Comparison Of The Sequential Versus The Alternate Administration Of Cisplatin-Etoposide And Topotecan Regimens As First Line Treatment In Extensive Stage Small Cell Lung Cancer (Sclc): A Preliminary Analysis Of A Multicenter Randomized Trial.

7045 Background: To compare the activity and tolerability of the sequential versus the alternate administration of cisplatin-etoposide and topotecan in patients with previously untreated extensive stage SCLC. Methods: 272 chemotherapy-naive SCLC patients have been enrolled into the study. Treatment consisted of either Arm-A(sequential): 4 cycles of cisplatin 75mg/m2 IV day-1 with etoposide 100mg/m2/d IV days 1–3 followed by 4 cycles of topotecan 1.5 mg/m2/d x5 days or Arm-B(alternate): cisplatin-etoposide at same doses on cycles 1,3,5,7 and topotecan on cycles 2,4,6,8. In both arms, cycles were repeated every 3 weeks without prophylactic growth factor support. Results: There is no statistically significant difference (p=NS) in any of the above comparisons between the two arms. A total of 1580 cycles of treatment have been administered (763 Arm-A; 817 Arm-B) with a median of 6.5 and 7 cycles/pt, respectively. Topotecan was administered in 87 pts of Arm-A and 128 pts of Arm-B. More cycles were delayed due to hematological toxicity in Arm-A 65 than Arm-B 44 (p=0.01). Dose reductions due to toxicity were similar in both arms. Toxicity (WHO criteria) per patient was (Arm-A/Arm-B): grade 3/4 neutropenia 54%/52% (p=ns), anemia 12%/14% (p=ns), thrombocytopenia 21%/17% (p=ns), febrile neutropenia 8%/7% (p=ns), asthenia 8%/2% (p=0.01). There were 5 toxic deaths in Arm-A versus 3 in Arm-B (p=0.5). Conclusions: From this preliminary analysis it seems that the two administration sequences result in comparable activity and tolerability in previously untreated patients with extensive stage SCLC. No significant financial relationships to disclose.