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A. Inoue
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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): A. Inoue
- 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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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-056 - Phase II Study of Carboplatin plus Weekly Nab-Paclitaxel in Elderly Patients with NSCLC: North Japan Lung Cancer Study Group Trial 1301 (ID 576)
09:30 - 09:30 | Author(s): A. Inoue
- Abstract
Background:
Recent IFCT-0501 trial demonstrated that carboplatin (CBDCA) combined with weekly paclitaxel (PTX) would be advantageous compared with monotherapy. Subsequently, CA031 trial suggested that weekly nab-paclitaxel (nab-PTX) was superior in efficacy and safety compared with 3-weekly PTX when combined with CBDCA. Since the subgroup analysis for elderly patients (pts) in CA031 showed very promising data (34% of overall response rate (ORR) and 8.0 months of progression-free survival (PFS)), we conducted this multicenter, non-randomized, open label, phase II trial to evaluate the efficacy and tolerability of CBDCA plus weekly nab-PTX regimen for elderly patients with advanced non-small cell lung cancer (NSCLC) prospectively.
Methods:
Eligible pts were aged 75 years or older with newly diagnosed clinical stage IIIB, IV, and postoperative recurrence NSCLC; ECOG performance status (PS) of 0-1; adequate organ function; written informed consent. Pts received CBDCA (AUC 6) on day 1 and nab-PTX (75mg/m[2]) on day1, 8, and 15, every 4 weeks. The primary endpoint was ORR and secondary endpoints were PFS, overall survival (OS), and toxicity profile. Assuming that ORR of 40% would be potential usefulness while ORR of 20% would be the lower limit of interest, 32 pts were required.
Results:
Between March 2013 and May 2014, 35 pts were enrolled and 32 pts were eligible. Median age was 78 years (range, 75-86), 84% (27/32) were male and 56% (18/32) were stage IV. 56% (18/32) had squamous cell carcinoma and 44% (14/32) had adenocarcinoma. Median treatment cycle was 4 (range, 1-6). ORR and DCR were 50% (95%CI: 33-67) and 94% (95%CI: 85-100), respectively. With a median follow-up of 9.1 months, median PFS was 6.4 months (95%CI: 4.8-8.0). Median OS had not been reached at the data cutoff point. Grade 3 or severer toxicities were as follows: neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). No febrile neutropenia and treatment-related deaths were observed.
Conclusion:
The combination of CBDCA and weekly nab-PTX demonstrated significant efficacy with acceptable toxicities in elderly patients with advanced NSCLC.
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P3.01-071 - RAS Inhibitor Prevent Proteinuria of NSCLC Patients Who Received Bevasizumab Chemotherapy: NJLCG 1303 (ID 1204)
09:30 - 09:30 | Author(s): A. Inoue
- Abstract
Background:
Proteinuria caused by bevacizumab (BV) often becomes an obstacle to continuation of the treatment. Renin-angiotensin system inhibitor (RASI), angiotensin receptor blocker and angiotensin converting enzyme inhibitor, has demonstrated anti-proteinuria effect in diabetic nephropathy and nondiabetic kidney disease. This retrospective observational study was conducted to evaluate the anti-proteinuria effect of RASI for NSCLC patients (pts) who received BV chemotherapy.
Methods:
We reviewed the medical records of NSCLC pts between 2008 and 2014 at 11 hospitals. Eligible pts had a treatment of BV chemotherapy, no proteinuria, and no diabetes mellitus. Clinical characteristics, use of the antihypertensive drugs, change of the blood pressure, and proteinuria generation were investigated during first 6 courses of BV chemotherapy.
Results:
A total of 211 pts were enrolled. Pts characteristics were: male/female 121/90; median age 63 (range 35-88); ECOG performance status 0-1/2-3 199/12; stage Ⅳ/recurrent 189/22; dose of BV(/kg) 7.5mg/15mg 21/190; BV cycle 1-2/3-4/5-6 18/55/138; antihypertensive drugs RASI/non-RASI/none 59/44/108. Proteinuria was observed in 49 pts (23%) as grade 1/2/3 33/14/2. The rate of proteinuria generation was significantly lower in the RASI group than non-RASI group (17% vs. 41%, P=0.025). Multivariate analysis revealed that RASI significantly reduced proteinuria (HR=0.43, 95% CI=0.17-0.91, P=0.043).
Conclusion:
RASI demonstrated anti-proteinuria effect for NSCLC pts who received BV therapy.
