ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(二十一)
on chemotherapy or relapsed within 6 months of adjuvant chemotherapyc Response Rate
[95% CI] 20/129 (15.5%)
[9.26% – 21.75%] 12/143 (8.4%)
[3.85% – 12.94%]
14.2 Non-Small Cell Lung Cancer
A multicenter, randomized, open-label study was conducted in 1052 chemonaive patients with Stage IIIb/IV non-small cell lung cancer to compare ABRAXANE in combination with carboplatin to paclitaxel injection in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. ABRAXANE was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel injection was administered as an intravenous infusion over 3 hours at a dose of 200 mg/m2, following premedication. In both treatment arms carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 of each 21-day cycle after completion of ABRAXANE/paclitaxel infusion. Treatment was administered until disease progression or development of an unacceptable toxicity. The major efficacy outcome measure was overall response rate as determined by a central independent review committee using RECIST guidelines (Version 1.0).
In the intent-to-treat (all-randomized) population, the median age was 60 years, 75% were men, 81% were White, 49% had adenocarcinoma, 43% had squamous cell lung cancer, 76% were ECOG PS 1, and 73% were current or former smokers. Patients received a median of 6 cycles of treatment in both study arms.
Patients in the ABRAXANE/carboplatin arm had a statistically significantly higher overall response rate compared to patients in the paclitaxel injection/carboplatin arm [(33% versus 25%) see Table 12]. There was no statistically significant difference in overall survival between the two study arms.
Table 12: Efficacy Results from Randomized Non-Small Cell Lung Cancer Trial (Intent-to-Treat Population) CI = confidence interval; DoR= Duration of response
ABRAXANE (100 mg/m2
weekly)
+ carboplatin
(N=521) Paclitaxel Injection
(200 mg/m2 every 3 weeks)
+ carboplatin
(N=531)
Overall Response Rate (ORR)
Confirmed complete or partial overall response, n (%) 170 (33%) 132 (25%)
95% CI 28.6, 36.7 21.2, 28.5
P-value (Chi-Square test) 0.005
Median DoR in months (95% CI) 6.9 (5.6, 8.0) 6.0 (5.6, 7.1)
Overall Response Rate by Histology
Carcinoma/Adenocarcinoma 66/254 (26%) 71/264 (27%)
Squamous Cell Carcinoma 94/229 (41%) 54/221 (24%)
Large Cell Carcinoma 3/9 (33%) 2/13 (15%)
Other 7/29 (24%) 5/33 (15%)
14.3 Adenocarcinoma of the Pancreas
A multicenter, multinational, randomized, open-label study was conducted in 861 patients comparing ABRAXANE plus gemcitabine versus gemcitabine monotherapy as first-line treatment of metastatic adenocarcinoma of the pancreas. Key eligibility criteria were Karnofsky Performance Status (KPS) ≥70, normal bilirubin level, transaminase levels ≤ 2.5 times the upper limit of normal (ULN) or ≤ 5 times the ULN for patients with liver metastasis, no prior cytotoxic chemotherapy in the adjuvant setting or for metastatic disease, no ongoing active infection requiring systemic therapy, and no history of interstitial lung disease. Patients with rapid decline in KPS (≥10 |
