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S. Sugawara
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MINI 15 - Chemotherapy Developments for Lung Cancer (ID 128)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:L. Crinò, C.P. Belani
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 1a-1f
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MINI15.02 - NEJ016: Phase II Study of CBDCA and Weekly PTX plus BEV Followed by BEV for Highly Selected Elderly Non-Squamous NSCLC Patients (ID 977)
16:50 - 16:55 | Author(s): S. Sugawara
- Abstract
- Presentation
Background:
It is considered that there is a population of “fit-elderly” patients, but how to select this population is undetermined. Two-drug regimen consisted of carboplatin (CBDCA) + weekly paclitaxel (PTX) in elderly patients with non-small cell lung cancer (NSCLC) was reported to be active but to have 4.4% of toxic deaths. When considering to add bevacizumab (BEV) to the two-drug regimen, meta-analysis of BEV-related adverse events taught that congestive heart failure (CHF) and arterial thromboembolic events increased in elderly patients. In this phase II study, we employed exclusion criteria of having both congestive heart failure (CHF) and diabetes mellitus (DM), which relates to arterial thromboembolism.
Methods:
Elderly (≥70 years old) patients with chemotherapy-naive, stage IIIB/IV or recurrent non-squamous NSCLC, ECOG-PS 0-1, measurable target lesion, and adequate organ functions were eligible for this study. Pts with CHF (i.e. those with brain natriuretic peptide (BNP) ≥ 100 pg/ml and ejection fraction (EF) ≤ 50%) and with DM (i.e. those with HbA1c ≥ 7.0%) were excluded. Treatment included CBDCA at AUC 5 on day 1, PTX at 90 mg/m[2] on days 1 and 8, and BEV at 15 mg/kg on day 1 of each 21-day cycle for up to 4 cycles, followed by maintenance BEV.
Results:
Thirty-six eligible patients (14 male, 22 female; median age, 75 years) were enrolled between February 2012 and September 2014. Fifteen and 21 patients had ECOG-PS of 0 and 1, respectively. The median number of CBDCA + weekly-PTX + BEV treatment cycles received was 4, and that of BEV maintenance dosing was 5. Grade 3/4 non-hematological and hematological toxicities were observed in 13 (36.1%) and 20 pts (55.6%), respectively. The most common grade 3/4 AEs included neutropenia (52.8%), hypertension (11%), anemia (8.3%), and infection (8.3%). No fatal AE was observed. The response rate, the primary endpoint of this study, was 69.4% (95% CI = 51.9–83.7), and median progression free survival was 9 months.
Conclusion:
CBDCA + weekly PTX + BEV followed by BEV was a feasible and effective first-line regimen for selected elderly non-squamous NSCLC patients. BNP, EF, and HbA1c may aid in selecting “bevacizumab-fit” elderly patients. Clinical information: UMIN000006622.
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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): S. Sugawara
- 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.
