OBJECTIVETo investigate the toxicity and safety of FOLFOX regimen concurrent with radiotherapy in neoadjuvant setting in patients with low rectal cancer.

METHODSFifty-six patients with stage T(3-4)N(0)M(0) and T(1-4)N(1-2)M(0) were eligible from Aug. 2004 to Jul. 2007. Upon entry the study, they received 4 cycles of chemotherapy with FOLFOX regimen. Radiotherapy was added from the second cycle of chemotherapy (CT). The total dose of radiotherapy (RT) was 46 Gy (2 Gy x 23). Total mesorectal excision (TME) was performed 4-8 weeks after RT.

RESULTSAmong them, 54 cases received 4 cycles of CT, 1 patient stopped CT after the second cycle of CT because of unrecovery from neutropenia. One patient stopped chemoradiotherapy(CRT) because of complicating with active pulmonary tuberculosis after 2 cycles of CT and 10 times of RT. Two occurred liver, lung and bone metastases after CT. Totally 220 cycles of CT were administrated. Fifty-two patients received operation after CRT, 50 with anal interior sphincter reservation, 19 with prophylactic ileac stoma. Anastomotic leakage occurred in 2 patients after operation, and rectal vaginal fistula in 2 patients 1 month after operation. According to the pathologic results, 7 patients achieved complete response, 41 partial response, 4 stable disease, and the objective response rate was 85.7%.

CONCLUSIONConcomitant treatment of FOLFOX regimen and RT in neoadjuvant setting of rectal cancer was safe and tolerable, and it suggests that protective ileostomy for anastomotic leakage following anus-preserving operation should be performed.

Adult ; Aged ; Chemotherapy, Adjuvant ; Female ; Fluorouracil ; administration & dosage ; Formyltetrahydrofolates ; administration & dosage ; Humans ; Male ; Middle Aged ; Neoadjuvant Therapy ; methods ; Neoplasm Staging ; Organoplatinum Compounds ; administration & dosage ; Radiotherapy, Adjuvant ; Rectal Neoplasms ; pathology ; therapy ; Rectum ; pathology ; Young Adult

No abstract available.
Colorectal Neoplasms* ; Fluorouracil* ; Leucovorin*

No abstract available.
Colorectal Neoplasms* ; Fluorouracil* ; Leucovorin*

OBJECTIVETo evaluate the efficacy and safety of the combination of oxaliplatin and ELF (VP16/CF/5-Fu) regimen in the treatment of patients with advanced gastric cancer.

METHODSOxaliplatin was given at a dose of 100 mg/m(2) i.v. 2 hours D1, calcium folinate (CF) 200 mg/m(2) i.v. 1/2 hour D1 approximately D3, 5-fluorouracil (5-Fu) 500 mg/m(2) i.v. 2 hours D1 approximately D3 and etoposide 100 mg/m(2) i.v. 3 hours D1 approximately D3. Cycles were repeated every 21 days. Efficacy and safety were evaluated every 2 cycles.

RESULTSSixty-nine patients were enrolled into the study. All cases were pathologically confirmed as gastric cancer (adenocarcinoma in 57 cases and signet ring cell carcinoma in 12 cases). 42 patients had newly diagnosed disease, and 27 patients had received previous chemotherapy. 62 patients were analyzed for response (7 complete responses and 25 partial responses) with total response rate 51.61%. The median time to progression was 5.7 months and the median overall survival was 9.2 months. The most common hematologic toxicities were anemia (29.0%), leucopenia (51.2%) and thrombocytopenia (21.2%). No grade 4 and grade 5 hematologic toxicities were observed. The most common non-hematologic toxicities were nausea (46.5%), vomiting (41.1%), peripheral sensory neuropathy (47.1%), and grade 2 alopecia (27.3%).

CONCLUSIONThis oxaliplatin combined with ELF regimen shows good efficacy and acceptable safety in advanced gastric cancer patients. It is worthy to be proved as a suitable alternative regimen in this indication.

