Phase II trial of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric cancer: a novel, safe, and effective regimen
| Autor: | Bruno C. Aragao, Andre M. Murad, Rodrigo C. Guimaraes, Andy Petroianu, Antonio O. Scalabrini-Neto, Luis O. M. Cabral |
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| Rok vydání: | 1999 |
| Předmět: |
myalgia
Adult Male Reoperation Cancer Research medicine.medical_specialty Antimetabolites Antineoplastic Adolescent Paclitaxel medicine.medical_treatment Neutropenia Adenocarcinoma Weight Gain Gastroenterology Stomach Neoplasms Laparotomy Internal medicine Antineoplastic Combined Chemotherapy Protocols Confidence Intervals Medicine Humans Prospective Studies Aged Neoplasm Staging Chemotherapy Analgesics business.industry Stomach Remission Induction Middle Aged medicine.disease Antineoplastic Agents Phytogenic Surgery Clinical trial Survival Rate Regimen medicine.anatomical_structure Oncology Fluorouracil Quality of Life Female medicine.symptom Safety business medicine.drug Follow-Up Studies |
| Zdroj: | American journal of clinical oncology. 22(6) |
| ISSN: | 0277-3732 |
| Popis: | This prospective phase II clinical trial was performed to explore the activity and efficacy of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric adenocarcinoma. Thirty-one patients ages 18 to 70 years, with Karnofsky performance status (KPS) >50, adequate cardiac, renal, and hepatic functions, measurable metastatic or locally unresectable disease, life expectancy > or =3 months, signed written informed consent, and without any previous chemotherapy were assigned to receive on an outpatient basis: paclitaxel--175 mg/m2, in a 3-hour infusion on day 1 and 5-fluorouracil--1.5 g/m2, also in a 3-hour infusion on day 2 every 21 days, for a maximum of seven cycles. A system to assess clinical benefit based on KPS, analgesic consumption, and weight gain was also used in this trial. Median age was 61 years (range, 31-70 years). The 29 patients eligible for response and toxicity evaluation underwent 147 cycles of chemotherapy. There were 19 (65.5%) objective responses (95% confidence interval: 48%-83%), including 7 (24.1%) complete responses and 12 (41.4%) partial responses. Three patients had the complete response pathologically confirmed. In three of six patients who went to second-look laparotomy, a potentially curative esophagogastrectomy was possible. The toxicity of this combination was considered low, predictable, and manageable and was characterized mainly by reversible alopecia, peripheral neuropathy, myalgia, and mild neutropenia. Fifteen (51.7%) patients attained a clinical benefit response. The median overall survival was 12 months (range, 2-30+ months) and the 30-month overall survival was 20%. This novel regimen appears to be very effective in advanced gastric cancer. The projected 2-year survival of 20% is higher than that achieved with other first-line regimens. These encouraging results indicate the need for further studies to confirm the merit of this regimen. |
| Databáze: | OpenAIRE |
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