BACKGROUND: A phase II randomised trial was performed with patients with SCLC to determine if the addition of carboplatin to cisplatin-etoposide might improve the response rate in second-line therapy. PATIENTS AND METHODS: Sixty-five eligible patients were randomised: 31 forCE (cisplatin 20 mg/m(2) and etoposide 100 mg/m(2) on days 1-3) and 34 for CCE (carboplatin 200 mg/m(2) on day 1, cisplatin 30 mg/m(2) on days 2-3, etoposide 100 mg/m(2) on days 1-3). RESULTS: Eighty-two per cent of these patients had an objective response to first-line therapy and, among responders, 63% had a treatment-free interval of >3 months after previous therapy. The best response rates were 29% [95% confidence interval (CI) 13-45] and 47% (95% CI 30-64) for CE and CCE, respectively, with median survival times of 4.3 and 7.6 months. Dose-intensity analysis revealed a significant improvement in the relative dose-intensity and etoposide absolute dose-intensity for CE. Toxicity was tolerable and comparable between the two study arms. CONCLUSION: CCE appears to be associated with a high objective response rate. The phase II randomised study design suggests that a comparison between the two regimens in a phase III trial would be interesting, but will probably be difficult to perform for reasons of accrual.
RCT Entities:
BACKGROUND: A phase II randomised trial was performed with patients with SCLC to determine if the addition of carboplatin to cisplatin-etoposide might improve the response rate in second-line therapy. PATIENTS AND METHODS: Sixty-five eligible patients were randomised: 31 for CE (cisplatin 20 mg/m(2) and etoposide 100 mg/m(2) on days 1-3) and 34 for CCE (carboplatin 200 mg/m(2) on day 1, cisplatin 30 mg/m(2) on days 2-3, etoposide 100 mg/m(2) on days 1-3). RESULTS: Eighty-two per cent of these patients had an objective response to first-line therapy and, among responders, 63% had a treatment-free interval of >3 months after previous therapy. The best response rates were 29% [95% confidence interval (CI) 13-45] and 47% (95% CI 30-64) for CE and CCE, respectively, with median survival times of 4.3 and 7.6 months. Dose-intensity analysis revealed a significant improvement in the relative dose-intensity and etoposide absolute dose-intensity for CE. Toxicity was tolerable and comparable between the two study arms. CONCLUSION:CCE appears to be associated with a high objective response rate. The phase II randomised study design suggests that a comparison between the two regimens in a phase III trial would be interesting, but will probably be difficult to perform for reasons of accrual.
Authors: Ana López-González; Pilar Diz; Lourdes Gutierrez; Elena Almagro; Andrés García Palomo; Mariano Provencio Journal: Ann Transl Med Date: 2013-04