1476P - Final results of a randomized phase 2 study comparing carboplatin plus irinotecan (CI) versus carboplatin plus amrubicin (CA) for extensive disease...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Small Cell Lung Cancer
Therapy
Biological Therapy
Presenter Youko Tsukita
Citation Annals of Oncology (2014) 25 (suppl_4): iv511-iv516. 10.1093/annonc/mdu355
Authors Y. Tsukita1, N. Morikawa2, S. Sugawara3, M. Maemondo4, T. Harada5, M. Harada6, A. Inoue7, Y. Kawashima3, Y. Fujita8, T. Kato9, H. Yokouchi10, H. Watanabe11, K. Usui12, T. Suzuki13, S. Oizumi14, H. Nagai15, M. Kanbe16, T. Nukiwa17
  • 1Respiratory Medicine, Miyagi Cancer Center, 9811293 - Natori/JP
  • 2Pulmonary Medicine,allergy And Rheumatology, Iwate medical university school of medicine, Iwate/JP
  • 3Department Of Respiratory Medicine, Sendai Kousei Hospital, Sendai/JP
  • 4Department Of Respiratory Medicine, Miyagi Cancer Center, Natori/JP
  • 5Center For Respiratory Diseases, JCHO Hokkaido Hospital, 062-8618 - Sapporo/JP
  • 6Department Of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center, 0030804 - Sapporo/JP
  • 7Department Of Respiratory Medicine, Tohoku University, JP-980-8575 - Sendai/JP
  • 8Department Of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa/JP
  • 9Department Of Respiratory Medicine, Kanagawa Cardiovasucular and Respiratory Center, 2360051 - Yokohama/JP
  • 10Pulmonary Medicine, Fukushima Medical University, 960-1247 - Fukushima/JP
  • 11Respiratory Medicine, Saka genaral hospital, Shiogama/JP
  • 12Division Of Respirology, NTT Medical Center Tokyo, Tokyo/JP
  • 13Division Of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka/JP
  • 14First Department Of Medicine, Hokkaido University School of Medicine, 060-8638 - Sapporo/JP
  • 15Respiratory Medicine, Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP
  • 16Internal Medicine, Senseki hospital, Shiogama/JP
  • 17Medical Commisioner, South Miyagi Medical Center, 9891253 - Miyagi/JP

Abstract

Aim

Cisplatin-based regimens are standard first-line chimotherapy for extensive-disease small -ell lung cancer (ED-SCLC). In patients (pts) unfit for cisplatin due to advanced age or poor performance status (PS), carboplatin plus etoposide (CE) is as effective as cisplatin plus etoposide (JCOG9702 trial), although its efficacy is not satisfactory. Carboplatin plus irinotecan (CI) and carboplatin plus amrubicin (CA) are promising new carboplatin-based regimens identified in our previous studies (NJLCG0405 and NJLCG0711). Accordingly, we conducted this randomized phase 2 study to compare these two regimens to select the more appropriate candidate for future phase 3 trials.

Methods

Chemotherapy-naive ED-SCLC pts were randomly assigned to receive 4-6 cycles of carboplatin (area under the curve [AUC] 5.0, day 1) plus irinotecan (70mg/m2,days 1 and 8) every 3 weeks (CI) or carboplatin (AUC 4.0, day1) plus amrubicin (mg/m2, days 1-3) every 3 weeks (CI). The primary endpoint was the overall response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS),and toxicity. Assuming that an ORR of 80% in eligible pts indicates potential usefulness and an ORR of 60% is the lower limit of interest, the target sample size was 35 pts in each arm (alpha, 0.05; beta, 0.80).

Results

Between December 2009 and March 2013, 71 pts were enrolled. One patient in CI and one patient in CA did not receive any protocol treatment due to rapid disease progression. Pt median age was 70 (51-84), with 16% female, and 91% of pts had good PS (0-1). The ORRs were 79% ( 95% confidence interval [CI]: 62-91) and 89% (95%CI: 73-93), median PFS were 5.1 and 6.2 months (hazard ratio [HR]=0.59, 95%CI: 0.35-0.98, p=0.042), and median overall survival were 12.2 months and 15.9 months with CI and CA, respectively. In the elderly (not less than 70), CA showed similar favorable effects compared with CI as well as less than 70.Toxicities of grade 3 or higher severity were neutropenia (CI, 53% and CA, 89%), anemia (CI, 26% and CA, 20%), thrombocytopenia (CI, 18% and CA, 14%), and febrile neutropenia (CI, 12% and CA, 29%). No treatment-related deaths were observed.

Conclusions

CA was numerically more effective than CI in chemo-naive ED-SCLC, with acceptable toxicity. This regimen could be selected for phase 3 trials.

Disclosure

All authors have declared no conflicts of interest.