Adenocarcinoma ; drug therapy ; pathology ; Adult ; Aged ; Anemia ; chemically induced ; Antineoplastic Agents ; administration & dosage ; adverse effects ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Signet Ring Cell ; drug therapy ; pathology ; Etoposide ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Leucovorin ; adverse effects ; therapeutic use ; Leukopenia ; chemically induced ; Levoleucovorin ; Male ; Middle Aged ; Nausea ; chemically induced ; Neoplasm Staging ; Organoplatinum Compounds ; administration & dosage ; adverse effects ; Remission Induction ; Stomach Neoplasms ; drug therapy ; pathology ; Survival Rate ; Thrombocytopenia ; chemically induced ; Vomiting ; chemically induced

PURPOSE: The purpose of this study was to evaluate the clinicopathological significance of responders with metastatic colorectal cancer treated with oxaliplatin chemotherapy. METHODS: A total of 52 patients with unresectable metastatic colorectal cancer were enrolled for treatment between March 2000 and August 2005. Patients received first line chemotherapy consisted of oxaliplatin 85 mg/m2 or 130 mg/m2 as a 2-hour infusion on day 1, concurrently with leucovorin (LV) 20 mg/m2 as a bolus infusion on day 1~5, followed by continuous infusion of 5-fluorouracil (5-FU) 425 mg/m2 on day 1~5. This treatment was repeated in 2 or 3 week intervals. All responses were assessed after 4 cycles of therapy by independent radiologic experts and categorized into two groups: responder (major reduction of tumor) and non-responder group (no change or progression of the tumor. RESULTS: The response rate was 51.9 percent (27/52 patients). There were no significant differences in clinicopathologic parameters between two groups. The decrease of CEA value after chemotherapy was significantly more frequent in the responder group than in the non-responder group. CONCLUSIONS: We could not find any clinical differences between the two groups, but these results suggest that oxaliplatin chemotherapy has a beneficial effect on tumor shrinkage and serum CEA value can be an indicator for tumor response of oxaliplatin in advanced colorectal cancer.
Colorectal Neoplasms* ; Drug Therapy* ; Fluorouracil ; Humans ; Leucovorin

Hepatocellular carcinomas are one of the most common malignancies in the world. However, no effective therapeutic modality has been proven to prolong the survival of patients in an inoperable stage. The purpose of this study was to determine the response rate and the toxicities of a combination of pirarubicin, UFT and leucovorin in patients with non-embolizable hepatocellular carcinomas, or who had progressed during their transcatheter arterial chemoembolization treatment. MATERIALS AND METHODS: Of 23 patients with a hepatocellular carcinoma, 11 had progressed during a transcatheter arterial chemoembolization, with the other 12 being transcatheter arterial chemoembolization-naive. All the patients were treated with pirarubicin (70 mg/m2 i.v., day 1), UFT (350 mg/m2 P.O., day 1~21), and leucovorin (25 mg/m2 P.O., day 1~21). RESULTS: Twenty patients were able to be evaluated, with a partial response being achieved in four, giving an overall response rate of 20% (95% confidence interval, 7~44%). The median overall survival time was 6 months, and the median survival time of the transcatheter arterial chemoembolization-naive patients was significantly longer than that of those treated by transcatheter arterial chemoembolization (p=0.012). The most significant dose-limiting toxicity was leucopenia and thrombocytopenia. CONCLUSION: The combination of pirarubicin, UFT and leucovorin therapies showed marginal antitumor activity and significant toxicity in patients with non-embolizable or failed transcatheter arterial chemoembolization hepatocellular carcinomas.
Carcinoma, Hepatocellular* ; Drug Therapy* ; Humans ; Leucovorin* ; Thrombocytopenia

