A randomised phase II study of the efficacy and safety of intravenous topotecan in combination with either cisplatin or etoposide in patients with untreated extensive disease small-cell lung cancer

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2005-08, Vol.49 (2), p.253-261
• Main Authors: Quoix, Elisabeth, Breton, Jean-Luc, Gervais, Radj, Wilson, Jonathan, Schramel, Franz, Cardenal, Felipe, Ross, Graham, Preston, Alaknanda, Lymboura, Margarita, Mattson, Karin
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Antiviral agents; Biological and medical sciences; Carcinoma, Small Cell - drug therapy; Carcinoma, Small Cell - pathology; Chemotherapy; Cisplatin - administration & dosage; Etoposide - administration & dosage; Female; Humans; Infusions, Intravenous; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Maximum Tolerated Dose; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Pneumology; Second line; Small-cell lung cancer; Survival Rate; Topotecan; Topotecan - administration & dosage; Treatment Outcome; Tumors of the respiratory system and mediastinum
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2005.02.008

Topotecan (Hycamtin ®) is active in small-cell lung cancer (SCLC). This phase II study investigated the efficacy and safety of topotecan in combination with either cisplatin or etoposide in untreated extensive disease SCLC (ED SCLC). Patients with untreated ED SCLC were randomised to treatment with T/C (topotecan 1.25 mg/(m 2 day) IV days 1–5, cisplatin 50 mg/m 2 IV day 5; 41 patients) or T/E (topotecan 0.75 mg/(m 2 day) IV days 1–5, etoposide 60 mg/(m 2 day) IV days 1–5; 41 patients) every 21 days. Response was evaluated by strict radiological criteria. Response rates were similar for T/C (63.4%, 95% CI: 48.7–78.2%) and T/E (61.0%, 95% CI: 46–76%) with one patient in each arm who underwent complete response. Median survival was 41.6 weeks (9.6 months) for the T/C group and 43.7 weeks (10.1 months) for the T/E group. Toxicity was primarily haematological in both groups. The proportion of patients with grades 3–4 anaemia was significantly higher in the T/C arm (46.4%) versus 20% with the T/E arm ( p = 0.018). The proportion of patients with grade 4 neutropenia was not significantly lower with T/C (56.1%) than with T/E (65.0%, p = 0.41), as was the incidence of associated events such as sepsis (T/C: 0%; T/E: 9.8%, p = 0.11). The overall deliverability of either regimen was similar. The most frequent non-haematological adverse experiences of all grades per patient were nausea (T/C: 43.9%; T/E: 36.6%), and alopecia (T/C: 39.0%; T/E: 56.1%). Topotecan did not appear to increase the frequency of adverse events specifically associated with cisplatin. This study showed T/C and T/E to be effective and well tolerated in patients with ED SCLC and further evaluation of topotecan in first line SCLC is warranted.