780TiP - Safety and efficacy of albumin-bound paclitaxel and oxaliplatin and S-1 as first-line treatment of patients with advanced gastric cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Gastric Cancer
Therapy
Biological therapy
Presenter Haizhou Lou
Authors H. Lou, H. Pan, Q. Pan, D. Li, W. Jin
  • Medical Oncology, Sir Run Run Shaw Hospital,college of medicine,Zhejiang University, 310016 - Hangzhou/CN

Abstract

Background

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel formulation of paclitaxel that does not require solvents such as polyoxyethylated castor oil and ethanol. Use of these solvents has been associated with toxic response, including hypersensitivity reactions and prolonged sensory neuropathy. This study was conducted to evaluate the efficacy and safety of combination chemotherapy with nab-paclitaxel plus oxaliplatin and S-1 as first-line treatment for patients with advanced gastric cancer.

Patients and methods

Eligible patients (pts) with histologically confirmed advanced gastric cancer, <75 years old, chemotherapy naive, PS 0 − 2, with adequate renal, hepatic and bone marrow functions and written informed consent are enrolled. Nab-paclitaxel is given with 135mg/m2 for 30-minute infusion followed by oxaliplatin 100 mg/m2 for 2-hour infusion on day 1. S-1 is given orally with 40mg or 60mg twice daily on day 1 − 14. Cycles were repeated every 3 weeks until progression/intolerance, or maximum 6 cycles. Subsequently, the patients with no progression/intolerance were given maintenance therapy of S-1 monotherapy with same dose/schedule as the combination therapy until progression or intolerance.The primary endpoint is progression free survival (PFS), and secondary endpoints are disease control rate (DCR), overall response rate (ORR), overall survival (OS), safety.

Results

From February 2011 to May 2012, total of 16 pts were enrolled, 13 pts received the study treatment, and 13 pts were eligible. Median age was 60, male/female was 3/10, PS:0/1/2 was 3/6/4 . A median of 5 cycles was administered (range, 3-6). ORR was 61.5% (8 of 13) and DCR (disease control rate: rate of CR + PR + SD) was 92.3% (12 of 13) for all eligible patients. The median follow-up time was 10.5 months, the median PFS was 6.3 months. In addition, other secondary endpoints of efficacy are under investigation. Hematological toxicity was mild; grade 3/4 neutropenia was noted in only 7.7% of patients. Alopecia was the most common non-hematological toxicity; Grade 3 alopecia occurred in 5 patients (38.5%).

Conclusions

Combination chemotherapy of albumin-bound paclitaxel with oxaliplatin and S-1 as first-line chemotherapy is effective and well tolerated in patients with advanced gastric cancer.

Disclosure

All authors have declared no conflicts of interest.