Erythr odysesthesia syndrome is a. peculiar toxic reaction due to anti-cancer drug. lt is characterized by a painful, purple-colored patch on the palms and soles, and may form bullae. We report a case of erythrodysesthesia syndrome in a 46-year-old woman. 5-FU and leucovorin were administered for 5 days because of her colon cancer. Two weeks after anti-cancer therapy, purple-colored erosive patch appeared on the face, and 10 days later, purple-colored vesicular patches were seen on both palms and soles, accompanied with pain. Histopathologic examination reveals a severe epidermal necrosis. Individual keratinocyte shows cytologic atypia and apoptotic body.
Colonic Neoplasms ; Female ; Fluorouracil* ; Humans ; Keratinocytes ; Leucovorin ; Middle Aged ; Necrosis

High-dose methotrexate (MTX) chemotherapy extends the duration of hospitalization and introduces the risks of serious complications related to delayed MTX excretion. The treatment of delayed MTX excretion is largely dependent on invasive measures such as hemodialysis because the clinical data regarding the efficacy or safety of carboxypetidase G2 is limited. We report here on the cases of two pediatric osteosarcoma patients with delayed MTX excretion and who were successfully managed using supportive measures. Potential life-threatening complications were prevented by administering high doses of leucovorin.
Child ; Hospitalization ; Humans ; Leucovorin ; Methotrexate ; Osteosarcoma ; Renal Dialysis

BACKGROUND: Methotrexate (MTX) is an antifolate antagonist that is widely used for treating various malignancies and non-malignant diseases. MTX levels should be monitored when used in high concentration to determine when to start leucovorin rescue. In this study, we evaluated the analytical performance of the EMIT Methotrexate Assay on a 200FR NEO Chemistry Analyzer (Toshiba Medical System Co., Japan) and compared it with Viva-E Drug Testing System (Siemens Healthcare, Germany). METHODS: According to the Clinical Laboratory and Standards Institute (CLSI) Evaluation Protocol (EP) 5-A2, three concentrations of the Liquichek Therapeutic Drug Monitoring Control (Bio-Rad Laboratories, USA) were analyzed twice a day for 20 days to monitor assay precision. The 200FR NEO and Viva-E instruments were compared using 40 patients' sera, according to CLSI EP9-A2. The linearity and carry-over rate were also evaluated. RESULTS: Between-run CVs for low-, medium-, and high-level controls were 4.9%, 0.9%, and 2.0%, respectively, whereas between-day CVs for low-, medium-, and high-level controls were 8.1%, 1.3%, and 3.5%, respectively. In the linearity test, the coefficient of determination (R2) was 0.98 (0.06-1.92 micromol/L). In the comparison study, R2 was 0.955, showing good correlation between the 200FR NEO and Viva-E instruments. The carry-over rate was 0.9%. CONCLUSIONS: The EMIT assay showed good precision, linearity, and carry-over rate on the Toshiba 200FR. An excellent correlation was observed when comparing results obtained using the Toshiba and Viva-E instruments. In conclusion, the Syva EMIT MTX assay can be readily used for MTX monitoring on the Toshiba 200FR NEO.
Chemistry ; Delivery of Health Care ; Drug Monitoring ; Leucovorin ; Methotrexate*

PURPOSE: We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC). MATERIALS AND METHODS: Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study. The patients received either irinotecan 180 mg/m2 on day 1 with LV bolus of 200 mg/m2 and FU bolus of 400 mg/m2, and this was followed by FU continuous infusion of 600 mg/m2 on day 1 and day 2 (the FOLFIRI regimen), or they were treated with LV bolus of 400 mg/m2 and FU bolus of 400 mg/m2 followed by FU continuous infusion of 2,400 mg/m2 for 46 hours (the simplified FOLFIRI regimen), and these treatments were repeated every 2 weeks until disease progression. RESULTS: The objective response rate was 23.1% (6/26) respectively, for both treatments. The median time to progression was 5.3 months (range: 0.4~19.9), and the overall survival was 11.2 months (range: 0.5~52.3). The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS). The non-hematological toxicities were similar for both treatment groups, with more frequent grade > or =3 neutropenia being noted for the simplified FOLFIRI regimen. CONCLUSION: The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.
Colorectal Neoplasms* ; Disease Progression ; Fluorouracil* ; Humans ; Leucovorin* ; Neutropenia ; Prospective Studies