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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
170P - A phase II trial of nab-paclitaxel and gemcitabine in patients with non-small cell lung cancer previously treated with platinum based chemotherapy (ID 346)
12:30 - 13:00 | Author(s): H. Ohnishi
Nab-Paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate in patients with metastatic pancreatic adenocarcinoma. Combination treatment increases intra-tumoral gemcitabine levels attributable to a decrease in the primary gemcitabine metabolizing enzyme, cytidine deaminase. Based on these data, we planned to assess the efficacy and safety of combination with nab-PTX + gemcitabine in patients with non-small-cell lung cancer (NSCLC) previously treated with platinum based chemotherapy.
Patients with advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function were eligible. Treatment consisted of nab-paclitaxel (100 mg/m) + gemcitabine (1000 mg/m) on days 1 and 8 of each 3-week cycle until progression disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS).
Of the 28 patients enrolled, 28 were evaluable for response and toxicity. The median age was 68 years (range 47–79), 23 male and 5 female. Histology subtypes were: adenocarcinoma 19 patients, squamous cell carcinoma 9 patients. Seventeen patients had ECOG PS 1 and 11 patients had PS 0. Twenty-four patients were 2[nd] line and 4 patients were 3[rd] line. The median number of cycles administered was 4(range 1–10). The overall response rate was 17.9%. The disease control rate was 67.9%. The median progression-free survival was 3.3 months (95% confidence interval [CI] = 1.6–4.7). Four patients (14.3%) had grade 3 anemia, 3 patients (10.7%) had grade 3 thrombocytopenia, 5 patients (17.9%) had grade 4 neutropenia. However, no patients developed febrile neutropenia. Remarkable non-hematologic toxicity was interstitial pneumonia with grade 3 in 4 patients (14.3%), neuropathy with grade 1 in 2 patients (7.1%) and infections with grade 3 in 2 patients (7.1%).
The efficacy of nab-Paclitaxel in combination with gemcitabine in advanced second or third-line NSCLC patients was limited and the high onset of interstitial pneumonia was unacceptable.
Clinical trial identification:
Legal entity responsible for the study:
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Has not received any funding
All authors have declared no conflicts of interest.