Sie befinden Sich nicht im Netzwerk der Universität Paderborn. Der Zugriff auf elektronische Ressourcen ist gegebenenfalls nur via VPN oder Shibboleth (DFN-AAI) möglich. mehr Informationen...

Details

Autor(en) / Beteiligte
Titel
Phase II study of the effectiveness and safety of trastuzumab and paclitaxel for taxane‐ and trastuzumab‐naïve patients with HER2‐positive, previously treated, advanced, or recurrent gastric cancer (JFMC45‐1102)
Ist Teil von
  • International journal of cancer, 2017-01, Vol.140 (1), p.188-196
Ort / Verlag
United States: Wiley Subscription Services, Inc
Erscheinungsjahr
2017
Link zum Volltext
Quelle
Wiley Online Library All Journals
Beschreibungen/Notizen
  • Paclitaxel is a standard second‐line gastric cancer treatment in Japan. Trastuzumab could be active as second‐line chemotherapy for taxane/trastuzumab‐naïve patients with epidermal growth factor 2 (HER2)‐positive advanced gastric cancer. Patients aged ≥20 years with HER2‐positive, previously treated (except for trastuzumab and taxane), unresectable or recurrent gastric adenocarcinoma underwent combined trastuzumab (first and subsequent doses of 8 and 6 mg kg−1, respectively, every 3 weeks) and paclitaxel (days 1, 8, 15, every 4 weeks) treatment. Study endpoints were best overall response, progression‐free survival, overall survival, and safety. From September 2011 to March 2012, 47 Japanese patients were enrolled. Forty patients discontinued treatment after a median of 128.5 (range 4–486) days. Complete and partial responses were obtained in one and 16 patients (response rate of 37% [95% CI 23–52]), respectively. Median progression‐free survival and overall survival were 5.1 (95% CI 3.8–6.5) and 17.1 (95% CI 13.5–18.6) months, respectively. Grade 3/4 adverse events were neutropenia (32.6%), leukopenia (17.4%), anemia (15.2%) and hypoalbuminemia (8.7%). There was no clinically significant cardiotoxicity or cumulative toxicity. Three (disturbed consciousness, pulmonary fibrosis, and rapid disease progression) grade 5 events occurred. In conclusion, trastuzumab combined with paclitaxel was well tolerated and was a promising regimen for patients with HER2‐positive, previously treated, advanced or recurrent gastric cancer. What's new? Second‐line chemotherapy can provide important survival benefits in patients with advanced or recurrent gastric cancer, and trastuzumab, a HER2‐targeting monoclonal antibody, could be especially useful in second‐line therapy, though its safety and effectiveness are yet to be fully explored. Here, combined trastuzumab‐paclitaxel therapy was assessed in Japanese patients with salvage line HER2‐positive advanced/recurrent gastric cancer. Trastuzumab‐naïve HER2‐positive patients showed high response rates and experienced prolonged survival on the trastuzumab plus paclitaxel regimen. The combination also was generally well tolerated. The findings indicate that HER2‐positive patients treated with paclitaxel can benefit further from the addition of trastuzumab.

Weiterführende Literatur

Empfehlungen zum selben Thema automatisch vorgeschlagen von bX