Advanced Gastric Cancer Patients May Benefit from Trastuzumab, Capecitabine, Oxaliplatin Trio

South Korean researchers report encouraging results for the addition of trastuzumab to the capecitabine and oxaliplatin backbone regimen in locally advanced or metastatic HER2-positive gastric cancer

medwireNews: Phase II trial findings indicate that trastuzumab together with capecitabine and oxaliplatin has promising efficacy and a favourable toxicity profile in patients with advanced human Epidermal growth factor receptor 2–positive gastric cancer.

In this multicentre trial, 55 previously untreated participants with locally advanced or metastatic gastric cancer were given open-label trastuzumab 8 mg/m2 in the initial cycle and 6 mg/m2 in later cycles plus capecitabine and oxaliplatin every 3 weeks until disease progression or intolerable toxicity.

Two patients achieved a complete response and 35 a partial response, giving an objective response rate of 68%. A further 12 participants had stable disease, which equated to a disease control rate of 89%.

After a median follow-up of 13.8 months, the median progression-free survival was 9.8 months, which the researchers note is higher than that reported by previous phase II trials of capecitabine and oxaliplatin in gastric cancer patients. This, they say, confirms that trastuzumab can augment the efficacy of chemotherapy in this patient population.

Additionally, the median overall survival was 21.0 months and the 1-year overall survival rate was 63%.

Researcher Yoon-Koo Kang, from University of Ulsan College of Medicine in Seoul, South Korea, and colleagues speculate that the lack of limitation with regard to the continuation of the chemotherapeutic regimen may have contributed to the prolonged survival observed in their study compared with previous findings.

“It may therefore be a better strategy to continue administering backbone cytotoxic agents until disease progression or unacceptable toxicity, although there have been no clinical trials that have compared fixed chemotherapy cycles and continuing chemotherapy in advanced gastric cancer patients”, they write in the European Journal of Cancer.

Neutropenia, anaemia, peripheral neuropathy and fatigue were the most frequent grade 3 and 4 adverse events, observed in 18%, 11%, 11% and 5% of patients, respectively. Moreover, one participant died as a result of severe diarrhoea and complicated sepsis attributed to treatment.

Yoon-Koo Kang et al say that trastuzumab plus capecitabine and oxaliplatin was “generally well tolerated”, with a comparable toxicity profile to that of the chemotherapy regimen alone.

They conclude: “Although our present study was not a randomised trial, our results provide background for further validation of [capecitabine and oxaliplatin] as first-line backbone chemotherapy in combination with trastuzumab.”

Reference

Ryu M-H, Yoo C, Kim JG, et al. Multicenter phase II study of trastuzumab in combination with capecitabine and oxaliplatin for advanced gastric cancer. Eur J Cancer 2015; Advance online publication 3 February. doi:10.1016/j.ejca.2014.12.015

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