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T. Katoh
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P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.07-006 - Final Results of Randomized Phase II Study of Carboplatin plus Irinotecan vs. Carboplatin plus Amrubicin for ED-SCLC (ID 931)
09:30 - 09:30 | Author(s): T. Katoh
- Abstract
Background:
Carboplatin-based regimens, such as carboplatin plus etoposide (CE), are among the standard regimens for the management of extended disease small-cell lung cancer (ED-SCLC). However, the efficacy of carboplatin-based regimens is unsatisfactory. Carboplatin plus irinotecan (CI) and carboplatin plus amrubicin (CA) are promising new carboplatin-based regimens identified in our previous studies. Accordingly, we conducted this randomized phase II study to identify the appropriate regimen for comparison with CE in future phase III trials.
Methods:
Chemotherapy-naïve patients with ED-SCLC were randomly assigned to receive 4–6 cycles of carboplatin (area under the curve [AUC] 5.0, day 1) plus irinotecan (70 mg/m[2], days 1 and 8) every 3 weeks (CI arm) or carboplatin (AUC 4.0, day 1) plus amrubicin (35 mg/m[2], days 1–3) every 3 weeks (CA arm). The primary endpoint was the overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity.
Results:
Between December 2009 and March 2013, 71 patients were enrolled. One patient in each arm did not receive any protocol treatment owing to rapid disease progression. The characteristics of the treated patients were as follows: median age, 70 years (range 51–84 years) and proportion of males, 84%. Delivered mean dose intensities (mean actual dose/mean planned dose) were similar for both arms: carboplatin 98% and irinotecan 94% for CI arm, and carboplatin 97% and amrubicin 94% for CA arm. The ORRs were 79% and 89%, median PFS was 5.1 and 6.2 months (CA; hazard ratio [HR] = 0.59, 95% CI: 0.35–0.98, P = 0.042), and median OS was 12.2 and 15.9 months in the CI and CA arms, respectively (CA; HR, 0.77; 95% CI: 0.49–1.29; P =.318). Grade 3 or higher 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%) were observed. No treatment-related deaths were observed. Overall, 25 patients (74%) in the CI arm and 28 patients (80%) in the CA arm received post-discontinuation therapies.
Conclusion:
CA was numerically effective than CI in chemotherapy-naïve patients with ED-SCLC, with acceptable toxicity. Therefore, CA could be selected for future phase III trials.
