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Low Toxicity and Reasonable Efficacy With Neoadjuvant Cisplatin, 5-FU, and Leucovorin for Locally Advanced Gastric Cancer

For patients with locally advanced gastric cancer, neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) provides reasonable efficacy and low toxicity, reports a study from Germany.

Although neoadjuvant chemotherapy for locally advanced gastric cancer offers a favourable clinical response for many patients, regimens such etoposide/adriamycin/cisplatin (EAP) are also associated with prohibitively high toxicity.

To evaluate the toxicity and efficacy of PLF in this setting, Katja Ott, MD, Klinikum rechts der Isar der Technischen Universitat Muchen, Germany, and colleagues conducted a phase II study of 49 patients with previously untreated locally advanced gastric cancer treated with neoadjuvant PLF. Tumour resection was done 2 weeks following the last administration of PLF.

Using the World Health Organization's (WHO) criteria, toxicity was defined as anaemia of more than grade 2, leukopaenia of more than grade 3, thrombocytopenia of more than grade 2, diarrhoea of more than grade 2 or mucositis of more than grade 2 on the day of administration.

Of the 49 enrolled patients, 42 were available for evaluation. Overall toxicity in these 42 patients was low, with fewer than 5% experiencing grade 3 toxicity and only 2 events of grade 4 toxicity. Thrombosis of the subclavian vein at the site of the implanted port system (n=6) and pulmonary embolism (n=1) were the most severe toxic complications.

None of the patients had a complete clinical response, although 11 (26%) patients had a partial response, 20 (48%) had minor responses, and 8(19%) had no change in their disease. Locoregional progressive disease occurred in 3 (7%) of patients. Overall, 11(26%) were defined as responders and 31 (74%) as no responders.

Median survival time for the 42 patients was 25.4 months, and 32 months after complete resection. Although the median survival time for clinically responding patients is not yet available, 5-year survival is 90%. For no responding patients, the median survival time was 20 months.

The authors conclude that neoadjuvant PFL provides reasonable efficacy with low toxicity for patients with locally advanced gastric cancer, and is associated with excellent prognosis in responding patients. They emphasize, however, that neoadjuvant chemotherapy remains an experimental approach in this setting and therefore patients should only be given this treatment as part of a clinical trial.

Gastric Cancer 2003;6:3:159-167. "Neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) in locally advanced gastric cancer: a prospective phase II study"

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