Adjuvant chemotherapy with cisplatin, etoposide, fluorouracil and leucovorin for gastric carcinoma.

PURPOSE: The aim of this study was to evaluate the efficacy of cisplatin, etoposide, 5-fluorouracil (5-FU), and leucovorin (L; CEFL) combination chemotherapy given as adjuvant treatment to patients with stage III gastric cancer. PATIENTS AND METHODS: A total of 33 patients who had undergone curative resection for stage III gastric adenocarcinoma were enrolled in our adjuvant chemotherapy protocol to receive 6 cycles of CEFL starting within 8 weeks from surgery. CEFL consisted of cisplatin 30 mg/m2 on days 1-3; 5-FU 300 mg/m2 continuous infusion on days 1-3; and etoposide 90 mg/m2 on days 1-3. Cycles were repeated every 4 weeks. Relapse-free survival (RFS) and overall survival (OS) were estimated using Kaplan-Meier method. Comparison between groups was carried out using log-rank test. RESULTS: Treatment was completed by 30 (91%) patients. After a mean follow-up of 31 months 15 (50%) patients have relapsed. Mean RFS was 31 months (range 6 to 114+). Patients with stage IIIA disease had longer RFS that those with stage IIIB (37 vs. 25 months, p>0.05). Mean OS was 35 months (range 4 to 114+), while stage IIIA patients survived longer than IIIB ones (42 vs. 27 months, p>0.05). Principal side effects of therapy were from the bone marrow and the gastrointestinal tract. There were 2 treatment-related deaths due to neutropenic sepsis. CONCLUSION: CEFL regimen appears to be an effective adjuvant treatment for patients with stage III gastric carcinoma as it prolongs both RFS and OS. However, its pronounced myelotoxicity requires the prophylactic use of granulocyte colony stimulating factor (G-CSF).

Second line chemotherapy with methotrexate and gemcitabine in patients with relapsing head and neck cancer.

PURPOSE: The aim of this study was to evaluate the efficacy and toxicity profile of the combination of methotrexate and gemcitabine given as second-line treatment in patients with relapsing and/or metastatic head and neck cancer (HNC). PATIENTS AND METHODS: A total of 21 patients with HNC who had relapsed after first-line treatment with cisplatin-containing regimens were enrolles. Treatment consisted of intravenous (i.v.) administration of methotrexate 30 mg/m(2) and gemcitabine 800 mg/m(2) on days 1, 8, and 15 in cycles of 28 days. Primary sites included the larynx, tongue, nasopharynx, hypopharynx, nasal cavity, and parotid gland. The study end point was the evaluation of treatment efficacy and toxicity. RESULTS: Seven (33%) patients received only 1 or 2 cycles and discontinued treatment because of disease progression. Among 14 patients evaluable for respone, 1 complete (CR) and 2 partial responses (PR) were observed, yielding a response rate of 21.4%. The patient with CR remains relapse-free for 74(+) months. The 2 PR patients relapsed after 14 and 25 months and are still alive at 18 and 32 months, respectively. Seven patients showed minor response (MR) or stable disease (SD) with symptomatic relief lasting 4-12 months (mean 8). All but 2 of adequately treated patients (12/14 or 85.7%) attained a clinical benefit response (CBR). Mean time to progression (TTP) of all patients was 8 months (range 1-74(+)), while mean overall survival (OS) was 14 months (range 1-74(+)). Toxicity was mild to moderate and easily manageable. CONCLUSION: Methotrexate and gemcitabine combination is an effective second-line treatment for patients with relapsing and/or metastatic HNC. Moreover, this regimen is well tolerated with mild to moderate, easy to treat, toxicity.