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In this open-label phase III study, researchers compared the safetyand efficacy of oral and IV topotecan in patients with small-cell lungcancer (SCLC) sensitive to initial chemotherapy.
A total of309 adults with limited or extensive-stage SCLC who had documentedcomplete or partial response (CR or PR) to first-line therapy withdisease recurrence after at least 90 days were randomised to oral(2.3mg/m2/day; n=153) or IV (1.5 mg/m2/day; n=151) topotecan on days 1to 5, every three weeks. Patients who responded to treatment (CR/PR)continued treatment until disease progression, or for two coursesbeyond best response. Primary endpoint was response rate; secondaryendpoints included duration of response, time to progression, time toresponse, survival, quality of life and toxicity.
Therapy wascompleted by 81% of the oral and 85% of the IV group. Inintent-to-treat analysis, response rates were similar for oral and IVtopotecan (18.3% vs 21.9%; difference of -3.6% 95%CI, -12.6–5.5%).Median survival times were also similar (33 and 35 weeks respectively;hazard ratio 0.98; 95% CI 0.77–1.2), as was median time to response(6.1 vs 6.1 weeks), median duration of response (18.3 vs 25.4 weeks)and median time to progression (11.9 vs 14.6 weeks).
Adverseeffects caused 12% of patients assigned to oral topotecan and 13% ofthose assigned to IV treatment to withdraw from therapy. Incidence ofgrade 4 toxicity in patients receiving oral and IV topotecan,respectively, was as follows: neutropenia in 47% and 64%,thrombocytopenia in 29% and 18%, grade 3 or 4 anaemia in 23% and 31%,and sepsis in 3%. The most frequent nonhaematological adverse events(all grades) included nausea (43% oral; 42% IV), alopecia (26% oral;30% IV), fatigue (31% oral; 36% IV) and diarrhoea (36% oral; 20% IV).
J Clin Oncol 2007;25(15):2086-92
