High-risk radically resected gastric cancer patients do not benefit of an adjuvant cisplatin containing regimen
2005; Lippincott Williams & Wilkins; Volume: 23; Issue: 16_suppl Linguagem: Inglês
10.1200/jco.2005.23.16_suppl.4023
ISSN1527-7755
AutoresStefano Cascinu, Roberto Labianca, Carlo Barone, Armando Santoro, Vincenzo Catalano, Oscar Bertetto, Sandro Barni, L. Frontini, Enrico Aitini, Irene Floriani,
Tópico(s)Cancer Treatment and Pharmacology
Resumo4023 Background: Adjuvant therapy of high risk gastric cancer is a debated question. Meta-analyses of randomized trials suggest a possible but small benefit for adjuvant chemotherapy but no study using cisplatin containing regimen was included in such meta-analyses. Recently, we reported a high level of activity in metastatic and locally advanced disease by using a weekly intensive chemotherapy with cisplatin, epidoxorubicin, 5fluorouracil and lederfolin (wPELF). Aim of this study is to assess the efficacy of this combination in adjuvant setting. Methods: Patients (pts) were randomized to PELF: 8 w of 1-day per w administration of CDDP 40 mg/sqm, epi-ADR 35 mg/sqm, LV 250 mg/sqm, 5FU 500 mgsqmq, GSH 1500 mg/sqm; on the other days lenograstim was administered at a dose of 6 μ/kg or 5FU/LV: 6 cycles of 5FU 370 mg/sqm days 1–5, LV 20 mg/sqm days 1–5; every 28 days. Results: Characteristics of the 397 pts enrolled from 1/98 to 1/03: median age 59 y (range 23–76); male 63%; PS (WHO) 0: 86%; 1: 10%, NV: 4%; histology: intestinal adenocarcinoma: 77%, diffuse undiff:11%, other: 10%, NV: 2%; grading: G1: 2%, G2: 23%, G3: 53%, NS: 22%; positive nodes (N+): N0: 5%, 1–6: 46%, 7–15: 29%, >15: 15%, NS: 5%. 74% had >15 resected nodes. WHO grade III/IV toxicities included: neutropenia (PELF 11%, 5FU/LV 8%), alopecia (PELF 30%, 5FU/LV 1%); diarrhoea (PELF 7%, 5FU/LV 11%); mucositis (PELF 5%, 5FU/LV 8%). No treatment-related death was observed. Only 9% of pts on PELF completed the treatment as scheduled vs 44% on 5FU/LV, while 26% on PELF and 20% on FU/LV interrupted treatment mainly due to toxicity. At a median follow-up of 3.5 y, when compared with 5FU/LV, the risk of death associated with PELF was not statistically different (Hazard Ratio (HR) 0.89, 95%CI 0.65–1.23) such as the risk for progression/death (HR 0.94, 95%CI 0.71–1.24). Pts with >6 N+ had a worse survival compared to pts with ≤ 6 N+ (HR 4.09, 95%CI 2.86–5.84), whereas the number of resected nodes had no prognostic effect. Conclusions: Our results suggest that pts with high risk radically resected gastric cancer do not benefit from an adjuvant cisplatin containing regimen. No significant financial relationships to disclose.
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