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H. Chen



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-013 - Nab-paclitaxel (Abraxane) based chemotherapy for pretreated elderly advanced NSCLC patients: an open-label, single center, randomized phase II trial (ID 919)

      09:30 - 09:30  |  Author(s): H. Chen

      • Abstract

      Background
      To evaluate the efficacy and safety of nab-paclitaxel single agent and in combination with nedaplatin in elderly patients who have had prior treatment in the recurrent or metastatic NSCLC setting.

      Methods
      Elderly (age ≥ 65) advanced NSCLC patients with ECOG PS 0-1 were recruited and 1:1 randomized to Abraxane single agent arm (arm A) or Abraxane plus nedaplatin arm (arm AP). In arm A Abraxane was 130 mg/m[2], d1, 8, q3w and in arm AP nedaplatin was added by 20 mg/m[2], d1-d3, q3w. The primary endpoint was ORR and secondary endpoints were DCR, PFS, OS and safety.

      Results
      From October 2009 to January 2013, 48 patients were enrolled, 24 patients in each arm. In arm AP, 1 patient was lost to follow up and 1 patient withdrew from study. The median treatment cycle number was 4 and more than 80% of patients finished 4 cycles. The overall ORR of all patients was 21.3% and DCR was 55.3%, median PFS was 4.5 months, and median OS was 12.6 months. There was no significant ORR difference between arm A and AP (16.7% vs 26.1%, P=0.665) as well as DCR (54.2% vs 56.5%, P=0.871). The median PFS was 3.3 months (95% CI: 1.74-4.86) in arm A and 5.5 months (95% CI: 1.59-9.41) in arm AP, with no significant difference (P=0.738). Median OS was 12.6 months in arm A (95% CI: 3.70-21.50) and 15.1 months in arm AP (95% CI: 6.71-23.49), with no significant difference (P=0.770). There was no significant difference of ORR between squamous cell carcinoma and adenocarcinoma subgroups within arm A or AP (P>0.05). There was no ORR difference between subgroups pretreated with or without solvent-based paclitaxel within arm A or AP (P>0.05). Most adverse events were grade 1-2. Grade 3-4 toxicities included neutropenia, thrombocytopenia, neuropathy, fatigue, nausea and vomiting. The incidence of ≥ grade 3 neutropenia were 62.5% in arm AP and 29.1% in arm A (P=0.020). There was no treatment related death. Table 1 Patients demographics and baseline characteristics (n=48)

      Characteristics All patients (n=48) Arm A (n=24) Arm AP (n=24)
      Age, years
      Mean (range) 70.8 (65-80) 71.0 (65-80) 70.5 (66-79)
      Gender, n (%)
      Male 31 (64.6) 16 (66.7) 15 (62.5)
      ECOG PS, n (%)
      0 17 (35.4) 10 (41.7) 7 (29.2)
      1 31 (64.6) 14 (58.3) 17 (70.8)
      TNM stage, n (%)
      IIIb 13 (27.1) 8 (33.3) 5 (20.8)
      IV 35 (72.9) 16 (66.7) 19 (79.2)
      Histology, n (%)
      Adenocarcinoma 32 (66.7) 17 (70.8) 15 (62.5)
      Squamous 16 (33.3) 7 (29.2) 9 (37.5)
      Smoking status, n (%)
      Yes 27 (56.2) 15 (62.5) 12 (50.0)
      No 21 (43.8) 9 (37.5) 12 (50.0)
      EGFR mutation, n (%)
      EGFR (-) 38 (79.2) 18 (75.0) 20 (83.3)
      EGFR (+) 10 (20.8) 6 (25.0) 4 (16.7)
      Pretreated with solvant-based paclitaxel
      Yes 13 (27.1) 6 (25.0) 7 (29.2)
      No 35 (72.9) 18 (75.0) 17 (70.8)
      Prior treatment
      Radiotherapy 7 (14.6) 4 (16.7) 3 (12.5)
      Targeted therapy 18 (37.5) 10 (41.7) 8 (33.3)
      Chemotherapy 42 (87.5) 20 (83.3) 22 (91.7)
      Median treatment cycle, n (range) 4 (1-8) 4 (2-8) 4 (1-6)

      Conclusion
      Nab-paclitaxel-based chemotherapy is well tolerated in pretreated elderly advanced NSCLC patients and has good ORR and OS. Nab-paclitaxel single agent is more adaptable for elderly patients’ performance status. Nab-paclitaxel can be used in patients formerly treated by solvent-based paclitaxel and there is no significant difference of clinical benefit between squamous cell carcinoma and adenocarcinoma.