22 patients in RCT and 13 in RT) and had to be closed prematurely due to poor accrual. The toxicity was mainly due to TMZ with WHO grade 3 and 4 thrombocytopenia in 3/22 versus 0/13, leucocytopenia in 1/22 versus 0/13 and lymphocytopenia in 7/22 versus 12/13 patients in RCT and RT respectively. Thirteen patients inRCT and six in RT progressed systemically and dropped out before first restaging of the response in brain. Median time to progression (TTP) was 2.4 months (95 % CI: 2-2.6 months) and 2.0 months (95 % CI: 0.5-3.5 months), median overall survival (OAS) was 3 months (95% CI: 1.7-3.1 months) and 6.3.months (95 % CI: 0.2-7.6 months) in RCT and RT, respectively. CONCLUSIONS: Like other studies before on patients with brain metastases, insufficient number of recruited patients does not allow conclusions on efficacy and toxicity as the study closed prematurely.
RCT Entities:
BACKGROUND: This multicentric randomized phase II study investigated the feasibility and toxicity of temozolomide (TMZ) added to whole brain radiotherapy (WBRT) followed by adjuvant TMZ in patients with multiple brain metastases of non-small-cell lung cancer (NSCLC). METHODS:Patients with multiple brain metastases from NSCLC aged ≥ 18 years, classified according to recursive partitioning analysis class I or II and with adequate organ functions were eligible. Treatment consisted of WBRT + TMZ 75 mg/m² for 2 weeks followed at day 28 by TMZ 100 mg/m²/day 2 weeks on/2 weeks off for up to 6 months (radiochemotherapy, RCT) or WBRT alone (radiotherapy, RT). RESULTS: The study enrolled only 35 patients (22 patients in RCT and 13 in RT) and had to be closed prematurely due to poor accrual. The toxicity was mainly due to TMZ with WHO grade 3 and 4 thrombocytopenia in 3/22 versus 0/13, leucocytopenia in 1/22 versus 0/13 and lymphocytopenia in 7/22 versus 12/13 patients in RCT and RT respectively. Thirteen patients in RCT and six in RT progressed systemically and dropped out before first restaging of the response in brain. Median time to progression (TTP) was 2.4 months (95 % CI: 2-2.6 months) and 2.0 months (95 % CI: 0.5-3.5 months), median overall survival (OAS) was 3 months (95% CI: 1.7-3.1 months) and 6.3.months (95 % CI: 0.2-7.6 months) in RCT and RT, respectively. CONCLUSIONS: Like other studies before on patients with brain metastases, insufficient number of recruited patients does not allow conclusions on efficacy and toxicity as the study closed prematurely.
Authors: Nicholas W Choong; Ann M Mauer; Philip C Hoffman; Charles M Rudin; Jerome D Winegarden; J Lee Villano; Mark Kozloff; James L Wade; David F Sciortino; Livia Szeto; Everett E Vokes Journal: J Thorac Oncol Date: 2006-03 Impact factor: 15.609
Authors: Fabio M Iwamoto; Antonio M Omuro; Jeffrey J Raizer; Craig P Nolan; Adília Hormigo; Andrew B Lassman; Igor T Gavrilovic; Lauren E Abrey Journal: J Neurooncol Date: 2007-11-07 Impact factor: 4.130
Authors: D Antonadou; M Paraskevaidis; G Sarris; N Coliarakis; I Economou; P Karageorgis; N Throuvalas Journal: J Clin Oncol Date: 2002-09-01 Impact factor: 44.544
Authors: Christian S Adonizio; James S Babb; Christine Maiale; Chao Huang; Judy Donahue; Michael M Millenson; Martha Hosford; Robert Somer; Joseph Treat; Eric Sherman; Corey J Langer Journal: Clin Lung Cancer Date: 2002-05 Impact factor: 4.785
Authors: Avinash Gupta; Corran Roberts; Finn Tysoe; Matthew Goff; Jenny Nobes; James Lester; Ernie Marshall; Carie Corner; Virginia Wolstenholme; Charles Kelly; Adelyn Wise; Linda Collins; Sharon Love; Martha Woodward; Amanda Salisbury; Mark R Middleton Journal: Br J Cancer Date: 2016-10-06 Impact factor: 7.640
Authors: Anna Patla; Tomasz Walasek; Jerzy Jakubowicz; Paweł Blecharz; Jerzy Władysław Mituś; Anna Mucha-Małecka; Marian Reinfuss Journal: Contemp Oncol (Pozn) Date: 2016-12-20
Authors: Ida Cedrych; Maksymilian A Kruczała; Tomasz Walasek; Jerzy Jakubowicz; Paweł Blecharz; Marian Reinfuss Journal: Contemp Oncol (Pozn) Date: 2016-12-20