Cisplatin plus irinotecan (PI) alternating with a three-drug combination of doxorubicin, cyclophosphamide and etoposide (ACE) in patients with extensive-stage small-cell lung cancer (ED-SCLC): A phase II study of Okayama Lung Cancer Study Group (OLCSG)

7313 Background: ACE regimen is considered to be one of the standard regimens for ED-SCLC. Recent JCOG study (JCOG 9511) demonstrated a significant superiority of PI regimen to cisplatin plus etoposide which is also a current standard regimen in the treatment of ED-SCLC. Based on these results, we designed this phase II study to determine the effectiveness and safety of an alternating chemotherapy consisting of PI and ACE in patients with ED-SCLC. Methods: Eligibility criteria included age under 76 years, presence of measurable disease, adequate organ function, no prior chemotherapy, ECOG performance status (PS) of 0–1 and written informed consent. In the 1st, 3rd and 5th cycles of chemotherapy, PI (cisplatin: 60 mg/m2 on day 1 and irinotecan: 60 mg/m2 on days 1, 8, 15) was given, and ACE (doxorubicin: 50 mg/m2 on day 1, cyclophosphamide: 750 mg/m2 on day 1 and etoposide: 80 mg/m2 on days 1, 2, 3) was administered in the 2nd, 4th and 6th cycles. Both regimens were repeated every 3 to 4 weeks unless intole...